対照群がない研究デザインで効果を推定する（時系列分断デザイン・自己対照研究デザイン）

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ରর܈͕ͳ͍ݚڀσβΠϯͰޮՌΛਪఆ͢Δ ʢ࣌ܥྻ෼அσβΠϯɾࣗݾରরݚڀσβΠϯʣ ࠤ౻ढ़ଠ࿕ ௕࡚େֶපӃྟচݚڀηϯλʔ TIVOUBSPTBUP!OBHBTBLJVBDKQ

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2 0WFSWJFX ूஂʹରͯ͠հೖΛ͓͜ͳͬͨͨΊɺ   հೖΛड͚͍ͯͳ͍ର৅ऀ͕͍ͳ͍ ͋Δूஂͷ͏ͪɺ   ΠϕϯτΛىͨ͜͠ਓͷσʔλ͔͠ͳ͍ ࣌ܥྻ෼அσβΠϯ ࣗݾରরݚڀσβΠϯ ରর܈ͷσʔλ͕ͳ͍ʂ

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ӸֶݚڀͷσβΠϯ

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ҩֶݚڀͷ෼ྨ 4 %FTDSJQUJPO &YQMPSJOH BTTPDJBUJPOT 1SFEJDUJPO $BVTBMJOGFSFODF %JBHOPTUJD QFSGPSNBODF FWBMVBUJPO هड़ ؔ࿈ͷ୳ࡧ ༧ଌ ҼՌਪ࿦ ਍அͷੑೳධՁ ม਺͸ͲΜͳ෼෍͔ʁ Ͳͷม਺͕Ξ΢τΧϜʹ ؔ࿈͢Δ͔ʁ Ξ΢τΧϜΛ༧ଌ͢Δ ॲஔ͕Ξ΢τΧϜʹ   Өڹ͢Δ͔ʁ ೚ҙͷධՁํ๏ͷ   ਍அੑೳ͸ʁ w )FSOÂO." )TV+ )FBMZ#"4FDPOE$IBODFUP(FU$BVTBM*OGFSFODF3JHIU"$MBTTJ fi DBUJPOPG%BUB4DJFODF5BTLT$IBODF+BO r w 7JUUJOHIP ff & (MJEEFO%7 4IJCPTLJ4$ .D$VMMPDI$&3FHSFTTJPONFUIPETJOCJPTUBUJTUJDTMJOFBS MPHJTUJD TVSWJWBM BOESFQFBUFENFBTVSFT NPEFMT4QSJOHFS4DJFODF#VTJOFTT.FEJB

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ҼՌਪ࿦ 5 " : w ॲஔ"͸ɺΞ΢τΧϜ:ʹӨڹ͢Δ͔ʁ w Ξ΢τΧϜ:ʹର͢Δॲஔ"ͷޮՌ͸ʁ ݪҼ ॲஔʢ5SFBUNFOUʣ հೖʢ*OUFSWFOUJPOʣ മ࿐ʢ&YQPTVSFʣ ݁Ռ Ξ΢τΧϜʢ0VUDPNFʣ

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ӸֶݚڀσβΠϯͷ෼ྨ 6 ରর܈͕͋ΔσβΠϯ ରর܈͕ͳ͍σβΠϯ ఻౷తͳσβΠϯ w ϥϯμϜԽൺֱࢼݧ w ԣஅݚڀ w ίϗʔτݚڀ w ঱ྫରরݚڀ w 1SF1PTUσβΠϯ ൃలతͳσβΠϯ w ࠩ෼ͷࠩσβΠϯ   %J ff FSFODFJO%J ff FSFODF %J% w ճؼ෼அσβΠϯ w ࣌ܥྻ෼அσβΠϯ w ࣗݾରরݚڀσβΠϯ

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ͳͥରর܈͕ඞཁ͔ʁ 7 WT WT 1PQVMBUJPO ॲஔ͋Γ " ॲஔͳ͠ " E[Ya=1] E[Ya=0] E[Y|A = 1] E[Y|A = 0] $BVTBMF ff FDU ҼՌޮՌ "TTPDJBUJPO ؔ࿈ )FSOÂO." 3PCJOT+. $BVTBM*OGFSFODF8IBU*G#PDB3BUPO$IBQNBO)BMM$3$'JHVSFΛվม ͜͜ΛධՁ͢ΔͨΊʹ   ରর܈͕ඞཁ

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ͳͥରর܈͕ͳ͍ͷ͔ʁᶃ 8 ࣌ؒ ېԎ৚ྫ ٸੑףಈ຺   ൃ঱਺ ਓ ਓ ਓ ਓ ਓ ਓ ਓ ࠃຽʹର͢Δ੓ࡦ΍ྙཧతͳ໰୊ʹΑΓɺ ूஂશһʹରͯ͠հೖΛ͓͜ͳͬͨͨΊɺհೖΛड͚͍ͯͳ͍ର৅ΛઃఆͰ͖ͳ͍ ͋Δूஂͷ͏ͪɼؔ৺ͷ͋ΔΠϕϯτΛىͨ͜͠ਓͷ਺ ؔ৺ͷ͋ΔհೖɿېԎ৚ྫ ؔ৺ͷ͋ΔΠϕϯτɿٸੑףಈ຺ൃ঱

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ͳͥରর܈͕ͳ͍ͷ͔ʁᶄ 9 ΠϕϯτΛىͨ͜͠ਓͷσʔλ͔͠ͳ͍ w ϫΫνϯ઀छঢ়گ w എܠ৘ใ ϫΫνϯ઀छऀ ϫΫνϯ઀छ։࢝ ෭൓Ԡ ෭൓Ԡ ෭൓Ԡ ࣌ؒ σʔλ͋Γ σʔλ͋Γ σʔλ͋Γ σʔλͳ͠ σʔλͳ͠ σʔλͳ͠ σʔλͳ͠ σʔλͳ͠ ෭൓ԠͱͳΓ͑Δ   Πϕϯτൃ঱ऀ /%#

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ूஂϨϕϧɾݸମϨϕϧ 10 ूஂʹରͯ͠հೖΛ͓͜ͳͬͨͨΊɺ   հೖΛड͚͍ͯͳ͍ର৅ऀ͕͍ͳ͍ ͋Δूஂͷ͏ͪɺ   ΠϕϯτΛىͨ͜͠ਓͷσʔλ͔͠ͳ͍ ूஂϨϕϧͷ৘ใ ʢ͋Δ࣌ؒ୯ҐͰूܭ͞ΕΔͨΊɺ   ݸମϨϕϧͷ৘ใ͕ෆ໌ʣ ݸମϨϕϧͷ৘ใ ࣌ܥྻ෼அσβΠϯ   ʢ෼அ࣌ܥྻσβΠϯʣ *OUFSSVQUFEUJNFTFSJFTEFTJHO   *54 ࣗݾରরݚڀσβΠϯ 4FMGDPOUSPMMFETUVEZEFTJHO   4$$4

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࣌ܥྻ෼அσβΠϯ *OUFSSVQUFEUJNFTFSJFTEFTJHO *54

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*54͸ԿΛධՁ͢Δ͔ʁ 12 ूஂʹର͢Δհೖ -FWFMDIBOHFհೖʹΑΔٸܹͳมԽ հೖલͷτϨϯυʢ܏͖ʣ հೖޙͷ   τϨϯυʢ܏͖ʣ 4MPQFDIBOHFհೖʹΑΔτϨϯυͷมԽ ूஂʹର͢ΔհೖͷޮՌΛධՁ͢Δ

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*54ʹదͨ͠σʔλ͸ʁ 13 ूஂʹର͢Δհೖ ౳ִؒͳ࣌఺Ͱଌఆ͞Εͨσʔλ հೖ։࢝࣌఺͕ΫϦΞ w Ξ΢τΧϜม਺ͷई౓͸ɺҰൠԽઢܗϞσϧͰѻ͑Δई౓ͳΒ0, w قઅͷΑ͏ͳपظੑΛߟྀ͢ΔͨΊͷ࣌఺਺Ҏ্͕ਪ঑

