Bilag 1. Søgestrategi

Transkript

1 Bilag 1 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 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. 47

2 Bilag 1 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 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) 48

3 Bilag 1 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: dansk selskab for obstetrik og gynækologi sundhedsstyrelsen søgemaskine til vejledninger fra forskellige hospitaler, bl.a. Rigshospitalet vejledninger for Hvidovre Hospital herunder etiske retningslinier og lovstof svensk förening för obstetrik & gynekologi 49

4 Bilag 1 Dato og database Pubmed #1 Søgning ((("1997"[Date - MeSH] : "2012"[Date - MeSH])) AND (randomized controlled trial OR metaanalysis[fil ter])) AND syntocinon Resultate r/ relevante hits 803/ søgning specificeres yderligere. Inkluderede studier Ekskluderede studier Pubmed # Pubmed #3 #1 NOT induction #2 AND nulliparity (MeSH) 495/ søgning specificeres yderligere. 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. Sadler, L et al A randomised controlled trial and meta-analysis of active management of labour. Publiceret I BJOG juli 2000, nr 107 (7), s Pubmed # Pubmed #5 Search ((((("199 7"[Date - MeSH] : "2012"[Date - MeSH])) AND randomized controlled trial[filter]) OR metaanalysis[fil ter]) AND oxytocin) NOT induction #4 AND nulliparity (MeSH) 402/ søgning specificeres Publiceret i BJOG sep. 2008; 115, s /2 Hinshaw, K. et al., 2008 Studiet er allerede inkluderet Studiet ekskluderes da det bygger på active management of labour Sadler, L et al Studiet er allerede ekskluderet 50

5 Bilag Pubmed # Pubmed #7 #4 AND dystocia #4 AND delayed treatment 15/0 7/2 Dencker, A. et al 2008 Early versus delayed oxytocin augmentation in nulliparous women with prolonged labour--a randomised controlled trial Pubmed # Pubmed # Pubmed # Pubmed #11 #4 AND early treatment Search (((("1997 "[Date - Completion] : "3000"[Date - Completion])) AND oxytocin) OR syntocinon) NOT induction #9 AND nulliparity (MeSH) #10 AND dystocia 27/ / søgning specificeres 496/ søgning specificeres 58/1 Publiceret i BJOG marts 2009, nr 116 (4), s Hinshaw, K. et al., 2008 Studiet er allerede inkluderet 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 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 51

6 Bilag Pubmed #12 #10 AND augment* 8/1 opgavens fokus, og studiet ekskluderes derfor. Akoury, H.A. et al Oxytocin augmentation of labor and perinatal outcome in nulliparas. Publiceret i Obstetrics and Gynecology august 1991, nr 78 (2), s Pubmed #13 #10 AND early treatment 30/3 Hinshaw et al Allerede inkluderet studie 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. 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 Studiets praksis er bygget på active management of labour. Derfor ekskluderes studiet i henhold til opgavens eksklusionskriterier. Geary, M A randomised controlled trial of early versus delayed use of amniotomy and oxytocin infusion in nulliparous labour. Publiceret i British Journal of 52

7 Bilag 1 Obstetrics and Gynaecology, September 1996, nr 103 (9), s Artiklen er udelukkende en kommentar til studet af Cammu (1996), og ekskluderes derfor Pubmed #14 #10 AND delayed treatment 11/3 Hinshaw et al. (2008) Studiet er allerede inkluderet Cammu (1996) Studiet er allerede ekskluderet Geary (1996) Studiet er allerede ekskluderet Cochrane Library #15 The cochrane library (Full text) -Browse by topics -Pregnancy and childbirth -Dystocia -Augmentation 6/1 Bugg, G. et al 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 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) Pubmed #16 Search ((("1997 "[Date - Publication] : "2012"[Date - Publication])) AND nulliparity) AND dystocia AND term 53/2 Kjaergaard, H et al 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 Studiet ekskluderes, da det ikke er 53

