Patient-Centered Outcomes and Key Study Procedure Finalization in the Pilot Feasibility Gout Randomized Trial

Abstract

Objective The aim of this study was to report patient-centered outcomes and finalization of key study procedures from a 9-month pilot internet randomized controlled trial of cherry extract versus diet modification. Methods We randomized 84 people with physician-confirmed gout in an internet study to cherry extract (n = 41) or dietitian-assisted diet modification for gout (n = 43). All study outcomes were collected via internet and phone calls. We finalized key study procedures. We assessed acceptability and feasibility of the intervention and satisfaction with study website. Results Study participant satisfaction with the intervention was high. The intervention was perceived as easy, enjoyable, understandable, and helpful (scores 65–88 for all; higher = better). The amount of time spent for the study was acceptable. Participant satisfaction with website interaction and content was very high; 85% or more were moderately to extremely satisfied. Significantly lower total calories, total carbohydrate, and saturated fat intake were noted at 6 months in the diet modification versus cherry extract group; differences were insignificant at 9 months. Six of the 8 Health Assessment Questionnaire sections/domains improved significantly from baseline to 9 months in cherry extract versus 2 Health Assessment Questionnaire sections/domains in the diet modification group. Key study procedures were finalized for a future trial, including an internet diet assessment tool, gout flare assessment, provider confirmation of gout diagnosis, patient reporting of classification criteria, and centralized laboratory-assisted serum urate testing. Conclusions High patient acceptability and feasibility of study/intervention and finalization of key study procedures indicate that hypothesis-testing internet gout trials of cherry extract and/or diet modification can be conducted in the future.

The Impact of Natural Product Dietary Supplements on Patients with Gout: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

“…A total of nine RCTs with 1156 participants were included in this review. Seven trials were conducted in China [20][21][22][23][24][25][26], 1 in the USA [27], and 1 in New Zealand [28]. All the studies were published from 2008 to 2019.…”

“…Seven studies evaluated herbal therapies, with the remaining two evaluating skim milk and cherry extract. Six trials had two arms; [20,25], one adopted the random envelope method [21], and the other used online computer random number generator [27]. e other two trials had an unclear risk for random sequence generation due to lack of detail [23,26].…”

“…Two trials had unclear randomization without description in sufficient detail [23,26]. Five trials had lower risk bias for allocation concealment [21,22,24,27,28]. ree trials were doubleblinded trials with a lower risk for blinding participants and study personnel [21,22,28].…”

“…Two trials did not use a blinding method to participants and study personnel during the study with a high risk due to the great appearance difference between Chinese medical formulation pills and decoction with conventional pharmaceutics such as indomethacin, benzbromarone, and allopurinol [20,25]. e other four trials had insufficient information to permit a judgment [23,24,26,27]. ree trials could be regarded as lower risk for blinding of outcome assessors [20][21][22].…”

“…One trial had high risk in outcome assessment due to a lack of blinding [25]. Five trials had unclear risk in outcome assessment without description in sufficient detail [23,24,[26][27][28]. Two trials reported cases with poor compliance which were dropped from the study [22,24], two trials reported cases lost to follow-up [21,28], and two trials had missing values in the results [20,27], which might affect the results.…”