Paradigm shift in clubfoot care strategies in Pakistan: A meta-analysis over three decades

Table 1 Distribution of clubfoot publications in Pakistan by treatment strategy and decade (1990-2025)

Year range	Surgical	Ponseti	Other conservative	Total conservative	Non-clinical	Total
1990-1999	4	0	0	0	0	4
2000-2004	3	0	1	1	0	4
2005-2009	2	3	1	4	1	7
2010-2014	8	14	0	14	3	25
2015-2019	5	13	0	13	4	22
2020-2024	4	39	2	41	13	58
2025	0	3	0	3	2	5
Total	26	72	4	76	23	125
%	20.8%	57.6%	3.2%	60.8%	18.4%	100%

Table 2 Risk of bias summary, n (%)

	Low risk	Moderate risk	Serious risk	Critical risk	No information
Confounding	12 (9.6)	48 (38.4)	55 (44)	6 (4.8)	4 (3.2)
	No adjustment for age/severity in older studies; better in recent Ponseti
Selection	25 (20)	60 (48)	35 (28)	3 (2.4)	2 (1.6)
	Retrospective designs were common pre-2010; prospective post-2015 improved
Classification	95 (76)	20 (16)	6 (4.8)	0	4 (3.2)
	Clear definitions in most (e.g., Ponseti protocol)
Deviations	18 (14.4)	55 (44)	45 (36)	5 (4)	2 (1.6)
	Bracing non-compliance is high in 40; co-interventions are unbalanced
Missing data	10 (8)	40 (32)	65 (52)	8 (6.4)	2 (1.6)
	Short follow-up (< 1 year in 70); loss to follow-up in 25
Measurement	30 (24)	70 (56)	20 (16)	1 (0.8)	4 (3.2)
	Pirani scoring standard, but no blinding in 60
Reported result	85 (68)	30 (24)	6 (4.8)	0	4 (3.2)
	Most pre-specified, selective in older surgical
Overall	8 (6.4)	52 (41.6)	53 (42.4)	8 (6.4)	4 (3.2)
	Moderate/Serious dominant; sensitivity excluded serious/critical (estimates stable)
Based on ROBINS-I, n = 125 native studies; grade downgraded for serious bias in confounding/missing data

ROBINS-I: Risk of bias in non-randomized studies - of interventions.

Table 3 Bias assessment summary

Bias type	Key findings	Grade
Publication bias	Funnel plots (Figure 5) showed no obvious asymmetry for success, relapse, or age reduction despite high heterogeneity (I2 aproximately 82%-90%); quantitative tests were not applied due to unreliability	Grade: Moderate; no strong evidence of publication bias
Selective reporting	91% (114/125) reported pre-specified outcomes; 7.2% omitted relapse (pre-2010); 69.7% < 1-year follow-up = overestimates success	Grade: Moderate; overestimate Ponseti success, underestimate relapse
Other sources of bias	Language/citation bias minimal (PakMediNet mitigated; 41 added studies = no change)	Minimal impact; grade: High
Sensitivity analyses	Excluding short/high-risk studies: Success 88.1%, relapse 213% (stable)	Findings stable
Overall interpretation	Low-to-moderate bias. Mandate standardized scoring (Pirani ≥ 6.0 initial; relapse = recurrence requiring intervention) and minimum 4-year follow-up	Grade for key outcomes: Ponseti success: Moderate; relapse: Moderate; paradigm shift: High
Random-effects model (DerSimonian-Laird); analyses in R v4.3.2 (meta, metafor)

Table 4 Comparison of success rate with conservative approaches

Year range	Method	Number of studies	Total sample size	Average sample size	Success rate (%)	Average follow-up duration
1990-1999	Ponseti	0	0	N/A	N/A	N/A
	Hiram Kite, Lovell, French	0	0	N/A	N/A	N/A
2000-2009	Ponseti	3	140	46.7	90.0	1-2 years
	Hiram Kite, Lovell, French	2	65	32.5	68.0	12 months
2010-2019	Ponseti	24	3690	136.7	88.2	About 2.2 years (weighted)
	Hiram Kite, Lovell, French	0	0	N/A	N/A	N/A
2020-2025	Ponseti	42	7465	177.7	88.0	1-4 years
	Hiram Kite, Lovell, French	2	200	100	70.0	1-2 years
Total	Ponseti	72	11295	150.7	87.2 (95%CI: 84.8-89.6)	1.8 years (weighted mean)
	Hiram Kite, Lovell, French	4	265	66.3	69.1 (95%CI: 62.3-75.9)	1.1 years

Statistical comparison (exploratory, I² = 88%): Ponseti vs other: RR = 1.26 (95%CI: 1.18-1.35), P < 0.001; limitations: High heterogeneity (I² = 88%); 68% missing; FU < 2 years in most. N/A: Not applicable; CI: Confidence interval; RR: Risk ratio; FU: Follow-up.

Table 5 Age at initiation of treatment: Surgical vs conservative approaches

Year range	Publications				mean ± SD age (months)
	Total	Surgical (n)	Conservative (n)	Non-clinical (n)	At presentation	Surgical	Conservative
1990-1999	4	4	0	0	13.8 ± 12.8	13.8 ± 12.8	N/A
2000-2009	11	5	5	1	20.9 ± 16.1	45.0 ± 30.5	16.8 ± 11.8
2010-2019	47	13	27	7	11.2 ± 15.6	54.2 ± 38.1	8.5 ± 7.0
2020-2025	63	4	44	15	9.5 ± 9.0	85.0 ± 45.0	7.7 ± 6.4
Total	125	26	76	23	11.4 ± 14.2	54.8 ± 39.6	8.2 ± 7.1

Surgical vs conservative: Mean difference = 46.6 months (95%CI: 41.2-52.0), P < 0.001; trend: Age at presentation decreased over time (r = -0.89, P < 0.001) - reflects early detection + Ponseti awareness. N/A: Not applicable.

Table 6 Follow-up duration for surgical and conservative studies, n (%)

Follow-up duration	Surgical studies	Conservative studies	Total studies
< 1 year	18 (69.2)	54 (71.1)	72 (70.6)
1-3 years	7 (26.9)	20 (26.3)	27 (26.5)
3-5 years	1 (3.8)	2 (2.6)	3 (2.9)
> 5 years	0 (0.0)	0 (0.0)	0 (0.0)
Total	26 (100)	76 (100)	102 (100)

Excluded (n = 23): Nonclinical or no follow-up reported; limitation: 18% (23/125) missing follow-up; none > 5 years = relapse likely underestimated.