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Title: Measuring capacity to consent to research in Indian schizophrenic patients with depressive symptoms

Authors: Melisa Pereira, Nilesh Shah, Avinash Desousa, Renita Bhamrah, Sridharan Kannan

Topic: Clinical Research

Abstract:

Individuals with neuropsychiatric disorders are believed to have poor decision-making capacity (DMC) due to significant deficits in their mental abilities, thus, hindering their capacity to provide informed consent. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) format is most extensively utilized by researchers for assessing the DMC of potential research subjects. Although the tool is globally recognized, little is known about its application in mentally-ill patients in India. Therefore, the present study was designed to measure the DMC to consent to research in Indian schizophrenic patients with depressive symptoms. Hundred patients aged 18–65 years with schizophrenia participated in this study. Of these, 50 patients had depressive symptoms as defined by the scores on Montgomery–Asberg Depression Rating Scale (MADRS).  All patients were asked to pretend that they were potential candidates for a hypothetical trial involving a new antipsychotic drug, and their DMC was assessed using MacCAT-CR. Majority of patients in both the schizophrenia and the schizophrenia with depressive symptoms groups demonstrated adequate understanding to consent to research. Schizophrenic patients with depressive symptoms showed weaker performance on all four abilities of DMC, namely, understanding, appreciation, reasoning and expression of choice, compared to patients with schizophrenia. This difference was statistically significant for understanding, appreciation and reasoning but not for expression of choice. These preliminary findings are among the first to illustrate the DMC to consent to research in Indian schizophrenic patients with depressive symptoms. Future work calls for larger samples to provide valuable information in this area.

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    COMMENT - 1

  • MELISA PEREIRA (Author) 16th Nov 2015 - 12:23 PM
    Inventors of MacCAT-CR?
    • MELISA PEREIRA (Author) 16th Nov 2015 - 12:30 PM
      Dr. Paul Appelbaum, the Elizabeth K. Dollard Professor of Psychiatry, Medicine and Law, and former president of the American Psychiatry Association, USA; and Dr. Thomas Grisso, Professor Emeritus in Psychiatry, University of Massachusetts Medical School, USA

  • COMMENT - 2

  • Kavita Gupta (Viewer) 16th Nov 2015 - 9:03 PM
    Dear Melisa Pereira,
    The article is very well written and quite informative as well.
    However, some points regarding pathogenesis of the underlying disease could have been taken into account reflecting the urge for need to look in this type of mental illness.

    Thank you,

    Regards,
    Kavita.
    • MELISA PEREIRA (Author) 26th Nov 2015 - 5:50 PM
      Dear Kavita,

      Thank you for your kind words of appreciation.
      Since the focus of this research was on DMC to consent to research for participation in trials, we chose to discuss about the same, and avoided information of repetitive nature-pathophysio & gen. diag of depression in schizophrenia already known to the med fraternity (DMC article for e.g. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2486336/).

      Going ahead, would like to share some valuable information on the pathogenesis available at http://apt.rcpsych.org/content/15/5/372 & http://link.springer.com/chapter/10.1007%2F978-0-387-72573-4_36

      Once again, thank you for your salient observations.

      Regards,
      Melisa

  • COMMENT - 3

  • MLUNGISI PATRICK MSIBI (Viewer) 17th Nov 2015 - 11:55 AM
    Dear Melisa,
    I had hope to see how do schizophrenic patients consent to partake in a study taking into cognissance the lack thereof of decision making capacity.
    • MELISA PEREIRA (Author) 17th Nov 2015 - 12:14 PM
      Dear Mlungisi,
      Thanks a lot for your comment. The ICF was customized and short, essential study information (e.g. nature and purpose of the study; treatment and experimental procedures; risks and benefits of study participation, etc.) was explained "part by part" for easy understanding, keeping in view the MacCAT-CR manual. The IC process was actually a two-way interaction- Q&A interview with the patients since communication holds a lot of importance in psychiatry. It was indeed a good experience for us to see how schizophrenic patients with depressive symptoms recollected study info and answered. I wish I could video/audio record the responses.

