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average VHI-10 and VFI scores began to downtrend to27.5/C610.2 and 42.9 /C616.4 but did not achieve the range
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of published minimally important clinical difference (MCID)f o re i t h e rq u e s t i o n n a i r e .
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36,37However, by 1 month, the
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change in the average VHI-10 and VFI scores re flected a
|
significant decrease compared to baseline, beyond the
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MCID range of a four-to-six-point decrease in total score.With repeat monthly injections both the average VHI-10and
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VFI scores continued to decrease signi ficantly with sub-
|
sequent follow-up evaluations at the two and three-month
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timepoints
|
Interestingly, at the four-month timepoint, both
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the VHI-10 and VFI scores continued to decrease, but onlythe VHI-10 score was signi ficantly lower than baseline
|
It is
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i m p o r t a n tt on o t et h a to n l y five patients have reached this
|
point in the study
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Therefore, it is perhaps too early to com-ment on the longevity of serial PRP injections in terms oftheir impact on these patient-reported outcomes.
|
Our preliminary work contains encouraging outcome
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trends that may point to positive outcome longevityregarding voice quality in patients treated with serialPRP injections
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Continued patient follow-up and enroll-ment will further elucidate the therapeutic role of PRP inlaryngology
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Determining the safety of PRP treatment isa crucial step toward characterizing its use in patientcare with respect to outpatient laryngeal procedures.While this work builds on earlier efforts from our institu-tion outlining the technical feasibility and safety of PRPinjections, ongoing enrollment will continue to substanti-ate our early findings.
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21While the contralateral vocal fold
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served as a control, incorporating a volume-occupyingcontrol such as saline or platelet-poor plasma could bebeneficial in de fini
|
tively attributing vocal improvements
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to the bioactive components in PRP.
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The trial contains clear limitations
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The subjective
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nature of patient-reported voice outcomes limits the scopeof meaningful conclusions about the procedure ’s long-
|
term ef ficacy
|
To that end, patient experiences need to be
|
correlated to objective anatomical changes and voiceparameters
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By the current trial design, patients willbe followed-up for a minimum of 12 months after the con-cluding injection
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Future work will assess objectiveoutcome measurement from video stroboscopic evaluationwhich will provide a functional clinical correlate to bolster
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the results thus far
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More work is also needed to deter-
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mine the optimal timing of PRP treatment and thenumber of injections needed to provide optimal effect.
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CONCLUSION
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The absence of any reported safety events during the
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application and follow-up period for 43 unilateral vocalfold injections using PRP indicates its safety for use inthe ambulatory care setting
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The standardized approach
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of PRP preparation and application to the vocal folds rep-resents a safe therapeutic approach for patients withvocal fold atrophy or scar
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Subjective improvements invocal quality were accompanied by signi ficant decreases
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in VHI-10 and VFI questionnaire scores in patientsincluded in this trial
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The overall trend of the patient-reported outcome measures indicates voice improvementsbeyond the limits of the MCID for these measures
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Whilethese results persisted for most patients during the trial,a few did report a gradual decline in voice quality afterreceiving a PRP injection
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Additional follow-up will deter-mine the true longevity and extent to which in-of fice PRP
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injections affect objective voice parameters
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Ongoingenrollment in the clinical trial will continue to assess thesafety and therapeutic bene fits of serial PRP injections.
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|
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