Neurol Sci (2014) 35:2001–2003 DOI 10.1007/s10072-014-1933-z

BRIEF COMMUNICATION

Attitude of epilepsy patients and their attendants for participating in research on status epilepticus Usha Kant Misra • Gourav Goyal • Abhijeet Kumar Kohat Ajit Kumar • Jayantee Kalita



Received: 13 March 2014 / Accepted: 29 August 2014 / Published online: 7 November 2014 Ó Springer-Verlag Italia 2014

Abstract To evaluate the reason joining in status epilepticus (SE) trial by epilepsy patients and attendants and their preferences for types of trials and consent. The participants were interviewed after giving a SE case summary. Their demographic details, reason of consenting or non-consenting and preference of trials and type of consent were noted. The responses of the patients and attendants were compared. 77 subjects participated and 47 (61 %) were willing to participate in the trial mainly due to self-interest (treatment by specialist, best treatment and treatment availability only by trial). The reasons for unwilling were apprehension and lack of will. The participants preferred a head-to-head trial over a placebo-controlled (21 vs. 3), proxy consent rather than waived consent (16 vs. 6) and preconsent (16 vs. 3). These responses were not different between patients and attendants. 61 % subjects were willing to participate in SE trial especially in head-to-head trial with proxy consent. Keywords Status epilepticus  Consent  Trial  Epilepsy  Ethics  Proxy consent

best care, altruistic reason, opinion or trust in their doctor [2, 3]. For emergency research, the willingness to participate will depend on the perception and attitude of the patients and their family members. In a medical emergency such as stroke, status epilepticus, head injury, meningoencephalitis and myocardial infarction, research is important. Often the patients in such emergency situation are unable to give informed consent and proxy consent is not immediately available. The surrogates may misinterpret the wishes of the family member which may be important if the treatment results in little chance of recovery. In such situation, waived informed consent (WIC) has been recommended in many countries. The benefit of WIC is at the cost of patients’ autonomy. Understanding the epilepsy patients’ or their attendants’ attitude towards participation in a trial on status epilepticus (SE) may have implications for future emergency research. We could not get any study evaluating the attitude, expectations, and the reason behind their decision to participate in research by Indian subjects. In this study, we report the willingness, reasons to participate and attitude towards consent in treatment trial of SE.

Introduction Methods Research is mandatory for improving medical care but should respect the principles of ethics. Informed consent is the essence of ethical research and includes disclosure, comprehension, voluntariness, competence and consent [1]. The patients participate in a trial in self-interest, for

U. K. Misra (&)  G. Goyal  A. K. Kohat  A. Kumar  J. Kalita Department of Neurology, Sanjay Gandhi Post Graduate Medical Sciences, Raebareily Road, Lucknow 226014, India e-mail: [email protected]; [email protected]

Inclusion The epilepsy patients and their attendants attending the neurology department who were on antiepileptic drugs and willing to participate have been included. Exclusion Cognitively impaired and those unwilling to participate were excluded.

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Interview

Table 1 Comparison of demographic variables of the participating and nonparticipating patients and attendants in status epilepticus trial

The patients and their accompanying attendants were separately interviewed by the investigators. The patients were first read a case summary to apprise the clinical and ethical problems related to SE. As a second step, patients and attendants underwent an interview. The interview was semi-structured and included demographic details and their views regarding type of consent (proxy, retrospective, preconsent and WIC), who should give the consent and why were enquired. The opinion and willingness to participate in a placebo-controlled trial on SE were recorded. The same questionnaire was applied to the attendants also.

Patients

Participating (n = 22)

Not willing to participate (n = 10)

P value

Age (years)

28.1 ± 11.3

33.7 ± 16.1

0.27

Male gender Female gender

11 11

8 2

0.11

Illiterate

2

2

0.63

Up to 5th class

1

0

Up to 10th class

6

2

Statistical analysis

Up to 12th class

3

3

The demographic details of the willing and unwilling patients as well as patients and their attendants were compared by Chi square or independent t test. The reasons for participation and nonparticipation between patients and attendants were also compared by Chi square test. The variable having a two-tailed P value \0.05 was considered significant. The statistical analysis was done using SPSS version 12.

