2..3. :9?j-,129: exp. :-!-89 X-127 id LBE: COXiACT EA: E FO!4 CODE: LAT AHE: TAL: TCTO: This form shold be completed in three stages. ection A shold be completed at the eception sation. The transcr:ption portion of ection B shold be completed while the participant proceeds with the visit. The interview portion of ection B, as well as ections C & D, shold then be completed dring the physical exam. The paper form is to be sed for data collection and keyed rnto the data entry system as soon as possible following its completion. D mber and ame ms.l be entered above. hhenever nmerical responses are reqired, enter the nmber so that the last digit appears in the rightmost box. Enter leading zeroes where necessary to fill all boxes. f a nmber is entered incorrectly, mark throgh the incorrect entm with an "".. Code the correct entry clearly above the incorrect entry. For "mltiple choiie,, and "yeslno', type qestions, circle the letter corresponding to the most appropriate response. f a letter is circled incorrectly, mark throgh it with an "X1' and circle the correct response. A. ECEPTO!'9CATO VE FOM (MA page 1 of 4) 1. Did yo bring the containers of ail nedications yo sed in the past.two veeks?............. es, all f "es all,,, go to ection B and begin transcription while'participant proceeds with clinic visit. f "ane of them", go to tem 3; transcribe those medications which were broght at this time. ome of them o 2. s this becase yo forgot, becase yo have not taken any medications at all in the last tvo veeks, or becase yo cold not bring yor medications?..... Took no medications T Forgot or was nable to bring medications 'F "That's all right. ince the information 'en medications is so important we wold still like to ask yo abot it dring the interview.', 3. Cold we follow p on this after the visit so that we can get the information from the (other) medication labe!s? {Explain follow-p options.}............................ es {Attempt to convert refsals; indicate on tinerary Form} o or not applicable Describe method of follow-p to be sed:
!.'ZZCATO vl FOPA (MA page 2 of 4). Tra cc) be scrietion (Csp:; tie :i~'-te followed by the ce..tpjit:o! f each nedicatron in the spaces OW. Ccnt:ne on second line f needed.):. nte?iev (For each medication, circ!e the appropriate response to the foiloving qestions.): c. "Was this medication d. "Did yo FAe rhis prescribed for yo, medication in L?e over-the-conter, past 24 hors?" or shared?" 4.?COD FL?3E - MEDCATO AE'kx COCETP,4TO b. 3. CODE OTC (o)/ HAED ()/ E ()/ O ()/ Ml. 1 1 n2. [ M3. 1 314. 1 1 1 J >l. M6. 1 1 t-48. 1 M9. ti HlO. L! 1 lll. [ 1
x-129 8. XDCATO ECOD iccntined)?ledcato V FO.. (MA page 3 of 4). Trmscription ico?y L!P!i.k fol:xed by the. nterflew (For each medication, circle CO';Cqii?ATC. k. of each medication :n tie spaces the appropriate response to the belov. Contrne cn second line if needed.): following qestions.): 4. "COD -';::?'BE ~CATO AHXa; COCZ++TAT:O c. - "Was this medication prescribed for yo, over-the-conter, or shared?" X ()/ OTC (): sh.4ed ()/ C4OL f) d. "Did yo take *is medication zn r-he past 24 hors?" ws ()/ O (,)/ LX~OW c?!12. x13. 'f14. M15. 316. 5. Total nmber of medications in bag:... 6. mber of q edcations nable to transcribe:... l 7. Transcriber Code mber:...
A-13.EDCATTO LTVE FOM (?!%A page & of &) c. reve "ow xold li'ke to ask abot a fev peczfic medications." a. Were ar.y of the nedicati ens yo tcok dring the past txo weeks for: {if "yes", verlf:; tiat nedicaticn na.2e is on nedrcation record.} a. High 91ood Pressre... es - tinkrcr.n - b. Angina or Chest Pain... c. Control of Heart hythm... d. Heart Failre... e. Blood Thinning... f. Diabetes or High Blood gar... g. troke... h. Leg pain when walking... ' 9. Dring the past tvo weeks, did yo take any Aspirin, Alka-eltzer, a cold medicine, or a headache powder?.................... es O nknown 1. Dring the past two weeks, did yo take any [other] medication for arthritis, fever, or mscle aches and pains, (or menstral cramps)?..... es {ead bracketed "other" inclde parenthetical nless no meds were reported; portion for females only.} o nknom D. ADX3KVE FO%GO 11. Date of medications interview:...... m-m-m Month Day ear 12. nterviewer Code mber:..,...,.
