Bilag 1

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Søgestrategi

Ud fra en forforståelse for emnet, er der søgt empiri til opgaven ud fra nedenstående søgestrategi.

Der er først lavet en bevidst tilfældig søgning i nedenstående databaser samt på Campusbiblioteket Rådmandsmarken, Sigurdsgade 26, 2200 København N. Dette for at spore ind på emnet (Glasdam 2011; 37).

Systematisk søgning giver imidlertid en langt bedre sikkerhed for at finde al relevant materiale (Ibid; 37), hvorfor der foretages en sådan søgning ud fra følgende søgeprofil:

syntocinon, nulliparity, oxytocin, dystocia, early treatment, delayed treatment, augment*, augmentation, term, partogram samt action line.

Følgende søgestrategi er valgt:

Inklusionskriterier:



Studier publiceret i 1997-2012



RCT og metaanalyser



studier, der udelukkende benytter data fra nullipara

Disse inklusionskriterier er valgt ud fra et ønske om, at opgaven kommer til at bygge på den nyeste viden på området, samt på studier med det studiedesign, der giver den størst mulige viden i forhold til det spørgsmål, der stilles (CEBM 2011b).

Eksklusionskriterier:



Studier, der tager udgangspunkt i Active management of labour.



Studier udført i ikke-vestlige lande



Studier, der omhandler igangsættelse



Studier, der omhandler fødselsoplevelsen i forhold til brug af s-drop

Ved Active management of labour laves bl.a. tidlig amniotomi (Henderson 2004; 442), ofte ved

indlæggelse. Det vurderes, at det ikke vil give mening at sammenligne studier med Active

management of labour med studier, hvor der udelukkende laves amniotomi ved dystoci, idet

risikoen for confounding ikke kan vurderes tilstrækkeligt.

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Studier udført i ikke-vestlige lande, er ofte svære at benytte i en dansk praksis, idet niveauet i obstetrisk praksis i disse studier ofte er forskelligt fra dansk niveau.

Studier, der omhandler igangsættelse og fødselsoplevelsen i forhold til brug af S-drop ekskluderes, de dette ikke er opgavens fokus.

Som udgangspunkt er der søgt ud fra emneord, da ”emneordssøgning som regel [giver] færre poster og en mere præcis søgning” (Glasdam 2011; 38).

Der er foretaget en systematisk søgning i følgende 3 databaser;

 PubMed er en offentlig tilgængelig udgave af databasen MEDLINE. Den bliver opdateret

dagligt, og man kan derfor finde artikler, der endnu ikke er blevet trykt. Emneområdet er hovedsageligt medicin, men også artikler omhandlende jordemodervirksomhed er at finde.

Af dansksprogede artikler findes kun de, der har været offentliggjort i afsnittet Videnskab i Ugeskrift for læger (Glasdsm 2011; 41). Det er et krav til artikler i Pubmed, at de skal være peer-reviewed

¹

. Derudover er der givet etiske og moralske retningslinjer til forfatterne.

 The Cochrane Library er en databaser, der udelukkende indeholder Cochrane Reviews, dvs

metaanalyser over randomiserede undersøgelser inden for medicin og sundhedsvidenskab.

Cochrane-samarbejdet er velrenomeret og kendt for sin høje standart, og da Cochrane reviews ligger højest i evidenshierarkiet, danner de derfor et vigtigt grundlag for evidensbaseret medicin herhjemme (Glasdam 2011; 42).

 CINAHL (Cumulative Index to Nursing and Allied Health) er en database, der indeholder

klap 3.000 tidsskifter inden for sygepleje mm. Derudover findes der henvisninger til andre typer af materialer. Der stilles forskellige krav til artiklerne alt efter typen af indhold.

Videnskabelige artikler bliver peer-reviewed, mens mere kvalitative artikler bliver bedømt ud fra faglig relevans og niveau (Glasdam 2011; 42).

Resultater af den systematiske søgning er i første omgang vurderet ud fra studiernes overskrifter.

Syntes en overskrift at kunne være relevant i forhold til opgaven, er studiets abstract ligeledes

1 At studier analyseres af eksperter mhp at vurdere, om de er af en kvalitet, der kan publiceres (HTA Glossary.net 2012)

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gennemlæst. Har det ikke herudfra været muligt at træffe en beslutning om et studies relevans for denne opgave, er studiet gennemlæst i sin helhed.

