Quantitative and qualitative analysis of study-related patient information sheets in randomised neuro-oncology phase III-trials

Hau, Peter; Kremmler, Lukas; Burock, Susen; Bogdahn, Ulrich; Wick, Wolfgang; Gleiter, Christoph H.; Koller, Michael

doi:10.1016/j.ejca.2013.09.006

Cited by 20 publications

(23 citation statements)

References 28 publications

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“…Parents indicated that a one page PIS was of sufficient length and that they would not wish to read much more than this when their child was ill. These findings confirm those from other trials that have indicated that the PIS should be short, and add to these findings by providing insights on what parents regard as user-friendly language 56. Parents also approved the open and comprehensive description of drug risks in the PIS.…”

Section: Discussionsupporting

confidence: 82%

Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting

et al. 2014

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ObjectiveTo inform the design of a randomised controlled trial (called EcLiPSE) to improve the treatment of children with convulsive status epilepticus (CSE). EcLiPSE requires the use of a controversial deferred consent process.DesignQualitative interview and focus group study.Setting8 UK support groups for parents of children who have chronic or acute health conditions and experience of paediatric emergency care.Participants17 parents, of whom 11 participated in telephone interviews (10 mothers, 1 father) and 6 in a focus group (5 mothers, 1 father). 6 parents (35%) were bereaved and 7 (41%) had children who had experienced seizures, including CSE.ResultsMost parents had not heard of deferred consent, yet they supported its use to enable the progress of emergency care research providing a child's safety was not compromised by the research. Parents were reassured by tailored explanation, which focused their attention on aspects of EcLiPSE that addressed their priorities and concerns. These aspects included the safety of the interventions under investigation and how both EcLiPSE interventions are used in routine clinical practice. Parents made recommendations about the appropriate timing of a recruitment discussion, the need to individualise approaches to recruiting bereaved parents and the use of clear written information.ConclusionsOur study provided information to help ensure that a challenging trial was patient centred in its design. We will use our findings to help EcLiPSE practitioners to: discuss potentially threatening trial safety information with parents, use open-ended questions and prompts to identify their priorities and concerns and clarify related aspects of written trial information to assist understanding and decision-making.

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Section: Discussionsupporting

confidence: 82%

Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting

et al. 2014

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“…We previously showed that the readability of French ICDs was much lower than that of high school level texts [2] and was not improved following IRB reviews [3]. Similarly, American IRBs often provide text for informed consent forms that falls short of their own readability standards [4] and readability was also low in other languages such as Spanish or German [5,6]. In a qualitative analysis aimed at determining what should be improved, a Danish group concluded that poor presentation and specialized terminology were barriers to comprehension [7].…”

Section: Introductionmentioning

confidence: 99%

Improved informed consent documents for biomedical research do not increase patients’ understanding but reduce enrolment: a study in real settings

Paris

Deygas

Cornu

et al. 2015

Brit J Clinical Pharma

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AIMSThe aim was to evaluate the comprehension of participants of an improved informed consent document (ICD). METHODThis was a randomized controlled French multicentre study performed in real conditions. Participants were adult patients undergoing screening for enrolment in biomedical research studies, who agreed to answer a validated questionnaire evaluating objective and subjective comprehension scored from 0 (no comprehension) to 100 (excellent comprehension). Patients were provided either the original ICD or an ICD modified in terms of structure and readability. The primary end point was the score of objective comprehension. The secondary end-points were the enrolment rate in the clinical study and patient characteristics associated with the score of objective comprehension. RESULTSFour hundred and eighty-one patients were included, 241 patients in the original ICD group and 240 patients in the modified ICD group. There was no difference between the two groups for the score of objective comprehension (original ICD 72.7 (95% CI 71.3, 74.1) vs. modified ICD 72.5 (95% CI 71.0, 74.0); P = 0.81). However, the rate of enrolment in the clinical study was lower in the group who received the modified ICD (64.4% (95% CI 58.3, 70.5)) than for the original ICD (73.0% (95% CI 67.4, 78.7)) (P = 0.042). Only female gender and high educational level were associated with a better objective comprehension. CONCLUSIONSImproving ICDs had no effect on participants' understanding, whereas the rate of enrolment was lower in this group. In attempts at improving potential participants' understanding of clinical research information, efforts and future trials should focus on other ways to improve comprehension.

