All subjects who had baseline evaluations, including all randomized subjects Visits Baseline Visits 1-3, Month 6, Month 12, Month 24 VISIT codes
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1 Trial CALERIE 2 Dataset (Rand SF-36 QOL instrument) Description RAD SF-36 QOL data from CRF. Includes responses to each item in the questionnaire and derived scores using SF-36 scoring algorithm (see QOL scoring MOP). Comments on data structure 1 record / DEIDUM / VISIT Population All subjects who had baseline evaluations, including all randomized subjects Visits Baseline Visits 1-3, Month 6, Month 12, Month 24 VISIT codes Source data files CRF/ RADSF1, RADSF2, RADSF3, DATEHDR, AALDATA/SUBJECT1 Final sort order DEIDUM VISIT DEIDUM Subject umber DEIDUM C PAGEUM CRF page number RADSF1.PAGEUM VISIT Visit PAGEUM Study Visit, based on CRF page (See Appendix) VISFMT SUBVISIT Sub-Visit PAGEUM Study Sub-visit, based on CRF page (See Appendix) SVISFMT SF36DT Date of SF-36 DATEHDR.STUDYDT DT DT SF36DRS Reason SF-36 not done DATEHDR.STUDYD TUD CRFSF36 SF-36 done SF36DT =1 if SF36DT is non-missing else =0 The following variables RADSF1 assign scores to each SF36 item according to the official scoring algorithm. Value refers to the value of the source variable as indicated in the CRF. =100 if value=1 =75 if value=2 RADSF1 Health RADSF1.HEALTH =50 if value=3 =25 if value=4 =0 if value=5 RADSF2 Health compared to last year RADSF1.GHLTHOW Same as RADSF1 0=Poor 25=Fair 50=Good 75=Very good 100=Excellent 0=Much worse now 25=Somewhat worse now 50=About the same 75=Somewhat better now 100=Much better now
2 RADSF3 Vigorous activities RADSF1.VIGORACT =50 if value=2 =100 if value=3 0=Yes, limited a lot 50 = Yes, limited a little 100=o, not limited at all RADSF4 Moderate activities RASDF1.MODACT Same as RADSF3 See RADSF3 RADSF5 Lifting or carrying groceries RADSF1.LIFTCARR Same as RADSF3 See RADSF3 RADSF6 Climbing several flights RADSF1.CLIMBSEV Same as RADSF3 See RADSF3 RADSF7 Climbing one flight RADSF1.CLIMB1 Same as RADSF3 See RADSF3 RADSF8 Bending, kneeling, stooping RADSF1.BEDIG Same as RADSF3 See RADSF3 RADSF9 Walking more than a mile RADSF1.WALKMILE Same as RADSF3 See RADSF3 RADSF10 Walking several blocks RADSF1.WALKSBLK Same as RADSF3 See RADSF3 RADSF11 Walking one block RADSF1.WALKBLCK Same as RADSF3 See RADSF3 RADSF12 Bathing or dressing yourself RADSF1.BATHIG Same as RADSF3 See RADSF3 RADSF13 Cut work time due to physical RADSF2.CUTWORK1 RADSF14 RADSF15 RADSF16 RADSF17 RADSF18 RADSF19 RADSF20 Accomplished less due to physical Limited kind of work due to phys. Difficulty with work due to phys. Cut work time due to emotional problems Accomplished less due to emotional probs Didn t work carefully due to emot. probs Phys/emot probs interfered w/ soc. acts. =100 if value=2 0=Yes 100=o RADSF2.ACCOMLE1 Same as RADSF13 See RADSF13 RADSF2.LIMWORK1 Same as RADSF13 See RADSF13 RADSF2.DIFWORK1 Same as RADSF13 See RADSF13 RADSF2.CUTWORK2 Same as RADSF13 See RADSF13 RADSF2.ACCOMLE2 Same as RADSF13 See RADSF13 RADSF2.CAREFUL Same as RADSF13 See RADSF13 RADSF2.SOCIAL Same as RADSF1 0=Extremely 25=Quite a bit 50=Moderately 75=Slightly 100=ot at all