MEDCATO VE FOM TCTO page A131 MEDCATO VE FOM TCTO VEO A 11/l/86 _. GEEAL TCTO The prpose of this component of the AC baseline examination is to assess medication sage in the two weeks preceding the examination date. Both prescription and non-prescription drgs are ascertained. To obtain this information the participant is asked dring the home interview to bring to the field center all medications taken in the two-week period prior to the baseline examination. The interviewer and transcriber shold be familiar with and nderstand the docment titled "General nstrctions For Completing Paper Forms" prior to completing this form. D mber, Contact ear, and ame shold be completed as described in that docment. f the paper fom is sed for data collection, the header information of the Medication rvey Form shold be completed prior to the arrival of the participant at the field center and the information keyed into the data entry system as soon as possible following its completion.. DETALED TCTO FO EACH TEM A. eception 1. Did yo bring the containers of all medications yo sed in the past two weeks?....... es, all some of them O f "es, all", go. to ection B and begin transcription. This can take place while participant proceeds with clinic visit. As the participant delivers the medications, indicate that they will be retrned at this same station before he/she leaves. Mention that medication and that if reqired, medications will names will be copied from the labels, be taken ot their container only in the * presence of, and with approval of the participant. Finally, indicate that rse or P.A. may later ask a few qestions abot each medication. Verify the that the medications bag is clearly identified with the participant's name. Do not open the medications bag or transcribe medications ntil the participant has signed the informed consent. f "ome of them" go to tem 3 to make arrangements for those medications which were not broght;'transcribe those medications which were broght at this time. AC POTOCOL 2. Cohort Component Procedres. Version 2.1 12188
MEDCATO VE FOM TCTO page A 132.1 f the participant has not broght any medications, qestion 2 is asked: 2. s this becase yo forgot, becase yo have not taken any medications at all in the last two weeks, or becase yo cold not bring yor medications?... Took no medications T i C* to tern 9, i Forgot or was nable Page 4 to bring medications F t f the participant took no medications in the past two weeks, ection A ends here. etrn the form to the participant's folder. n sch cases, the interview portion of the form begins with item 9. Qestion 3 is asked if the participant did take some medications in the past two weeks, bt did not bring them to the field center (or only broght some of them): hatls all right. ince the information on medications is so important we wold still like to ask yo abot it dring the interview." 3. Cold we follow p on this after the visit so that we can get the information from the (other) medication labels? (Explain follow-p options.}................... es o or not applicable f the participant agrees to follow-p, arrangements are made for obtaining the information over the telephone or throgh a visit by a field interviewer. Describe the method of follow-p after item 3 on the form. f the participant did bring some of his/her medications, complete as mch of the form as possible sing them at this time. n case of deliberate omission to bring medications to the field center, this is indicated on the tinerary heet and conversion is attempted at a later stage dring the medical review of reslts with the participant. Even if the participant refses to cooperate, attempt to complete as mch of the form as possible, especially items 8 throgh 1. B. Medication Transcription Open the medications carrier and remove all medications, prescriptions, and containers. Complete the transcription section, copying each medication name fond on containers, prescriptions, or lists. Transcribe medication names in fll (block letters if sing the paper form). nclde all parts of the medication name as well as nmbers and/or letters that identify the strength. Copy the name first, followed by the concentration or strength of the medication, if a single concentration is listed. Examples: Chlor-Trimethon 12 mg; Teldrin 8mg; Ascorbic Acid 25 mg; ostril l/22; Anacin Maximm trength. Copy also any nmbers and codes that appear to follow, or be part of the name. Examples: Anacin-3; Acerola C (1 mg); Triaminic-12; Ovral-28; Ortho-ovm lo/ll-28; tartnatal 1 + 1; letin PH; -K Ampicillin; Caltrate 6 + Vitamin D. f in dobt, it is preferable to add information that may be significant and help later in identifying (and coding) a medication. AC POTOCOL 2. Cohort Component Procedres. Version 2.1 12188
