Psychological impact and awareness of androgenetic alo ...

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1 J Asian Med Stud Assoc J Asian Med Stud Assoc. 2020;8(4 Suppl3):1-29 Psychological impact and awareness of androgenetic alo- pecia among Filipino male patients: an observational study in the Ospital ng Maynila Medical Center Fenny Leets Santoso 1 , Benedicto dL Carpio 2 , Eileen R. Morales 2 , Armelia Andrea L. Torres 2 1 Resident, Ospital ng Maynila Medical Center- Department of Dermatology 2 Consultant, Ospital ng Maynila Medical Center- Department of Dermatology Correspondence should be addressed to: Fenny Leets Santoso, Ospital ng Maynila Medical Center Department of Dermatology, Quirino Avenue cor. Roxas Boulevard, Malate, Manila. Tel: +639396394390 /+6281212489301 E-mail: [email protected] Cite this article as: Santoso FL, Carpio BdL, Morales ER, Torres AAL. Psychological impact and awareness of androgenetic alopecia among Filipino male patients: an observational study in the Ospital ng Maynila Medical Center. J Asian Med Stud Assoc. 2020;8(4 Suppl3):1-29 Received: 01 Feb 2020; Accepted: 24 Apr 2020. Appendix 1. IRB Approval

Transcript of Psychological impact and awareness of androgenetic alo ...

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J Asian Med Stud Assoc

J Asian Med Stud Assoc. 2020;8(4 Suppl3):1-29

Psychological impact and awareness of androgenetic alo-

pecia among Filipino male patients: an observational

study in the Ospital ng Maynila Medical Center

Fenny Leets Santoso1, Benedicto dL Carpio2, Eileen R. Morales2, Armelia Andrea L. Torres2

1Resident, Ospital ng Maynila Medical Center- Department of Dermatology 2Consultant, Ospital ng Maynila Medical Center- Department of Dermatology

Correspondence should be addressed to:

Fenny Leets Santoso, Ospital ng Maynila Medical Center – Department of Dermatology, Quirino Avenue cor.

Roxas Boulevard, Malate, Manila. Tel: +639396394390 /+6281212489301

E-mail: [email protected]

Cite this article as: Santoso FL, Carpio BdL, Morales ER, Torres AAL. Psychological impact and awareness of

androgenetic alopecia among Filipino male patients: an observational study in the Ospital ng Maynila Medical

Center. J Asian Med Stud Assoc. 2020;8(4 Suppl3):1-29

Received: 01 Feb 2020; Accepted: 24 Apr 2020.

Appendix 1. IRB Approval

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Appendix 2. Hospital Anxiety and Depression Scale Copyright

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Appendix 3. Informed consent Form Adult (English version) ICF version 2_5 July 2019

Study Title: Psychological Impact and Awareness of Androgenetic Alopecia Among Fili-

pino Male Patients Aged 18 to 65 seen at the Outpatient Department of the Ospital ng

Maynila Medical Center, Department of Dermatology

Study Site: Ospital ng Maynila Medical Center, Department of Dermatology OPD

Principal Investigator: Fenny Leets Santoso, MD Contact Number: 5246061 loc 133

Co-investigators: Benedict dL Carpio, MD

Eilleen R. Morales, MD

Armelia Andrea L. Torres, MD

Sponsor: There is no financial support from any pharmaceutical nor funding companies.

Introduction

Good day! I am Dr. Fenny Leets Santoso, Dermatology Resident of the Department of Derma-

tology, Ospital ng Maynila Medical Center. My co-investigators and I are doing a study on

psychological problem (anxiety, depression) and awareness in patients with male pattern hair

loss. We invite you to be part of this study. This consent form may contain words that you do

not understand. Please ask me to stop as we go through the information and I will take time to

explain.

Purpose of the Research

People nowadays are concerned about their hair because it has an important role in their phys-

ical appearance. The purpose of this study is to investigate the risk of anxiety and depression

in male patients with male pattern hair loss and their perception and concern of their hair con-

dition. We want to learn more about this problem in order to improve our examination and

treatment for this disease.

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Type of Research Intervention

This study will involve your participation to fill up questionnaires.

Participation Selection

You are invited to take part in this research if you comply with all of the following conditions:

(1) 18 to 65 years of age, (2) with male pattern baldness (3) understand English or Filipino.

However, if you are taking medicine that can cause hair loss or you have other types of hair

loss, you will be excluded.

Voluntary Participation

Your participation in this research is entirely voluntary. It is your choice whether to participate

or not. If you choose not to participate, all the services you receive at this clinic will continue

and nothing will change.

