Patient-reported Outcomes and Outcome Measures in Childbirth Perineal Trauma Research: a Systematic Review

Overview

Journal Int Urogynecol J

Publisher Springer

Specialties Gynecology & Obstetrics
Urology

Date 2021 Jun 18

PMID 34143238

Citations 4

Authors

Stergios K Doumouchtsis

Jemina Loganathan

John Fahmy

Gabriele Falconi

Maria Rada

Abdullatif Elfituri

Jorge Milhem Haddad

Vasilios Pergialiotis

Cornelia Betschart

Affiliations

Soon will be listed here.

Abstract

Introduction And Hypothesis: In evaluating the effectiveness of interventions in perineal trauma research, outcomes reported by patients should have a prominent focus. There is no international consensus regarding the use of either patient-reported outcomes (PROs) or tools used to determine these outcomes (patient-reported outcome measures, PROMs). The objective was to evaluate the selection, reporting and geographical variations of PROs and PROMs in randomised controlled trials (RCTs) on perineal trauma.

Methods: We performed a systematic review of RCTs in perineal trauma research evaluating outcome and outcome measure reporting. We identified PROs and PROMs and grouped PROs into domains and themes, a classification system based on a medical outcome taxonomy.

Results: Of 48 included RCTs, 47 reported PROs. In total, we identified 51 PROs. Outcome reporting consistency was low, with 27 PROs reported only once. Nine PROs were reported more than five times, the most frequent being perineal pain, with no geographical variation in reporting. Four themes encompassing 12 domains were identified. The most frequently reported theme was "Clinical", with 25 PROs grouped within four domains. "Resource use" and "Adverse events" themes were rarely reported, with only five PROs. PROMs also exhibited variation. Most common were visual analogue scale (VAS; 100 mm), Cleveland Clinic Continence Score, The Faecal Incontinence Quality of Life scale, VAS (0-10) and the McGill Pain Questionnaire.

Conclusions: Significant heterogeneity in PROs and PROMs was observed among RCTs. Despite inconsistency, PROs are the most prevalent outcome in perineal trauma research. Patient-reported adverse events are underreported. Their use in determining the effectiveness and safety of interventions makes their integration important in perineal trauma core outcome sets. Identification and grouping of outcomes will assist future core outcome consensus studies.

Citing Articles

The relationship between perineal trauma and postpartum psychological outcomes: a secondary analysis of a population-based survey.

Opondo C, Harrison S, Sanders J, Quigley M, Alderdice F BMC Pregnancy Childbirth. 2023; 23(1):639.

PMID: 37674105 PMC: 10481495. DOI: 10.1186/s12884-023-05950-6.

Evaluation of outcome reporting in clinical trials of physiotherapy in bronchiectasis: The first stage of core outcome set development.

Hamzeh H, Spencer S, Kelly C, Pilsworth S PLoS One. 2023; 18(3):e0282393.

PMID: 36928192 PMC: 10019700. DOI: 10.1371/journal.pone.0282393.

The impact of implementing patient-reported measures in routine maternity care: a systematic review.

Chen A, Vayrynen K, Schmidt A, Leskela R, Torkki P, Heinonen S Acta Obstet Gynecol Scand. 2022; 101(11):1184-1196.

PMID: 36065150 PMC: 9812106. DOI: 10.1111/aogs.14446.

Development and initial validation of a Swedish inventory to screen for symptoms of deficient perineum in women after vaginal childbirth: 'Karolinska Symptoms After Perineal Tear Inventory'.

Rotstein E, Von Rosen P, Karlstrom S, Knutsson J, Rose N, Forslin E BMC Pregnancy Childbirth. 2022; 22(1):638.

PMID: 35964017 PMC: 9375344. DOI: 10.1186/s12884-022-04964-w.

References

Aguiar M, Farley A, Hope L, Amin A, Shah P, Manaseki-Holland S . Birth-Related Perineal Trauma in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis. Matern Child Health J. 2019; 23(8):1048-1070. PMC: 6606670. DOI: 10.1007/s10995-019-02732-5. View

Frohlich J, Kettle C . Perineal care. BMJ Clin Evid. 2015; 2015. PMC: 4356152. View

Smith L, Price N, Simonite V, Burns E . Incidence of and risk factors for perineal trauma: a prospective observational study. BMC Pregnancy Childbirth. 2013; 13:59. PMC: 3599825. DOI: 10.1186/1471-2393-13-59. View

Dudding T, Vaizey C, Kamm M . Obstetric anal sphincter injury: incidence, risk factors, and management. Ann Surg. 2008; 247(2):224-37. DOI: 10.1097/SLA.0b013e318142cdf4. View

