Before we start the medical measurements, I would like to check that you have read the information which was sent to you in advance. There will be an opportunity later on to ask any questions about the blood and saliva samples, but in the meantime, do you have any questions at this stage about any of the other measurements?
Before we start, I need to ask you to sign this form. It shows which measurements you have said you are willing for me to carry out. Please remember that if at any time you change your mind about any measurement you only need to tell me. I will also make a note of your decisions on this copy (NURSE: SHOW COHORT MEMBER COPY OF CONSENT BOOKLET) and then at the end of the interview I will leave this for you to keep for future reference. NURSE: ASK COHORT MEMBER TO READ, SIGN AND DATE COSENT FORM 1.
Can I check what you have?
First I'm going to check your near vision. IF RESPONDENT EVER WEARS GLASSES OR CONTACT LENSES, ASK: Please put on what you would normally wear for reading or close work. If you don't wear glasses specially for reading or close work, please wear your usual distance glasses or contact lenses, even if you don't always use them.
ASK RESPONDENT TO READ OUT THE SMALLEST COMPLETE LINE OF WORDS THEY CAN MANAGE. CODE SIZE.
ASK RESPONDENT TO READ OUT THE SMALLEST COMPLETE LINE OF WORDS THEY CAN MANAGE. CODE SIZE.
Now I'm going to check your distance vision, that is how well you see things which are a bit further away.For this you need to wear the glasses or contact lenses you use for activities such as going out, driving or watching TV.
HOLD GLASSES FACING YOU, WITH EAR PIECES POINTING TOWARDS +. LOOK AT + THROUGH WEARER'S RIGHT LENS - THE LENS TO YOUR LEFT. (IF BIFOCALS OR VARIFOCALS LOOK THROUGH TOP HALF OF LENS.) DOES + LOOK BIGGER, SMALLER OR THE SAME? IT DOES NOT MATTER IF IT IS DISTORTED
NURSE: OFFER BLOOD PRESSURE RESULTS TO COHORT MEMBER. [ALL THREE READINGS FOR SYSTOLIC BP, DIASTOLIC BP, PULSE SHOWN ON SCREEN] ENTER THESE ON [COHORT MEMBER'S NAME]'S MEASUREMENT RECORD CARD(COMPLETE NEW RECORD CARD IF REQUIRED). [INSTRUCTION TO NURSE TO TICK BOX ON MEASUREMENT RECORD CARD AND GIVE APPROPRIATE FEEDBACK - SEE BOX BELOW]
I am going to test your hearing by measuring the faintest sounds you can hear. I will play you two different tones in each ear, and with each tone, I will play it at different levels of loudness and softness. As soon as you hear a sound, raise your finger. Keep it raised as long as you can hear the sound, no matter which ear you hear it in. Put your finger down when you cannot hear the sound. It is important that you keep as quiet as possible, in order to hear the quietest tones. Even if the sound is very faint, and no matter which ear it is in, raise your finger. It will help if you breathe quietly through your mouth. No matter how faint the sound you hear, raise your finger when you think you can hear it and lower your finger when you can't hear the sound any longer.
Earlier on you said that you didn't want your weight tested. Can you tell me why you said that or have you changed your mind since then?
NURSE: ASK COHORT MEMBER FOR AN ESTIMATED WEIGHT. [IF PREGNANT: ESTIMATED WEIGHT SHOULD BE IMMEDIATELY PRIOR TO THIS PREGNANCY] WILL IT BE GIVEN IN KILOGRAMS OR IN STONES AND POUNDS? IF COHORT MEMBER DOESN'T KNOW WEIGHT USE <CTRL+K>, IF COHORT MEMBER ISN'T WILLING TO GIVE WEIGHT USE <CTRL+R>.
I would now like to measure your waist and hips. These measurements are very useful for assessing the distribution of weight over the body.
RECORD ANY PROBLEMS WITH WAIST MEASUREMENT:
NURSE CHECK: CODE ONE ONLY.
TAKE A READING FROM THE RIGHT EYE FIRST. THEN TAKE A READING FROM THE LEFT EYE. PRINT OUT THE RESULTS. MAKE SURE THE QUALITY SCORE IS 8 OR HIGHER. IF QUALITY SCORE IS 7 OR LOWER, CHECK YOUR POSITION, LIGHT LEVELS AND THAT THE SUBJECTS IS NOT BLINKING AND THEN REPEAT UP TO 3 TIMES. PRINT OUT RESULTS. ENTER SUMMARY (BOTTOM ROW) SCORES FOR EACH EYE INTO CAPI. CODE '1' TO CONTINUE.
CONSENT TO BLOOD SAMPLING If you agree I would now like to take a sample of your blood. As explained in the information sheet, this is an important part of the study, because the blood can be analysed in a number of ways. Some tests will be performed in the lab as soon as they receive the sample. Other tests may be done in future on portions of blood which have been stored frozen for many years. There is currently interest in genetic tests which use the DNA contained in white blood cells, and you were sent a separate leaflet explaining this. Do you have any questions about the blood collection or the storage of blood or DNA for medical research purposes?
We need your written permission to collect a blood sample, to store portions of it for future research, to use the DNA, and to store the white blood cells so that in future they can be used as a renewable source of DNA. You can choose whether to give your signed consent for each of these four things.
