Consent for Participation in a Research Study: Improvement in Quality of Life After Lipoedema Liposuction

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10-15 minutes to complete.

The researcher (Mr Vasu Karri) requests your consent to participate in a study about the effect of lipoedema liposuction on your quality of life. The answers you provide in this questionnaire will be used by Mr Karri in the study.

This consent also asks your permission to use related observations as data in the study (such as post-op pain scores, total volume of fat removed, etc).

Participation in this study is completely voluntary. If you decide not to participate there will be no negative consequences.

Please be aware, you may stop participating at any time and/or decide not to answer any specific question. All the data will be anonymised and kept securely for a period of 10 years after the questionnaire submission, in accordance with the Data Protection Act 1998.

By submitting this form, you are indicating that you have read the description of the study, are over the age of 18, and agree to the terms as described.

If you have any questions, or would like a copy of this consent, please contact us at; The Karri Clinic Suite 2 Albion Mills Albion Lane Willerby East Yorkshire HU10 6DN or info@thekarriclinic.co.uk
Thank you in advance for your participation.

Name(Required)

First Last

Consent

I voluntarily agree to participate in this research study.

I understand the purpose and nature of the study, which is evaluate the effect of upper and lower limb lipoedema liposuction on my quality of life. I will be required to complete a quality of life questionniare, that incorporates Short-Form 36 questionnaire, World Health Organisation questionnaire and a 17-item symptom score.

I understand that even if I agree to participate now, I can withdraw at any time or refuse to answer any question without any consequences of any kind.

I understand that I will not benefit directly from participating in this research.

I understand that all information I provide for this study will be treated confidentially.

I understand that my participation involves completing the Quality of Life Questionnaire before and after surgery.

I understand that if Mr Karri publishes the results of this research, my identity will remain anonymous. This will be done by adding my results to other participants results and using the average result.

I understand that under Freedom of Information legalisation I am entitled to access the information I have provided at any time while it is in storage.

I understand that I am free to contact Mr Karri to seek further clarification and information at any time.

I understand that this signed consent form and completed Quality of Life Questionnaire will be retained in a secure database that only Mr Karri and nominated individuals have access to until 2032.

Sign

Signature(Required)

Date(Required)

DD slash MM slash YYYY

Patient Details

Today's Date

DD slash MM slash YYYY

Name

First Last

Address

Street Address Address Line 2 City Postcode

Have you had lipoedema surgery already?

Yes

If yes, how many operations have you had up to this point?

What is your date of birth?

Day

Month

Year

What is your ethnicity?

White

Black

Asian (Indian, Pakistani, Bangladeshi)

Other Asian

Arab

Mixed ethnicity

Other ethnic group

Which statement best describes your living arangements?

I live with partner/ spouse / family / friends

I live alone

I live in a nursing home, hospital or other

Long-term care home

Other

For how long have you had problems with your lower limbs, which you are about to have surgery?

Less than 1 year

1 to 5 years

6 to 10 years

More than 10 years

Have you been told by a doctor that you have any of the following? (Tick all that apply)

Heart disease (for example angina, heart attack or heart failure)

High blood pressure

Problems caused by stroke

Leg pain when walking due to poor circulation

Lung disease (e.g. asthma, chronic bronchitis or emphysema

Diabetes

Diseases of the nervous system (e.g. Parkinson's disease or M.S.)

Kidney disease

Liver disease

Cancer (within the last 5 years)

Depression

Arthritis

SHORT FORM 36 - please answer the following 36 questions completely, honestly and without interruptions.

1. In general, would you say your health is

Excellent	Very good	Good	Fair	Poor

2. Compared to one year ago, how would you rate your health in general now?

Much better than 1 year ago	Somewhat better than one year ago	About the same	Somewhat worse than one year ago	Much worse than one year ago

LIMITATIONS OF ACTIVITIES

The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much?

	Yes, limited a lot	Yes, limited a little	No, not limited at all
3. Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports
4. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf
5. Lifting or carrying groceries
6. Climbing one flight of stairs
7. Climbing several flights of stairs
8. Bending, kneeling or stooping
9. Walking one block
10. Walking several blocks
11. Walking more than a mile
12. Bathing or dressing yourself

During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?

	Yes	No
13. Cut down the amount of time you spent on work or other activities
14. Accomplished less than you would like
15. Were limited in the kind of work or other activities
16. Had difficulty performing the work or other activities (for example, it took extra effort)

During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?

	Yes	No
17. Cut down the amount of time you spent on work or other activities
18. Accomplished less than you would like
19. Didn't do work or other activities as carefully as usual

20. During the past 4 weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbours, or groups?

Not at all	Slightly	Moderately	Quite a bit	Extremely

21. How much bodily pain have you had in the past 4 weeks?

None	Very mild	Mild	Moderate	Severe	Very severe

22. During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?

Not at all	A little bit	Moderately	Quite a lot	Extremely

These questions are about how you feel and how things have been with you during the past 4 weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the 4 weeks...

	All of the time	Most of the time	A good bit of the time	Some of the time	A little of the time	None of the time
23. Did you feel full of energy?
24. Have you been a very nervous person?
25. Have you felt so down in the dumps that nothing could cheer you up?
26. Have you felt calm and peaceful?
27. Did you have a lot of energy?
28. Have you felt downhearted and blue?
29. Did you feel worn out?
30. Have you been a happy person?
31. Did you feel tired?

32. During the past 4 weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)?

All of the time	Most of the time	Some of the time	A little of the time	None of the time

How TRUE or FALSE is each of the following statements for you.

	Definitely true	Mostly true	Don't know	Mostly false	Definitely false
33. I seem to get sick a little easier than most people
34. I am as healthy as anyone I know
35. I expect my health to get worse
36. My health is excellent

Lipoedema Symptom Score

How do you rate your pain intensity?

None	Minor	Medium	Strong	Very Strong

	Never	Seldom	Sometimes	Often	Almost always
How often are the affected areas painful?
Spontaneous bruising
Legs feel heavy
The affected areas on my legs feel cold
The affected areas on my arms feel cold
Ankle swelling
Lower back pain
Difficulty climbing stairs
Difficulty kneeling down
The affected areas are sensitive to touch or pressure
Knee pain
Difficulty walking

Your appearance

	Strongly disagree	Disagree	Undecided	Agree	Strongly agree
I am unhappy with the appearance of my legs
I find it difficult to get clothes that fit
I find it difficult to get shoes / boots that fit
I am self-conscious of showing my legs in public

This field is for validation purposes and should be left unchanged.