3 RADSF21 Bodily pain RADSF2.BODPAI =100 if value=1 =80 if value=2 =60 if value=3 =40 if value=4 =20 if value=5 =0 if value=6 RADSF22 Pain interfered with normal work RADSF2.ITERFE Same as RADSF1 RADSF23 Full of pep RADSF3.PEP Same as RADSF21 RADSF24 ervous RADSF3.ERV =20 if value=2 =40 if value=3 =60 if value=4 =80 if value=5 =100 if value=6 0=Very severe 20=Severe 40=Moderate 60=Mild 80=Very mild 100=one 0=Extremely 25=Quite a bit 50=Moderately 75=A little bit 100=ot at all 0=one of the time 20=A little of the time 40=Some of the time 60=A good bit of the time 80=Most of the time 100=All of the time 0=All of the time 20=Most of the time 40=A good bit of the time 60=Some of the time 80=A little of the time 100=one of the time RADSF25 Down in the dumps RADSF3.DOW Same as RADSF24 See RADSF24 RADSF26 Calm and peaceful RASF3.CALM Same as RADSF21 See RADSF21 RADSF27 Lot of energy RADSF3.EERG Same as RADSF21 See RADSF21 RADSF28 Downhearted and blue RADSF3.BLUE Same as RADSF24 See RADSF24 RADSF29 Worn out RADSF3.WOR Same as RADSF24 See RADSF24 RADSF30 Happy RADSF3.HAPPY Same as RADSF21 See RADSF21 RADSF31 Tired RADSF3.TIRED Same as RADSF24 See RADSF24 RADSF32 Phys/emot probs interfered w/ soc. acts. RADSF3.EMOTPROB =25 if value=2 =50 if value=3 =75 if value=4 =100 if value=5 0=All of the time 25=Most of the time 50=Some of the time 75=A little of the time 100=one of the time
4 RADSF33 Get sick easily RADSF3.SICK Same as RADSF32 RADSF34 As y as anybody RADSF3.HEALTHYA Same as RADSF1 0=Definitely True 25=Mostly true 50=Don t know 75=Mostly false 100=Definitely false 0=Definitely false 25=Mostly false 50=Don t know 75=Mostly true 100=Definitely true RADSF35 Expect to get worse RADSF3.EHWORSE Same as RADSF32 See RADSF33 Health is excellent RADSF3.HEXCEL Same as RADSF1 See RADSF34 SF36 umber of non-missing SF-36 umber of non-missings among RADSF1 responses RADSF1 MISSF36 umber of missing SF-36 responses RADSF1 Defined only if CRFSF36=1 umber of missings among RADSF1 Missing if CRFSF36<1. =Average of PFSCORE SF-36 Physical functioning RADSF3,4,5,6,7,8,9,10, RADSF3,4,5,6,7,8,9,10,11,12 if >= 8 11,12 of the components are non-missing. Else missing RLPHSCOR RLEPSCOR SF-36 Role limits. due to phys. SF-36 Role limits. due to emot. probs. RADSF13,14,15,16 RADSF17,18,19 EFSCORE SF-36 Energy / fatigue RADSF23,27,29,31 EWBSCORE SF-36 Emotional well being RADSF24,25,26,28,30 SFSCORE SF-36 Social functioning RADSF20, 32 =average of RADSF13,14,15,16 if all 4 components are non-missing =average of RADSF17,18,19 if all 3 components are non-missing, =average of RADSF23,27,29,31 if all 4 components are non-missing, =average of RADSF24,25,26,28,30 if all 5 components are non-missing, =average of RADSF20,32 if SF=2 if both components are non-missing,
5 PAISCOR SF-36 Pain RADSF21,22 GHSCORE SF-36 General RADSF1,33,34,35,36 =average of RADSF21,22 if P=2 if both components are non-missing, =average of RADSF1,33,34,35,36 if all 5 components are non-missing,
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