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“…To assist understanding and parent-practitioner communication, parents emphasised the need for clear and concise written information materials alongside verbal tailored explanation. 38,40 Similar to the findings in other clinical trials, 19,39 parents recommended amending language used in both written and verbal explanations, and provided insight on what parents regard as appropriate language specifically in the context of septic shock. This recommendation may be related to a recent increase in media coverage on sepsis in children, with the term being associated with a high risk of mortality in children with severe infection.…”

Section: Results Of the Integrated Perspectives Studymentioning

confidence: 61%

“…19 This is consistent with previous findings that emphasise the need for simple, non-medicalised information to improve parental understanding of trial information and inform their research decisions. 19,21,39 Tailored explanations appeared to address parents' priorities, concerns and misconceptions. These findings were used to develop the FiSh pilot trial site staff training, which emphasises the need for recruiters to provide opportunities for questions as parents are unlikely to voice potential concerns.…”

Section: Key Findings To Inform the Pilot Trialmentioning

confidence: 99%

Restricted fluid bolus versus current practice in children with septic shock: the FiSh feasibility study and pilot RCT

Inwald

Canter

Woolfall

et al. 2018

Health Technol Assess

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Background There has been no randomised controlled trial (RCT) of fluid bolus therapy in paediatric sepsis in the developed world despite evidence that excess fluid may be associated with harm. Objectives To determine the feasibility of the Fluids in Shock (FiSh) trial – a RCT comparing restricted fluid bolus (10 ml/kg) with current practice (20 ml/kg) in children with septic shock in the UK. Design (1) Qualitative feasibility study exploring parents’ views about the pilot RCT. (2) Pilot RCT over a 9-month period, including integrated parental and staff perspectives study. Setting (1) Recruitment took place across four NHS hospitals in England and on social media. (2) Recruitment took place across 13 NHS hospitals in England. Participants (1) Parents of children admitted to a UK hospital with presumed septic shock in the previous 3 years. (2) Children presenting to an emergency department with clinical suspicion of infection and shock after 20 ml/kg of fluid. Exclusion criteria were receipt of > 20 ml/kg of fluid, conditions requiring fluid restriction and the patient not for full active treatment (i.e. palliative care plan in place). Site staff and parents of children in the pilot were recruited to the perspectives study. Interventions (1) None. (2) Children were randomly allocated (1 : 1) to 10- or 20-ml/kg fluid boluses every 15 minutes for 4 hours if in shock. Main outcome measures (1) Acceptability of FiSh trial, proposed consent model and potential outcome measures. (2) Outcomes were based on progression criteria, including recruitment and retention rates, protocol adherence and separation between the groups, and collection and distribution of potential outcome measures. Results (1) Twenty-one parents were interviewed. All would have consented for the pilot study. (2) Seventy-five children were randomised, 40 to the 10-ml/kg fluid bolus group and 35 to the 20-ml/kg fluid bolus group. Two children were withdrawn. Although the anticipated recruitment rate was achieved, there was variability across the sites. Fifty-nine per cent of children in the 10-ml/kg fluid bolus group and 74% in the 20-ml/kg fluid bolus group required only a single trial bolus before shock resolved. The volume of fluid (in ml/kg) was 35% lower in the first hour and 44% lower over the 4-hour period in the 10-ml/kg fluid bolus group. Fluid boluses were delivered per protocol (volume and timing) for 79% of participants in the 10-ml/kg fluid bolus group and for 55% in the 20-ml/kg fluid bolus group, mainly as a result of delivery not being completed within 15 minutes. There were no deaths. Length of hospital stay, paediatric intensive care unit (PICU) transfers, and days alive and PICU free did not differ significantly between the groups. Two adverse events were reported in each group. A questionnaire was completed by 45 parents, 20 families and seven staff were interviewed and 20 staff participated in focus groups. Although a minority of site staff lacked equipoise in favour of more restricted boluses, all supported the trial. Conclusions Even though a successful feasibility and pilot RCT were conducted, participants were not as unwell as expected. A larger trial is not feasible in its current design in the UK. Future work Further observational work is required to determine the epidemiology of severe childhood infection in the UK in the postvaccine era. Trial registration Current Controlled Trials ISRCTN15244462. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 51. See the NIHR Journals Library website for further project information.

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Quantitative and qualitative analysis of study-related patient information sheets in randomised neuro-oncology phase III-trials

Cited by 20 publications

References 28 publications

Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting

Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting

Improved informed consent documents for biomedical research do not increase patients’ understanding but reduce enrolment: a study in real settings

Restricted fluid bolus versus current practice in children with septic shock: the FiSh feasibility study and pilot RCT

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