De studier, der er henholdsvis inkluderet og ekskluderet fra denne opgave på baggrund af gennemlæsning af deres abstract eller hele studiet, er beskrevet i nedenstående skema.

Har studiet opfyldt denne opgaves inklusionskriterier og eksklusionskriterier, er studiet inkluderet i opgaven.

Følgende hjemmesider, som jeg i forvejen havde kendskab til, er benyttet i opgaven:

www.dsog.dk – dansk selskab for obstetrik og gynækologi www.sst.dk – sundhedsstyrelsen

www.vip.regionh.dk – søgemaskine til vejledninger fra forskellige hospitaler, bl.a. Rigshospitalet www.gyncph.dk – vejledninger for Hvidovre Hospital

www.jordemoderforeningen.dk – herunder etiske retningslinier og lovstof

www.sfog.se – svensk förening för obstetrik & gynekologi

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Dato og database

Søgning Resultate r/

relevante hits

Inkluderede studier Ekskluderede studier

06.11.12 Pubmed

#1

((("1997"[Date - MeSH] :

"2012"[Date - MeSH])) AND (randomized controlled trial OR

metaanalysis[Fil ter])) AND syntocinon

803/

søgning specificeres yderligere.

06.11.12 Pubmed

#2

#1 NOT induction

495/

søgning specificeres yderligere.

06.11.12 Pubmed

#3

#2 AND nulliparity (MeSH)

37/2 Hinshaw, K. et al., 2008

A randomised controlled trial of early versus delayed oxytocin augmentation to treat primary dysfunctional labour in nulliparous women.

Publiceret i BJOG sep.

2008; 115, s. 1289-9

Sadler, L et al. 2000

A randomised controlled trial and meta-analysis of active

management of labour.

Publiceret I BJOG juli 2000, nr 107 (7), s. 909-15

Studiet ekskluderes da det bygger på active management of labour 06.11.12

Pubmed

#4

Search ((((("199 7"[Date - MeSH] :

"2012"[Date - MeSH])) AND randomized controlled trial[Filter]) OR metaanalysis[Fil ter]) AND oxytocin) NOT induction

402/

søgning specificeres

06.11.12 Pubmed

#5

35/2 Hinshaw, K. et al., 2008 Studiet er allerede inkluderet

Sadler, L et al. 2000

Studiet er allerede ekskluderet

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06.11.12 Pubmed

#6

#4 AND dystocia

15/0

06.11.12 Pubmed

#7

#4 AND delayed treatment

7/2 Dencker, A. et al 2008 Early

versus delayed oxytocin augmentation in

nulliparous women with prolonged labour--a randomised controlled trial Publiceret i BJOG marts 2009, nr 116 (4), s. 530-36 ______________________

Hinshaw, K. et al., 2008 Studiet er allerede inkluderet

06.11.12 Pubmed

#8

#4 AND early treatment

27/0

10.11.12 Pubmed

#9

Search (((("1997

"[Date - Completion] :

"3000"[Date - Completion])) AND oxytocin) OR syntocinon) NOT induction

19.016/

10.11.12 Pubmed

#10

496/

søgning specificeres 10.11.12

Pubmed

#11

#10 AND dystocia

58/1 Rouse, D.J. et al 2001

Active phase labor arrest:

revisiting the 2-hour minimum.

Publiceret i Obstetrics and Gynecology, oktober 2001, nr 98 (4), s. 550-4.

Studiet ønsker at afgøre, hvor lang tid, der skal gå fra dystoci til sectio.

Ved dystoci gives pt. S-drop samtidig med, at der oplægges et intrauterint katheter til at måle trykket i uterus. Dette er ikke

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opgavens fokus, og studiet ekskluderes derfor.

10.11.12 Pubmed

#12

#10 AND augment*

8/1 Akoury, H.A. et al 1991.

Oxytocin augmentation of labor and perinatal outcome in nulliparas.

Publiceret i Obstetrics and

Gynecology august 1991, nr 78 (2), s. 227-230

Studiet ønsker at undersøge det perinatale udkomme ved nullipara, der har fået s-drop med nullipara, der ikke har. Fødslerne er varetaget efter Active management of labour og ekskluderes derfor på baggrund af opgavens eksklusionskriterier.

