Form Telaah Jurnal Evidence Based Medicine M Farm Klin 6 Januari 2014 Nama Peserta Didi !

"ctaviana Maria #im$olon 1% #e$ut an disain dari &enelitian 'an( dila&or an di )urnal terse$ut! *+ross sectional, +ase control% +ohort, Eksperimental- Kuasi E s&erimental. 2% #e$ut an Fo us dari &enelitian terse$ut! *Mani/estasi lini - +ausation- Pro(nosisDia(nosis- Terapi. 0% #e$ut an 1or sheet 'an( &alin( te&at untu di(una an untu telaah ritis la&oran &enelitian dalam )urnal terse$ut adalah 2or sheet! *Mani/estasi lini - #'stematic 3evie24Metaanal'sis- Pro(nosis- Dia(nosis- Terapi.% 4% #e$ut an Po&ulation4Pro$lem dari &enelitian 'an( dila&or an di )urnal terse$ut 5dolescent smo er 6% 7ntervension4 7ndicator4 7nde8 dari &enelitian 'an( dila&or an di )urnal terse$ut adalah Ta in( #3 $u&ro&ion h'drochloride 000 m(4d *n9106. and 000 m(4d *n9104. /or 6 2ee s 6% #e$ut an +ontrol dari &enelitian 'an( dila&or an di )urnal terse$ut No ta in( #3 $u&ro&ion h'drochloride *n9100. /or 6 2ee s :% #e$ut an "utcome dari &enelitian 'an( dila&or an di )urnal terse$ut E//icac' and sa/et' o/ 2 dosa(es o/ #3 $u&ro&ion ;+l *160 m(4d and 000 m(4d. /or smo in( cessation <% #e$ut an =alidit' dari &enelitian 'an( dila&or an di )urnal terse$ut a% 3ecruitment > 1ere the su$)ects re&resentative o/ the tar(et &o&ulation? YES, THEYRE 1. ;ealth', smo in( adolescents 2ere recruited%%@ 2. Eli(i$le su$)ects! A 14 to 1: 'ears o/ a(e A smo ed at least 6 ci(arettes &er da' A had an e8haled +" level (reater than or eBual to 10 &&m A had at least 2 &revious Buit attem&ts A 2ei(hed at least 40,6 ( A 2ere En(lish literate *6thA(rade level. A 2ere motivated to Buit smo in( 0. E8clusion criteria! 1. current use o/ to$acco &roducts other than ci(arettes or other smo in( cessation treatments2. histor' or current dia(nosis or treatment o/ &anic disorder, &s'chosis, $i&olar disorder, or eatin( disorder0. su$stance a$use or de&endence *other than nicotine. in the 0months &reAcedin( the stud'4. current clinical de&ression or 5D;D6. an' &s'choactive dru( treatment 2ithin 4 2ee s o/ the stud' treatment &hase6. increased seiCure ris *&ersonal or /amil' histor' o/ seiCure disorder, :. receivin( treatment that increased seiCure ris .<. si(ni/icant cardiovascular disease D. (irls 2ho &re(nant, lactation or un2illin(ness to use medicall' acce&ta$le contrace&tion

4. #iCe o/ stud' (rou&! 5 total o/ 012 su$)ects 2ere recruited

See Study Population (SR Bupropion trial p. 1069)

$% 5llocation > 1ere the stud' (rou&s com&ara$le? YES, THEYRE 3andomisation and concealment This &a&er states! 5ctive stud'medication and identicalAa&&earin( &lace$o2ere &re&ac a(ed into 0 sets o/ identicalAa&&earin( $lister cards in accordance 2ith a computer-generated randomization list% #u$)ects came to the research clinic /or a $aseline4&reBuit visit and were randomized to receive #3 $u&ro&ion h'drochloride *000m(4d or 000m(4d. or &lace$o%
See Intervention (SR Bupropion trial p. 1069)

1. +haracteristics o/ the stud' (rou&s c% Maintenance > 1as the com&ara$le status o/ the stud' (rou&s maintained throu(h eBual mana(ement and adeBuate /ollo2 u&? YES, IT WAS 1. Mana(ement and measurement A This &a&er states! #tud' medication 2as administered as 1 ta$let orall' once a da' /or the /irst 0 da's o/ treatment, /ollo2ed $' 1 stud' medication ta$let ta en t2ice dail' *mornin( and evenin(. /or the duration o/ the treatment &hase
See Intervention (SR Bupropion trial p. 1069)