Procedures

We are asking you to help us learn more about the psychological impact of male pattern hair

loss. We are inviting you to take part in this research project. If you accept, you will be exam-

ined by a Dermatology Resident and the Resident will tell you what type of male pattern hair

loss you have. Second, you will be asked to fill out a questionnaire which will be provided and

collected by the investigator, Dr. Fenny Santoso. You may answer the questionnaire by your-

self, or it can be asked to you verbally and you may answer it verbally, so that the investigator

will write the answer down for you. If you do not wish to answer any question in this question-

naire, you may skip and move on to the next question. All information that you will provide

will be kept confidential. Your name will be coded questionnaire to protect your identity. Your

questionnaire will be identified by code that the Investigator will assign. No one else except

the investigator will have access to your questionnaire.

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Duration

This study will involve your participation to fill out the questionnaire that will take about fifteen

minutes.

Risks

In the questionnaire, there may be some questions regarding your personal information that

you may feel uncomfortable to answer. You may opt to skip a question answer that you may

feel uncomfortable to answer or may decide not to take part in the study if you do not wish to

do so, and that is also fine. You do not have to give us any reason for not responding to any

questions or withdrawal from the study.

Benefit

This study may help to bring benefits to society as the result of finding relationship between

psychological problem and male pattern hair loss.

Reimbursements

You will not be provided any incentive to take part in this study.

Confidentiality

All participants will be assigned with substitute codes for information that identifies the par-

ticipants. The data will be stored in a locked file cabinet and password protected laptop with

limited access only by the Primary Investigator. Only the primary investigator will collect,

code, and maintain the data. All paper documents that may contain participant identifiers and

data regarding the patient will be properly disposed as soon as they are no longer needed.

Sharing the Results

The knowledge that we get from this research will be shared through publications and confer-

ences.

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Right to Refuse or Withdraw

You do not have to take part in this study if you do not wish to do so, and choosing to participate

will not affect your treatment. You may stop participating in the survey any time that you wish.

If you have questions or concerns after the survey or you would like to receive a copy of the

final aggregate results of this study, please contact:

Fenny Leets Santoso, MD

Primary Investigator

Department of Dermatology

Ospital ng Maynila Medical Center

Telephone number: 09396394390

This study was reviewed and approved by the Institutional Review Board of Manila Central

University-FDTMF IRB. You may contact

MA. ROSARIO E. BONAGUA, MD

Chair, MCU-FDTMF IRB

MCU-Filemon D. Tanchoco, Sr. Medical Foundation

Samson Road, EDSA, Caloocan City

Telephone Nos.: 364-1071 to 77 local 183

Thank you very much for your cooperation.

Certificate of consent:

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I have read and understood the information sheet given to me. I have had the opportunity to

ask questions about it and any questions that I have asked have been answered to my satisfac-

tion. I consent voluntarily to participate in this research.

Print name of Patient: _______________

Signature of Patient: ________________

Date: __________________

If illiterate

I have witnessed the accurate reading of the consent form of the potential participant, and the

individual has had the opportunity to ask questions. I confirm that the individual has given

consent freely

And

Print Name of Witness ___________

Signature of Witness ____________ Thumb Print of Participant

Date: ________________________

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Appendix 3. Informed consent Form Adult (Tagalog version) - ICF version 2_5 July 2019

Pamagat ng pananaliksik: Psychological Impact and Awareness of Androgenetic Alope-

cia Among Filipino Male Patients Aged 18 to 65 seen at the Outpatient Department of the

Ospital ng Maynila Medical Center, Department of Dermatology

Lugar ng pananaliksik: Ospital ng Maynila Medical Center, Department of Dermatology

OPD

Pangunahing imbestigador: Fenny Leets Santoso, MD Contact Number: 5246061 loc 133

Co-imbestigador: Benedict dL Carpio, MD

Eilleen R. Morales, MD

Armelia Andrea L. Torres, MD

Sponsor: Walang suporta sa pananalapi mula sa anumang mga parmasyutiko o mga kumpanya

ng pagpopondo.

Panimula

Ako si Dra. Fenny Santoso, isang Residente ng Dermatolohiya sa Department of Dermatology,

Ospital ng Maynila Medical Center. Ako at ang aking mga co-imbestigador ay gumagawa ng

isang pananaliksik sa sikolohikal (pagkabalisa, depresyon, at kamalayan) sa mga pasyente na

may pagkawala ng buhok sa mga kalalakihan. Inaanyayahan kitang maging bahagi ng panana-

liksik na ito. Ang form ng pahintulot na ito ay maaaring maglaman ng mga salita na hindi mo

mauunawaan. Mangyaring hilingin sa akin na huminto habang dumadaan kami sa impor-

masyon at magbibigay ako ng oras upang ipaliwanag.