Derudover er studiet fra 1991, og ligger således uden for opgavens inklusionskriterier.

10.11.12 Pubmed

#13

30/3 Hinshaw et al. 2008 Allerede inkluderet studie

Cammu, H, Van Eeckhout, E 1996

A randomised controlled trial of early versus delayed use of amniotomy and oxytocin infusion in nulliparous labour.

Publiceret i British Journal of Obstetrics and Gynaecology, april 1996, nr 103 (4), s. 313-8

Studiets praksis er bygget på active management of labour. Derfor ekskluderes studiet i henhold til opgavens eksklusionskriterier.

__________________________

Geary, M. 1996

A randomised controlled trial of early versus delayed use of amniotomy and oxytocin infusion in nulliparous labour.

Publiceret i British Journal of

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Obstetrics and Gynaecology, September 1996, nr 103 (9), s. 939- 40.

Artiklen er udelukkende en kommentar til studet af Cammu (1996), og ekskluderes derfor.

10.11.12 Pubmed

#14

11/3 Hinshaw et al. (2008) Studiet er allerede inkluderet

Cammu (1996)

Studiet er allerede ekskluderet Geary (1996)

Studiet er allerede ekskluderet 06.11.12

Cochrane Library

#15

The cochrane library (Full text) -Browse by topics

-Pregnancy and childbirth -Dystocia -Augmentation

6/1 Bugg, G. et al. 2011.

Oxytocin versus no treatment or delayed treatment for slow progress in the ﬁrst stage of spontaneous labour (Review) Reviewet medtager 8 studier, hvoraf 5 af studierne ikke opfylder denne opgaves inklusionskriterier idet 5 af studierne er fra

henholdsvis 1981, 1985, 1987, 1991 og 1996. Derudover er et af studierne fra Thailand, dvs. ikke et land, vi normalt sammenligner os med rent obstetrisk, mens endnu et andet studie inkluderer multipara.

De to af studierne, der opfylder denne opgaves inklusionskriterier, er allerede inkluderet i studiet (Dencker, A. et al 2008 samt Hinshaw, K. et al., 2008).

06.11.12 Pubmed

#16

Search ((("1997

"[Date - Publication] :

"2012"[Date - Publication])) AND

nulliparity) AND dystocia AND term

53/2 Kjaergaard, H et al. 2009

Incidence and outcomes of dystocia in the active phase of labor

in term nulliparous women with spontaneous labor onset.

Publiceret i Acta Obestetrics and Gynecology of Scandinavia 2009, nr 88 (4), s. 402-07.

Studiet ekskluderes, da det ikke er

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et RCT eller metaanalyse.

Rouse, D.J. et al 2001 Et allerede ekskluderet studie 10.11.12

Pubmed

#17

Search ((("1997

"2012"[Date - Completion])) AND

partogram) AND nulliparity AND randomi*

1/0

10.11.12 Pubmed

#18

Search (((("1997

"2012"[Date - Completion])) AND action line) AND partogram) AND randomi*

8/3 Lavender, T et al. 2006 Effect of

different partogram action lines on birth outcomes:

a randomized controlled trial.

Publiceret i Obstetrics and Gynecology, august 2006, nr 108 (2), s. 295-302.

______________________

Lavender, T. et al. 1998 Partogram action line study: a randomised trial.

Publiceret i British Journal of Obstetrics and

Gynecology, September 1998, nr 105 (9), s. 976-80

Pattinson, R.C. et al.

Agressive or expectant management of labour: a randomised clinical trial.

Publiceret i BJOG, maj 2003, nr 110 (5), s. 457-61.

Studiet ekskluderes da det er baseret på den fattige del af befolkningen i Sydafrika. Det er altså ikke umiddelbart et land og en befolkningsgruppe der er

sammenlignelig med dansk praksis.

Derudover foretages der ikke i studiet amniotomi ved dystoci, idet der herved sker en øgning i risikoen for overførsel af HIV fra mor til barn. Det vurderes således, at praksis i studiet ligger for langt fra dansk praksis.

10.11.12 Cinahl

#19

Limiters - Published Date from:

19970101- 20121231;

Randomized Controlled Trials;

Language:

Danish, English, Norwegian, Swedish Expanders -

50/2 Dencker 2009.