Williams A, Bartram C, Halligan S, Spencer J, Nicholls R, Kmiot W . Anal sphincter damage after vaginal delivery using three-dimensional endosonography. Obstet Gynecol. 2001; 97(5 Pt 1):770-5. DOI: 10.1016/s0029-7844(01)01318-7. View

Selo-Ojeme D, Okonkwo C, Atuanya C, Ndukwu K . Single-knot versus multiple-knot technique of perineal repair: a randomised controlled trial. Arch Gynecol Obstet. 2016; 294(5):945-952. DOI: 10.1007/s00404-016-4101-2. View

Fernando R, Sultan A, Kettle C, Radley S, Jones P, OBrien P . Repair techniques for obstetric anal sphincter injuries: a randomized controlled trial. Obstet Gynecol. 2006; 107(6):1261-8. DOI: 10.1097/01.AOG.0000218693.24144.bd. View

Fynes M, Marshall K, Cassidy M, Behan M, Walsh D, OConnell P . A prospective, randomized study comparing the effect of augmented biofeedback with sensory biofeedback alone on fecal incontinence after obstetric trauma. Dis Colon Rectum. 1999; 42(6):753-8; discussion 758-61. DOI: 10.1007/BF02236930. View

Oakley S, Ghodsi V, Crisp C, Estanol M, Westermann L, Novicki K . Impact of Pelvic Floor Physical Therapy on Quality of Life and Function After Obstetric Anal Sphincter Injury: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2016; 22(4):205-13. DOI: 10.1097/SPV.0000000000000255. View

10.

Leroux N, Bujold E . Impact of chromic catgut versus polyglactin 910 versus fast-absorbing polyglactin 910 sutures for perineal repair: a randomized, controlled trial. Am J Obstet Gynecol. 2006; 194(6):1585-90. DOI: 10.1016/j.ajog.2006.01.011. View

11.

Rydningen M, Dehli T, Wilsgaard T, Rydning A, Kumle M, Lindsetmo R . Sacral neuromodulation compared with injection of bulking agents for faecal incontinence following obstetric anal sphincter injury - a randomized controlled trial. Colorectal Dis. 2017; 19(5):O134-O144. DOI: 10.1111/codi.13632. View

12.

Yildizhan R, Yildizhan B, Sahin S, Suer N . Comparison of the efficacy of diclofenac and indomethacin suppositories in treating perineal pain after episiotomy or laceration: a prospective, randomized, double-blind clinical trial. Arch Gynecol Obstet. 2009; 280(5):735-8. DOI: 10.1007/s00404-009-1006-3. View

13.

Jiang H, Qian X, Carroli G, Garner P . Selective versus routine use of episiotomy for vaginal birth. Cochrane Database Syst Rev. 2017; 2:CD000081. PMC: 5449575. DOI: 10.1002/14651858.CD000081.pub3. View

14.

Aasheim V, Nilsen A, Reinar L, Lukasse M . Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2017; 6:CD006672. PMC: 6481402. DOI: 10.1002/14651858.CD006672.pub3. View

15.

Pergialiotis V, Durnea C, Elfituri A, Duffy J, Doumouchtsis S . Do we need a core outcome set for childbirth perineal trauma research? A systematic review of outcome reporting in randomised trials evaluating the management of childbirth trauma. BJOG. 2018; 125(12):1522-1531. DOI: 10.1111/1471-0528.15408. View

16.

Harman N, Bruce I, Callery P, Tierney S, Sharif M, OBrien K . MOMENT--Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. 2013; 14:70. PMC: 3716725. DOI: 10.1186/1745-6215-14-70. View

17.

Williamson P, Altman D, Bagley H, Barnes K, Blazeby J, Brookes S . The COMET Handbook: version 1.0. Trials. 2017; 18(Suppl 3):280. PMC: 5499094. DOI: 10.1186/s13063-017-1978-4. View

18.

Ghai V, Subramanian V, Jan H, Pergialiotis V, Thakar R, Doumouchtsis S . A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set. BJOG. 2020; 128(4):628-634. DOI: 10.1111/1471-0528.16412. View

19.

Durnea C, Pergialiotis V, Duffy J, Bergstrom L, Elfituri A, Doumouchtsis S . A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set. Int Urogynecol J. 2018; 29(12):1727-1745. PMC: 6244754. DOI: 10.1007/s00192-018-3781-5. View

20.

Rada M, Jones S, Falconi G, Haddad J, Betschart C, Pergialiotis V . A systematic review and meta-synthesis of qualitative studies on pelvic organ prolapse for the development of core outcome sets. Neurourol Urodyn. 2020; 39(3):880-889. DOI: 10.1002/nau.24297. View