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ંΕઢճؼϞσϧɿ*54Ͱར༻͢Δ౷ܭղੳख๏ 14 ંΕઢճؼϞσϧ 4FHNFOUFESFHSFTTJPONPEFM w հೖʹΑΔٸܹͳมԽ w հೖʹΑΔτϨϯυͷมԽ Yt = β0 + β1 T + β2 Xt + β3 (T − Ti )Xt %BUF 5 9U 5J 55J 9 : ʜ ʜ w 5ݚڀ։࢝࣌఺͔Βܦաͨ࣌ؒ͠ w 9UհೖલޙΛද͢ࢦࣔม਺   ʢհೖલɺհೖޙʣ w 5Jհೖ͕࢝·ͬͨ࣌఺ ˞͜ͷϞσϧ͸ɺ࿦จʹΑͬͯؒҧ͍͕͋ΔͷͰ஫ҙ

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ંΕઢճؼϞσϧʹ͓͚Δύϥϝʔλͷղऍᶃ 15 ંΕઢճؼϞσϧ Yt = β0 + β1 T + β2 Xt + β3 (T − Ti )Xt #BTFMJOFMFWFM E[Yt |T = 0, Xt = 0] = β0 1SFTMPQF E[Yt+1 − Yt |T ≤ Ti , Xt = 0] = E[Yt+1 |T ≤ Ti , Xt = 0] − E[Yt |T ≤ Ti , Xt = 0] = {β0 + β1 (T + 1)} − {β0 + β1 T} = β1 1PTUTMPQF E[Yt+1 − Yt |T > Ti , Xt = 1] = {β0 + β1 (T + 1) + β2 + β3 (T + 1 − Ti )} − {β0 + β1 (T) + β2 + β3 (T − Ti )} = β1 + β3 5 հೖ : 5 9U 5J 55J 9U β0 β1 β1 + β3

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ંΕઢճؼϞσϧʹ͓͚Δύϥϝʔλͷղऍᶄ 16 ંΕઢճؼϞσϧ Yt = β0 + β1 T + β2 Xt + β3 (T − Ti )Xt 5 հೖ : 5 9U 5J 55J 9U 4MPQFDIBOHF 1PTUTMPQF − 1SFTMPQF = β1 + β3 − β1 = β3 -FWFMDIBOHF E[Yt |T = Ti , Xt = 1] − E[Yt |T = Ti , Xt = 0] = {β0 + β1 Ti + β2 + β3 (Ti − Ti )} − {β0 + β1 Ti } = β2 β0 β1 β1 + β3 τϨϯυͷมԽ β3 ϨϕϧͷมԽ β2

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*54σβΠϯͷ௕ॴ 17 ूஂʹର͢ΔհೖͷޮՌΛධՁͰ͖Δ ूஂϨϕϧͰมԽ͠ͳ͍ɾ؇΍͔ͳަབྷΛແࢹͰ͖Δ w հೖલޙͷτϨϯυ w հೖʹΑΔٸܹͳมԽ w հೖʹΑΔτϨϯυͷมԽ w ͜ΕΒΛਤࣔͰ͖Δ w ूஂ಺ͷ೥ྸͷ෼෍΍ܦࡁঢ়گͷ෼෍౳͸ɺಉ͡ूஂΛॎஅతʹ௥੻͢ΔͨΊແࢹͰ͖Δ

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*54σβΠϯͷ஫ҙ఺ᶃ 18 قઅੑͷ੍ޚ w ܦ࣌σʔλͰ͋ΔͨΊɺΞ΢τΧϜ͸قઅͷӨڹΛड͚͍ͯΔ͔΋͠Εͳ͍ w ྫ͑͹ɺײછ঱ͷጶױऀ਺ΛධՁ͢Δ৔߹͸ɺقઅʹΑͬͯጶױऀ਺͸૿ݮ͢Δ w ϞσϧΛ޻෉͢Δ͜ͱͰ੍ޚ͢Δ w ݄ͷμϛʔσʔλΛೖΕΔ w ݄ʹରͯ͠ϑʔϦΤؔ਺΍εϓϥΠϯΛ͋ͯΔ ࣗݾ૬ؔͷ੍ޚ w ܦ࣌σʔλͰ͋ΔͨΊɺࣗݾ૬͕ؔ͋Δ͔΋͠Εͳ͍ w ࣗݾ૬͕ؔ͋Δͱɺ4&ͷաখਪఆˠλΠϓ*Τϥʔ૿Ճ w #FSOBM ͸ɺʮقઅੑΛ੍ޚ͢Ε͹ɺࣗݾ૬ؔ΋੍ޚͰ͖ΔͩΖ͏ʯͱݴ͍ͬͯΔ͕ɺ   ϞσϦϯάޙʹධՁ͢΂͖ʢFH%VSCJO8BUTPOUFTUʣ w "3*."Λ࢖͍ͬͯΔ࿦จ΋͋Δʢ·ͩΑ͘෼͔Βͳ͍ʣ

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*54σβΠϯͷ஫ҙ఺ᶄ 19 ࣌ؒґଘੑަབྷͷ੍ޚ w ݚڀظؒ಺ʹٸʹมԽ͢ΔΑ͏ͳม਺͸ϞσϧʹؚΊΔ΂͖ w ͱ࿦จதͰΑ͘આ໌͕͋Δ͕ɺ   ϨϕϧͷมԽΛޮՌࢦඪͱߟ͑ͯɺհೖͷ༗ແΛॲஔม਺ͱ͢Δͱɺॲஔม਺ʹӨڹΛ༩͑ ͳ͚Ε͹ɺͦΕ͸ަབྷҼࢠͰ͸ͳ͍ͷͰ͸ʁ w ͨͩ͠ɺΞ΢τΧϜʹ͸Өڹ͢ΔͩΖ͏͔Βɺਪఆ஋ͷޮ཰ΛߴΊΔҙຯ͸͋Δ͸ͣ

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*54Λֶश͢ΔͨΊͷಓඪ 20 w #FSOBM+- $VNNJOT4 (BTQBSSJOJ"*OUFSSVQUFEUJNFTFSJFTSFHSFTTJPOGPSUIFFWBMVBUJPOPGQVCMJDIFBMUI JOUFSWFOUJPOTBUVUPSJBM*OU+&QJEFNJPM'FC rɹʲ࠷΋Ҿ༻͞Ε͍ͯΔνϡʔτϦϧ࿦จɻϞσϧʹؒҧ ͍͕͋Δͷʹ஫ҙʳ w ,POUPQBOUFMJT& %PSBO5 4QSJOHBUF%" #VDIBO* 3FFWFT%3FHSFTTJPOCBTFERVBTJFYQFSJNFOUBMBQQSPBDIXIFO SBOEPNJTBUJPOJTOPUBOPQUJPOJOUFSSVQUFEUJNFTFSJFTBOBMZTJT#.++VOIɹʲ࣮ྫ΋ؚΊͯ୺తʹ· ͱΊͯ͋Δʳ w 9JBP) "VHVTUP0 8BHFOBBS#)3F fl FDUJPOPONPEFSONFUIPETBDPNNPOFSSPSJOUIFTFHNFOUFESFHSFTTJPO QBSBNFUFSJ[BUJPOPGJOUFSSVQUFEUJNFTFSJFTBOBMZTFT*OU+&QJEFNJPM+VM rʲਖ਼͍͠ϞσϦϯάΛղ આʳ w 8BHOFS", 4PVNFSBJ4# ;IBOH' 3PTT%FHOBO%4FHNFOUFESFHSFTTJPOBOBMZTJTPGJOUFSSVQUFEUJNFTFSJFTTUVEJFT JONFEJDBUJPOVTFSFTFBSDI+$MJO1IBSN5IFS"VH rɹʲগʑݹ͍͕ɺνϡʔτϦΞϧ࿦จͷ࣍ʹಡΉ ͷ͕ྑ͍ʳ w 5VSOFS4- ,BSBIBMJPT" 'PSCFT"# 5BMKBBSE. (SJNTIBX+. $IFOH"$ FUBM%FTJHODIBSBDUFSJTUJDTBOETUBUJTUJDBM NFUIPETVTFEJOJOUFSSVQUFEUJNFTFSJFTTUVEJFTFWBMVBUJOHQVCMJDIFBMUIJOUFSWFOUJPOTBSFWJFX+$MJO&QJEFNJPM +VOrɹʲ*54Λར༻͍ͯ͠ΔݚڀͷϨϏϡʔ࿦จʳ w )BCFS/" $MBSLF%FFMEFS& 4BMPNPO+" 'FMMFS" 4UVBSU&"$07*%1PMJDZ*NQBDU&WBMVBUJPO"HVJEFUPDPNNPO EFTJHOJTTVFT"N+&QJEFNJPM<*OUFSOFU>+VO"WBJMBCMFGSPNIUUQEYEPJPSHBKFLXBCɹʲ*54 Λ$07*%ʹద༻͢Δ͍͞ͷ஫ҙ఺͕·ͱΊΒΕ͍ͯΔ࿦จʳ