MEDCATO VE FOM TCTO page A 132.2 Do not record information in the interview section at this time. Example:. Transcriotion (Copy the AME followed by the. nterview [For each medication, circle COCEBTATO of each medication in the spaces the appropriate response to the below. Contine on second line if needed.): following qestions.): c. "Was this medication d. "Did yo fake this prescribed for yo, medication in the over-the-conter, past 24 hors?" or shared?" 4. ECOD a. MBE MEZDCATOAME & COCETATO b. CODE C. X (/ OTC to)/ HAGD ()/ lcow () E ()/ O (J/ J?Kow f) Ml. M2. 1 1 1 1 1 1 1 1 1 1 1 1 1 1 When listing medications, record prescription medications first; then aspirin, aspirin-containing medications, and anti-inflammatory preparations (aspirin, Alka-eltzer, headache powders, cold medicine, medication for arthritis); then list over-the-conter preparations; list vitamins and food spplements last. Once all names are transcribed, cont the total nmber of different medications (inclding those which cold not be transcribed) and enter this nmber in item 5. et aside any containers which have no clear label or identification, as well as medications withot containers. ames shold be left blank on the form ' for these medications. Add the nmber of these medications which yo were nable to transcribe, and enter this nmber in item 6. For example, if there were 7 medications in the bag, and yo were able to transcribe 5 of them, items 5 and 6 wold be completed as follows: 5. Total nmber of medications in bag:.............. 1 ' t 1 6. mber of medications nable to transcribe:...... ' AC POTOCOL 2. Cohort Component Procedres. Version 2.1 12188
MEDCATO VE FOM TCTO page A 133 Open containers to examine medications only in the presence of the participant. f necessary, make a note on the form, and let the participant know that the rse/p.a. will identify these medications with the participant. Enter yor AC code nmber in item 7, retrn the medications into the medications bag, attach the M form to the bag, and proceed to the medication srvey, or take them to the station identified for the medication srvey. At no time shold the medications be left nattended at the eception area. C. nterview To begin the medications srvey, retrieve the appropriate bag and form, verifying the participant's name. Place all medications from the bag on the desk or conter so that the participant can see each one. Take each medication, one at a time, and verify its name and concentration transcribed on the form. Correct discrepancies following the procedre for all paper forms. ext, show the medication to the participant and ask the two qestions to the right of the transcribed medication names: c. Was this medication prescribed for yo, over-the-conter, or shared? For the prposes of this stdy, a prescription medicine is one for which the participant has received from his or her physician a prescription that is filled by a pharmacist. An over-the-conter medication is one that may be prchased withot a prescription from a physician. Physicians sometimes do write prescriptions for over-the-conter medicines. For example, the participant may take one aspirin a day. f the physician wrote a prescription for the aspirin, then it conts as a prescription medicine. f the physician recommended the se of an over-the-conter medicine sch as aspirin bt did not write a prescription for it, then the aspirin does not cont as a prescription medication. d. Did yo take this medication in the past 24 hors? The first qestion cc.1 is intended to clarify whether the medication was a perscription written specifically for the participant (X), which may be obvios from the container or a prescription, a prescription written for another individal (HAED), or a prodct prchased over the conter (OTC). f this cannot be determined from the container or the participant, mark the "nknown" response (KOW). Be sre to ask the participant if a prodct was prescribed. Even if it is normally an OTC prodct, or not labelled as prescription, it may have been prescribed. f the participant has indicated s/he took no medications, or only sch prodcts as vitamins, it is permissible to preface the qestion with an explanation. " know yo said yo took no medications, bt we se these qestions as a memory jogger." The second qestion (d.) is self-explanatory. To assist the participant in remembering, one may state the qestion specifying a time on the previos day. For example, "Have yo taken this medication since 1: AM yesterday?" AC POTOCOL 2. Cohort Component Procedres. Version 2.1 12188
