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A successful clinical trial is dependent on recruitment. Between December 2003 and February 2006, our team successfully enrolled 289 participants in a large, single-center, randomized placebo-controlled trial (RCT) studying the impact of the patient-doctor relationship and acupuncture on irritable bowel syndrome (IBS) patients. This paper reports on the effectiveness of standard recruitment methods such as physician referral, newspaper advertisements, fliers, audio and video media (radio and television commercials) as well as relatively new methods not previously extensively reported on such as internet ads, ads in mass-transit vehicles and movie theater previews. We also report the fraction of cost each method consumed and fraction of recruitment each method generated. Our cost per call from potential participants varied from $3–$103 and cost per enrollment participant varied from $12–$584. Using a novel metric, the efficacy index, we found that physician referrals and flyers were the most effective recruitment method in our trial. Despite some methods being more efficient than others, all methods contributed to the successful recruitment. The iterative use of the efficacy index during a recruitment campaign may be helpful to calibrate and focus on the most effective recruitment methods.

A successful clinical trial is dependent on recruitment. Between December 2003 and February 2006, our team successfully enrolled 289 participants in a large, single-center, randomized placebo-controlled trial (RCT) studying the impact of the patient-doctor relationship and acupuncture on irritable bowel syndrome (IBS) patients. This paper reports on the effectiveness of standard recruitment methods such as physician referral, newspaper advertisements, fliers, audio and video media (radio and television commercials) as well as relatively new methods not previously extensively reported on such as internet ads, ads in mass-transit vehicles and movie theater previews. We also report the fraction of cost each method consumed and fraction of recruitment each method generated. Our cost per call from potential participants varied from $3–$103 and cost per enrollment participant varied from $12–$584. Using a novel metric, the efficacy index, we found that physician referrals and flyers were the most effective recruitment method in our trial. Despite some methods being more efficient than others, all methods contributed to the successful recruitment. The iterative use of the efficacy index during a recruitment campaign may be helpful to calibrate and focus on the most effective recruitment methods.
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Few complementary and alternative medicine (CAM) institutions require their students to undergo substantive training in research literacy and conduct, and well-developed programs to train CAM institution faculty in research are virtually non-existent. As part of a National Center for Complementary and Alternative Medicine (NCCAM) initiative to increase research capacity at CAM institutions, the New England School of Acupuncture (NESA), in collaboration with the Harvard Medical School (HMS) Osher Institute, was awarded a Developmental Center for Research on Complementary and Alternative Medicine (DCRC) grant. This article discusses a number of initiatives that we designed and implemented to train NESA students, faculty members, and alumni in the foundations of clinical research and to stimulate interest in both participating in research and receiving additional research training. Specific initiatives included a 30-hour faculty "Foundations of Research" course; a year-long course entitled, "How to Write a Publishable Case Report"; institution of a monthly research seminar series; revision of an already required student research course; and the addition of 2 new student-mentored independent research electives. We discuss successes and challenges encountered in developing and administering these initiatives and the overall impact they have had on research culture and productivity at NESA.
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Study Objective To assess feasibility, and collect preliminary data for a subsequent randomized, sham-controlled trial to evaluate Japanese-style acupuncture for reducing chronic pelvic pain and improving health-related quality of life (HRQOL) in adolescents with endometriosis. Design Randomized, sham-controlled trial. Settings Tertiary-referral hospital. Participants Eighteen young women (13–22y) with laparoscopically-diagnosed endometriosis-related chronic pelvic pain. Interventions A Japanese style of acupuncture and a sham acupuncture control. Sixteen treatments were administered over 8 weeks. Main Outcome Measures Protocol feasibility, recruitment numbers, pain not associated with menses or intercourse, and multiple HRQOL instruments including Endometriosis Health Profile, Pediatric Quality of Life, Perceived Stress, and Activity Limitation. Results Fourteen participants (out of 18 randomized) completed the study per protocol. Participants in the active acupuncture group (n = 9) experienced an average 4.8 (SD = 2.4) point reduction on a 11 point scale (62%) in pain after 4 weeks, which differed significantly from the control group's (n = 5) average reduction of 1.4 (SD = 2.1) points (P = 0.004). Reduction in pain in the active group persisted through a 6-month assessment; however, after 4 weeks, differences between the active and control group decreased and were not statistically significant. All HRQOL measures indicated greater improvements in the active acupuncture group compared to the control; however, the majority of these trends were not statistically significant. No serious adverse events were reported. Conclusion Preliminary estimates indicate that Japanese-style acupuncture may be an effective, safe, and well-tolerated adjunct therapy for endometriosis-related pelvic pain in adolescents. A more definitive trial evaluating Japanese-style acupuncture in this population is both feasible and warranted.