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ࣗݾରরݚڀσβΠϯ 4FMGDPOUSPMMFETUVEZEFTJHO 4$$4 w ͜ͷσβΠϯ͸ɺʹ։࠵͞Εͨ3&26*3&ݚڀձͰൃද͞Εͨࢿྉ΍ٞ࿦Λࢀߟʹ͓ͯ͠Γ·͢ɻ w ࣗݾରরݚڀσβΠϯͷ֓ཁ͸ɺٶ஍ल໌ઌੜʢઍ༿େֶʣͷεϥΠυΛࢀߟʢ࢖༻ͷྃঝऔಘࡁΈʣ w ࣗݾରরέʔεγϦʔζσβΠϯͷ֓ཁ͸ɺ   Ԟଜହ೭ઌੜʢҰൠࣾஂ๏ਓྟচӸֶݚڀਪਐػߏʣͷεϥΠυΛࢀߟʢ࢖༻ͷྃঝऔಘࡁΈʣ

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ࣗݾରরݚڀσβΠϯ 22 ϫΫνϯ઀छऀ ϫΫνϯ઀छ։࢝ ෭൓Ԡ ෭൓Ԡ ෭൓Ԡ w ʢجຊతʹʣ   Ξ΢τΧϜ͕ൃੜͨ͠ਓͷΈର৅ͱ͢Δ w ݚڀର৅ऀͱͳͬͨҰਓҰਓʹରͯ͠ɺ   ͭҎ্ͷ࣌఺ΛݸਓͷதͰൺֱ͢Δ ࣌ؒ ݸମ಺Ͱൺֱޙɺ଍͠ࠐΜͰ   ूஂͱͯ͠മ࿐ͱΞ΢τΧϜͷؔ࿈ΛධՁ͢Δ

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ࣗݾରরݚڀσβΠϯͷར఺ 23 w ະଌఆɾະ஌ͷަབྷҼࢠͷҰ෦ΛݪཧతʹऔΓআ͘͜ͱ͕Ͱ͖Δ w ݸମ಺Ͱൺֱ͢ΔͨΊ w ಛʹ%#ݚڀ͸ະଌఆͷަབྷҼࢠ͕ଟ͍ͨΊɺϝϦοτ͕େ͖͍ ݸମ಺ͰมԽ͠ͳ͍Ҽࢠ ؍࡯ظؒͷؒʹݸମ಺ͰมԽ͠ͳ͍Ҽࢠ w ੑผ w Ҩ఻৘ใ w طԟ w ੜ׆श׳ w ೥ྸʢ؍࡯ظؒʹΑΔʣ ࣌ؒʹґଘͯ͠มԽ͢ΔҼࢠ w ༀࡎͷ෰ༀྔ ैདྷͷݚڀσβΠϯͱಉ༷ͷରॲ͕ඞཁ w ݚڀର৅ऀͷϦΫϧʔτͷෛ୲͕ݮΔ w ରর܈͕ۃ୺ʹগͳ͍৔߹ʹ΋దԠͰ͖Δ ٶ஍ઌੜͷεϥΠυʢIUUQTXXXTMJEFTIBSFOFU)JEFBLJ.JZBDIJTTʣ

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ࣗݾରরݚڀσβΠϯͷछྨ 24 മ࿐ʹண໨͢Δ͔ʁ Ξ΢τΧϜͷൃੜʹண໨͢Δ͔ʁ ࣌ؒ മ࿐ΞϯΧʔͷσβΠϯ Ξ΢τΧϜΞϯΧʔͷσβΠϯ മ࿐͔ͯ͠Βɺ͍ͭΞ΢τΧϜ͕ൃੜ͔ͨ͠ʁ Ξ΢τΧϜൃੜͷલɺ͍ͭമ࿐͔ͨ͠ʁ ࣗݾରরέʔεγϦʔζσβΠϯ έʔεΫϩεΦʔόʔσβΠϯ $BTFDSPTTPWFSEFTJHO 4FMGDPOUSPMMFEDBTFTFSJFTEFTJHO

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༻ޠͷఆٛɿമ࿐ΞϯΧʔͷσβΠϯ 25 മ࿐͕Ξ΢τΧϜΛҾ͖ى͜͢͜ͱ͕   ੜ෺ֶతʹ΋ͬͱ΋Β͍͠ظؒ য఺ظؒ ࢀরظؒ 'PDBMXJOEPXT 3FGFSFOUXJOEPXT 3JTLQFSJPE $POUSPM#BTFMJOFQFSJPE മ࿐͕Ξ΢τΧϜͷൃੜʹ   Өڹ͠ͳ͍ͱߟ͑ΒΕΔظؒ w മ࿐Λى఺ʢ*OEFYʣʹয఺ظؒͱࢀরظؒΛઃఆ w Ξ΢τΧϜͷ༗ແΛয఺ظؒͱࢀরظؒͰൺֱ͢Δ

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༻ޠͷఆٛɿΞ΢τΧϜΞϯΧʔͷσβΠϯ 26 മ࿐͕Ξ΢τΧϜΛҾ͖ى͜͢͜ͱ͕   ੜ෺ֶతʹ΋ͬͱ΋Β͍͠ظؒ ࢀরظؒ য఺ظؒ 'PDBMXJOEPXT 3FGFSFOUXJOEPXT 3JTLQFSJPE $POUSPM#BTFMJOFQFSJPE മ࿐͕Ξ΢τΧϜͷൃੜʹ   Өڹ͠ͳ͍ͱߟ͑ΒΕΔظؒ w Ξ΢τΧϜΛى఺ʢ*OEFYʣʹয఺ظؒͱࢀরظؒΛઃఆ w മ࿐ͷ༗ແΛয఺ظؒͱࢀরظؒͰൺֱ͢Δ

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ࣗݾରরݚڀσβΠϯΛద༻͢ΔͨΊͷ޷·͍͠৚݅ 27 ᶃ Ξ΢τΧϜ͸ɺٸͳൃ঱ ᶄ മ࿐͸ɺҰաੑ w அଓతͰ͋Γɺമ࿐ͷޮՌΛҡ࣋͢Δظ͕ؒ୹͍ w ϫΫνϯͳΒ͹ɺޮՌ͸༗ޮੑͰ͸ͳ͘ɺ෭൓Ԡͱߟ͑Δ Ξ΢τΧϜ ൃ঱ മ࿐ മ࿐ য఺ظؒ য఺ظؒ ࣌ؒ w )BTIFNJ/B[BSJ44 .BOTPVSOJB."$BTFDSPTTPWFSBOEDBTFUJNFDPOUSPMTUVEJFTDPODFQUT EFTJHO BOEBOBMZTJT+&QJEFNJPM#JPTUBU 0DU r w (SFFOMBOE4$POGPVOEJOHBOEFYQPTVSFUSFOETJODBTFDSPTTPWFSBOEDBTFUJNFDPOUSPMEFTJHOT&QJEFNJPMPHZ.BZ r w -BTI5- 7BOEFS8FFMF5+ )BOFVTF4 3PUINBO,+.PEFSOFQJEFNJPMPHZ GPVSUIFEJUJPO8PMUFST,MVXFS