8 Bilag 1 et RCT eller metaanalyse. Rouse, D.J. et al Pubmed # Pubmed # Cinahl #19 Search ((("1997 "[Date - Completion] : "2012"[Date - Completion])) AND partogram) AND nulliparity AND randomi* Search (((("1997 "[Date - Completion] : "2012"[Date - Completion])) AND action line) AND partogram) AND randomi* Limiters - Published Date from: ; Randomized Controlled Trials; Language: Danish, English, Norwegian, Swedish Expanders - 1/0 8/3 Lavender, T et al Effect of different partogram action lines on birth outcomes: a randomized controlled trial. Publiceret i Obstetrics and Gynecology, august 2006, nr 108 (2), s Lavender, T. et al Partogram action line study: a randomised trial. Publiceret i British Journal of Obstetrics and Gynecology, September 1998, nr 105 (9), s /2 Dencker Studiet er allerede inkluderet Hinshaw Studiet er allerede inkluderet Et allerede ekskluderet studie Pattinson, R.C. et al. Agressive or expectant management of labour: a randomised clinical trial. Publiceret i BJOG, maj 2003, nr 110 (5), s 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. 54

9 Bilag 1 Apply related words; Also search within the full text of the articles Search modes - Boolean/Phrase Cinahl #20 oxytocin OR syntocinon AND nulliparity NOT Induction Limiters - Published Date from: ; Language: Danish, English, Norwegian, Swedish Search modes - Boolean/Phrase 1.155/ søgning specificeres Cinahl # Cinahl #22 Oxytocin OR syntocinon AND nulliparity #20 AND dystocia #20 AND delayed treatment 33/1 Shields, S.G. et al Dystocia in nulliparous women Publiceret i American Family Physician, juni 2007, nr 75(11), s Artiklen er beskrivende omkring dystoci, men det er ikke et egentlig studie. Derfor er artiklen ikke relevant for opgave 3/2 Bugg, G.J. et al Studiet er allerede ekskluderet. Frälich, M

10 Bilag 1 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 Cinahl #23 #20 AND early treatment Artiklen kommenterer på Bugg, G.J et al. 2011, hvilket er ekskluderet fra denne opgave. Således opfylder artiklen ikke opgavens inklusionskritier. 2/1 Bugg, G.J. et al Studiet er allerede ekskluderet. 56

11 Bilag 2 Jadad-score 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) Var studiet beskrevet som double-blindet? (1 point) Dencker, A. et al Ja (1 point) Ja (1 point) Hinshaw, K. et al Ja (1 point) Ja (1 point) Lavender, T. et al. (1998) Ja (1 point) Ja (1 point) Lavender, T. et al. (2006) Ja (1 point) Ja (1 point) Nej (0 point) Nej (0 point) Nej (0 point) Nej (0 point) Var metoden til blinding beskrevet og var den passende/upassende (identisk placebo, aktiv placebo, dummy) (1 point/ minus 1 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) I alt 3 point 3 point 2 point 3 point 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) 57

12 Bilag 3 Dencker, A. et al 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 Introduction Background and objectives 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 a Scientific background and explanation of rationale b 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 Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they 532 were assessed 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)

13 Bilag 3 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 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. Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 532 Ikke beskrevet 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 b 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 b For each group, losses and exclusions after randomisation, together with reasons 531 Recruitment 14a Dates defining the periods of recruitment and follow-up b 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 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) b 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 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

14 Bilag 3 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 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 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 60

15 Bilag 3 Hinshaw, K. et al 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 Title and abstract Introduction Background and objectives Item No Checklist item 1a Identification as a randomised trial in the title b 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 Flere outcome measures er inkluderet I abstractet, end hvad der er beskrevet i metoden. I metodeafsnittet er kun sectiorate inkluderet som outcome measure Reported on page No 2a Scientific background and explanation of rationale b Specific objectives or hypotheses 1290 Methods Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio b 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 b Settings and locations where the data were collected 1290 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered 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 b 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 Sample size 7a How sample size was determined