Studiet er allerede

inkluderet _____________________

Hinshaw 2008.

Studiet er allerede inkluderet

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Apply related words; Also search within the full text of the articles Search modes - Boolean/Phrase

oxytocin OR syntocinon AND nulliparity NOT Induction 10.11.12

Cinahl

#20

Limiters - Published Date from:

19970101- 20121231;

Language:

Danish, English, Norwegian, Swedish

Search modes - Boolean/Phrase Oxytocin OR syntocinon AND nulliparity

1.155/

10.11.12 Cinahl

#21

#20 AND dystocia

33/1 Shields, S.G. et al. 2007

Dystocia in nulliparous women Publiceret i American Family Physician, juni 2007, nr 75(11), s.

1671-8

Artiklen er beskrivende omkring dystoci, men det er ikke et egentlig studie. Derfor er artiklen ikke relevant for opgave

10.11.12 Cinahl

#22

3/2 Bugg, G.J. et al. 2011.

Studiet er allerede ekskluderet.

___________________________

Frälich, M. 2012

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Oxytocin for slow progress in the first stage of spontaneous labour is not associated with different rates of caesarean or assisted delivery compared with no treatment or delayed use in second stage Publiceret i

Evidence Based Medicine, juni 2012, nr 17(3), s. 83-4

Artiklen kommenterer på Bugg, G.J et al. 2011, hvilket er ekskluderet fra denne opgave. Således opfylder artiklen ikke opgavens

inklusionskritier.

10.11.12 Cinahl

#23

2/1 Bugg, G.J. et al. 2011.

Studiet er allerede ekskluderet.

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Jadad-score

Dencker, A. et al.

2008

Hinshaw, K. et al.

2008

Lavender, T. et al. (1998)

Lavender, T. et al. (2006) Var studie beskrevet

som randomiseret?

(1 point)?

Var metoden til at randomisering beskrevet og var den passende (et bord med tilfældige numre,

computerskabt, etc)?

(1 point/ minus 1 point)

Ja (1 point)

Ja (1 point) _____________

Ja (1 point)

Ja (1 point) _____________

Ja (1 point)

Var studiet beskrevet som double-blindet? (1 point)

Var metoden til blinding beskrevet og var den

passende/upassende (identisk placebo, aktiv placebo, dummy) (1 point/

minus 1 point)

Nej (0 point) Nej (0 point) Nej (0 point) Nej (0 point)

Var der en beskrivelse af de, som trak sig fra studiet og de, der dropped ud af studiet? (1 point)

Ja (1 point) Ja (1 point) Nej (0 point) Studiet beskriver 4 dropouts samt grunden hertil.

Studiet mangler dog at beskrive, hvordan disse dropouts er fordelt mellem grupperne (Jadad 2007;

55)

Ja (1 point) Studiet beskriver 25 dropouts samt grunden hertil.

Studiet giver ligeledes en beskrivelse af, hvorledes dropouts er fordelt mellem grupper (Jadad 2007; 55)

I alt 3 point 3 point 2 point 3 point

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58

Dencker, A. et al. 2008

For at kontrollere, at checklisten er forstået korrekt, er der CONSORT’s vejledning i checklisten benyttet (CONSORT group 2010b)

CONSORT 2010 checklist of information to include when reporting a randomised trial

* Section/Topic

Item

No Checklist item

Reported on page No Title and abstract

1a Identification as a randomised trial in the title 530

1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)

Funding og trial registration er ikke noteret i abstract. Til gengæld fremgår disse informationer af side 536. 530 Introduction

Background and objectives

2a Scientific background and explanation of rationale 530 + 531

2b Specific objectives or hypotheses. Beskrevet som objective og ikke som en hypotese. 531 Methods

Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 531

3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons Ikke relevant

Participants 4a Eligibility criteria for participants 531

4b Settings and locations where the data were collected 531

Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

531 + 532 Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they

were assessed

532

6b Any changes to trial outcomes after the trial commenced, with reasons 532

Sample size 7a How sample size was determined 532

7b When applicable, explanation of any interim analyses and stopping guidelines Ikke relevant Randomisation:

Sequence generation

8a Method used to generate the random allocation sequence 532

8b Type of randomisation; details of any restriction (such as blocking and block size) 532

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Allocation concealment mechanism

9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

532

Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions. At dette ikke er beskrevet, har sandsynligvis ikke indflydelse på bias.