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Thomsen RW, Öztürk B, Pedersen L, Nicolaisen SK, Petersen I, Olsen J, et al.   Hospital Records of Pain, Fatigue, or Circulatory Symptoms in Girls Exposed to Human Papillomavirus Vaccination: Cohort, Self-Controlled Case Series, and Population Time Trend Studies.   Am J Epidemiol. 2020 Apr 2;189(4):277–85. ࣗݾରরέʔεγϦʔζσβΠϯɿ۩ମྫ മ࿐ΞϯΧʔͷσβΠϯ

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29 32 ώτύϐϩʔϚ΢Πϧεʢ)17ʣϫΫνϯ͸҆શ͔ʁ ର৅ूஂ w ݚڀର৅ظؒதʹࡀͷ஀ੜ೔Λܴ͑ͨঁࣇ ਓ w )17ϫΫνϯͱؔ࿈͢ΔՄೳੑͷ͋ΔΞ΢τΧϜʢ಄௧ɺ᷺ଵײͳͲʣΛཧ༝ʹҩྍػ ؔΛड਍ͨ͠ ਓ Ξ΢τΧϜ ಄௧ɺඇಛҟతͳ仏௧ɺ᷺ଵײ΍ർ࿑ɺස຺ɺ௿݂ѹ΍ࣦਆ മ࿐ʢΞϯΧʔʣ )17ϫΫνϯ઀छ য఺ظؒʢ'PDBMXJOEPXʣ )17ϫΫνϯ઀छޙ೥ؒ ࢀরظؒʢ3FGFSFOUXJOEPXʣ ࡀͷ஀ੜ೔͔Βࡀͷ஀ੜ೔ͷ಺ɺ࣍ͷظؒΛআ͍ͨظؒ w য఺ظؒ w ઀छ௚લ೔ؒΛআ֎ʢϫΫνϯ઀छ͸݈߁ͳ࣌ظʹ͍ͨ͘Ίʣ ϝϞ σϯϚʔΫͷφγϣφϧσʔλϕʔε ࣗݾରরέʔεγϦʔζσβΠϯʢ5IPNTFOͷྫʣ য఺ظؒʢ೥ؒʣ ࢀরظؒ ࡀͷ஀ੜ೔ ࡀͷ஀ੜ೔ ࢀরظؒ )17ϫΫνϯ઀छ 5IPNTFO38 ¹[UÛSL# 1FEFSTFO- /JDPMBJTFO4, 1FUFSTFO* 0MTFO+ FUBM   )PTQJUBM3FDPSETPG1BJO 'BUJHVF PS$JSDVMBUPSZ4ZNQUPNTJO(JSMT&YQPTFEUP)VNBO1BQJMMPNBWJSVT7BDDJOBUJPO   $PIPSU 4FMG$POUSPMMFE$BTF4FSJFT BOE1PQVMBUJPO5JNF5SFOE4UVEJFTɹ"N+&QJEFNJPM"QS r

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σʔλʢ5IPNTFOͷྫʣ 30 *% ؍࡯ظؒ։࢝࣌ͷ   ೔ྸ য఺ظؒͷ   ։࢝࣌ͷ೔ྸ য఺ظؒͷ   ऴྃ࣌ͷ೔ྸ ಄௧਍அ࣌ͷ   ೔ྸ ؍࡯ऴྃ೔ͷ   ೔ྸ ࠷΋γϯϓϧͳԾ૝σʔλ ճؼ෼ੳ͕Ͱ͖Δܗ΁ม׵ *% Πϕϯτʢ಄௧ʣ   ͷ༗ແ Πϕϯτൃੜ೔ য఺ࢀরظؒͷ ։࢝೔ য఺ࢀরظؒͷ ऴྃ೔ ظؒ മ࿐ʢϫΫνϯ઀छʣͷ ༗ແ JOEJW- FWFOU FWFOUEBZ MPXFS VQQFS JOUFSWBM SJTL 4$$4QBDLBHFGPSNBUEBUBؔ਺ 8IJUBLFS)+ 'BSSJOHUPO$1 4QJFTTFOT# .VTPOEB15VUPSJBMJOCJPTUBUJTUJDTUIFTFMGDPOUSPMMFEDBTFTFSJFTNFUIPE   4UBU.FE.BZ r

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৚݅෇͖ϙΞιϯճؼϞσϧͰൃੜ཰ൺΛਪఆ 31 *% Πϕϯτʢ಄௧ʣ   ͷ༗ແ Πϕϯτൃੜ೔ য఺ࢀরظؒͷ ։࢝೔ য఺ࢀরظؒͷ ऴྃ೔ ظؒ മ࿐ʢϫΫνϯ઀छʣͷ ༗ແ JOEJW- FWFOU FWFOUEBZ MPXFS VQQFS JOUFSWBM SJTL 8IJUBLFS)+ 'BSSJOHUPO$1 4QJFTTFOT# .VTPOEB15VUPSJBMJOCJPTUBUJTUJDTUIFTFMGDPOUSPMMFEDBTFTFSJFTNFUIPE   4UBU.FE.BZ r

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݁Ռͷهࡌʢ5IPNTFOͷྫʣ 32 5IFSFXBTOPTVCTUBOUJBMBTTPDJBUJPOCFUXFFO)17WBDDJOBUJPOBOE   IFBEBDIF BNPOH HJSMTXJUIBSFDPSE*33 $* ʜ 5IPNTFO38 ¹[UÛSL# 1FEFSTFO- /JDPMBJTFO4, 1FUFSTFO* 0MTFO+ FUBM   )PTQJUBM3FDPSETPG1BJO 'BUJHVF PS$JSDVMBUPSZ4ZNQUPNTJO(JSMT&YQPTFEUP)VNBO1BQJMMPNBWJSVT7BDDJOBUJPO   $PIPSU 4FMG$POUSPMMFE$BTF4FSJFT BOE1PQVMBUJPO5JNF5SFOE4UVEJFTɹ"N+&QJEFNJPM"QS r ෲ௧ ಄௧ ඇಛҟతͳ仏௧ ௿݂ѹࣦਆ ස຺ ᷺ଵײ΍ർ࿑ ൃੜ཰ൺ

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ࣗݾରরέʔεγϦʔζσβΠϯͷڧΈͱऑΈ 33 w܁Γฦ͠ൃੜ͢ΔΠϕϯτʹద͍ͯ͠Δ w ࣌ؒґଘڞมྔΛௐ੔Ͱ͖Δ ԞଜઌੜͷεϥΠυʢIUUQTXXXTMJEFTIBSFOFUPLVNVSBZBTVZVLJTTʣ ڧΈ ऑΈ w Πϕϯτൃੜ͕ɺͦͷޙͷമ࿐΍؍࡯ظؒʹӨڹͯ͠͸ͳΒͳ͍

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Maclure M.   The case-crossover design: a method for studying transient effects on the risk of acute events. Am J Epidemiol. 1991 Jan 15;133(2):144–53. έʔεΫϩεΦʔόʔσβΠϯɿ۩ମྫ Ξ΢τΧϜΞϯΧʔͷσβΠϯ

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Ϟνϕʔγϣϯ 35 ৺ے伷࠹ʢ.*ʣͷൃ঱ʹӨڹ͢Δൃ঱௚લͷཁҼΛௐ΂͍ͨʂ ଟ͘ͷ.*͸ɺൃ঱લͷ਺͔࣌ؒΒ਺೔ͷ׆ಈ͕Ҿ͖ۚʹͳͬͯΔͩΖ͏ɻ έʔείϯτϩʔϧݚڀΛܭը͠Α͏ɻ Ͱ΋ɺίϯτϩʔϧ܈ͷ৘ใΛूΊΔͷେมͩΑͶʜɻ έʔείϯτϩʔϧݚڀͰ͸ɺ   έʔεͱίϯτϩϧͷݪूஂ͕ಉ͡ඞཁ͕͋Δ έʔεͱಉ͡ݪूஂ͸ʁ έʔεࣗ਎ ݪूஂ έʔε ίϯτϩʔϧ έʔεΫϩεΦʔόʔσβΠϯ .BDMVSF.5IFDBTFDSPTTPWFSEFTJHOBNFUIPEGPSTUVEZJOHUSBOTJFOUF ff FDUTPOUIFSJTLPGBDVUFFWFOUT   "N+&QJEFNJPM+BO r $BTFDSPTTPWFSEFTJHO

