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THE ROLE OF THE SCLERODERMA SOCIETY (UK) IN IMPROVING RECRUITMENT TO CLINICAL TRIALS IN SYSTEMIC SCLEROSIS
K. Fligelstone1, M. Dziadzio2, R. Smith3, R. Stratton3, C. Denton3 and C. Black3.
1Scleroderma Society, London, United Kingdom, 2Northwick Park Hospital, London, United Kingdom and 3Royal Free Hospital, London, United Kingdom

Background: For rare diseases such as scleroderma (SSc), it may be difficult to recruit sufficient number of patients to clinical trials. The role of patient support groups in this process, to our knowledge, has not been investigated.

The Scleroderma Society (SS) - a UK patient support group with over 300 members - helped to recruit both patients and healthy controls (HC) for one clinical trial conducted at RFH {Dziadzio M et al. QJM 2005;89:485-92}. The trial required a single 3-h visit to the hospital when intradermal blisters were raised, interstitial fluid drawn and blood and urine samples taken. There were no financial inducements. Passive recruitment was by advertisements in the RFH and on the SS website. An SS member, who was also the first study patient, carried out active recruitment. Members were telephoned prior to scheduled clinic appointments or in-patient admissions. Patients' relatives and friends were encouraged to act as HC. Results of the trial were fed back to SS members by the investigators both in a Newsletter and during the Annual Society Meetings.

To suggest ways of improving future participation in clinical studies, SS performed an audit of the participants' motivations.

Methods: The effectiveness of active recruitment was determined. The trial recruiter conducted a guided telephone survey of those participants who were current SS members, using a prepared questionnaire.

Results: 41/49 patients and 15/22 HC were members of SS at the time of the trial. Of those approached, 86% agreed to volunteer for the trial. 13/15 HC and 32/49 patients were available for interview; unfortunately 8/49 SSc patients had died. 30/ 32 patients and 14/15 HC were satisfied with the way active recruitment was conducted. All HC and 29/32 patients gave as primary motivation their desire to support SSc research. Patients expressed: a) perception of future personal benefit (27), b) support for SSc research at RFH (15), c) potential for better future outcomes for other SSc patients (10). In the HC group, the desire to support relatives or friends suffering from SSc was the most important factor (10/13). Both groups were interested in the results of the trial and welcomed the feedback provided (30/32 SSc; 10/13 HC). More patients than HC had taken part in other SSc trials (14/32 vs 1/13). All 32 SSc patients and 10/13 HC were willing to take part in future studies.

Conclusions: SS became the major recruiter of subjects to the trial and achieved excellent levels of enrolment. A clear understanding of current and future benefits of the study motivated patients, and was facilitated by the personal contact with the SS recruiter. Engaging with patients, and reporting trial results in lay language helps make patients the protagonists of research and will encourage participation in clinical studies. Friends and relatives of SSc patients may ameliorate feelings of despair at their inability to help by participating. The results underline the important role of patient groups in supporting clinical research.

SL0003   INTERNET AS A TOOL FOR PATIENT SUPPORT GROUPS TO PROVIDE QUALITY INFORMATION
M. Dziadzio 1 , K. Fligelstone 2 , R. Smith 1 , S. Ensz 3 , C. Denton 1 , C. Black 1
1 Centre for Rheumatology, Royal Free Hospital, 2 Chair, Scleroderma Society, London, United Kingdom, 3 International Scleroderma Network, Edina, MN, United States

Abstract: BACKGROUND: Scleroderma is a rare connective tissue disease diagnosed worldwide. There are only few specialist centres and the care and support for patients is still limited. New strategies for delivering information and support are being developed. In this patient support groups are invaluable as well as providing a link between patients and health professionals. Their presence is however restricted to the developed countries. The Internet is an easy and quick way of communication and is a powerful source of information.
AIM: 1) To compare the inquiries received by the Scleroderma Society (SS), UK with those received by the International Scleroderma Network (ISN), the latter presented at EULAR 2003 (1).
METHOD: E-mail questions submitted to the Scleroderma Society (6 months, n = 68) and Medical Committees of ISN (over 3 months, n = 166) were categorised on the basis of information requested and analysed retrospectively. Differences were analysed using the ×2-test and significance was set at p<0.001.
RESULTS: Demographics are shown in Table 1. Between ISN and SS there was a significant difference in language of submission (with 37% of inquiries to ISN in 7 major languages other than English and 100% in English to SS) and geographical location. Medical professionals contributed 10% of inquiries (Table 1). ISN attracted a significant interest from countries other than UK and USA (35%); SS had mostly UK inquiries (66%). Over 40% of the inquiries related to medical issues.
CONCLUSIONS: This analysis shows a similar pattern of questions submitted to both organisations and highlights the main areas of information requested. There is an inevitable bias towards countries with Internet access. Worldwide collaboration of medical professionals with patient organisations should lead to a better understanding of clinical needs and better support. Web presence and e-mail contacts should be used by patient organisation in order to improve the quality and availability of support.
REFERENCE:
(1) M. Dziadzio, R. Smith, S. Ensz, L. Ydler, J. Jackson, K.J. Howell, C.J. Knight, C.M. Black. A pilot database analysis of enquiries submitted to the medical committee of an International Scleroderma Website. Ann Rheum Dis Suppl: EULAR 2003 FRI0078.

Table: