Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at ≤1.2 kHz in Previously Implanted Subjects.

OBJECTIVE: The WHISPER randomized controlled trial (RCT) evaluates safety and clinical effectiveness of subperception spinal cord stimulation (SCS) at ≤1.2 kHz in subjects previously implanted with an SCS system for treatment of chronic, neuropathic pain. METHODS: WHISPER is a prospective, multicenter RCT with a crossover design sponsored by Boston Scientific, Marlborough, MA (ClinicalTrials.gov: NCT02314000). Eligible subjects were randomized (N = 140) to receive subperception or supraperception for three months and then crossed over to receive the alternative. Upon completion of crossover period, subjects who preferred subperception were followed up to one year. Overall pain, quality-of-life, and other outcomes were collected in the study. The primary endpoint was the overall pain responder rate (≥50% improvement from baseline) with no increase in medications. Secondary endpoints consisted of pain scores, physical disability, quality of life, and treatment preference. RESULTS: The study met its primary endpoint and demonstrated noninferiority between supraperception and subperception in a prespecified cohort of 70 randomized subjects (Interim Analysis). Thirty-nine percent of subjects with subperception settings and 29% with supraperception settings had a greater than or equal to 50% reduction in their overall pain scores with no increase in average daily medication at three-months post-activation as compared with baseline. Further assessment of all participating study subjects (N = 140) revealed similar results. Subjects were previously implanted 3.8 ± 2 years and had a disability score (Oswestry Disability Index) of 70.2 ± 11.4 at study start. Of the randomized subjects that completed the End of Period 2 Visit, 93 (66%) preferred subperception SCS and their mean overall pain reduced from 7.3 ± 1.1 (N = 89) at baseline to 4.0 ± 2.1 (N = 80) at 12-months post-activation. Post hoc analysis also demonstrated that multiple options provide superior outcomes, as supported by a 74% increase in the responder rate when subjects could choose their most effective option (47%) compared with supraperception alone (27%). DISCUSSION: Subperception SCS at ≤1.2 kHz is safe and effective in subjects with extreme physical disability and previously implanted for chronic pain. Further, by providing study participants with different waveform options, increased pain relief was achieved.

Escalonamento psicofísico da influência da marca na percepção de sabor do chocolate pelo consumidor / Psychophysical scaling of brand influence on consumer perception of chocolate flavor

O objetivo do estudo foi entender a influência da marca na percepção de sabor do chocolate pelos consumidores. Foram avaliados 16 sujeitos (31,8 anos, ± 4,2 anos, 8 mulheres) medindo suas avaliações sobre os sabores de chocolates de diferentes marcas, com e sem o conhecimento da marca, e também sobre as marcas sem degustação do produto, como expectativa de sabor, utilizando Escalonamento Psicofísico de Estimativa de Magnitude Direta (EMD). Este método obtém do sujeito a sua impressão subjetiva direta do estímulo físico. Um chocolate foi escolhido como referencia (módulo) e recebeu o valor numérico de 100. A tarefa dos sujeitos foi degustar os chocolates, comparando com a degustação do módulo, e atribuir notas de acordo com a diferença de percepção de sabor, se a percepção de sabor fosse duas vezes melhor do que o módulo, ele deveria designar uma nota duas vezes o valor de referência. O procedimento foi o mesmo para as duas outras condições experimentais, marca e sabor conhecendo a marca. O expoente da curva de potência foi utilizado como a quantificação da magnitude da percepção dos sujeitos. O expoente obtido na avaliação somente do chocolate foi de 0,389 (Coeficiente de Correlação de Pearson r2=0,94) enquanto que somente da marca foi de 0,581 (r2=0,96). Teoricamente pode-se determinar o expoente da percepção de sabor com conhecimento da marca que seria 0,389/0,581 = 0,669, sendo que o expoente obtido empiricamente foi de 0,675 (r2=0,92). Assim concluí-se que a utilização da metodologia de Estimativa de Magnitude Direta para quantificar a preferência subjetiva dos sujeitos por chocolates considerando 2 variáveis, sabor e marca, foi bem sucedida. Os resultados sugerem que a associação de marca e sabor contribui para um efeito mais poderoso sobre a decisão sobre quanto o chocolate é mais saboroso. E como o expoente da percepção do sabor sabendo a marca é maior que os outros dois expoentes isolados pode-se sugerir que a marca possui uma grande influência na decisão

The aim of study was understand brand influence on consumer perception of chocolate flavor. 16 subjects (31.8 years, ± 4.2 years, 8 women) were evaluated by measuring their reviews of the flavors of different brands of chocolates, with and without the knowledge of the brand, and also about the brands without tasting the product, as expectation of flavor, using Psychophysical Scaling of Direct Ratio Magnitude Estimation (RME). This method gets the subject direct subjective impression of the physical stimulus. A chocolate was chosen as reference (modulus) and received the numerical value of 100. The task of subjects was tasting the chocolates, compare to the tasting of the module and assign grades according to the difference in taste perception, if perception of flavor was twice better than module, he should assign a score twice the reference value. The procedure was the same for the other two experimental conditions brand and flavor knowing the brand. The exponent of power law was used to quantify the magnitude of the perception of the subjects. The obtained exponent when examining only chocolate was 0.389 (Pearson correlation coefficient r2=0.94) while only the brand was 0.581 (r2=0.96). Theoretically, we can determine the exponent of the perception of flavor with brand awareness that would be 0.389/0.581=0.669, where the exponent obtained empirically was 0.675 (r2=0.92). Thus we conclude that the use of the methodology of Direct Ratio Magnitude Estimation to quantify the subject subjective preference for chocolate, considering two variables, flavor and brand, was successful. The results suggest that the association of brand and flavor makes for a more powerful effect on the decision about how much chocolate is tastier. And as the exponent of flavor perception knowing the brand is bigger than the other two isolates exponents can suggest that the brand has a great influence on the decision