Ikke beskrevet Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those

assessing outcomes) and how Ikke relevant

11b If relevant, description of the similarity of interventions Ikke relevant

Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 532 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses 532 Results

Participant flow (a diagram is strongly recommended)

13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and

were analysed for the primary outcome. Benytter intention to treat. 531

13b For each group, losses and exclusions after randomisation, together with reasons 531

Recruitment 14a Dates defining the periods of recruitment and follow-up 531

14b Why the trial ended or was stopped Ikke relevant

Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 532 Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was

by original assigned groups 533-535

Outcomes and estimation

17a For each primary and secondary outcome, results for each group, and the estimated effect size and its

precision (such as 95% confidence interval) 533-535

17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended Ikke relevant Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing

pre-specified from exploratory. Da 37 deltagere blev randomiseret, blev der foretaget en sub-gruppe analyse, hvor disse deltagere blev ekskluderet. Resultatet af denne analyse var identisk med den planlagte analyse. Inklusion af disse deltagere havde

således ikke indflydelse på resultatet. 532-534

Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) Ikke relevant Discussion

Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses.

Mulige bias vurderes i diskussionen. Sample size og violation af sample size berøres også. 533 + 535

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60 Generalisability 21 Generalisability (external validity, applicability) of the trial findings. Studiet er tilfredsstillende gennemført. Mulige bias er

diskuteret. Sample size har taget højde for violation af sample size. Der er gennemført en ekstra analyse, hvor data fra inkluderede

deltagere, der ikke mødte inklusionskriterierne, er blevet fjernet. Studiets eksterne validitet virker således høj. 533-535 Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence.

Studiet sammenholder både resultater med øvrige studier der støtter og modsiger deres resultater. 533-535 Other information

Registration 23 Registration number and name of trial registry 536

Protocol 24 Where the full trial protocol can be accessed, if available Ikke

beskrevet Funding 25 Sources of funding and other support (such as supply of drugs), role of funders 536

*We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials.

Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org.

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Hinshaw, K. et al. 2008

For at kontrollere, at checklisten er forstået korrekt, er der CONSORT’s vejledning i checklisten benyttet (CONSORT group 2010b)

CONSORT 2010 checklist of information to include when reporting a randomised trial

* Section/Topic

Item

1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts).

Trial registration og funding er ikke inkluderet i abstract, men er beskrevet på side 1295.Flere outcome measures er inkluderet I

abstractet, end hvad der er beskrevet i metoden. I metodeafsnittet er kun sectiorate inkluderet som outcome measure. 1289 Introduction

2a Scientific background and explanation of rationale 1289-1290

2b Specific objectives or hypotheses 1290

Methods

Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 1290-1292 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons Ikke relevant Participants 4a Eligibility criteria for participants. Kun få eksklusionskriterier er beskrevet. Dette kan have en effekt på resultaterne. 1290-1291

Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were

actually administered 1291-1292

Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed. Kun primary outcome (sectiorate) er beskrevet. Der måles på øvrige outcomes, men disse er ikke beskrevet i

metodeafsnittet. 1292

6b Any changes to trial outcomes after the trial commenced, with reasons. Funding var ikke tilstrækkelig til at inkludere det oprindelig antal deltagere for at opnå den forventede power. Derfor blev power sænket fra 95% til 80% og færre deltagere var

nødvendigt. 1292

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62 7b When applicable, explanation of any interim analyses and stopping guidelines. Analyser undervejs er ikke beskrevet i

designet, men foretaget da fundingen udløb. Ikke relevant

Randomisation:

Sequence generation

8b Type of randomisation; details of any restriction (such as blocking and block size) 1291

Allocation

concealment mechanism

1291 Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to

interventions. Implementeringen af randomisering er beskrevet i meget overordnede vendinger. Dette bør dog ikke have nogen

indflydelse på resultaterne. 1291

Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those

Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes. Beskrivelsen af hvilke statistiske

metoder, der vil blive benyttet er overordnet. Brugen af de statistiske metoder er ikke specifikt relateret til outcome measures. 1292

12b Methods for additional analyses, such as subgroup analyses and adjusted analyses Ikke relevant Results

were analysed for the primary outcome. Vist i tabelform. 1290

13b For each group, losses and exclusions after randomisation, together with reasons. Ingen drop-outs. Ikke relevant.

