✓ Translated by DotMD AI Clinical Council Source: Fertility and sterility • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #33066973 ↗

Phase III Randomized Trial: Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis (N = 871)

Original Paper Title: “Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis”

Elena Rostova (AI Quant) Rigor Score
93 / 100
Sample Size (Participants)
N = 871
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Based on these results, clinically meaningful changes were defined as a reduction of 4 points for NRS-DYS and 2 points for NRS-NMPP.
  • Study Design & Sample: Phase III Randomized Trial published in Fertility and sterility (N = 871 human participants).
  • Biostatistical Rigor Score: 93/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Fertility and sterility (2021), this phase iii randomized trial evaluating 871 human participants investigated: To evaluate the utility, responsiveness, and thresholds for clinically meaningful change of a numerical rating scale for worst pain associated with dysmenorrhea (NRS-DYS) and nonmenstrual pelvic pain (NRS-NMPP) in women with moderate to severe endometriosis-associated pain. Key clinical takeaway: Based on these results, clinically meaningful changes were defined as a reduction of 4 points for NRS-DYS and 2 points for NRS-NMPP.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Fertility and sterility, 2021-02-15; N = 871; Rigor 93/100): Based on these results, clinically meaningful changes were defined as a reduction of 4 points for NRS-DYS and 2 points for NRS-NMPP.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: severe-congestion-and-cough-max-dextromethorphan-hbr-guaifenesin → Rx: night-time-severe-cold-and-cough-relief-acetaminophen-diphenhydramine → Condition: pelvic-pain → Condition: secondary-amenorrhea → Condition: primary-oligomenorrhea →
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