Adverse events arising from a palliative care survey

Abstract

Development of evidence-based practice requires investigation of the attitudes and needs of patients, families and healthcare professionals, particularly for sensitive subject areas. Cystic fibrosis (CF) is a recessively inherited life-limiting disorder resulting in early death. Patients with this condition generally expect that lung transplantation will be an available treatment option; however, this is uncertain. A dual approach to care that involves both preparing patients for transplant assessment, while simultaneously exploring acceptable palliative care options is needed. A survey amongst patients with CF, their families and health carers was conducted to understand their attitudes and needs in relation to end-of-life care. The survey encompassed five separate domains, with a total of 60 questions requiring approximately 20 min to complete. Of the 200 surveys sent to patients, 82 (41%) completed responses were received. The Institutional Ethics Committee received six complaints from families of seven patients (3.5% of those surveyed). This article explores the nature of the adverse responses to the survey. The majority of complaints were received from family members rather than from patients. Complaints described dissatisfaction with the topic, little warning about the study and felt it to be inappropriate for their family member’s level of health. Survey instruments used to determine attitudes and needs in relation to end-of-life patient care are likely to elicit adverse responses that should be reported in a similar way to other investigational studies. Also arising from adverse responses and the complaint process, is the impact of criticism on study researchers.

Keywords

adverse effects chronic disease cystic fibrosis family surveys

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References

Pessin, H. , Galietta, M. , Nelson, CJ , Brescia, R. , Rosenfeld, B. , Breitbart, W. Burden and benefit of psychosocial research at the end of life. J Palliat Med 2008; 11: 627-632.

Emanuel, EJ , Fairclough, DL , Wolfe, P. , Emanuel, LL

Talking with terminally ill patients and their caregivers about death, dying, and bereavement: is it stressful? Is it helpful?

Arch Intern Med 2004; 164: 1999-2004.

Nhmrc. National Statement on Ethical Conduct in Human Research. http://www.nhmrc.gov.au/guidelines/ethics/human_research/pubs.htm; 2007 [updated 2007; cited] (accessed 8 July 2008).

Yankaskas, JR , Marshall, BC , Sufian, B. , Simon, RH , Rodman, D. Cystic fibrosis adult care: consensus conference report. Chest 2004; 125(Suppl. 1): 1S-39S.

Liou, TG , Woo, MS , Cahill, BC Lung transplantation for cystic fibrosis. Curr Opin Pulm Med 2006; 12: 459-463.

Philip, JA , Gold, M. , Sutherland, S. , Finlayson, F. , Ware, C. , Braithwaite, M. , et al. End-of-life care in adults with cystic fibrosis. J Palliat Med 2008; 11: 198-203.

Mitchell, I. , Nakielna, E. , Tullis, E. , Adair, C. Cystic fibrosis. End-stage care in Canada . Chest 2000; 118: 80-84.

Krousel-Wood, M. , Muntner, P. , Jannu, A. , Hyre, A. , Breault, J.

Does waiver of written informed consent from the institutional review board affect response rate in a low-risk research study?

J Investig Med 2006; 54: 174-179.

Lindenauer, PK , Benjamin, EM , Naglieri-Prescod , D. , Fitzgerald, J. , Pekow, P. The role of the institutional review board in quality improvement: a survey of quality officers, institutional review board chairs, and journal editors. Am J Med 2002; 113: 575-579.

10.

Seal, M. Patient advocacy and advance care planning in the acute hospital setting. Aust J Adv Nurs 2007; 24: 29-36.

11.

Evans, M. , Robling, M. , Maggs Rapport, F. , Houston, H. , Kinnersley, P. , Wilkinson, C. It doesn’t cost anything just to ask, does it? The ethics of questionnaire-based research. J Med Ethics 2002; 28: 41-44.

12.

Califf, RM , Morse, MA , Wittes, J. , Goodman, SN , Nelson, DK , DeMets, DL , et al. Toward protecting the safety of participants in clinical trials . Control Clin Trials 2003; 24: 256-271.

13.

Macrae, DJ The Council for International Organizations and Medical Sciences (CIOMS) guidelines on ethics of clinical trials. Proc Am Thorac Soc 2007; 4: 176-178 [discussion 8-9].

14.

Swazo, NK Calculating risk/benefit in X-linked severe combined immune deficiency disorder (X-SCID) gene therapy trials: the task of ethical evaluation. J Med Philos 2006; 31: 533-564.

15.

Scarvalone, PA , Cloitre, M. , Spielman, LA , Jacobsberg, L. , Fishman, B. , Perry, SW Distress reduction during the structured clinical interview for DSM-III-R. Psychiatry Res 1996 ; 59: 245-249.

16.

Faulkner, A. ABC of palliative care. Communication with patients, families, and other professionals . BMJ 1998; 316: 130-132.

17.

Dunscombe, M. The good research guide for small-scale social research projects. Buckingham: Open University Press; 1998.

18.

Fanos, JH , Johnson, JP Barriers to carrier testing for adult cystic fibrosis sibs: the importance of not knowing. Am J Med Genet 1995; 59: 85-91.

19.

Forrest, LE , Delatycki, MB , Skene, L. , Aitken, M. Communicating genetic information in families-a review of guidelines and position papers. Eur J Hum Genet 2007; 15: 612-618.

20.

Thomson, C.

Protecting health information privacy in research: what’s an ethics committee like yours doing in a job like this?

J Law Med 2006; 13: 304-310.

21.

Edwards, A. , Elwyn, G. , Hood, K. , Atwell, C. , Robling, M. , Houston, H. , et al. Patient-based outcome results from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice. Fam Pract 2004; 21: 347-354.