14b Why the trial ended or was stopped. Manglende funding som beskrevet tidligere. 1292 Baseline data 15 A table showing baseline demographic and clinical characteristics for each group. Tabel 1. 1292 Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was

by original assigned groups. Antal deltagere der blev analyseret i hver gruppe for de forskellige outcome measures er givet i

figure 1. 1290

precision (such as 95% confidence interval). Resultaterne er gengivet i tabellerne 2-4. Resultatet for primary outcome (1293-1294)

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(sectiorate) nævnes ikke i teksten i resultatafsnittet, og fremgår således kun i tabel 2.

17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended 1293 Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing

pre-specified from exploratory Ikke relevant

Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses.

Studiet beskriver fint dets begrænsninger og svagheder. Det nævnes dog ikke, at læseren i sin fortolkning af resultaterne bør tage højde for, at 30 ud af 204 i den afventende gruppe får oxytocin indenfor de første 8 timer.

1294 Generalisability 21 Generalisability (external validity, applicability) of the trial findings. Gennemførslen af studiet var fint. Resultatet for

sectiorate bør således være externt validt. 1290-1294

Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 1294 Other information

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64

Lavender, T. et al. 1998

For at kontrollere, at checklisten er forstået korrekt, er der CONSORT’s vejledning i checklisten benyttet (CONSORT group 2010b)

CONSORT 2010 checklist of information to include when reporting a randomised trial

* Section/Topic

Item

1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 976 Introduction

2b Specific objectives or hypotheses 977

Methods

Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 977-978 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons 978

actually administered 978

Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they

were assessed 978

6b Any changes to trial outcomes after the trial commenced, with reasons Ikke relevant

7b When applicable, explanation of any interim analyses and stopping guidelines Ikke relevant Randomisation:

Sequence generation

8b Type of randomisation; details of any restriction (such as blocking and block size) Ikke beskrevet

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interventions

Ikke beskrevet Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those

Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 978 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses 978 Results

were analysed for the primary outcome 978-979

by original assigned groups 979

precision (such as 95% confidence interval) 979

17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended 979 Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing

pre-specified from exploratory 979

Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Ikke beskrevet Generalisability 21 Generalisability (external validity, applicability) of the trial findings Hele artiklen Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 980

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66 Other information

Registration 23 Registration number and name of trial registry Ikke

beskrevet

beskrevet Funding 25 Sources of funding and other support (such as supply of drugs), role of funders Ikke

beskrevet

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Lavender, T. et al. 2006

For at kontrollere, at checklisten er forstået korrekt, er der CONSORT’s vejledning i checklisten benyttet (CONSORT group 2010b)

CONSORT 2010 checklist of information to include when reporting a randomised trial

* Section/Topic

Item

1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 295 Introduction

2b Specific objectives or hypotheses. Beskrevet som et objective og ikke som en hypotese. 296 Methods

Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 296-298 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons. Ingen

ændringer beskrevet Ikke relevant

actually administered 297-298

Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they

were assessed 297-298

6b Any changes to trial outcomes after the trial commenced, with reasons. Ingen ændringer beskrevet Ikke relevant

Sample size 7a How sample size was determined. 298

7b When applicable, explanation of any interim analyses and stopping guidelines 298 Randomisation:

Sequence generation

8a Method used to generate the random allocation sequence 296-297

8b Type of randomisation; details of any restriction (such as blocking and block size). Stratifiseret for at sikre at

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68

grupperne var så ens som muligt 297

interventions Ikke relevant

Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those

Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 298 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses. Der blev foretaget analyse af

hvilken effekt fødselsstedet havde: midwife led vs. delivery suite. 298

Results

were analysed for the primary outcome 298-299

by original assigned groups 299-301

precision (such as 95% confidence interval) 300-301

17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended 300-301 Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing

pre-specified from exploratory 300-301

Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Ikke beskrevet

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Generalisability 21 Generalisability (external validity, applicability) of the trial findings Ikke beskrevet Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 299-300 Other information

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