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Patients in the placebo arms of randomized controlled trials (RCT) often experience positive changes from baseline. While multiple theories concerning such “placebo effects” exist, peculiarly, none has been informed by actual interviews of patients undergoing placebo treatment. Here, we report on a qualitative study (n = 27) embedded within a RCT (n = 262) in patients with irritable bowel syndrome. Besides identical placebo acupuncture treatment in the RCT, the qualitative study patients also received an additional set of interviews at the beginning, midpoint, and end of the trial. Interviews of the 12 qualitative subjects who underwent and completed placebo treatment were transcribed. We found that patients (1) were persistently concerned with whether they were receiving placebo or genuine treatment; (2) almost never endorsed “expectation” of improvement but spoke of “hope” instead and frequently reported despair; (3) almost all reported improvement ranging from dramatic psychosocial changes to unambiguous, progressive symptom improvement to tentative impressions of benefit; and (4) often worried whether their improvement was due to normal fluctuations or placebo effects. The placebo treatment was a problematic perturbation that provided an opportunity to reconstruct the experiences of the fluctuations of their illness and how it disrupted their everyday life. Immersion in this RCT was a co-mingling of enactment, embodiment and interpretation involving ritual performance and evocative symbols, shifts in bodily sensations, symptoms, mood, daily life behaviors, and social interactions, all accompanied by self-scrutiny and re-appraisal. The placebo effect involved a spectrum of factors and any single theory of placebo—e.g. expectancy, hope, conditioning, anxiety reduction, report bias, symbolic work, narrative and embodiment—provides an inadequate model to explain its salubrious benefits.
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Patients in the placebo arms of randomized controlled trials (RCT) often experience positive changes from baseline. While multiple theories concerning such “placebo effects” exist, peculiarly, none has been informed by actual interviews of patients undergoing placebo treatment. Here, we report on a qualitative study (n = 27) embedded within a RCT (n = 262) in patients with irritable bowel syndrome. Besides identical placebo acupuncture treatment in the RCT, the qualitative study patients also received an additional set of interviews at the beginning, midpoint, and end of the trial. Interviews of the 12 qualitative subjects who underwent and completed placebo treatment were transcribed. We found that patients (1) were persistently concerned with whether they were receiving placebo or genuine treatment; (2) almost never endorsed “expectation” of improvement but spoke of “hope” instead and frequently reported despair; (3) almost all reported improvement ranging from dramatic psychosocial changes to unambiguous, progressive symptom improvement to tentative impressions of benefit; and (4) often worried whether their improvement was due to normal fluctuations or placebo effects. The placebo treatment was a problematic perturbation that provided an opportunity to reconstruct the experiences of the fluctuations of their illness and how it disrupted their everyday life. Immersion in this RCT was a co-mingling of enactment, embodiment and interpretation involving ritual performance and evocative symbols, shifts in bodily sensations, symptoms, mood, daily life behaviors, and social interactions, all accompanied by self-scrutiny and re-appraisal. The placebo effect involved a spectrum of factors and any single theory of placebo – e.g. expectancy, hope, conditioning, anxiety reduction, report bias, symbolic work, narrative and embodiment – provides an inadequate model to explain its salubrious benefits.
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Evidence that placebo acupuncture is an effective treatment for chronic pain presents a puzzle: how do placebo needles appearing to patients to penetrate the body, but instead sitting on the skin’s surface in the manner of a tactile stimulus, evoke a healing response? Previous accounts of ritual touch healing in which patients often described enhanced touch sensations (including warmth, tingling or flowing sensations) suggest an embodied healing mechanism. In this qualitative study, we asked a subset of patients in a singleblind randomized trial in irritable bowel syndrome to describe their treatment experiences while undergoing placebo treament. Analysis focused on patients’ unprompted descriptions of any enhanced touch sensations (e.g., warmth, tingling) and any significance patients assigned to the sensations. We found in 5/6 cases, patients associated sensations including “warmth” and “tingling” with treatment efficacy. The conclusion offers a “neurophenomenological” account of the placebo effect by considering dynamic effects of attentional filtering on early sensory cortices, possibly underlying the phenomenology of placebo acupuncture.
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