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36 .*ൃ঱ ΞϯΧʔ 32 ίʔώʔͷઁऔ͸ɺ.*ൃ঱ͷҾ͖ۚʹͳΔ͔ʁ ର৅ूஂ .*ൃ঱ͨ͠ਓ Ξ΢τΧϜʢΞϯΧʔʣ ৺ے伷࠹ʢ.*.ZPDBSEJBM*OGBSDUJPOʣ മ࿐ ίʔώʔઁऔ য఺ظؒʢ'PDBMXJOEPXʣ .*ൃ঱௚લͷ࣌ؒ ࢀরظؒʢ3FGFSFOUXJOEPXʣ աڈ೥ؒʢ.*ൃ঱௚લͷ࣌ؒΛআ͘ʣ ղੳ୯Ґ ࣌ؒ ϝϞ ΠϯλϏϡʔௐࠪʢ.*ൃ঱ޙɺதԝ஋೔Ͱฉ͖औΓʣ য఺ظؒ ࢀরظؒ ࣌ؒ ʜ ࣌ؒ ࣌ؒ ࣌ؒ ࣌ؒ ࣌ؒ ࣌ؒ ࣌ؒ ؍࡯ظؒʢ೥ؒʣ έʔεΫϩεΦʔόʔσβΠϯʢ.BDMVSFͷྫʣ

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σʔλʢ.BDMVSFͷྫʣ 37 *% .*ൃ঱લͷ࠷ޙͷ   ίʔώʔઁऔ ίʔώʔͷઁऔස౓ ࠷ޙͷമ࿐͕   য఺ظؒࢀরظؒ ظ଴͞ΕΔ য఺ظؒࢀরظؒ IPVST EBZ NJOVUFT EBZ IPVST NPOUI IPVST EBZ IPVST EBZ IPVST NPOUI IPVST EBZ IPVST EBZ IPVST EBZ IPVST EBZ .BDMVSF ͷදΛվม ೔ճҿΉ͔Β   ೥ؒͰɺظ଴͞ΕΔয఺ظؒʢ࣌ؒʣ͸ճº೔࣌ؒ ظ଴͞ΕΔࢀরظؒʢ࣌ؒʣ͸೔º࣌ؒ࣌ؒ ࣌ؒ .BDMVSF.5IFDBTFDSPTTPWFSEFTJHOBNFUIPEGPSTUVEZJOHUSBOTJFOUF ff FDUTPOUIFSJTLPGBDVUFFWFOUT   "N+&QJEFNJPM+BO r ࣌ؒ

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σʔλͷΠϝʔδʢ*%ʣ 38 .*ൃ঱ য఺ظؒ ࢀরظؒ ࣌ؒ ʜ ࣌ؒ ࣌ؒ ࣌ؒ ࣌ؒ ࣌ؒ ࣌ؒ ࣌ؒ ຖ೔ճҿΉਓ *% .*ൃ঱લͷ࠷ޙͷ   ίʔώʔઁऔ ίʔώʔͷઁऔස౓ ࠷ޙͷമ࿐͕   য఺ظؒࢀরظؒ ظ଴͞ΕΔ য఺ظؒࢀরظؒ IPVST EBZ য఺ظؒ ࢀরظؒ ࠷ޙͷമ࿐ظؒ 1FSTPOUJNF º

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σʔλͷΠϝʔδʢ*%ʣ 39 .*ൃ঱ য఺ظؒ ࢀরظؒ ࣌ؒ ʜ ࣌ؒ ࣌ؒ ࣌ؒ ࣌ؒ ࣌ؒ ࣌ؒ ࣌ؒ ϲ݄ʹճҿΉਓ *% .*ൃ঱લͷ࠷ޙͷ   ίʔώʔઁऔ ίʔώʔͷઁऔස౓ ࠷ޙͷമ࿐͕   য఺ظؒࢀরظؒ ظ଴͞ΕΔ য఺ظؒࢀরظؒ IPVST NPOUI য఺ظؒ ࢀরظؒ ࠷ޙͷമ࿐ظؒ 1FSTPOUJNF º

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݁Ռʢ.BDMVSFͷྫʣ 40 *% .*ൃ঱લͷ࠷ޙͷ   ίʔώʔઁऔ ίʔώʔͷઁऔස౓ ࠷ޙͷമ࿐͕   য఺ظؒࢀরظؒ ظ଴͞ΕΔ য఺ظؒࢀরظؒ IPVST EBZ NJOVUFT EBZ IPVST NPOUI IPVST EBZ IPVST EBZ IPVST NPOUI IPVST EBZ IPVST EBZ IPVST EBZ IPVST EBZ 33.) 13,517 7,355 = 1.8 য఺ظؒʹ മ࿐͕͋ͬͨέʔεͷ   ظ଴ࢀরظؒͷ࿨ ࢀরظؒʹ മ࿐͕͋ͬͨέʔεͷ   ظ଴য఺ظؒͷ࿨ .BOUFM)BFOT[FMਪఆྔ 3BUFSBUJP .BDMVSF.5IFDBTFDSPTTPWFSEFTJHOBNFUIPEGPSTUVEZJOHUSBOTJFOUF ff FDUTPOUIFSJTLPGBDVUFFWFOUT   "N+&QJEFNJPM+BO r ίʔώʔઁऔ࣌ؒҎ಺ͷ.*ൃ঱཰ൺ

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.BOUFM)BFO[FMਪఆྔʢ3BUFSBUJPʣᶃ 41 য఺ظؒ ࢀরظؒ 5PUBM ࠷ޙͷമ࿐ظؒ "J "J 1FSTPOUJNF 5J 5J 5J RRMH = ∑N i=1 A1i T0i /T+i ∑N i=1 A0i T1i /T+i αϯϓϧαΠζ/ Ұͭͷ૚͸ɺҰਓͷݸମͰ׬݁ .BOUFM)BFOT[FMਪఆྔ ҰਓͻͱΓͷݸମΛ૚ͱߟ͑ͯɺ৘ใΛ଍͠ࠐΜͰ͍͘ ݸମ಺ͰɺϚονϯά͍ͯ͠ΔΠϝʔδ

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.BOUFM)BFO[FMਪఆྔʢ3BUFSBUJPʣᶄ 42 *% য఺ظؒ ࢀরظؒ ࠷ޙͷമ࿐ظؒ 1FSTPOUJNF *% য఺ظؒ ࢀরظؒ ࠷ޙͷമ࿐ظؒ 1FSTPOUJNF য఺ظؒ ࢀরظؒ 5PUBM ࠷ޙͷമ࿐ظؒ "J "J 1FSTPOUJNF 5J 5J 5J RRMH = ∑N i=1 A1i T0i /T+i ∑N i=1 A0i T1i /T+i RRMH = 1 ⋅ 5116/8776 + 0 ⋅ 8730/8776 0 ⋅ 3650/8776 + 1 ⋅ 36/8776 *% *% = 142

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݁Ռͷهࡌʢ.BDMVSFͷྫʣ 43 33.) 13,517 7,360 = 1.8 'PSUIFPOFIPVSQFSJPEBGUFSESJOLJOHDP ff FF   UIFSBUFSBUJPJT QFSDFOU$* .BDMVSF.5IFDBTFDSPTTPWFSEFTJHOBNFUIPEGPSTUVEZJOHUSBOTJFOUF ff FDUTPOUIFSJTLPGBDVUFFWFOUT   "N+&QJEFNJPM+BO r

