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Title: Determination of relationship and frequency of sensorineural hearing loss in previously diagnosed di

Authors: Amrit Karmarkar

Topic: Clinical Research

Abstract:

Background

Sensorineural hearing loss (SNHL) is most common form of hearing loss, (90% of hearing loss cases). It was observed that diabetes and hypertension both can cause SNHL through diabetic microangiography and hypertensive retinopathy in ear respectively. Considering prevalence of diabetes and hypertension in India, particularly in state of Maharashtra and their association with sensorineural hearing loss, it was decided to evaluate relationship and frequency of SNHL in adult population of Mumbai metropolitan region.

Methodology

The aim of study was to investigate relationship and frequency of SNHL due to previously diagnosed diabetes mellitus and/or hypertension in adult population of Mumbai metropolitan region. In present study, protocol was designed for semi-structured qualitative interviews of physicians to determine relationship and prevalence of SNHL.  In total 25 respondents were replied to semi-structured interviews.

Results

Semi-structured interviews of physicians and audiologists revealed that there exists close association with duration and control of diabetes and/or hypertension. In semi-structured interviews it was found that out of all SNHL patients, there were 71.43% cases of diabetes; 39.29% cases of hypertension; and 53.57% of both diabetes and hypertension. Severity of hearing loss due to diabetes and/or hypertension was found to be moderate with more prevalence in age group of 50-60 years.

 

Conclusion

It was found that sensorineural hearing loss occurs due to diabetes and/or hypertension. Better control of these conditions at early stage might prevent causation or progression of sensorineural hearing loss. There is need to create awareness amongst public about hearing loss and utility of hearing aids. 

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    COMMENT - 1

  • Kavita Gupta (Viewer) 19th Nov 2015 - 11:53 PM
    Dear Amrit Karmarkar,

    Nice effort for this innovative article.
    However, I do have some queries:
    1. Why ethical approval is not obtained?
    According to the Ethical Guidelines, it is mandatory to obtain a ethical approval if your research involves human beings whether interventional or non-interventional.

    2. Did you obtain written Informed consent form from the participants?

    3. Which statistical tool did you use for the significance of your study?

    Thanking you,

    Regards,
    Kavita.
    • Amrit Bhalchandra Karmarkar (Author) 20th Nov 2015 - 4:31 PM
      Response to comments:
      @ Kavita Gupta
      Thanks alot for this review and appreciation.
      1. Ethical approval
      First of all, this study is semi-structured qualitative interview of physicians. No patients are involved in it. Physicians opinions were asked in interviews so as to get information about patients. Hence it is only non-interventional study. Also note that not single patients are involved. Even for interviews, protocol was made and as per protocol questions were asked. Also note that physicians asked first for their consent to give interview and then assured them about confidentiality. Due to word limits of paper, protocol was not attached with paper.

      2. As no patients are invovled, no ethical committee and no informed consent of patients is required.

      3. As you see, sample size was so small, it is better way to draw conclusions using percentage data and comparing them. Why to complicate the results section by adding unnecessary statistics when sample size is less which can investigate difference easily.

  • COMMENT - 2

  • Dr Bashir Adam Yakasai (Viewer) 20th Nov 2015 - 5:59 AM
    I share with Kavita that, ethical approval should have been obtained, particularly that audiological assessment requires some invasive procedures.
    • Amrit Bhalchandra Karmarkar (Author) 20th Nov 2015 - 4:31 PM
      Response to comments:
      @ Kavita Gupta
      Thanks alot for this review and appreciation.
      1. Ethical approval
      First of all, this study is semi-structured qualitative interview of physicians. No patients are involved in it. Physicians opinions were asked in interviews so as to get information about patients. Hence it is only non-interventional study. Also note that not single patients are involved. Even for interviews, protocol was made and as per protocol questions were asked. Also note that physicians asked first for their consent to give interview and then assured them about confidentiality. Due to word limits of paper, protocol was not attached with paper.

      2. As no patients are invovled, no ethical committee and no informed consent of patients is required.

      3. As you see, sample size was so small, it is better way to draw conclusions using percentage data and comparing them. Why to complicate the results section by adding unnecessary statistics when sample size is less which can investigate difference easily.