      Best Regards
      Melisa

  • COMMENT - 4

  • MELISA PEREIRA (Author) 17th Nov 2015 - 11:55 AM
    Dear Kavita,

    Thank you for your kind words of appreciation.
    Since the focus of this research was on DMC to consent to research for participation in trials, we chose to discuss about the same, and avoided information of repetitive nature-pathophysio & gen. diag of depression in schizophrenia already known to the med fraternity (DMC article for e.g. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2486336/).

    Going ahead, would like to share some valuable information on the pathogenesis available at http://apt.rcpsych.org/content/15/5/372 & http://link.springer.com/chapter/10.1007%2F978-0-387-72573-4_36

    Once again, thank you for your salient observations.

    Regards,
    Melisa
    • Dr Bashir Adam Yakasai (Viewer) 19th Nov 2015 - 3:51 AM
      Dear Melisa,

      What statistical instrument did you use to analyse your data? and was it by choice you did not make any conclusion in reporting your work?
      • MELISA PEREIRA (Author) 19th Nov 2015 - 3:17 PM
        Dear Dr. Bashir,

        Thank you for your valuable comments.

        1) Our statistician used standard IBM's SPSS Statistics software for analysis.
        2) Since the submission guidelines mentioned 'Discussion/Conclusion' as a single entity for original manuscripts, we chose to include conclusion as an ending paragraph in the Discussion section.

        Best Regards
        Melisa

  • COMMENT - 5

  • Kavita Gupta (Viewer) 19th Nov 2015 - 3:08 PM
    Dear Melisa,

    1. Did you yourself take the personal interview from the patients or just obtained a feedback form?
    2. Is there any limitation for your study being conducted?

    Regards,
    Kavita.
    • MELISA PEREIRA (Author) 19th Nov 2015 - 3:39 PM
      Dear Kavita,

      1) I conducted personal interviews under the guidance of HOD & a Sr. Psychiatrist at the hospital.
      2) Limitations of the study are i) Sample population allowed by EC for masters/doctoral students dissertation research (other than home university) was 100 ii) Study patients were from Mumbai area. Therefore, further research in different parts of India using larger population would validate the results of this study (we are planning to chalk out the same at various sites in India by mid 2016) iii) Financial limitation- this research was non-funded.

      Regards
      Melisa

  • COMMENT - 6

  • Kavita Gupta (Viewer) 19th Nov 2015 - 3:16 PM
    Dear Melisa,
    As pointed out by Author Dr Bashir Adam Yakasai, it could be depicted that you have used ANOVA statistical tool in your study which is being only mentioned in the observation table. It is advisable if you would have also mentioned it the main body of your article so as to avoid any sort of confusion.

    Thanking you,

    Regards,
    Kavita.
    • MELISA PEREIRA (Author) 19th Nov 2015 - 3:24 PM
      Dear Kavita,

      ANOVA & Mann Whitney U test has been used. We missed mentioning it in the main body while done in Tables 1, 2 and 3.

      Regards
      Melisa

  • COMMENT - 7

  • Dr. AJIT V PANDYA (Viewer) 20th Nov 2015 - 8:55 PM
    1.how many % of Indian suffer from schizophrenia ?
    2. are there pre-stage in schizophrenia.......what is age - average..?
    • MELISA PEREIRA (Author) 21st Nov 2015 - 12:09 AM
      Dear Dr. Ajit,

      Thank you for your queries.
      1) As many as 51 million people worldwide suffer from schizophrenia, with a rough estimate of 4.3 to 8.7 million (approx 12.5 %) people in India based on population (Ref: http://www.schizophrenia.com/szfacts.htm# Crosref: NIMH)

      2) Yes, schizophrenia usually starts with an early phase called prodromal phase. Schizophrenia is rarely diagnosed at this time since most of the symptoms shown up are non-psychotic in nature. Think of this prodromal phase like the spring season: the symptoms are starting to show, but they are still 'baby' symptoms and aren't full-blown yet.