Layunin ng Pananaliksik

Sa ngayon ang mga tao ay nag-aalala tungkol sa kanilang buhok dahil may mahalagang papel

ito sa kanilang pisikal na hitsura. Ang layunin ng pananaliksik na ito ay upang siyasatin ang

panganib ng pagkabalisa at depresyon sa mga lalaking pasyente na may pagkawala ng buhok

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at ang kanilang pang-unawa at pagmamalasakit sa kalagayan ng kanilang buhok. Gusto naming

matuto nang higit patungkol sa problemang ito upang mapabuti ang aming pagsusuri at pag-

gamot sa sakit na ito.

Uri ng Pamamagitan ng Pananaliksik

Ang pagsusuring ito ay patungkol sa pagsagot ng mga katanungan.

Pagpipilian sa Paglahok

Inaanyayahan kang makilahok sa pananaliksik na ito kung ikaw ay mayrooon ng lahat ng mga

sumusunod na kondisyon: (1) 18 taon hanggang 65 taong gulang, (2) lalaking may “pattern

baldness” (3) nakakkaunawa ng Ingles o Tagalog. Gayunpaman, kung ikaw ay umiinom ng

gamot na maaaring maging sanhi ng pagkawala ng buhok o mayroon kang iba pang mga uri

ng pagkawala ng buhok, ikaw ay hindi kasama.

Boluntaryong paglahok

Ang pagsali sa pananaliksik na ito ay kusang- loob at boluntaryo. Kung pinili mong hindi lu-

mahok, ang lahat ng mga serbisyo na iyong natatanggap sa klinika na ito ay magpapatuloy at

walang magbabago.

Pamamaraan

Hinihiling namin sa iyo na tulungan kaming matuto nang higit pa tungkol sa sikolohikal na

epekto ng pagkawala ng buhok ng lalaki sa pattern. Inaanyayahan ka naming makilahok sa

proyektong ito. Kung tatanggapin mo, ikaw ay susuriin ng Residente ng Dermatolohiya at sasa-

bihin sa iyo ng Resident kung anong uri ng male pattern na pagkawala ng buhok ang mayroon

ka. Pangalawa, hihilingin ka na punan ang isang questionnaire na ibibigay at kukuhanin ng

imbestigador na si Dr. Fenny Santoso. Maari mo itong sagutan mag-isa o kaya ay maaari mong

hililingin na sagutan ito para saiyo ng imebestigator habang ikaw ay nagsasalita. Kung hindi

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mo nais na sagutin ang anuman sa mga katanungan na ito, maaari mong laktawan at magpatu-

loy sa susunod na tanong. Ang lahat ng impormasyong iyong ibibigay, ay mananatiling kom-

pidensyal. Ang iyong pangalan ay hindi isusulat sa form ng mga katanungan. Ito ay makikilala

o malalaman lamang sa pamamagitan ng code na itatalaga ng Imbestigador. Walang sinuman

maliban ang investigator ay magkakaroon ng access sa iyong questionnaire.

Tagal

Ang iyong pagsagot sa mga katanungan kung ikaw ay makikilahok sa pagsasaliksik na ito ay

tatagal ng labing – limang minute.

Mga panganib

Maaaring may ilang mga katanungan tungkol sa iyong personal na impormasyon na hindi ka

komportableng sagutin. Nasa sa iyo kung sasagutan mo o hindi ang mga katanungan o kung

nais mo o hindi na makilahok sa pananaliksik na ito. Hindi mo kailangang bigyan kami ng

anumang dahilan para hindi tumugon sa anumang mga tanong.

Benepisyo

Ang pag-aaral na ito ay maaaring makatulong upang magdala ng mga benepisyo sa lipunan

bilang resulta ng paghahanap ng relasyon sa pagitan ng sikolohikal na problema at pagkawala

ng buhok ng lalaki.

Mga Pagbabayad

Walang ano mang bayad o insentibo ang ibibigay sa iyo sa paglahok sa pananaliksik na ito.

Kumpidensyal

Ang lahat ng mga kalahok ay bibigyan ng mga “substitute codes” para sa impormasyong

magpapakilala sa kanila. Ang data ay maiimbak sa isang naka-lock na file cabinet at laptop na

“password-protected” na may limitadong pag-access lamang ng Imbestigator. Tanging ang

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pangunahing imbestigador ang mangongolekta, magkko-code, at magtatabi ng data. Ang lahat

ng mga dokumento ng papel na maaaring maglaman ng mga impormasyon patungkol sa mga

kalahok ay maayos napupunitin at itatapon sa lalong madaling panahon kapat ito ay hindi na

kailangan.

Pagbabahagi ng Mga Resulta

Ang kaalaman na makukuha namin mula sa pananaliksik na ito ay ibabahagi sa pamamagitan

ng mga pahayagan at kumperensya.

