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. 2025 Sep 23.
doi: 10.1097/SCS.0000000000011991. Online ahead of print.

The Pakistan Palatal Fistula Difficulty Index (PPFDI): Development and Initial Validation of a Novel Scoring Index for Surgical Complexity and Referral Guidance

Muhammad Daiem  1   2 , Ghulam Q Fayyaz  1 , Muhammad Sohail  3 , Farrukh A Khalid  3 , Muhammad M Bashir  3 , Marvee Turk  4 , Samra Bokhari  5 , Muhammad A Mustehsan  6 , Marshall G Miles  7 , Peter J Taub  8 , Phuong Nguyen  9 , Jesse Taylor  10 , Corstiaan Breugem  11
Affiliations

The Pakistan Palatal Fistula Difficulty Index (PPFDI): Development and Initial Validation of a Novel Scoring Index for Surgical Complexity and Referral Guidance

Muhammad Daiem et al. J Craniofac Surg. .

Abstract

Palatal fistulae remain the most common complication following cleft palate repair, with recent studies reporting incidence rates ranging from 2% to 35%. Existing classification systems offer limited guidance on surgical complexity or referral pathways. This study developed and validated the Pakistan Palatal Fistula Difficulty Index (PPFDI), a novel scoring system designed to quantify fistula complexity based on 6 domains: location, size, configuration, number of fistulae, recurrence history, and velopharyngeal function. A 3-tiered framework was proposed to guide referral based on complexity level and surgeon experience. Each domain was scored on a 3-point ordinal scale, yielding a total score range of 6 to 18. Content and face validity were established through a modified Delphi process involving 30 expert cleft surgeons, with all 6 domains achieving ≥70% agreement. Inter-rater reliability was assessed using standardized, anonymized clinical case files (n=30) independently scored by 4 senior cleft surgeons. The PPFDI demonstrated strong inter-rater reliability (ICC=0.87, 95% CI: 0.87-0.95), with domain-specific ICCs ranging from 0.78 to 0.92. The mean PPFDI score was 11.1 (SD=2.9), with 43.3% of cases classified as high complexity (score ≥12). Agreement between PPFDI-informed referral tier and clinician-determined referral need was 91.7% (Cohen kappa=0.81), indicating excellent alignment. The PPFDI offers a reliable and clinically meaningful method to stratify palatal fistula complexity and may support more structured decision-making in both low-resource and high-resource settings. Further validation through multicenter studies and correlation with surgical outcomes is warranted to confirm its broader clinical applicability.

Keywords: Cleft lip and palate; fistula classification; palatal fistula; palatoplasty; referral guidance; surgical complexity; surgical outcomes.

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Conflict of interest statement

The authors report no conflicts of interest.

References

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