2. Follo2 u& su$)ects A This &a&er states! 5t each visit, su$)ects received $rie/ individual cessation counselin( related to chan(in( smo in( $eAhaviors,e(, identi/'in( social su&&ort identi/'in( motivations $arriers toBuittin(, reco(nitiono/ tri((ers /or smo in( mana(ement o/ nicotine cravin( 2ithdra2al s'm&toms stress mana(ement% Follo2 u& visits occurred at 12 2ee s *tele&hone visit. and 26 2ee s a/ter the tar(et Buit date and assessed smo in( status, use o/ cessation aids, and adverse events

See Intervention (SR Bupropion trial p. 1069)

0. Eosses to /ollo2 u& 3esearch &a&ers re&ortin( 3+T should include a /lo2chart the num$ers o/ su$)ects and their &ro(ress throu(h the trial% The #3 Bu&ro&ion trial /lo2chart sho2s! 012 su$)ects 2ere randomiCed *100 to &lace$o- 106 to #3 Bu&ro&ion 000 m(4d- 104 to #3 Bu&ro&ion 000 m(4d.

012 su$)ects 2ere anal'sed 2hile 11D discontinued treatment &hase and /ollo2 u&A&hase *60 discontinued treatment &hase- 6D discontinued /ollo2 u& &hase.
See Figure 2 (SR Bupropion trial p. 10 1)

d% Measurement > 1ere the outcomes measured 2ith! 1. Blinded su$)ects and assessors, and4or A This &a&er states! #tud' su$)ects and researchers remained !lind to treat"ent (rou& assi(nment throu(hout the stud'% 2. "$)ective outcomes No statement
See Intervention (SR Bupropion trial p. 1069)

D% #e$ut an 7m&ortanc' dari &enelitian 'an( dila&or an di )urnal terse$ut a. 1hat is the ma(nitude o/ the thera&' e//ect? Efficacy
Averag e (1-6 weeks) $ %tinin e ER EER1 EER ! ARR 1
( EREER1 )

ARR !
( EREER! )

RRR1 (ARR1" ER) 0,000 0,<00

RRR! (ARR !" ER ) 0,D66 1,000

##T1 (1" ARR1 ) 0,260 0,200

##T! (1" ARR! ) 0,0D0 0,126

11,6 6

16,0 11

22,6 14

0,< 6

11,1 <

+E3! Place$o EE31! Bu&ro&ion ;+l 000 m(4d EE32! Bu&ro&ion ;+l 000 m(4d 7n this trial, A 3331 +" ! 0,000 or 00F% 1e can sa' that #3 Bu&ro&ion 000 m(4d decreased +" level $' 00F relative to those 2ho received &lace$o +otinine ! 0,<00 or <0,0F% 1e can sa' that #3 Bu&ro&ion 000 m(4d decreased urinar' cotinine level $' <0,0F relative to those 2ho received &lace$o A 3332 +" is 0,D66 or D6,6F% 1e can sa' that #3 Bu&ro&ion 000 m(4d decreased +" level $' D6,6F relative to those 2ho received &lace$o +otinine is 1,000 or 100F% 1e can sa' that #3 Bu&ro&ion 000 m(4d decreased urinar' cotinine level $' 100F relative to those 2ho received &lace$o A NNT1 +"! 0,260 G 0,260 or 26% This means 2e need to treat 26 &eo&le 2ith #3 Bu&ro&ion 000 m(4d to &revent 1 additional &erson /rom Buittin( smo in( cessation Hrinar' cotinine! 0,200 or 20% This means 2e need to treat 20 &eo&le 2ith #3 Bu&ro&ion 000 m(4d to &revent1 additional &erson /rom Buittin( smo in( cessation

NNT2 +"! 0,0D0 or D% This means 2e need to treat D &eo&le 2ith #3 Bu&ro&ion 000 m(4d to &revent 1 additional &erson /rom Buittin( smo in( cessation Hrinar' cotinine! 0,126 G 0,10 or 10% This means 2e need to treat 10 &eo&le 2ith #3 Bu&ro&ion 000 m(4d to &revent 1 additional &erson /rom Buittin( smo in( cessation