      3) Average age of onset is 18 in men and 25 in women (Ref: http://www.schizophrenia.com/szfacts.htm#).

  • COMMENT - 8

  • Dr. AJIT V PANDYA (Viewer) 20th Nov 2015 - 10:26 PM
    3. is this disease curable or prevetable at early stage ? why ?
    • MELISA PEREIRA (Author) 21st Nov 2015 - 12:06 AM
      Although International Clinical Practice Guidelines for prodromal/ pre-psychotic period has recommended neuropsychiatrists to i) monitor mental state ii) use antipsychotic agents if patient meets ICD/DSM V criteria for psychotic disorder, initiation of such interventions during the prodrome faces controversies today because of unresolved issues as: (i) how to accurately identify susceptible individuals who are in true need of preventive intervention; (ii) at what developmental point in the prodrome medication should be initiated; (iii) how long medication should be continued; and (iv) what medication is optimal for the prodrome.

      Future research studies on treatment/prevention of prodromal phase in schizophrenia would help us get some valuable insights

  • COMMENT - 9

  • MELISA PEREIRA (Author) 20th Nov 2015 - 11:14 PM
    Dear Dr. Ajit,

    Thank you for your queries.
    1) As many as 51 million people worldwide suffer from schizophrenia, with a rough estimate of 4.3 to 8.7 million (approx 12.5 %) people in India based on population (Ref: http://www.schizophrenia.com/szfacts.htm# Crosref: NIMH)

    2) Yes, schizophrenia usually starts with an early phase called prodomal phase. Schizophrenia is rarely diagnosed at this time since most of the symptoms shown up are non-psychotic in nature. Think of this prodomal phase like the spring season: the symptoms are starting to show, but they are still 'baby' symptoms and aren't full-blown yet.

    3) Average age of onset is 18 in men and 25 in women (Ref: http://www.schizophrenia.com/szfacts.htm#).

  • COMMENT - 10

  • Pramod Kumar Jagannathrao Wable (Viewer) 21st Nov 2015 - 7:13 PM
    Dear Authors,

    Interesting article; however I was not able to see any reference to the recently updated DCGI guidance on the consenting practice.

    Can you please elaborate?

    Kind regards,

    Pramod Wable
    • MELISA PEREIRA (Author) 22nd Nov 2015 - 1:25 AM
      Dear Pramod,

      Thank you for your query. Are you referring to the draft guidance on AV Recording of consenting process? If so, have not mentioned since the topic is currently facing substantial debate and yet to become a law.

      Talking about this draft guidance dated Jan 9, 2014, CDSCO vide F. No. GCT/20/SC/Clin./2013 DCG1 dated Nov 19, 2013 issued direction that in all clinical trials, in addition to the requirement of obtaining written informed consent, AV recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent is required. There are many anticipated advantages of AV recording like reliability, transparency, confirmation of informed decision and improvement in quality of conduct of informed consent process. On the other hand, the current challenges deemed controversial include i) many government-funded clinical trial sites not having appropriate infrastructure required to make AV recording at the sites possible, ii) Indian culture with tradition of ladies using ghunghat and burkhas especially in rural India may be reluctant to get videographed, iii) Those suffering from some specific diseases such as Hep C, HIV, leprosy, TB may hesitate to subject themselves to AV recording due to the attached/perceived social stigma, iv) Issues with data storage and risk of tampering iv) Recording of LARs & IWs in case of special population v) SOPs for AV.

      V G Somani, joint drug controller, CDSCO said, "Although it is the Supreme Court decision, many will refuse to this. We cannot ask HIV or similar patient to go in front of the camera. We have to do this systematically and we are open to all kind of discussions." (Ref: http://www.dnaindia.com/money/report-patients-informed-consent-for-clinical-trails-to-be-captured-on-cam-2026807)

      Best Regards
      Melisa