Grading the quality of evidence for the primary and clinically important outcomes for the effectiveness of mixed approach interventions in pregnancy

S Thangaratinam; E Rogozińska; K Jolly; S Glinkowski; W Duda; E Borowiack; T Roseboom; J Tomlinson; J Walczak; R Kunz; BW Mol; A Coomarasamy; KS Khan

Appendix 15Grading the quality of evidence for the primary and clinically important outcomes for the effectiveness of mixed approach interventions in pregnancy

Publication Details

Table

Publication Details

Copyright

Included under terms of UK Non-commercial Government License.

Publisher

NIHR Journals Library, Southampton (UK)

NLM Citation

Thangaratinam S, Rogozińska E, Jolly K, et al. Interventions to Reduce or Prevent Obesity in Pregnant Women: A Systematic Review. Southampton (UK): NIHR Journals Library; 2012 Jul. (Health Technology Assessment, No. 16.31.) Appendix 15, Grading the quality of evidence for the primary and clinically important outcomes for the effectiveness of mixed approach interventions in pregnancy.

Quality assessment							Summary of findings					Importance

							No. of patients		Effect		Quality

No. of studies	Design	Limitations	Inconsistency	Indirectness	Imprecision	Other considerations	Mixed approach	Control	Relative (95% CI)	Absolute
Gestational weight gain (kg) (better indicated by lower values)
6	Randomised trials	No serious limitations^a^,^b	No serious inconsistency	No serious indirectness	Serious^c	Reporting bias^d	506	488	–	MD 0.36 lower (1.4 lower to 0.68 higher)	⊕⊕⊖⊖ Low	Important
Birthweight (kg) (better indicated by lower values)
5	Randomised trials	No serious limitations^a^,^b	No serious inconsistency	No serious indirectness	Serious^c	Reporting bias^d	264	245	–	MD 0.02 lower (0.1 lower to 0.07 higher)	⊕⊕⊖⊖ Low	Important
LGA
5	Randomised trials	No serious limitations^a^,^b	No serious inconsistency	Serious^e	No serious imprecision	None	18/237 (7.6%)	22/223 (9.9%)	RR 0.75 (0.41 to 1.38)	25 fewer per 1000 (from 58 fewer to 37 more)	⊕⊕⊕⊖ Moderate	Critical
SGA
2	Randomised trials	No serious limitations^a^,^b	No serious inconsistency	No serious indirectness	No serious imprecision	None	14/181 (7.7%)	17/164 (10.4%)	RR 0.76 (0.39 to 1.48)	25 fewer per 1000 (from 63 fewer to 50 more)	⊕⊕⊕⊕ High	Critical
Pre-eclampisa
3	Randomised trials	No serious limitations^a^,^b	Serious^f	No serious indirectness	Serious^c	None	10/193 (5.2%)	6/176 (3.4%)	RR 1.48 (0.56 to 3.94)	16 more per 1000 (from 15 fewer to 100 more)	⊕⊕⊖⊖ Low	Critical
Gestational hypertension
3	Randomised trials	No serious limitations^a^,^b	Serious^f	No serious indirectness	Serious^c	None	28/223 (12.6%)	23/207 (11.1%)	RR 1.19 (0.74 to 1.9)	21 more per 1000 (from 29 fewer to 100 more)	⊕⊕⊖⊖ Low	Critical
GDM
3	Randomised trials	No serious limitations^a^,^b		No serious indirectness	Serious^c	None	16/205 (7.8%)	15/185 (8.1%)	RR 0.96 (0.49 to 1.86)	3 fewer per 1000 (from 41 fewer to 70 more)	⊕⊕⊕⊖ Moderate	Critical
Preterm delivery
3	Randomised trials	No serious limitations^a^,^b	No serious inconsistency	Serious^e	No serious imprecision	None^d	12/198 (6.1%)	11/181 (6.1%)	RR 1.02 (0.47 to 2.21)	1 more per 1000 (from 32 fewer to 74 more)	⊕⊕⊕⊖ Moderate	Critical
Caesarean section
5	Randomised trials	No serious limitations^a^,^b	No serious inconsistency	Serious^e	No serious imprecision	Reporting bias^g	66/297 (22.2%)	62/267 (23.2%)	RR 0.95 (0.7 to 1.28)	12 fewer per 1000 (from 70 fewer to 65 more)	⊕⊕⊖⊖ Low	Critical
Induction of labour
1	Randomised trials	No serious limitations	No serious inconsistency^h	No serious indirectnessⁱ	Serious^c	None	24/42 (57.1%)	21/43 (48.8%)	RR 1.17 (0.78 to 1.75)	83 more per 1000 (from 107 fewer to 366 more)	⊕⊕⊕⊖ Moderate	Critical
Post-partum haemorrhage: not reported
0	–	–	–	–	–	None	0/0 (0%)	0/0 (0%)	–	–		Critical
Intrauterine death: not reported
1^k	Observational studies	Very serious¹	No serious inconsistency	Serious^e	No serious impression	None	3/88 (3.4%)	3/86 (3.5%)	OR 098 (0.19 to 2.56)	1 fewer per 1000 (from 28 fewer to 50 more)	⊕⊖⊖⊖ Very low	Critical
Admission to NICU: not reported
1^k	Observational studies	Very serious¹	No serious inconsistency	Serious^e	No serious impression	None	21/88 (23.9%)	42/86 (48.8%)	OR 0.33 (0.17 to 0.63)	249 fewer per 1000 (from 113 fewer to 349 fewer)	⊕⊖⊖⊖ Very low	Critical
Shoulder dystocia
1	Randomised trials	No serious limitations^a^,^b	No serious inconsistency	No serious indirectness	Serious^c	None	1/124 (0.8%)	1/111 (0.9%)	RR 0.9 (0.06 to 14.14)	1 fewer per 1000 (from 8 fewer to 118 more)	⊕⊕⊕⊖ Moderate	Critical
Birth trauma: not measured
0	–	–	–	–	–	None	0/0 (0%)	0/0 (0%)	–	–		Critical
Neonatal hypoglycaemia
2	Randomised trials	No serious limitations	No serious inconsistency	No serious indirectness	Serious^c	Reporting bias^j	5/141 (3.5%)	2/128 (1.6%)	RR 2.35 (0.47 to 11.76)	19 more per 1000 (from 172 more to 9 fewer)	⊕⊕⊖⊖ Low	Critical

a: Poor information about allocation concealment, which was assessed as not strongly significant.

b: Poor information about blinding of subjective outcomes, which was assessed as not strongly significant.

c: Wide CI crossing line of no effect.

d: Slight skew in funnel plot for given outcome.

e: Women with GDM.

f: Differences in range of interventions (intervention programme, behavioural intervention, advisory concerning adequate weight gain).

g: Meaningful skew in funnel plot for given outcome.

h: Single study.

i: Small sample size.

j: Difficult to interpret as only two studies.

k: Data from observational studies Penchar 2009.⁸²

l: Study of low quality (Penchart 2009⁸²); weakness in cohort representativeness, selection of exposed cohort, asscertainment of exopsure and cohorts comparability.