Helen L Ford | PubMed Health

PubMed2006

The effect of consent guidelines on a multiple sclerosis register.

BACKGROUND: The 1998 Data Protection Act and guidelines from the General Medical Council on informed consent have caused concern for medical researchers and particularly those involved in the management of disease registers. OBJECTIVE: The aim of this study was to determine rates of consent for a multiple sclerosis (MS) community-based register and to investigate authorization bias by examining the characteristics of those refusing consent. METHODS: A consent letter was developed with the advice and support of an advisory group which included people with MS. All people with MS on the prevalent register (n=820) were informed about the register and its purposes and asked to indicate whether they would like their details to be removed from the register. RESULTS: Thirty-four (4.1%) people with MS asked for their details to be removed from the register. There was a significant difference in disease course in this group with more patients with benign relapsing remitting disease compared to the prevalent population. There was no significant difference in age or sex distribution. The proportion of people not giving consent was similar to a local stroke register. Prospectively all new patients have given written informed consent. CONCLUSION: Patients refusing consent may have different disease characteristics than those who consent. The potential for response bias needs to be considered in the development of a UK MS register.

Confidentiality↗

PubMed2002

A prospective study of the incidence, prevalence and mortality of multiple sclerosis in Leeds.

OBJECTIVE: To establish the prospective incidence of multiple sclerosis and mortality rates of people with multiple sclerosis in Leeds Health Authority and an updated prevalence of multiple sclerosis on 31 October 1999. METHODS: A population based prevalence register established on 30 April 1996 was maintained by prospectively registering all new cases of multiple sclerosis, flagging all cases with the National Health Service Central Register for notification of deaths and by registering all new clinical events. General practitioners notified patients with multiple sclerosis moving into or out of the area. RESULTS: 136 incident cases were prospectively registered from 30 April 1996 living in Leeds Health Authority (with an estimated resident population of 728,840). 57 deaths were notified. 792 people with multiple sclerosis were identified living in Leeds on 31 October 1999. The mean annual incidence rate for the three-year period 1996-1998 was 6.1/10(5) (95% CI: 5.1-7.2). The sex ratio of incident cases was 2.3 to 1 women to men. On 31 October 1999 the prevalence of multiple sclerosis in the Leeds Health Authority was 108.7/10(5) (95% CI: 101.2-116.5). This compares with a prevalence of 97.3/10(5) (95% CI: 90.3-104.7) on 30 April 1996. The prevalence of definite and probable multiple sclerosis was 93.3/10(5) (95% CI: 86.4-100.6) and of suspected multiple sclerosis was 15.4/10(5) (95% CI 12.7-18.5). Crude annual mortality rates of people with multiple sclerosis for 1997 and 1998 were 1.9/10(5) (95% CI: 1.1 to 3.2) and 3.2/10(5) (95% CI: 2.0 to 4.7). Multiple sclerosis was noted as the underlying cause of death in 8 (14%) cases. CONCLUSION: The incidence of multiple sclerosis in the Leeds Health Authority is similar to that in the south of the United Kingdom. The difference in successive prevalence figures is less than that published in other serial studies. Multiple sclerosis was notified as the underlying cause of death in a minority of deaths in people with multiple sclerosis.

Adult↗