Safety
A&verse Event ER EER1 EER ! ARR 1
( EREER1 )

ARR !
( EREER! )

RRR1 (ARR1" ER) 0,0D0 0,006 0,266 0,066 0,<04

RRR! (ARR !" ER ) 0,1<< 0,464 0,26< 0,006 0

##H1 (1" ARR1 ) 0,204 0,141 0,161 1,42D 0,12<

##H! (1" ARR! ) 0,0D< 0,0D0 0,16: 0,2:< 0

Hea&a'( e %)g( T(r%at S*mpt%m Sleep &ist)r+an 'e #a)sea

64,4 20,0 20,0 10,: D,:

4D,6 16,2 1:,1 11,4 1:,6

44,2 12,6 1:,0 14,0 D,:

4,D :,1 6,2 0,: :,<

10,2 10,< 6 0,6 0

7n this trial, A NN;1 *#3 Bu&ro&ion 160 m(4d. ;eadache! 20% This means 2e need to treat 20 &eo&le 2ith #3 Bu&ro&ion 160 m(4d to cause 1 additional &erson to have headache +ou(h! 14% This means 2e need to treat 14 &eo&le 2ith #3 Bu&ro&ion 160 m(4d to cause 1 additional to have cou(h Throat s'm&tom! 16% This means 2e need to treat 16 &eo&le 2ith #3 Bu&ro&ion 160 m(4d to cause 1 additional &erson to have throat s'm&tom #lee& distur$ance! 140% This means 2e need to treat 140 &eo&le 2ith #3 Bu&ro&ion 160 m(4d to cause 1 additional &erson to have slee& distur$ance Nausea! 10% This means 2e need to treat 10 &eo&le 2ith #3 Bu&ro&ion 160 m(4d to cause1 additional &erson to have nausea 9I3an(e! 10A140% This means 2e need to treat 10A140 &eo&le 2ith #3 Bu&ro&ion 160 m(4d to cause1 additional &erson to have adverse events A NN;2 *#3 Bu&ro&ion 000 m(4d. ;eadache! 10% This means 2e need to treat 10 &eo&le 2ith #3 Bu&ro&ion 000 m(4d to cause 1 additional &erson to have headache +ou(h! D% This means 2e need to treat D &eo&le 2ith #3 Bu&ro&ion 000 m(4d to cause 1 additional to have cou(h Throat s'm&tom! 1:% This means 2e need to treat 1: &eo&le

2ith #3 Bu&ro&ion 000 m(4d to cause 1 additional &erson to have throat s'm&tom #lee& distur$ance! 2<% This means 2e need to treat 2< &eo&le 2ith #3 Bu&ro&ion 000 m(4d to cause 1 additional &erson to have slee& distur$ance Nausea! 10% This means 2e need to treat 10 &eo&le 2ith #3 Bu&ro&ion 000 m(4d to cause1 additional &erson to have nausea 9I3an(e! This means 2e need to treat DA2< &eo&le 2ith #3 Bu&ro&ion 000 m(4d to cause1 additional &erson to have adverse events

10% #e$ut an 5&&lica$ilit' dari &enelitian 'an( dila&or an di )urnal terse$ut a. 7s our &atient so di//erent /rom those in the stud' that its results cannot a&&l'? 7n 7ndonesian settin(s, our &atient has the inclusion criteria e8ce&t the En(lish literate $. 7s the treatment /easi$le in our settin(? This trial is /easi$le in our &ractice settin(% #3 Bu&ro&ion ;+l 160 m( and 000 m( availa$le in our hos&ital

c. 1hat are our &atient@s &otential $ene/its and harms /rom the thera&'? Ei elihood o/ $ein( hel&ed and harmed *E;;. E;; 9 *14NNT. - *14NN;. E;;1 9 *1426.- *1410. 9 0,6 E;;2 9 *14D.- *14D. 91 7t means that #3 Bu&ro&ion ;+l 160 m(4d is 0,6 times more li el' to hel& more than to harm 7t means that #3 Bu&ro&ion ;+l 000 m(4d is 1 times more li el' to hel& more than to harm