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έʔεΫϩεΦʔόʔσβΠϯͷԾఆ 44 ᶃമ࿐ͷ෼෍͕ɺݚڀظؒத͸Ұఆ ຖ೔ճҿΉਓ ϲ݄ʹճҿΉਓ ᶃ`മ࿐֬཰͕ɺΞ΢τΧϜൃ঱ʹରͯ͠ɺ৚݅෇͖ಠཱ ˠଌఆ͞Εͨɺ࣌ؒมಈͷަབྷҼࢠ͸ௐ੔͠ͳ͚Ε͹ͳΒͳ͍ w .JUUMFNBO." .PTUPGTLZ&&YDIBOHFBCJMJUZJOUIFDBTFDSPTTPWFSEFTJHO*OU+&QJEFNJPM0DU r w (SFFOMBOE4$POGPVOEJOHBOEFYQPTVSFUSFOETJODBTFDSPTTPWFSBOEDBTFUJNFDPOUSPMEFTJHOT&QJEFNJPMPHZ.BZ r w .PTUPGTLZ& $PVMM#" .JUUMFNBO.""OBMZTJTPG0CTFSWBUJPOBM4FMGNBUDIFE%BUBUP&YBNJOF"DVUF5SJHHFSTPG0VUDPNF&WFOUTXJUI "CSVQU0OTFU&QJEFNJPMPHZ/PW r w -BTI5- 7BOEFS8FFMF5+ )BOFVTF4 3PUINBO,+.PEFSOFQJEFNJPMPHZ GPVSUIFEJUJPO8PMUFST,MVXFS ˠ৚݅෇͖ϩδεςΟοΫճؼϞσϧ͕ඞཁ

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Wang SV, Schneeweiss S, Maclure M, Gagne JJ.   “First-wave” bias when conducting active safety monitoring of newly marketed medications   with outcome-indexed self-controlled designs.   Am J Epidemiol. 2014 Sep 15;180(6):636–44. έʔεΫϩεΦʔόʔσβΠϯɿ۩ମྫ Ξ΢τΧϜΞϯΧʔͷσβΠϯ

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46 .*ൃ঱ ΞϯΧʔ 32 ৽نൢച͞ΕͨΞϦϐϓϥκʔϧ   ʢ߅ਫ਼ਆපༀʣͷ෰༻͸ɺ   .*ൃ঱ͷҾ͖ۚʹͳΔ͔ʁ ɹࢢൢޙͷ෭࡞༻ௐࠪ ର৅ूஂ w .*ൃ঱ͨ͠ਓ w .*ൃ঱ͷϦεΫ͸͋Δະൃ঱ऀ Ξ΢τΧϜ ৺ے伷࠹   ʢ.*.ZPDBSEJBM*OGBSDUJPOʣ മ࿐ ΞϦϐϓϥκʔϧ෰༻ য఺ظؒ .*ൃ঱೔ͷલ೔ʢ೔ؒʣ ࢀরظؒ .*ൃ঱೔ͷલʙ೔ʢ೔ؒʣ ղੳ୯Ґ ਓ ϝϞ OBUJPOBM.FEJDBJE"OBMZUJDF9USBDU อݥͷσʔλʢʙ೥ʣ σβΠϯʢ8BOH47ͷྫɿҰ෦ʣ ৽نൃച   ʢʣ ճ໨ௐࠪ ճ໨ௐࠪ ճ໨ௐࠪ ճ໨ௐࠪ ʜ ʜ ܧଓతͳϞχλϦϯά 8BOH47 4DIOFFXFJTT4 .BDMVSF. (BHOF++ɹl'JSTUXBWFzCJBTXIFODPOEVDUJOHBDUJWFTBGFUZNPOJUPSJOHPGOFXMZNBSLFUFENFEJDBUJPOT   XJUIPVUDPNFJOEFYFETFMGDPOUSPMMFEEFTJHOT"N+&QJEFNJPM4FQ r

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47 ɹ݁Ռʢ8BOH47ͷྫɿҰ෦ʣᶃ 8BOH47 4DIOFFXFJTT4 .BDMVSF. (BHOF++ɹl'JSTUXBWFzCJBTXIFODPOEVDUJOHBDUJWFTBGFUZNPOJUPSJOHPGOFXMZNBSLFUFENFEJDBUJPOT   XJUIPVUDPNFJOEFYFETFMGDPOUSPMMFEEFTJHOT"N+&QJEFNJPM4FQ r έʔεΫϩεΦʔόʔσβΠϯͰղੳ ࢢൢޙ͙͢͸03ߴͯ͘ɺ   ࣌ؒܦͭͱ௿͘ͳΔʁ

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ༀࡎӸֶͰى͜Γ΍͍͢όΠΞε 48 ৽نༀࡎ͸ɺമ࿐֬཰͕ҰఆͰ͸ͳ͍ ࣌ؒ ༀࡎͷྲྀ௨ྔ ఆৗঢ়ଶ ༀࡎͷྲྀ௨ྔ͕ఆৗঢ়ଶʹࢸΔ·Ͱ͸ɺ   έʔεΫϩεΦʔόʔσβΠϯ͔Β   ಘͨਪఆ஋͸όΠΞε͞ΕΔ 'JSTUXBWFCJBT ඇఆৗঢ়ଶ

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49 ूஂϨϕϧͷമ࿐܏޲͕มΘΔͱ͖ɺͲ͏͢Δ͔ʁ έʔελΠϜίϯτϩʔϧσβΠϯ $BTFUJNFDPOUSPMEFTJHO ඇఆৗঢ়ଶ

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έʔελΠϜίϯτϩʔϧσβΠϯ $BTFUJNFDPOUSPMEFTJHO $5$

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51 .*ൃ঱ ΞϯΧʔ 32 ৽نൢച͞ΕͨΞϦϐϓϥκʔϧ   ʢ߅ਫ਼ਆපༀʣͷ෰༻͸ɺ   .*ൃ঱ͷҾ͖ۚʹͳΔ͔ʁ ɹࢢൢޙͷ෭࡞༻ௐࠪ ର৅ूஂ w .*ൃ঱ͨ͠ਓ w .*ൃ঱ͷϦεΫ͸͋Δະൃ঱ऀ Ξ΢τΧϜ ৺ے伷࠹   ʢ.*.ZPDBSEJBM*OGBSDUJPOʣ മ࿐ ΞϦϐϓϥκʔϧ෰༻ য఺ظؒ .*ൃ঱೔ͷલ೔ʢ೔ؒʣ ࢀরظؒ .*ൃ঱೔ͷલʙ೔ʢ೔ؒʣ ղੳ୯Ґ ਓ ϝϞ OBUJPOBM.FEJDBJE"OBMZUJDF9USBDU อݥͷσʔλʢʙ೥ʣ σβΠϯʢ8BOH47ͷྫɿҰ෦ʣ ৽نൃച   ʢʣ ճ໨ௐࠪ ճ໨ௐࠪ ճ໨ௐࠪ ճ໨ௐࠪ ʜ ʜ ܧଓతͳϞχλϦϯά 8BOH47 4DIOFFXFJTT4 .BDMVSF. (BHOF++ɹl'JSTUXBWFzCJBTXIFODPOEVDUJOHBDUJWFTBGFUZNPOJUPSJOHPGOFXMZNBSLFUFENFEJDBUJPOT   XJUIPVUDPNFJOEFYFETFMGDPOUSPMMFEEFTJHOT"N+&QJEFNJPM4FQ r

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52 .*ൃ঱ ΞϯΧʔ έʔελΠϜίϯτϩʔϧσβΠϯʢ8BOH47ͷྫʣ 8BOH47 4DIOFFXFJTT4 .BDMVSF. (BHOF++ɹl'JSTUXBWFzCJBTXIFODPOEVDUJOHBDUJWFTBGFUZNPOJUPSJOHPGOFXMZNBSLFUFENFEJDBUJPOT   XJUIPVUDPNFJOEFYFETFMGDPOUSPMMFEEFTJHOT"N+&QJEFNJPM4FQ r έʔε ίϯτϩʔϧ ONBUDI w ೥ྸɺੑผͰέʔεͱϚονϯά w Ϛονϯάର৅ͷέʔεͷΞ΢τΧϜൃ঱೔ʢج४೔ʣʹ.*ͷϦεΫ͕͋Δ w ج४೔͔Β೔Ҏ্લ͔ΒҩྍอݥʹՃೖ͍ͯ͠Δ w য఺ظؒͱࢀরظؒ͸ɺϚονϯάͨ͠έʔεͱἧ͑Δ ORCCO(cases) ORCCO(controls) മ࿐ޙͷ   Ξ΢τΧϜൃ঱ͷΦοζൺ ࢀরظؒʹର͢Δ   য఺ظؒͷമ࿐Φοζൺ മ࿐֬཰্͕͕Δ മ࿐֬཰͕Լ͕Δ ௐ੔ ORCCO(cases) ORCCO(controlss) ΞϦϐϓϥκʔϧ ΞϦϐϓϥκʔϧ ج४೔

