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）

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

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

ӸֶݚڀͷσβΠϯ

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

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

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

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

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

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঱ऀ /%#

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

࣌ܥྻ෼அσβΠϯ *OUFSSVQUFEUJNFTFSJFTEFTJHO *54

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

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

ં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

ં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

ં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

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

*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

*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͸ͣ

*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

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

ࣗ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

ࣗ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

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

༻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

༻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

ࣗ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

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

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

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

৚݅෇͖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

݁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

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

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

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

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

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 ࣌ؒ

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

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

݁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

.BOUFM)BFO[FMਪఆྔʢ3BUFSBUJPʣᶃ 41 য఺ظؒ ࢀরظؒ 5PUBM ࠷ޙͷമ࿐ظؒ "J "J 1FSTPOUJNF 5J
5J 5 J 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

.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 5 J 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

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

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

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

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

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

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

49 ूஂϨϕϧͷമ࿐܏޲͕มΘΔͱ͖ɺͲ͏͢Δ͔ʁ έʔελΠϜίϯτϩʔϧσβΠϯ $BTFUJNFDPOUSPMEFTJHO ඇఆৗঢ়ଶ

έʔελΠϜίϯτϩʔϧσβΠϯ $BTFUJNFDPOUSPMEFTJHO $5$

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

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೔

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

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

έʔεΫϩεΦʔόʔσβΠϯɿ σʔλͷܗͱ3Λ࢖ͬͨ౷ܭղੳ

࢝఺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 ೖྗ

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

ղੳ༻σʔλ࡞੒ίʔυᶃ 58 ४උ σʔλೖྗ

ղੳ༻σʔλ࡞੒ίʔυᶄ 59 ੨͍෦෼ͷܭࢉ

౷ܭղੳίʔυ 60

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

ࣗݾରরݚڀσβΠϯͷ·ͱΊ

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

ࣗ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

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

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

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

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）

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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