Research Methodology

research methodologyResearch into placebo effects and the therapeutic relationship investigates how ritual, symbols, meaning, empathy, hope, compassion and trust – what can collectively be called the “moral imagination” – are translated into clinical outcomes and better health. Developing reliable research methodologies that quantify and categorize these intangible phenomena is a veritable challenge for researchers. Just as important is overcoming potential biases and prejudices through rigorous and innovative approaches that are based in the principles of evidence-based medicine. The PiPS team has made important contributions to the development of such methodologies through the following activities:

  • Analyses of bias and potential distortions in scientific research, including placebo research.
  • Analyses of potential limitations of the reliability of single-methodology studies.
  • Investigations into more efficient methods for detecting drug-placebo differences in randomized trials.
  • Studies comparing the outcomes of clinical trials with and without “placebo run in” periods.
  • Analysis of methodology in placebo studies

Related Publications

Ballou S et al.  Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial.  Trials June, 2017

Hróbjartsson A et al. Placebo effect studies are susceptible to response bias and other types biases. J Clin Epidemiol 2011; 64: 1223-9.

Kelley JM, Kaptchuk TJ. Group analysis versus individual responses: the inferential limits of randomized controlled trials. Cont Clinical Trials 2010; 31:423-28.

Kaptchuk TJ et al. Do “placebo responders” exist? Cont Clin Trials 2008; 29: 587-95.

Kaptchuk TJ. Effect of interpretative bias on research evidence. BMJ 2003;326: 1453-55.

Kaptchuk TJ. The double-blind randomized controlled trial: gold standard or golden calf? J Clin Epidemiol 2001;54:541-49.

Kaptchuk TJ et al. Do medical devices have enhanced placebo effects? J Clin Epidemiol 2000;53:786-92.

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