Person: Kelley, John
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Kelley
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Kelley, John
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Publication The Influence of the Patient-Clinician Relationship on Healthcare Outcomes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials(Public Library of Science, 2014) Kelley, John; Kraft-Todd, Gordon; Schapira, Lidia; Kossowsky, Joe; Riess, HelenObjective: To determine whether the patient-clinician relationship has a beneficial effect on either objective or validated subjective healthcare outcomes. Design: Systematic review and meta-analysis. Data Sources Electronic databases EMBASE and MEDLINE and the reference sections of previous reviews. Eligibility Criteria for Selecting Studies Included studies were randomized controlled trials (RCTs) in adult patients in which the patient-clinician relationship was systematically manipulated and healthcare outcomes were either objective (e.g., blood pressure) or validated subjective measures (e.g., pain scores). Studies were excluded if the encounter was a routine physical, or a mental health or substance abuse visit; if the outcome was an intermediate outcome such as patient satisfaction or adherence to treatment; if the patient-clinician relationship was manipulated solely by intervening with patients; or if the duration of the clinical encounter was unequal across conditions. Results: Thirteen RCTs met eligibility criteria. Observed effect sizes for the individual studies ranged from d = −.23 to .66. Using a random-effects model, the estimate of the overall effect size was small (d = .11), but statistically significant (p = .02). Conclusions: This systematic review and meta-analysis of RCTs suggests that the patient-clinician relationship has a small, but statistically significant effect on healthcare outcomes. Given that relatively few RCTs met our eligibility criteria, and that the majority of these trials were not specifically designed to test the effect of the patient-clinician relationship on healthcare outcomes, we conclude with a call for more research on this important topic.Publication Conscientiousness is modified by genetic variation in catechol-O-methyltransferase to reduce symptom complaints in IBS patients(BlackWell Publishing Ltd, 2014) Hall, Kathryn; Tolkin, Benjamin R; Chinn, Garrett M; Kirsch, Irving; Kelley, John; Lembo, Anthony; Kaptchuk, Ted; Kokkotou, Efi; Davis, Roger; Conboy, LisaBackground: Attention to and perception of physical sensations and somatic states can significantly influence reporting of complaints and symptoms in the context of clinical care and randomized trials. Although anxiety and high neuroticism are known to increase the frequency and severity of complaints, it is not known if other personality dimensions or genes associated with cognitive function or sympathetic tone can influence complaints. Genetic variation in catechol-O-methyltransferase (COMT) is associated with anxiety, personality, pain, and response to placebo treatment. We hypothesized that the association of complaint reporting with personality might be modified by variation in the COMT val158met genotype. Methods: We administered a standard 25-item complaint survey weekly over 3-weeks to a convenience sample of 187 irritable bowel syndrome patients enrolled in a placebo intervention trial and conducted a repeated measures analysis. Results: We found that complaint severity rating, our primary outcome, was negatively associated with the personality measures of conscientiousness (β = −0.31 SE 0.11, P = 0.003) and agreeableness (β = −0.38 SE 0.12, P = 0.002) and was positively associated with neuroticism (β = 0.24 SE 0.09, P = 0.005) and anxiety (β = 0.48 SE 0.09, P < 0.0001). We also found a significant interaction effect of COMT met alleles (β = −32.5 SE 14.1, P = 0.021). in patients genotyped for COMT val158met (N = 87) specifically COMT × conscientiousness (β = 0.73 SE 0.26, P = 0.0042) and COMT × anxiety (β = −0.42 SE 0.16, P = 0.0078) interaction effects. Conclusion: These findings potentially broaden our understanding of the factors underlying clinical complaints to include the personality dimension of conscientiousness and its modification by COMT.Publication Effects of placebos without deception compared with no treatment: protocol for a systematic review and meta-analysis(BMJ Publishing Group, 2015) Petkovic, Grace; Charlesworth, James E G; Kelley, John; Miller, Franklin; Roberts, Nia; Howick, JeremyIntroduction: Placebos have long provided a robust control for evaluating active pharmacological preparations, but frequently demonstrate a variable therapeutic effect when delivered in