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53 ɹ݁Ռʢ8BOH47ͷྫɿҰ෦ʣᶄ 8BOH47 4DIOFFXFJTT4 .BDMVSF. (BHOF++ɹl'JSTUXBWFzCJBTXIFODPOEVDUJOHBDUJWFTBGFUZNPOJUPSJOHPGOFXMZNBSLFUFENFEJDBUJPOT   XJUIPVUDPNFJOEFYFETFMGDPOUSPMMFEEFTJHOT"N+&QJEFNJPM4FQ r ࣌ؒΛ௨ͯ͠OVMM

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Ξ΢τΧϜΞϯΧʔσβΠϯͷ·ͱΊ 54 έʔεΫϩεΦʔόʔ έʔελΠϜίϯτϩʔϧ ࢖༻͢Δ৘ใ έʔεʢΞ΢τΧϜൃ঱ྫͷΈʣ w έʔεʢΞ΢τΧϜൃ঱ྫʣ w ίϯτϩʔϧ   ʢΞ΢τΧϜඇൃ঱ྫʣ ղੳํ๏ w .BOUFM)BFOT[FMਪఆ w ৚݅෇͖ϙΞιϯճؼ w ৚݅෇͖ϩδεςΟοΫճؼ w Ϛονϯά w ৚݅෇͖ϩδεςΟοΫճؼ Ծఆ w മ࿐܏޲͕Ұఆ w മ࿐ͱΞ΢τΧϜൃ঱͕৚݅෇͖ಠཱ w έʔεͱ   ίϯτϩʔϧͷമ࿐܏޲͕ಉ͡ w മ࿐ͱΞ΢τΧϜൃ঱͕৚݅෇͖ಠཱ ௕ॴ Ξ΢τΧϜൃ঱ྫͷ৘ใͷΈͰྑ͍ മ࿐܏޲Λௐ੔Ͱ͖Δ ୹ॴ മ࿐܏޲͕ఆৗঢ়ଶͰͳ͚Ε͹ͳΒͳ͍ ద੾ͳίϯτϩʔϧͷ৘ใ͕ඞཁ

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έʔεΫϩεΦʔόʔσβΠϯɿ σʔλͷܗͱ3Λ࢖ͬͨ౷ܭղੳ

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࢝఺ͱͳΔղੳ༻σʔλʢ.BDMVSFͷྫʣ 56 *% .*ൃ঱લͷ࠷ޙͷ   ίʔώʔઁऔ ίʔώʔͷઁऔස౓ ࠷ޙͷമ࿐͕   য఺ظؒ ࠷ޙͷമ࿐͕ ࢀরظؒ ظ଴͞ΕΔ য఺ظؒ ظ଴͞ΕΔ ࢀরظؒ ݚڀظؒ JE MBTU@FY@UJNF GSFR@FY GSFR@FY@VOJU GPDBM@FY SFG@FY 5@GPDBM 5@SFG 5 IPVST EBZ E NJOVUFT EBZ E IPVST NPOUI N IPVST EBZ E IPVST EBZ E IPVST NPOUI N IPVST EBZ E IPVST EBZ E IPVST EBZ E IPVST EBZ E .BDMVSF.5IFDBTFDSPTTPWFSEFTJHOBNFUIPEGPSTUVEZJOHUSBOTJFOUF ff FDUTPOUIFSJTLPGBDVUFFWFOUT   "N+&QJEFNJPM+BO r ೖྗ ೖྗ ೖྗ ܭࢉ ೖྗ

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ऴ఺ͱͳΔղੳ༻σʔλʢ.BDMVSFͷྫʣ 57 *% য఺ظؒ PSࢀরظؒ Ξ΢τΧϜͷൃ঱ JE FYQPTVSF DBTF ᶃ*%͝ͱͷFYQPTVSF ͕ରԠ͢Δظؒͷ਺͚ͩߦ͕͋Δ ߦ ߦ ߦ ߦ ᶄDBTFʹ͸ɺ·ͣ͢΂ͯΛೖΕΔ ᶅ֤JEɺ֤FYQPTVSFͷߦ໨ͷΈ   ֤ظؒͷമ࿐ͷ༗ແʹରԠ͢ΔΑ͏ʹDBTFʹΛೖΕΔ Ξ΢τΧϜൃ঱͸ɺJE͝ͱʹճͷΈ͔ͩΒ ߦ ߦ

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ղੳ༻σʔλ࡞੒ίʔυᶃ 58 ४උ σʔλೖྗ

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ղੳ༻σʔλ࡞੒ίʔυᶄ 59 ੨͍෦෼ͷܭࢉ

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౷ܭղੳίʔυ 60

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ղੳ༻σʔλ࡞੒ίʔυᶅ 61 ऴ఺σʔληοτΛ࡞੒ ᶃ*%͝ͱͷFYQPTVSF ͕ରԠ͢Δظؒͷ਺͚ͩߦ͕͋Δ ᶄDBTFʹ͸ɺ·ͣ͢΂ͯΛೖΕΔ ᶅ֤JEɺ֤FYQPTVSFͷߦ໨ͷΈ   ֤ظؒͷമ࿐ͷ༗ແʹରԠ͢ΔΑ͏ʹDBTFʹΛೖΕΔ

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ࣗݾରরݚڀσβΠϯͷ·ͱΊ

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മ࿐ΞϯΧʔσβΠϯͱΞ΢τΧϜΞϯΧʔσβΠϯͷ࢖͍෼͚ʢࢲݟʣ 63 മ࿐ΞϯΧʔͷσβΠϯ Ξ΢τΧϜΞϯΧʔͷσβΠϯ മ࿐͔ͯ͠Βɺ͍ͭΞ΢τΧϜ͕ൃੜ͔ͨ͠ʁ Ξ΢τΧϜൃੜͷલɺ͍ͭമ࿐͔ͨ͠ʁ ࣗݾରরέʔεγϦʔζσβΠϯ έʔεΫϩεΦʔόʔσβΠϯ w ؔ৺ͷ͋Δമ࿐͸Ұͭ w ؔ৺ͷ͋ΔΞ΢τΧϜͷछྨ͸ෳ਺ w ʢྫɿϫΫνϯ઀छͱ͞·͟·ͳ෭൓Ԡʣ w ؔ৺ͷ͋Δമ࿐ͷछྨ͸ෳ਺ w ؔ৺ͷ͋ΔΞ΢τΧϜ͸Ұͭ w ʢྫɿ৺ے伷࠹ͱ͞·͟·ͳമ࿐ʣ w ಛఆͷΞ΢τΧϜൃੜ঱ྫΛूΊͨ   σʔλϕʔεʢ࣬ױϨδετϦʣͱ૬ੑ͕ྑ͍ w ํ๏࿦ͷݚڀ͕ਐΜͰΔ w ํ๏࿦ͷݚڀ͕ਐΜͰͳ͍