MEDCATO VE FOM TCTO page A-134.1 Example:. Transcriotion (Copy the AME followed by the COCEXATO of each medication in the spaces below. Contine on second line if needed.):. nterview (For each medication, circle the appropriate response to the following qestions.): c. Was this medication d. "Did yo take this prescribed for yo, medication in the over-the-conter, past 24 hors?" or shared?" X (/ 4. OTC (O)/ E ()/ ECOD a. b. HAED ()/ O (J/ MBE MEDCATO AME & COCEXATO CODE O. KOW m KOW (V Ml. t 1,, io.""'1 epeat this process (verify name, ask the qestions) for all medications. Determine from item 6 at the end of the medication transcription page whether there were any medications in the bag for which the transcriber was nable to transcribe a name. These may inclde nmarked containers, loose pills, and containers with more than one medication. Ask the participant to open any nmarked containers, and to handle loose pills. With the participant's help and sing a PD, attempt to identify these medications. f possible, enter the names and concentrations, and ask the two qestions as above. f no neqivocal identification is possible, write KOW for the medication name and draw two horizontal lines throgh the boxes for the medication code nmber. f additional meds can be transcribed, adjst the total for item 6, "nmber of medications nable to transcribe" accordingly. After this has been completed for all containers, prescriptions, and medications in the bag, probe the participant on whether all medications taken in the previos two weeks are inclded. For any additional medications recalled by the participant, record the names and answer the qestions with as mch detail as possible. f there is any dobt,. arrange for a phone call dring which the participant can provide accrate information. Often dring an interview, the participant will recall other medications or vitamins s/he took dring the past two weeks. These shold be added to the list at this time, jst as if they had been in the bag. The prescription or OTC natre, and whether they were sed in the previos 24 hors are then recorded. However, the nmber of medications in the bag is not changed at this time, to alert s to the fact that the participant has provided these names from memory and AC staff have not transcribed these names from a written record. tem 8 is to be asked of anyone who took any medications dring the past two weeks, regardless of whether or not they were broght to the clinic. n addition to the listing of individal medication names, we want to know why people may be taking medications. Ask if medications were taken in the past two weeks for the eight listed reasons. f answered affirmatively, be sre that the AC POTOCOL 2. Cohort Component Procedres. Version 2.1 12/88
MEDCATO VE FOM TCTO page A 134.2 name was listed, bt it is not necessary to indicate which medication corresponds to which reason. Acceptable synonyms are given below: a. High Blood Pressre = hypertension b. Angina or Chest Pain = heart pains c. Control of Heart hythm = medicine for fast or irreglar heart rate or heartbeats d. Heart Failre = congestive heart failre, not heart attack e. Blood Thinning = anticoaglation h. Leg pain when walking = cladication For example, if the participant had taken medication for high blood pressre and cladication, record as follows: 8. Were any of the medications yo took dring the past two weeks for: (f "es", verify that medication name is on medication record.} es L!2 nknovm a. High Blood Pressre... b. Angina or Chest Pain... c. Control of Heart hythm... d. Heart Failre... e. Blood Thinning... f. Diabetes or High Blood gar... g. troke... h. Leg pain when walking... tems 9 and 1 are to be asked of all participants, regardless of whether they reported taking any medications dring the past two weeks. The same preamble to qestion 8 abot "jogging the memory" may also be sed before qestions 9 and/or 1: " know yo said yo took no medications, bt we se these qestions as a memory jogger." 9. Dring the past two weeks, did yo take any Aspirin, Alka-eltzer, a cold medicine, or a headache powder?.................... es o nknown n item 9, we ask abot aspirin or aspirin containing medications becase these may affect some of the hemostasis tests. Again, confirm whether the names are on the medication record. AC POTOCOL 2. Cohort Component Procedres. Version 2.1 12188
MEDCATO VE FOM TCTO page A 134.3 1. Dring the past two weeks, did yo take any [other] medication for arthritis, fever, or mscle aches and pains, (or menstral cramps)?..... es {ead bracketed "other" nless no meds were reported; inclde parenthetical portion for females only.} o, nknown n item 1, we ask abot analgesic and anti-inflammatory medications that are not aspirin-based, becase they also affect the hemostasis tests. Confirm whether the names are on the medication list. Follow the instrctions provided after the qestion. eview the form for completeness, and place yor code in the spaces provided in item 12. ecre all medications in the bag and explain to the participant that he/she shold pick it p from the eceptionist before leaving. Place the form in the participant's folder, and escort the participant to the next station. etrn the medications bag to a secre place at the eception work station. Medication Coding at the Field Center Each medication name is coded by trained field center personnel. This may be done after the participant has left. A (hard copy) translation dictionary is sed at the field center, or matching software if done at the Coordinating Center. Only exact matches and specific spelling variants listed in the dictionary are coded, by entering the corresponding nmeric code in the boxes provided on the form. AC POTOCOL 2. Cohort Component Procedres. Version 2.1 12188