double-blinded placebo-controlled trials. Delivery of placebos as treatment alone has been considered unethical, as it has been thought that deception is essential for their effect. However, recent evidence suggests that clinical benefit can be derived from placebos delivered without deception (unblinded/open-label) manner. Here, we present a protocol for the first systematic review and meta-analysis of studies of the effects of non-deceptive placebos compared with no treatment. Methods and analysis This protocol will compare the effect of placebos delivered non-deceptively to no treatment. It will also assess the methods of delivery used for non-deceptive placebos. Studies will be sought through relevant database searches and will include those within disease settings and those among healthy controls. To be included, trials must include both non-deceptive (open-label) placebo and no treatment groups. All data extraction and analysis will be conducted by two independent reviewers. The analysis will evaluate any differences in outcome measures between the non-deceptive placebo and no treatment groups. Outcome measures will be the clinically-relevant outcomes detailed in the primary papers. The delivery methods, such as verbal instructions, which may provide positive expectations and outcomes, of non-deceptive placebos will also be assessed. Each study will be comprehensively assessed for bias. Subgroup analyses will identify any discrepancies among heterogeneous data. Ethics and dissemination This review does not require ethical approval. The completed review will be widely disseminated by publication and social media where appropriate. This protocol has been registered on PROSPERO (2015:CRD42015023347).Publication Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial(BioMed Central, 2017) Ballou, Sarah; Kaptchuk, Ted; Hirsch, William; Nee, Judy; Iturrino, Johanna; Hall, Kathryn; Kelley, John; Cheng, Vivian; Kirsch, Irving; Jacobson, Eric; Conboy, Lisa; Lembo, Anthony; Davis, RogerBackground: Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo. However, several recent RCTs, including patients with irritable bowel syndrome (IBS), chronic low back pain, and episodic migraine, have demonstrated that individuals receiving open-label placebo (OLP) can still experience symptomatic improvement and benefit from honestly described placebo treatment. Methods and design This paper describes an innovative multidisciplinary trial design (n = 280) that attempts to replicate and expand upon an earlier IBS OLP study. The current study will compare OLP to double-blind placebo (DBP) administration which is made possible by including a nested, double-blind RCT comparing DBP and peppermint oil. The study also examines possible genetic and psychological predictors of OLP and seeks to better understand participants’ experiences with OLP and DBP through a series of extensive interviews with a randomly selected subgroup. Discussion OLP treatment is a novel strategy for ethically harnessing placebo effects. It has potential to re-frame theories of placebo and to influence how physicians can optimize watch-and-wait strategies for common, subjective symptoms. The current study aims to dramatically expand what we know about OLP by comparing, for the first time, OLP and DBP administration. Adopting a unique, multidisciplinary approach, the study also explores genetic, psychological and experiential dimensions of OLP. The paper ends with an extensive discussion of the “culture” of the trial as well as potential mechanisms of OLP and ethical implications. Trial registration ClinicalTrials.gov, identifier: NCT02802241. Registered on 14 June 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1964-x) contains supplementary material, which is available to authorized users.Publication A Treatment Trial of Acupuncture in IBS Patients(Nature Publishing Group, 2009) Lembo, Anthony; Conboy, Lisa; Kelley, John; Schnyer, Rosa S; McManus, Claire A; Quilty, Mary T; Kerr, Catherine; Drossman, Doug; Jacobson, Eric; Davis, Roger; Kaptchuk, TedObjective: To compare the effects of true and sham acupuncture in relieving symptoms of IBS. Methods: A total of 230 adult IBS patients (75% females, average age 38.4 yrs) were randomly assigned to 3 weeks of true or sham acupuncture (6 treatments) following a 3 week ‘run-in’ with sham acupuncture in an ‘augmented’ or ‘limited’ patient-practitioner interaction. A third arm of the study included a waitlist control group. The primary outcome was the IBS Global Improvement Scale (IBS-GIS) (range 1–7); secondary outcomes included IBS Symptom Severity Scale (IBS-SSS), Adequate Relief (IBS-AR) and IBS-Quality of life (IBS-QOL). Results: Though there was no