A pilot study on the development and preliminary validation of the diabetic neuropathy short form 11 to assess quality of life in Indonesia

Diabetic neuropathy significantly impairs quality of life through symptoms such as pain, numbness, and physical limitations. Despite its high prevalence, there is a lack of specific instruments to comprehensively assess quality of life in affected patients, particularly in Indonesia. This pilot study aimed to develop and preliminarily validate the Diabetic Neuropathy Short Form 11 (DN-SF11), a concise questionnaire comprising 11 items across five dimensions: Pain, Physical Function, Therapy Impact, Vitality, and Mental Health. The instrument was developed through literature review and expert consensus using the Delphi method and Content Validity Index (CVI). Statistical validation was conducted in 40 participants using Partial Least Squares Structural Equation Modelling (PLS-SEM), which is suitable for exploratory analysis. The DN-SF11 demonstrated strong internal consistency (Cronbach’s alpha = 0.883) and satisfactory convergent and discriminant validity. The structural model indicated that Physical Function and Therapy Impact positively influence Vitality, which in turn significantly predicts Mental Health outcomes. These findings provide preliminary evidence supporting the DN-SF11 as a reliable and practical instrument for assessing quality of life in diabetic neuropathy patients. Further large-scale validation studies are recommended.