For Tonsillo-Pharyngitis Assessment (TPA), VAS has been used effectively. Please refer to the paper "Utility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study".

Thank you very much Dr. Prasad Kulkarni.

You will want to measure the severity of the pharyngitis separately from the related pain intensity. This will allow you to run correlations on these 2 variables. For pain measurement, I recommend the Painometer, a hand held pain assessment tool which contains a VAS and also sensory and affective pain word descriptors that the subject chooses. This will give you the affective, sensory, and over all intensity scores for pain in this condition. Please see Fall-Dickson et al pubs for use of Painometer. All the best with your clinical trial!

Dr. Jane Fall-Dickson,  Thank you very much for your sugestion as well best wishes.

This should keep you busy for a while!  Although the data is not published most of these outcomes have been validated following FDA's guidance.

Regards,

Papers:

1. Schachtel B, Aspley S, Shephard A, Shea T, Smith G, Sanner K, Savino L, Rezuke J, Schachtel E. Onset of action of a lozenge containing flurbiprofen 8.75 mg: a randomized, double-blind, placebo-controlled trial with a new method for measuring onset of analgesic activity. Pain. 2014 Feb;155(2):422-8.

2. Schachtel B, Aspley S, Shephard A, Shea T, Smith G, Schachtel E. Utility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study. Trials. 2014 Jul 3;15:263.

3. Shephard A, Smith G, Aspley S, Schachtel BP. Randomised, double-blind, placebo-controlled studies on flurbiprofen 8.75 mg lozenges in patients with/without group A or C streptococcal throat infection, with an assessment of clinicians' prediction of 'strep throat'. Int J Clin Pract. 2015 Jan;69(1):59-71.

Abstracts:

1.    Schachtel BP, Aspley S, Sternberg M, Berry P, Muir N, Sanner K, Rezuke J, Savino L, Shephard A, Shea T, Schachtel E. Onset of demulcent and analgesic activity of flurbiprofen lozenge. Int J Clin Pharm 2012;34:143–258.

2.    Schachtel B, Aspley S, Berry P, Shephard A, Sanner K, Shea T, Smith G, Schachtel E. Chief Complaint: the therapeutogenic stimulus as the primary, individualized endpoint in clinical trials. Journal of Pain 2012;13(4)Supplement:S6.

3.    Schachtel B, Aspley S, Berry P, Muir N, Shephard A, Shea T, Smith G, Schachtel E. Efficacy of a novel (lozenge) delivery of flurbiprofen over 24 hours. Journal of Pain 2012;13(4)Supplement:S74.

4.    Aspley S, Schachtel B, Berry P, Shephard A, Sanner K, Shea T, Smith G. The Chief Complaint: evidence of its use as an endpoint in a clinical trial. Journal of Pain 2012;13(4)Supplement:S4.

5.    Schachtel B, Aspley S, Berry P, Shephard A, Shea T,Sanner K, Smith G,Schachtel E. Efficacy of flurbiprofen 8.75mg lozenges in patients with swollen/inflamed sore throat. Abstract presented at the 14th World Congress on Pain, 27 – 31 August 2012, Milan.

6.    Aspley S, Schachtel B, Berry P, Shephard A, Shea T, Smith G, Lorton M, Schachtel E. Efficacy and safety of multiple uses of flurbiprofen 8.75mg lozenge over 1 week. Abstract presented at the 14th World Congress on Pain, 27 – 31 August 2012, Milan.

7.    Aspley S, Schachtel B, Berry P, Shephard A, Sanner K, Savino L, Rezuke J, Shea T, Smith G. Treatment of odynophagia and dysphagia by flurbiprofen 8.75 mg lozenges. Pain Research & Management 2012;17(3):203.

8.    Schachtel B, Aspley S, Berry P, Shephard A, Shea T, Smith G, Sanner K, Savino L, Rezuke J, Schachtel E. Efficacy and duration of flurbiprofen 8.75 mg lozenge. Clinical Pharmacology in Drug Development 2012;1(4):194.

9.    Schachtel B, Aspley S, Berry P, Smith G, Shephard A, Shea T, Schachtel E. A patient-centered method for determining onset of action. Clinical Pharmacology in Drug Development 2012;1(4):194–195.

10. Schachtel B, Aspley S, Berry P, Shephard A, Shea T, Smith G, Schachtel E. A new cough model: de-hawthornizing a clinical trial. Clinical Pharmacology in Drug Development 2012;1(4):195.

11. Aspley S, Schachtel B, Berry P, Shephard A, Shea T, Smith G, Schachtel E. Flurbiprofen lozenges in patients with a “bad sore throat”. Journal of Pain 2013;14(4):S59.

12. Schachtel B, Aspley S, Berry P, Shephard A, Shea T, Smith G, Schachtel E. The “Definite Improvement Level” (DIL) as a determinant of drug efficacy. Journal of Pain 2013;14(4):S5.

13. Shephard A, Smith G, Aspley S, Schachtel B. Efficacy of flurbiprofen 8.75 mg lozenges for streptococcal and non-streptococcal sore throat: pooled analysis of two randomised, placebo-controlled studies. Abstract presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), 27 – 30 April 2013, Berlin.