statistically significant difference between acupuncture and sham acupuncture on the IBS-GIS (41% vs. 32%, p=0.25), both groups improved significantly compared to the wait list control group (37% vs. 4%, p=0.001). Similarly, small differences that were not statistically significant favored acupuncture on the other three outcomes: IBS-AR (59% vs 57%, p=0.83), IBS-SSS (31% vs 21%, p=0.18) and IBS-QOL (17% vs 13%, p=0.56). Eliminating responders during the run-in period did not substantively change the results. Side effects were generally mild and only slightly greater in the acupuncture group. Conclusion: This study did not find evidence to support the superiority of acupuncture compared to sham acupuncture in the treatment of IBS.Publication Evidence-Based Practice and Psychological Treatments: The Imperatives of Informed Consent(Frontiers Media S.A., 2016) Blease, Charlotte R.; Lilienfeld, Scott O.; Kelley, JohnPublication Empathic nonverbal behavior increases ratings of both warmth and competence in a medical context(Public Library of Science, 2017) Kraft-Todd, Gordon T.; Reinero, Diego A.; Kelley, John; Heberlein, Andrea S.; Baer, Lee; Riess, HelenIn medicine, it is critical that clinicians demonstrate both empathy (perceived as warmth) and competence. Perceptions of these qualities are often intuitive and are based on nonverbal behavior. Emphasizing both warmth and competence may prove problematic, however, because there is evidence that they are inversely related in other settings. We hypothesize that perceptions of physician competence will instead be positively correlated with perceptions of physician warmth and empathy, potentially due to changing conceptions of the physician’s role. We test this hypothesis in an analog medical context using a large online sample, manipulating physician nonverbal behaviors suggested to communicate empathy (e.g. eye contact) and competence (the physician’s white coat). Participants rated physicians displaying empathic nonverbal behavior as more empathic, warm, and more competent than physicians displaying unempathic nonverbal behavior, adjusting for mood. We found no warmth/competence tradeoff and, additionally, no significant effects of the white coat. Further, compared with male participants, female participants perceived physicians displaying unempathic nonverbal behavior as less empathic. Given the significant consequences of clinician empathy, it is important for clinicians to learn how nonverbal behavior contributes to perceptions of warmth, and use it as another tool to improve their patients’ emotional and physical health.Publication Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma(Massachusetts Medical Society, 2011-07-14) Wechsler, Michael E.; Kelley, John; Boyd, Ingrid O.E.; Dutile, Stefanie; Marigowda, Gautham; Kirsch, Irving; Israel, Elliot; Kaptchuk, TedBACKGROUND In prospective experimental studies in patients with asthma, it is difficult to determine whether responses to placebo differ from the natural course of physiological changes that occur without any intervention. We compared the effects of a bronchodilator, two placebo interventions, and no intervention on outcomes in patients with asthma. METHODS In a double-blind, crossover pilot study, we randomly assigned 46 patients with asthma to active treatment with an albuterol inhaler, a placebo inhaler, sham acupuncture, or no intervention. Using a block design, we administered one each of these four interventions in random order during four sequential visits (3 to 7 days apart); this procedure was repeated in two more blocks of visits (for a total of 12 visits by each patient). At each visit, spirometry was performed repeatedly over a period of 2 hours. Maximum forced expiratory volume in 1 second (FEV1) was measured, and patients’ self-reported improvement ratings were recorded. RESULTS Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV1, as compared with approximately 7% with each of the other three interventions (P<0.001). However, patients’ reports of improvement after the intervention did not differ significantly for the albuterol inhaler (50% improvement), placebo inhaler (45%), or sham acupuncture (46%), but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control (21%) (P<0.001). CONCLUSIONS Although albuterol, but not the two placebo interventions, improved FEV1 in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes. Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical-management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes.Publication Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome(BMJ, 2008) Kaptchuk, Ted; Kelley, John; Conboy, Lisa; Kerr, Catherine; Davis, Roger; Jacobson, Eric; Kirsch, Irving; Schyner, R. N; Nam, B. H.; Nguyen, L. T; Park, Min Hi; Rivers, A. L; McManus, C.; Kokkotou, Efi; Drossman, D. A; Goldman, Peter; Lembo, AnthonyObjective To investigate whether placebo effects can experimentally be separated into the response to three components—assessment and observation, a therapeutic ritual (placebo treatment), and a supportive patient-practitioner relationship—and then progressively combined to produce incremental clinical improvement in patients with irritable bowel syndrome. To assess the relative magnitude of these components. Design A six week single blind three arm randomised controlled trial. Setting Academic medical centre. Participants 262 adults (76% women), mean (SD) age 39 (14), diagnosed by Rome II criteria for and with a score of ≥150 on the symptom severity scale. Interventions For three weeks either waiting list (observation), placebo acupuncture alone (“limited”), or placebo acupuncture with a patient-practitioner relationship augmented by warmth, attention, and confidence (“augmented”). At three weeks, half of the patients were randomly assigned to continue in their originally assigned group for an additional three weeks. Main outcome measures Global improvement scale (range 1-7), adequate relief of symptoms, symptom severity score, and quality of life. Results At three weeks, scores on the global improvement scale were 3.8 (SD 1.0) v 4.3 (SD 1.4) v 5.0 (SD 1.3) for waiting list versus “limited” versus “augmented,” respectively (P<0.001for trend). The proportion of patients reporting adequate relief showed a similar pattern: 28% on waiting list, 44% in limited group, and 62% in augmented group (P<0.001 for trend). The same trend in response existed in symptom severity score (30 (63) v 42 (67) v 82 (89), P<0.001) and quality of life (3.6 (8.1) v 4.1 (9.4) v 9.3 (14.0), P<0.001). All pairwise comparisons between augmented and limited patient-practitioner relationship were significant: global improvement scale (P<0.001), adequate relief of symptoms (P<0.001), symptom severity score (P=0.007), quality of life (P=0.01). Results were similar at six week follow-up. Conclusion Factors contributing to the placebo effect can be progressively combined in a manner resembling a graded dose escalation of component parts. Non-specific effects can produce statistically and clinically significant outcomes and the patient-practitioner relationship is the most robust component.Publication Patient and Practitioner Influences on the Placebo Effect in Irritable Bowel Syndrome(Ovid Technologies (Wolters Kluwer Health), 2009) Kelley, John; Lembo, Anthony; Ablon, John; Villanueva, Joel J.; Conboy, Lisa; Levy, Raymond; Marci, Carl; Kerr, Catherine; Kirsch, Irving; Jacobson, Eric; Riess, Helen; Kaptchuk, TedObjective: To determine whether placebo responses can be explained by characteristics of the patient, the practitioner, or their interpersonal interaction. Methods: We performed an analysis of videotape and psychometric data from a clinical trial of IBS patients treated with placebo acupuncture in either a warm empathic interaction (Augmented, n=96), a neutral interaction (Limited, n=97), or a waitlist control (Waitlist, n=96). We examined the relations between placebo response and: (1) patient personality and demographics; (2) treating practitioner; and (3) the patient-practitioner interaction as captured on videotape and rated by the Psychotherapy Process Q-Set (PQS). Results: Patient extraversion, agreeableness, openness to experience, and female gender were associated with placebo response, but these effects held only in the augmented group. Regression analyses controlling for all other independent variables suggest that only extraversion is an independent predictor of placebo response. There were significant differences between practitioners in outcomes, and this effect was twice as large as the effect attributable to treatment group assignment. Videotape analysis indicated that the augmented group fostered a treatment relationship similar to a prototype of an ideal healthcare interaction. Conclusions: Gender and personality influenced placebo response, but only in the warm, empathic, augmented group. This suggests that to the degree a placebo effect is evoked by the patient-practitioner relationship, personality characteristics of the patient will be associated with placebo response. This finding may explain why consistent predictors of the placebo response have been difficult to detect. In addition, practitioners differed markedly in effectiveness, despite standardized interactions. We propose that the quality of the patient-practitioner interaction accounts for the significant difference between the groups in placebo response.