Karapatan na tumanggi o hindi lumahok

Hindi mo kailangang makilahok sa pag-aaral na ito kung hindi mo nais na gawin ito, at ang

pagpili na lumahok ay hindi makakaapekto sa i paggamot sa iyo. Maaari kang tumigil sa pagsali

sa survey anumang oras na nais mo.

Kung mayroon kang mga katanungan o alalahanin pagkatapos ng survey o nais mong maka-

tanggap ng isang kopya ng pangwakas na pinagsama-samang mga resulta sa pag-aaral na ito,

mangyaring makipag-ugnayan kay:

Fenny Leets Santoso, MD

Pangunahing imbestigador

Department of Dermatology

Ospital ng Maynila Medical Center

Numero ng telepono: 09396394390

Ang pag-aaral na ito ay sinuri at inaprubahan ng Institutional Review Board ng Manila Central

University-FDTMF IRB. Maaari kang makipag-ugnay

MA. ROSARIO E. BONAGUA, MD

Chair, MCU-FDTMF IRB

MCU-Filemon D. Tanchoco, Sr. Medical Foundation

Samson Road, EDSA, Caloocan City

Numero ng telepono: 364-1071 to 77 local 183

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Maraming salamat po sa inyong kooperasyon.

Sertipiko ng pahintulot:

Aking binasa at naintindihan Mabuti ang mga impormasyon na ibinigay sa akin. Ako ay may

Karapatan na magtanong patungkol ditto at kung may mga katanungan na tinanong sa aking

na nasagot sa aking kasiyahan. Kusang-loob akong lumahok sa pananaliksik na ito.

I-print ang pangalan ng Pasyente: _____________________

Lagda ng Pasyente: ___________

Petsa: ______________________

Kung mangmang

Nasaksihan ko ang tamang pagbabasa ng form ng pahintulot ng potensyal na kalahok, at ang

indibidwal ay nagkaroon ng pagkakataon na magtanong. Kinukumpirma ko na ang bawat in-

dibidwal ay binigyan ng pahintulot..

AT

I-print ang Pangalan ng saksi _________________

Lagda ng Saksi ____________

Petsa: ____________________ Thumb Print ng Kalahok

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Appendix 4. Research flow

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Appendix 5. HAMILTON-NORWOOD CLASSIFICATION8

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Appendix 6. HOSPITAL ANXIETY AND DEPRESSION SCALE (ENGLISH VER-

SION)

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Appendix 6. HOSPITAL ANXIETY AND DEPRESSION SCALE (FILIPINO VER-

SION)

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Appendix 7. MALE PATTERN HAIR LOSS SURVEY (English Version)

Initial Name : ______________

Date of Collection : MM / DD / YY

Age : ______

Education

o Elementary

o Secondary

o Bachelor

How long have you been suffering with this condition?

o < 5 years

o 5 - 10 years

o > 10 years

Have you ever done some research about this condition?

o YES

o NO

If YES, mention what kind of research.

o Internet

o Friends

o Advertisement

o Seek consult to the doctor

o Others: ___________________

Has this condition been treated before?

o YES

o NO

If YES, mention what kind of treatment.

o Medical treatment (Minoxidil, Finasteride)

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o Light Therapy

o Hair transplant

o Hair shampoo

o Herbal therapy

o Wigs or hair pieces

o Others: __________________

Were you satisfied with the medication?

o YES

o NO

IF NO, mention why.

o Low effects

o High costs

o Required long-term treatment

o Others: __________________

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Appendix 7. MALE PATTERN HAIR LOSS SURVEY (Tagalog Version)

Paunang Pangalan : ______________

Petsa ng Koleksyon : MM / DD / YY

Edad : ____

Edukasyon

o Elementary

o Secondary

o College

Gaano katagal na kayo ay nagdurusa sa kondisyong ito?

o < 5 taon

o 5 - 10 taon

o > 10 taon

Nakagawa ka na ba ng pananaliksik tungkol sa kondisyong ito?

o Oo

o Hindi

Kung Oo, banggitin kung anong uri ng pananaliksik.

o Internet

o Kaibigan

o Patalastas sa TV, Radyo, Diyaryo, Billboard

o Kumunsulta sa doktor

o At iba pa: _____________________

Naipagamot mo na ba ito dati?

o Oo

o Hindi

Kung Oo, banggitin kung anong uri ng gamotan.

o Gamutan na ginawa ng doktor (Minoxidil, Finasteride)

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o Magaan na terapi

o Pagpapatransplant ng buhok

o Shampoo

o Herbal na gamot

o Peluka o hibla ng buhok

o At iba pa: ______________________

Napunan ba ang sakit mo ng gamot na ito?

o Oo

o Hindi

Kung Hindi, banggitin kung bakit.

o Mahina ang epekto

o Magastos

o Pangmatagalan gamutan

o At iba pa: _______________________