A feasibility study of signed consent for the collection of patient identifiable information for a national paediatric clinical audit database

Abstract

ConclusionQuetiapine and rivastigmine seemed of no benefit in patients with dementia and agitation in institutional care, and quetiapine was associated with greater cognitive decline than placebo. Our results suggest that quetiapine should not be used in people with dementia and highlight concerns regarding the long term use of antipsychotics in these patients.We thank the Alzheimer's Research Trust for their support in our programme of work to evaluate the impact of antipsychotics on cognition; Alistair Burns for his helpful comments on the manuscript; and Andrea Burton for her helpful advice regarding the sensitivity analysis. Contributors: See bmj.com Funding: The study was funded largely from general donations to C Ballard's research programme and profits from previously completed commercially funded clinical trials, with additional support from the Alzheimer's Research Trust. Competing interests: C Ballard has received honorariums and research donations to support his general research programme from Astra Zeneca and Novartis. Ethical approval: The study was approved by a properly constituted local research ethics committee. One refusal (0.2%) was received. Consent rates were significantly better for children who were more severely ill on admission and for hospital stays of six days or more, and significantly poorer for children aged 10-14 years. Long hospital stays and children aged 10-14 years remained significant in a stepwise regression model of the factors that were significant in the univariate model. Conclusion Systematically obtaining individual signed consent for sharing patient identifiable information with an externally located clinical audit database is difficult. Obtaining such consent is unlikely to be successful unless additional resources are specifically allocated to training, staff time, and administrative support.

Obtaining data linkage consent for children: factors influencing outcomes and potential biases

“…Consent rates for children in the surveys identified ranged from 43% (McKinney et al 2005) to 92% (Tate et al 2006). Generally, minority groups provided lower consent rates (McKinney et al 2005;Tate et al 2006), with some evidence that higher socioeconomic status related to higher rates of consent (Klassen et al 2005;Tate et al 2006).…”

“…McKinney et al (2005) sought consent from parents who had children admitted into a paediatric intensive care unit. Tate, Calderwood, Dezateaux & Joshi (2006) asked for birth register and maternity data from a cross-section of mothers of new-borns, but as a single request.…”

“…Generally, minority groups provided lower consent rates (McKinney et al 2005;Tate et al 2006), with some evidence that higher socioeconomic status related to higher rates of consent (Klassen et al 2005;Tate et al 2006). These sociodemographic differences are similar to those found in research of adults (see ).…”

Predictors of Adolescents’ Consent to Use Health Records for Research and Results from Data Collection in a Swedish Twin Cohort

“…When the choice to consent is dependent on characteristics pertaining to the individual or context, the selection of participants for the study is consequently non-random, which introduces the possibility of bias in estimations of associations within the sample (Groenwold et al, 2013;Hernan et al, 2004) It has previously been demonstrated that individuals who consent to medical research participation may be different in several ways from those who decline participation, but consistent patterns are lacking (Kho et al, 2009). For example, several studies have shown that males were more likely to consent (Damery et al, 2011;Knies et al, 2012; Twins' Consent to Research Using Health Records Matsui et al, 2005;Schwartz et al, 2005;Woolf et al, 2000), whereas others have not demonstrated any sex difference in consent rates (Al-Shahi et al, 2005;Baker et al, 2000;Beebe et al, 2011;Buckley et al, 2007;Huang et al, 2007;Klassen et al, 2005;McKinney et al, 2005) and some have seen a higher likelihood of consent among females (Dunn et al, 2004;Kho et al, 2009). The age of the potential study participants may play a part in the choice to consent.…”

The effect of privacy legislation on observational research

“…In an increasing number of examples, such refusal has resulted in decreased participation, selection bias (Table 2), incomplete research and dismantled disease registries. 1,[6][7][8][9][10][11][12] Fortunately, there are not many published examples from Canada; however, we are still in the relative early days following privacy legislation. Until this legislation is tested and precedents are set, the potential for further detrimental effects on observational research remains.…”