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ࣗݾରরέʔεγϦʔζσβΠϯΛֶश͢ΔͨΊͷಓඪ 64 w $BEBSFUUF4. .BDMVSF. %FMBOFZ+"$ 8IJUBLFS)+ )BZFT,/ 8BOH47 FUBM$POUSPMZPVSTFMG*41&FOEPSTFE HVJEBODFJOUIFBQQMJDBUJPOPGTFMGDPOUSPMMFETUVEZEFTJHOTJOQIBSNBDPFQJEFNJPMPHZ1IBSNBDPFQJEFNJPM%SVH4BG +VO rɹʲༀࡎӸֶͷཱ৔͔Βͷ·ͱΊʳ w 8IJUBLFS)+ 'BSSJOHUPO$1 4QJFTTFOT# .VTPOEB15VUPSJBMJOCJPTUBUJTUJDTUIFTFMGDPOUSPMMFEDBTFTFSJFTNFUIPE 4UBU.FE.BZ rɹʲίʔυ෇͖νϡʔτϦΞϧʳ w )BMMBT+ 8IJUBLFS) %FMBOFZ+" $BEBSFUUF4. 1SBUU/ .BDMVSF.5IF6TFPG"DUJWF$PNQBSBUPSTJO4FMG$POUSPMMFE %FTJHOT"N+&QJEFNJPM0DU r777ɹʲ৽͍͠ϨϏϡʔʳ w 1FUFSTFO* %PVHMBT* 8IJUBLFS)4FMGDPOUSPMMFEDBTFTFSJFTNFUIPETBOBMUFSOBUJWFUPTUBOEBSEFQJEFNJPMPHJDBM TUVEZEFTJHOT#.+4FQJɹʲ୹͍ϨϏϡʔʳ w 'BSSJOHUPO1 8IJUBLFS) 8FMEFTFMBTTJF:(4FMG$POUSPMMFE$BTF4FSJFT4UVEJFT".PEFMMJOH(VJEFXJUI3$3$1SFTT QɹʲԞଜઌੜͷ͓͢͢Ίʳ

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έʔεΫϩεΦʔόʔσβΠϯΛֶश͢ΔͨΊͷಓඪᶃ 65 ֓؍Λ͔ͭΉ w $BEBSFUUF4. .BDMVSF. %FMBOFZ+"$ 8IJUBLFS)+ )BZFT,/ 8BOH47 FUBM$POUSPMZPVSTFMG*41&FOEPSTFE HVJEBODFJOUIFBQQMJDBUJPOPGTFMGDPOUSPMMFETUVEZEFTJHOTJOQIBSNBDPFQJEFNJPMPHZ1IBSNBDPFQJEFNJPM%SVH4BG +VO rɹʲༀࡎӸֶͷཱ৔͔Βͷ·ͱΊʳ w $BSSBDFEP.BSUÍOF[& 5BSBDJEP. 5PCJBT" 4BF[. 'JHVFJSBT"$BTFDSPTTPWFSBOBMZTJTPGBJSQPMMVUJPOIFBMUI F ff FDUTBTZTUFNBUJDSFWJFXPGNFUIPEPMPHZBOEBQQMJDBUJPO&OWJSPO)FBMUI1FSTQFDU"VH rɹ ʲͲ͏ͳྖҬͰ࢖ΘΕ͍ͯΔ͔ɺͳΜͱͳ͘௫Ήʳ w )BTIFNJ/B[BSJ44 .BOTPVSOJB."$BTFDSPTTPWFSBOEDBTFUJNFDPOUSPMTUVEJFTDPODFQUT EFTJHO BOEBOBMZTJT+ &QJEFNJPM#JPTUBU0DU rɹʲํ๏࿦ͷ·ͱΊͱͯ͠Θ͔Γ΍͘͢ஸೡɻ؆୯͕ͩ਺ࣜ΋σʔλͷܗ΋ࡌͬ ͍ͯΔɻͨͩ͜͠ͷ··Ͱ͸ղੳͰ͖ͳ͍ʳ w .PTUPGTLZ& $PVMM#" .JUUMFNBO.""OBMZTJTPG0CTFSWBUJPOBM4FMGNBUDIFE%BUBUP&YBNJOF"DVUF5SJHHFSTPG 0VUDPNF&WFOUTXJUI"CSVQU0OTFU&QJEFNJPMPHZ/PW rɹʲෳ਺ͷσβΠϯͷํ๏࿦ϨϏϡʔͱͯ͠͸ ࠷΋ৄ͍͠ɻ͔͠͠೉͍͠ɻ֤࿦Λษڧ͠ͳ͕ΒɺԿ౓΋ৼΓฦΔ΂͠ʳ

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έʔεΫϩεΦʔόʔσβΠϯΛֶश͢ΔͨΊͷಓඪᶄ 66 έʔεΫϩεΦʔόʔσβΠϯ w ˒4IJPTBLBJ, ,BHJNVSB5$BTF$SPTTPWFS4UVEZ+BQBOFTF+PVSOBMPG1IBSNBDPFQJEFNJPMPHZ:BLV[BJFLJHBLV rɹʲ೔ຊޠจݙʳ w ˒.BDMVSF.5IFDBTFDSPTTPWFSEFTJHOBNFUIPEGPSTUVEZJOHUSBOTJFOUF ff FDUTPOUIFSJTLPGBDVUFFWFOUT"N+ &QJEFNJPM+BO rɹʲΞ΢τΧϜ͕ΞϯΧʔͷࣗݾରরσβΠϯͷىݯͱͳΔ࿦จɻදͷ਺஋ʹͱ͜ΖͲ ͜Ζϛε͕͋ΔͷͰ஫ҙʳ w .JUUMFNBO." -FXJT3" .BDMVSF. 4IFSXPPE+# .VMMFS+&5SJHHFSJOHNZPDBSEJBMJOGBSDUJPOCZNBSJKVBOB $JSDVMBUJPO+VO rɹʲέʔεΫϩεΦʔόʔσβΠϯΛ࢖ͬͨݚڀͷ۩ମྫɻΘ͔Γ΍͍͢ʳ w .JUUMFNBO." .PTUPGTLZ&&YDIBOHFBCJMJUZJOUIFDBTFDSPTTPWFSEFTJHO*OU+&QJEFNJPM0DU rɹ ʲόΠΞεͷߏ଄Λཧղ͢Δɻ%"(Λ͍ࣔͯ͠ΔͷͰཧղ͠΍͍͢ʳ w ;IBOH;$BTFDSPTTPWFSEFTJHOBOEJUTJNQMFNFOUBUJPOJO3"OO5SBOTM.FE4FQ ɹʲ3Λ࢖ͬͨղੳ νϡʔτϦΞϧ࿦จɻίʔυ͸ݹ͘ɺ෼͔ΓͮΒ͍ɻ͜ͷࢿྉͷίʔυݟͯʳ

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έʔεΫϩεΦʔόʔσβΠϯΛֶश͢ΔͨΊͷಓඪᶅ 67 έʔελΠϜίϯτϩʔϧσβΠϯ w ˒8BOH47 4DIOFFXFJTT4 .BDMVSF. (BHOF++l'JSTUXBWFzCJBTXIFODPOEVDUJOHBDUJWFTBGFUZNPOJUPSJOHPGOFXMZ NBSLFUFENFEJDBUJPOTXJUIPVUDPNFJOEFYFETFMGDPOUSPMMFEEFTJHOT"N+&QJEFNJPM4FQ rɹ ʲέʔεΫϩεΦʔόʔͷऑΈΛཧղ্ͨ͠ͰɺέʔελΠϜίϯτϩʔϧσβΠϯͷϞνϕʔγϣϯ͕෼͔Δ۩ମྫɻʳ w 4VJTTB45IFDBTFUJNFDPOUSPMEFTJHO&QJEFNJPMPHZ.BZ rɹʲέʔελΠϜίϯτϩʔϧσβΠϯͷى ݯͱͳΔ࿦จʳ w (SFFOMBOE4$POGPVOEJOHBOEFYQPTVSFUSFOETJODBTFDSPTTPWFSBOEDBTFUJNFDPOUSPMEFTJHOT&QJEFNJPMPHZ .BZ rɹʲ(SFFMBOE͔ΒέʔελΠϜίϯτϩʔϧσβΠϯ͕͏·͍͔͘ͳ͍ྫͷఏࣔʳ w 4VJTTB45IFDBTFUJNFDPOUSPMEFTJHOGVSUIFSBTTVNQUJPOTBOEDPOEJUJPOT&QJEFNJPMPHZ+VM rɹ ʲ(SFFOMBOEͷ࿦จʹର͢Δ4VJTTBͷ੾Γฦ͠࿦จʳ