How long ago did you have anything to eat or drink, excluding water - please include snacks and cups of tea, coffee, alcohol or soft drinks?
READ OUT TO ALL: The next set of questions will probably be easier if you read them and answer them yourself, using the computer. The computer is very easy to use. The questions are quite personal and, this way, your answers will be completely confidential and I won't see them. When you have finished, the whole section will get automatically locked up inside the computer so that I can't look back at it.
Which of these things have you done in the last seven days?
Think back to when your regular drinking was at its highest level. The next two questions are about the time when you were drinking at your highest level over a period of three months or longer. During the time your drinking was at its highest level, how often did you have a drink containing alcohol?
Please indicate your reasons for not drinking. You can choose as many as apply. If more than one answer applies, type the first number then press the SPACE bar then type the next number then press the space bar again etc. When you have entered all the numbers that apply, press the ENTER key.
Please indicate if any of the following have influenced your drinking. You can choose as many as apply. If more than one answer applies, type the first number then press the SPACE bar then type the next number then press the space bar again etc. When you have entered all the numbers that apply, press the ENTER key.
Why did you give up drinking alcohol? You can choose as many as apply. If more than one answer applies, type the first number then press the SPACE bar then type the next number then press the space bar again etc. When you have entered all the numbers that apply, press the ENTER key.
Why did you cut down on your drinking? You can choose as many as apply. If more than one answer applies, type the first number then press the SPACE bar then type the next number then press the space bar again etc. When you have entered all the numbers that apply, press the ENTER key.
That was the last question for you to answer on the computer yourself. We hope that you were able to answer the questions without too much trouble. Now that you have reached the end, thinking back, are there any answers you would like to change, or is there anything you would like to add to any of the answers you have given?
NURSE: THE NEXT SECTION IS THE CIS-R INTERVIEW. MAKE SURE THE CM CAN ANSWER THESE QUESTIONS IN CONFIDENCE. PLEASE EXPLAIN THAT THESE QUESTIONS ARE CONFIDENTIAL, AND ASK ANYONE ELSE IN THE ROOM TO LEAVE FOR A FEW MINUTES. MAKE SURE THAT THE INTERVIEW CANNOT BE OVERHEARD.
Thinking about the night you had the least sleep in the past week, how long did you spend trying to get to sleep? (If you woke up or were woken up I want you to allow a quarter of an hour to get back to sleep)
Some people have phobias; they get nervous or uncomfortable about specific things or situations when there is no real danger. For instance they may get nervous when speaking or eating in front of strangers, when they are far from home or in crowded rooms, or they may have a fear of heights. Others become nervous at the sight of things like blood or spiders. In the past month have you felt anxious, nervous or tense about any specific things or situations when there was no real danger?
The next questions are concerned with general anxiety/nervousness/tension only. [I will ask you about the anxiety which is brought on by the phobia about specific things or situations later] On how many of the past seven days have you felt generally anxious/nervous/tense?
In the past week, when you've been anxious/nervous/tense, have you had any of the symptoms shown on this card? CODE ALL THAT APPLY
Sometimes people avoid a specific situation or thing because they have a phobia about it. For instance, some people avoid eating in public or avoid going to busy places because it would make them feel nervous or anxious. In the past month, have you avoided any situation or thing because it would have made you feel nervous or anxious, even though there was no real danger?
Can you look at this card and tell me which of the situations or things listed made you the most anxious/nervous/tense in the past month? INTERVIEWER: CODE ONE ONLY
Can you look at this card and tell me which of the situations or things did you avoid the most in the past month? INTERVIEWER: CODE ONE ONLY
In the past week, on those occasions when you felt anxious/nervous tense did you have any of the symptoms on this card? INTERVIEWER: CODE ALL THAT APPLY
Finally, we need to collect a couple of samples of your saliva. Saliva contains a substance called cortisol, which is a measure of stress. Because cortisol levels vary during the day, we need to take samples at specific times. Would you be willing to take samples of your saliva during the next couple of days. It won't take very much time. We will give you an envelope to post the samples to us.
SHOW RESPONDENT RED AND BLUE DOTS ON CAPS. RED DOT FOR FIRST SAMPLE - 45 MINUTES AFTER WAKING UP (BEFORE BREAKFAST). IMPORTANT, DON'T CLEAN TEETH, EAT OR DRINK ANYTHING FIRST, ESPECIALLY NO FRUIT OR FRUIT JUICES. BLUE DOT FOR SECOND SAMPLE - 3 HOURS AFTER FIRST SAMPLE. IMPORTANT, DON'T EAT OR DRINK IN THE 15 MINUTES BEFORE SAMPLE (EG BEFORE LUNCH). CODE '1' TO CONTINUE
GIVE COHORT MEMBER INSTRUCTION LEAFLET, RETURN FORM AND ENVELOPE. ATTACH ONE BARCODE LABEL ON BACK OF FORM AND ONE ON EACH SALIVETTE. EXPLAIN THE TWO SAMPLES TO BE TAKEN ON THE SAME DAY. WHAT TO DO IF SECOND SAMPLE MISSED OR TUBES LOST - PHONE FOR REPLACEMENTS, NUMBER ON LEAFLET. COHORT MEMBER SHOULD WRITE TIME AND DATE OF COLLECTION ON FORM. TUBES AND FORM IN ENVELOPE, POST. NO NEED FOR A STAMP. CODE '1' TO CONTINUE