Graduation

9

2

Post-graduation

1

1

Urban

13

6

Rural

9

4

Hindu

18

10

Muslim

4

0

Attendants

Participating (n = 27)

Not willing to participate (n = 17)

P value

Age (years)

41.7 ± 9.3

40.8 ± 14.0

0.80

Male gender

21

13

0.92

Female gender Education

6

4

Education

Residence

Religion

Results There were 76 participants including 32 patients and 44 attendants. A total of 38 patients were screened and 6 were excluded. Amongst the attendants, 38.6 % were parents, 15.9 % spouse and 45.5 % first degree relatives. There was no difference between unwilling and willing patients and attendants with respect to their demographic details (Table 1). 31.3 % patients and 38.6 % attendants were unwilling to participate in the SE trial. The reasons for nonparticipation in the patients and attendants were apprehension in 6/10, unwillingness in 3/3, indecisiveness in 1/0 and unwilling to take risk in 0/2. Two attendants were unwilling due to delay in consenting and doubt about the efficacy of the therapy. The reasons for willingness to participate by the patients and attendants were examination by an expert (8/9), helping future treatment (3/6), respect of doctors’ opinion (7/4), fear of losing doctors’ favor (1/0), prompt treatment (0/1), availability of drug only through trail (2/3) and progress of medicine (1/4). These responses were not significantly different between patients and attendants. Head-to-head trial was preferred by patients and attendants (22/30) compared to placebo-controlled (1/4). Regarding the consent in the emergency trial, the patients and attendants preferred proxy consent (16/8), WIC (6/11), preconsent (3/6) and retrospective consent (2/0) and these responses were not significantly different between the two groups.

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0.96

Illiterate

3

2

Up to 5th class

1

0

Up to 10th class

7

3

Up to 12th class

8

2

Graduation

6

6

Post-graduation

2

4

Urban

11

10

Rural

16

7

Hindu

23

15

Muslim

4

2

0.15

0.41

Residence 0.24

Religion 0.77

Discussion In this study, 68.7 % patients and 61.4 % attendants were willing to participate in a SE trial with the hope of expert care, future improvement of treatment and respecting doctors’ opinion. Majority wanted head-to-head trial than

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placebo-controlled. Two-third individuals wanted consent; mostly proxy consent and only one-third were in favor of WIC. 31.3 % patients and 38.6 % attendants were not willing to participate in the SE trial mostly due to apprehension. These responses were not different between patients and attendants which may be due to similar educational and cultural background. This is the first study evaluating the problem regarding consent in SE trail by neurologist using direct interview of the epilepsy patients and their attendants. The results of this study therefore, are more representative of SE patients than the general population. Indian medicine usually is paternalistic and most of the medical decisions are left on the physician. It was interesting to note that two-third of participants wanted consent rather than WIC. This response may be due to higher socioeconomic and educational status of the participants. The majority of our patients were against a placebo-controlled trial. The placebo-controlled trial is justified when supported by sound methodology and does not expose the participant to excessive risk [4]. In randomized controlled trial, the principle of clinical equipoise is important. The study starts with null hypothesis with genuine medical uncertainty about various therapies included in the trial design. The use of placebo in the face of established treatment has been criticized as it would imply giving suboptimal treatment to a proportion of patients [5]. When physician and researchers focus on the same patient, they may have a conflict of interest. As a physician they have the obligation to provide the best

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possible therapy but as researcher they are committed to provide the best scientific result using a placebo without knowing if the patient is getting it. Combining these two roles is not unethical if the risk is slight. The present study is limited by small sample size from a single center therefore, the results cannot be generalized. Further studies are recommended to evaluate the attitude and behavior pattern in different regions and different socioeconomic groups towards emergency trial. Acknowledgments We thank Rakesh Kumar Nigam and Deepak Kumar Anand for secretarial help. Conflict of interest

There is no conflict of interest to declare.

References 1. Foex BA (2001) The problem of informed consent in emergency medicine research. Emerg Med J 18:198–204 2. Cassileth BR, Lusk EJ, Miller DS, Hurwitz S (1982) Attitudes toward clinical trials among patients and the public. JAMA 248:968–970 3. Emanuel EJ, Patterson WB (1998) Ethics of randomized clinical trials. J Clin Oncol 16:365–371 4. Miller FG, Brody H (2002) What makes placebo-controlled trials unethical? Am J Bioeth 2:3–9 5. Freedman B, Weijer C, Glass KC (1996) Placebo orthodoxy in clinical research. I: empirical and methodological myths. J Law Med Ethics 24:243–251

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Attitude of epilepsy patients and their attendants for participating in research on status epilepticus.

To evaluate the reason joining in status epilepticus (SE) trial by epilepsy patients and attendants and their preferences for types of trials and cons...
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