      @ Dr. Bashir Adam Yakasai
      Please read paper carefully. No patient was involved in study and no audiological tests are conducted. This research is based on pure semi-structured interview of physicians. Hence no ethical approval is needed.
      Reply

  • COMMENT - 3

  • Amrit Bhalchandra Karmarkar (Author) 20th Nov 2015 - 3:34 PM
    Response to comments:
    @ Kavita Gupta
    Thanks alot for this review and appreciation.
    1. Ethical approval
    First of all, this study is semi-structured qualitative interview of physicians. No patients are involved in it. Physicians opinions were asked in interviews so as to get information about patients. Hence it is only non-interventional study. Also note that not single patients are involved. Even for interviews, protocol was made and as per protocol questions were asked. Also note that physicians asked first for their consent to give interview and then assured them about confidentiality. Due to word limits of paper, protocol was not attached with paper.

    2. As no patients are invovled, no ethical committee and no informed consent of patients is required.

    3. As you see, sample size was so small, it is better way to draw conclusions using percentage data and comparing them. Why to complicate the results section by adding unnecessary statistics when sample size is less which can investigate difference easily.

    @ Dr. Bashir Adam Yakasai
    Please read paper carefully. No patient was involved in study and no audiological tests are conducted. This research is based on pure semi-structured interview of physicians. Hence no ethical approval is needed.

  • COMMENT - 4

  • Diana Thamby Ebenezer (Viewer) 26th Nov 2015 - 6:19 PM
    Dear Author,

    This is the relevant Study as Diabetes and Hypertension are on the rise in developing countries. This study is basically the perception of treating Doctors on the issue mentioned in the title. Are you sure about this is the Qualitative Research and not Quantitative Research?

    Ethical considerations has become the point of discussion as you have mentioned "As this is non interventional study of physicians no ethical approval was obtained". This is highly questionable. Whether Intenventional (Experimental) or Descriptive (Observational) , all scietific stuides need to seek permission from an approved Ethical/ Scientific Committee. It is the responsibility of the Committe to give permission and decide and suggest alternates if any ethical issues involved.

    This kind of information could have been avoided if Ethical approval not sought. It adds credibility to our work if approved by an ethical Committee.
    • Amrit Bhalchandra Karmarkar (Author) 27th Nov 2015 - 4:20 PM
      Dear Diana
      Thanks for your comments. It is qualitative research. Data obtained in it was converted to quantitative so that results could be showed graphically.
      Ethical considerations:
      Although, your consideration is right. But in India, non interventional study and that too in physicians does not require approval of ethics committee.
      The study design of study was already reviewed and approved by Cranfield University, UK faculty members and found that no approval is necessary if study is to be conducted in India. When study was carried out, there was lots of confusion in Indian regulations about whether approval should be given to interventional and non interventional studies and at that time, revision of regulations i.e. registration of IECs and IRBs with CDSCO was going on. So many ethics committees that we have approached for this study (including IRBs from KEM Hospital, Nair Hospital, Topiwala College and Tata Hospital, all at Mumbai) said that this study does not need approval of ethics committee.

  • COMMENT - 5

  • Vinod Ramesh Gyanchandani (Viewer) 27th Nov 2015 - 4:44 PM
    Dear Amrit,

    I am in agreement with the statement that SNHL was found in 71 .43% cases of diabetes;39.29% cases of hypertension; and 53.57% of both diabetes and hypertension and the Severity of hearing loss due to diabetes and/or hypertension was found to be moderate with more prevalence
    in age group of 50-60 years. I have gone through one more study which concludes that one of the major reason for Hearing loss is non-functioning of Schwann's cells of neurons and it is predominantly weak if Occipital lobe of cerebrum is compromised and this is the same lobe which takes care of cardiovascular activities of human body. So in addition to better control of these conditions at early stage via awareness amongst public about hearing loss and utility of hearing aids; could we do anything scientifically to reduce % cases.
    • Amrit Bhalchandra Karmarkar (Author) 27th Nov 2015 - 4:53 PM
      Dear Dr. Vinod Gyanchandani
      Thanks for your comments. Certainly in India, there is need to conduct these type of bridging studies. Also awareness programs are not there. We are planning to conduct such programs as next part of study. Also this study is being conducted now in bigger area of population so as to estimate exact prevalence