16 Bilag 3 Randomisation: Sequence generation 7b When applicable, explanation of any interim analyses and stopping guidelines. Analyser undervejs er ikke beskrevet i designet, men foretaget da fundingen udløb. 8a Method used to generate the random allocation sequence b Type of randomisation; details of any restriction (such as blocking and block size) 1291 Ikke relevant 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 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 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. Beskrivelsen af hvilke statistiske metoder, der vil blive benyttet er overordnet. Brugen af de statistiske metoder er ikke specifikt relateret til outcome measures b Methods for additional analyses, such as subgroup analyses and adjusted analyses Ikke relevant 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. Vist i tabelform b For each group, losses and exclusions after randomisation, together with reasons. Ingen drop-outs. Ikke relevant. Recruitment 14a Dates defining the periods of recruitment and follow-up b Why the trial ended or was stopped. Manglende funding som beskrevet tidligere Baseline data 15 A table showing baseline demographic and clinical characteristics for each group. Tabel 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 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). Resultaterne er gengivet i tabellerne 2-4. Resultatet for primary outcome ( )

17 Bilag 3 (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 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. 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 Generalisability 21 Generalisability (external validity, applicability) of the trial findings. Gennemførslen af studiet var fint. Resultatet for sectiorate bør således være externt validt Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence 1294 Other information Registration 23 Registration number and name of trial registry 1295 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 1295 *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 63

18 Bilag 3 Lavender, T. et al 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 Introduction Background and objectives 1a Identification as a randomised trial in the title 976 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 976 2a Scientific background and explanation of rationale b Specific objectives or hypotheses 977 Methods Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio b Important changes to methods after trial commencement (such as eligibility criteria), with reasons 978 Participants 4a Eligibility criteria for participants 977 4b Settings and locations where the data were collected 977 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were 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 Sample size 7a How sample size was determined 978 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 978 8b Type of randomisation; details of any restriction (such as blocking and block size) Ikke beskrevet 64

19 Bilag 3 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 Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 977 Ikke beskrevet 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 b Methods for additional analyses, such as subgroup analyses and adjusted analyses 978 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 b For each group, losses and exclusions after randomisation, together with reasons 978 Recruitment 14a Dates defining the periods of recruitment and follow-up b Why the trial ended or was stopped Ikke relevant Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 979 Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 979 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) b 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 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 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

20 Bilag 3 Other information Registration 23 Registration number and name of trial registry Ikke beskrevet 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 Ikke beskrevet *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 66

21 Bilag 3 Lavender, T. et al 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 Introduction Background and objectives 1a Identification as a randomised trial in the title 295 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) 295 2a Scientific background and explanation of rationale b 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 b Important changes to methods after trial commencement (such as eligibility criteria), with reasons. Ingen ændringer beskrevet Ikke relevant Participants 4a Eligibility criteria for participants 296 4b Settings and locations where the data were collected 296 Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed b Any changes to trial outcomes after the trial commenced, with reasons. Ingen ændringer beskrevet Ikke relevant Sample size 7a How sample size was determined b When applicable, explanation of any interim analyses and stopping guidelines 298 Randomisation: Sequence generation 8a Method used to generate the random allocation sequence b Type of randomisation; details of any restriction (such as blocking and block size). Stratifiseret for at sikre at 67

22 Bilag 3 Allocation concealment mechanism grupperne var så ens som muligt 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 Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Ikke relevant 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 b 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 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 b For each group, losses and exclusions after randomisation, together with reasons 299 Recruitment 14a Dates defining the periods of recruitment and follow-up b Why the trial ended or was stopped Ikke relevant Baseline data 15 A table showing baseline demographic and clinical characteristics for each group 299 Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 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) b For binary outcomes, presentation of both absolute and relative effect sizes is recommended Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory 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 Ikke beskrevet

23 Bilag 3 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 Other information Registration 23 Registration number and name of trial registry 295 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 295 *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 69

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