14. Shephard A, Smith G, Aspley S, Schachtel B. Symptomatic relief in streptococcal and non-streptococcal sore throat patients: pooled analysis of two randomised, placebo-controlled studies. Abstract presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), 27–30 April 2013, Berlin.

15. "Schachtel B, Aspley S, Shephard A, Shea T, Smith G, Sanner K, Schachtel E, Brignull E. Demonstration of functional relief (improved swallowing) by flurbiprofen lozenge. From Pharmacology 2013: Proceedings of the British Pharmacological Society at: http://www.pa2online.org/abstracts/vol11issue3abst073p.pdf"

16. Schachtel B, Shephard A, Aspley S, Smith G. SPID2 and SPID24 in the evaluation of acute analgesics taken episodically. Journal of Pain 2014;15(4):S5.

17. Shephard A, Smith G, Aspley A, Schachtel B. Differential diagnosis of Strep A and C [abstract]. Int J Infect Dis 2014;21S:356.

18. Schachtel B, Shephard A, Smith G, Schachtel E, Aspley S. Subjective and objective indicators of group A streptococcal sore throat. Abstract presented at the 19th World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians (WONCA) Europe Conference, 2–5 July 2014, Lisbon, Portugal.

19. Schachtel B, Shephard A, Smith G, Schachtel E, Aspley S. How long does sore throat last? Abstract presented at the 19th World Organization of National Colleges, Academies and Academic Associations of General Practitioners/Family Physicians (WONCA) Europe Conference, 2–5 July 2014, Lisbon, Portugal.

20. Shephard A, Schachtel B, Smith G, Aspley S, Gooi C. Clinical Features of Group A Streptococcal Throat Infection: Findings from Randomised Controlled Trials. Malays Fam Physician 2014;9(Supplement 1):83.

21. Schachtel B, Shephard A, Smith G, Aspley S, Gooi C. Efficacy and safety of multiple doses of flurbiprofen 8.75 mg lozenge over 1 week. Malays Fam Physician 2014;9(Supplement 1):83.

22. Shephard A, Smith G, Aspley S, Schachtel B. Clinical indicators used by practitioners to diagnose group A streptococcal throat infection: findings from two double-blind, randomised, placebo-controlled, multi-centre trials. Abstract presented at the 74th International Pharmaceutical Federation (FIP) World Congress of Pharmacy and Pharmaceutical Sciences, 31 August–4 September 2014, Bangkok, Thailand.

23. Schachtel B, Shephard A, Sanner K, Savino L, Rezuke J, Schachtel E, Smith G, Aspley S. Use of a single post-treatment assessment to demonstrate analgesic efficacy. Abstract presented at the International Association for the Study of Pain (IASP) 15th World Congress, October 6–11, 2014, Buenos Aires, Argentina.

24. Shephard A, Smith G, Aspley S, Schachtel E, Schachtel B. Efficacy of flurbiprofen 8.75 mg lozenges in patients with swollen/inflamed sore throat. Abstract presented at the International Association for the Study of Pain (IASP) 15th World Congress, October 6–11, 2014, Buenos Aires, Argentina.

25. Schachtel B, Shephard A, Smith G, Aspley S, Sanner K, Savino L, Schachtel E, Lorton MB, Shea T. Relief of sore throat pain with flurbiprofen 8.75 mg lozenge. Abstract presented at the Annual Scientific Meeting of the British Pain Society (BPS), 21–23 April 2015, Glasgow, UK.

26. Shephard A, Shea T, Smith G, Schachtel E, Schachtel B. An alternative to antibiotics for the symptomatic relief of sore throat – evidence from a randomised, controlled study of flurbiprofen lozenge. Abstract presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), 25–28 April 2015, Copenhagen, Denmark.

27. Shephard A. Shea T, Smith G, Schachtel B. Diagnosis of streptococcal throat infection in a randomised, controlled study of flurbiprofen lozenge. Abstract presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), 25–28 April 2015, Copenhagen, Denmark.

28. Schachtel B, Shephard A, Aspley S, Smith G, Sanner K, Savino L, Schachtel E, Shea T. Demonstration of clinically important relief and the percent change in pain intensity at the time of meaningful relief by flurbiprofen 8.75 mg lozenge. Abstract presented at the 34th Annual Scientific Meeting of the American Pain Society, May 13–16, 2015, Palm Springs, CA, USA.

29. Schachtel B, Shephard A, Aspley S, Smith G, Shea T, Sanner K, Savino L, Schachtel E. Effect of flurbiprofen 8.75 mg lozenge on coughing in patients with upper respiratory tract infection. Abstract presented at the American Cough Conference, June 5–6, 2015, Washington DC, USA.

30. Schachtel B, Aspley S, Shephard A, Smith G, Sanner K, Savino L, Schachtel E, Lorton MB, Shea T. The Qualities of Sore Throat Index (QuaSTI): first use in a clinical trial testing the effects of flurbiprofen 8.75 mg lozenge on patient-reported qualities of throat pain. Abstract presented at the 12th Congress of the European Association for Clinical Pharmacology and Therapeutics (EACPT), 27–30 June 2015 in Madrid, Spain.