Study of the Therapeutic Effects of Intercessory Prayer (STEP) in Cardiac Bypass Patients: A Multicenter Randomized Trial of Uncertainty and Certainty of Receiving Intercessory Prayer

Herbert Benson, MD; Jeffery A. Dusek, PhD; Jane B. Sherwood, RN; Peter Lam, PhD; Charles F. Bethea, MD; William Carpenter, MDiv; Sidney Levitsky, MD; Peter C. Hill, MD; Donald W. Clem, Jr, MA; Manoj K. Jain, MD, MPH; David Drumel, MDiv; Stephen L. Kopecky, MD; Paul S. Mueller, MD; Dean Marek; Sue Rollins, RN, MPH; Patricia L. Hibberd, MD, PhD

Disclosures

Am Heart J. 2006;151(4):934-942. 

In This Article

Methods

The STEP was a multicenter randomized clinical trial, monitored by an independent Data Safety Monitoring Board (DSMB). The institutional review board at 6 participating hospitals (Integris Baptist Medical Center, Oklahoma City, OK; Beth Israel Deaconess Medical Center, Boston, MA; Washington Hospital Center, Washington, DC; Baptist Medical Center, Memphis, TN; Mayo Clinic, Rochester, MN; St Joseph's Hospital, Tampa, FL) approved the protocol, all amendments, and fall procedures for obtaining informed consent. Details of the study design and methods have been published elsewhere.[20]

Patients scheduled for nonemergent CABG were eligible to participate in the study. Patients were identified in the cardiac catheterization laboratory, preoperative testing area, or on surgical schedule, and they were contacted with permission of their surgeon, cardiologist, or primary care physician. Inclusion criteria were 18 years or older and able to read or understand English. Patients were excluded if they were scheduled for emergent CABG (next available operating room slot), CABG more than 14 days after enrollment, other planned surgery within 30 days of CABG, minimally invasive CABG, ongoing chest pain, unstable angina, or CABG with planned valve replacement, stent, angioplasty, or carotid endarterectomy. There were no eligibility criteria relating to religious belief—patients of any or no religious faith were eligible to participate. Each patient was informed about the study and asked to sign the informed consent document. Enrolled patients were informed that their first name and first initial of their last name might be forwarded to 3 Christian prayer groups. Preoperatively, subjects were asked whether they believed in spiritual healing and whether friends, relatives, and/or members of their religious institution would be praying for them.

Randomization assignments (serially numbered, opaque, sealed envelopes)[21] were stratified by center using permuted blocks of size 9, 12, and 15 presented in random order. The envelope message for patients in groups 1 (uncertain, with intercessory prayer) and 2 (uncertain, no intercessory prayer) stated that they “may or may not be prayed for.” The message for patients in group 3 (certain, with intercessory prayer) stated that they “will be prayed for.” Study staff observed as each patient opened their randomization envelope, but the staff remained unaware of the contents. The enrollment form (patient's first name, first initial of last name, study identification number, dates of randomization, and scheduled surgery) was then faxed to the coordinating center. Patients were instructed to refrain from notifying study personnel or hospital staff of their treatment assignment.

The first name, first initial of last name, and an anonymous site code for patients assigned to groups 1 and 3 (those to receive intercessory prayer) were placed on the prayer list for 14 consecutive days, starting the night before each patient's scheduled surgery. The same daily updated list was faxed to each of 3 intercessory prayer groups every weekday throughout the study,[20] and the list was posted in a central location not later than 7:15 PM EST each evening, with intercessory prayer beginning by midnight for patients on the list. The intercessors agreed to add the phrase “for a successful surgery with a quick, healthy recovery and no complications” to their usual prayers.

Intercessors from 3 Christian groups (2 Catholic groups [St Paul's Monastery, St Paul, MN; Community of Teresian Carmelites, Worcester, MA) and 1 Protestant group [Silent Unity, Lee's Summit, MO]) provided study prayer throughout the trial. We were unable to locate other Christian, Jewish, or non-Christian groups that could receive the daily prayer list required for this multiyear study.

The primary outcome was presence of any postoperative complications defined by the Society of Thoracic Surgeons Adult Cardiac Surgery Database—within 30 days of CABG.[18] Secondary end points were the presence of any “major event” (defined by the New York State Cardiac Surgery Reporting System[19]) and 30-day mortality. Trained research nurses at each site reviewed medical records of study subjects for presence of complications within 30 days of CABG. All patients discharged alive before postoperative day 30 were called to determine if they had been readmitted to any other hospital within 30 days of surgery. All patients' medical records were independently audited.[20] All investigators, research nurses, interviewers, and auditors were blinded to patients' group assignment throughout the study.

We anticipated that approximately 50% of the patients in group 2 (uncertain, no intercessory prayer) would have a complication within 30 days of CABG.[2] On the basis of investigator consensus, we hypothesized that if 40% of patients in group 1 (uncertain, with intercessory prayer) and 30% of patients in group 3 (certain, with intercessory prayer) had any complication within 30 days of CABG, these reductions would be clinically important. We anticipated that 5% of patients would be lost to follow-up during the study period, all of whom would conservatively be assumed to have had a complication for the intent-to-treat analysis. We calculated our sample size using these adjusted proportions (45%, 55%, and 35%), a 2-sided α level of .025 (Bonferroni adjustment[22] for 2 primary comparisons—group 1 [uncertain, with intercessory prayer] vs group 2 [uncertain, no intercessory prayer] and group 3 [certain, with intercessory prayer] vs group 1 [uncertain, with intercessory prayer] and a single interim analysis [O'Brien Fleming boundaries[23,24] for early stopping for efficacy or futility; null hypothesis rejected for |z| > 3.1495 and accepted for |z| < 0.7769; EaST, Cytel Software Corporation, Cambridge, MA]). Because we required 572 patients per group to compare group 1 with group 2 and 600 per group to compare group 1 with group 3, the final sample size was 600 patients per group or 1800 patients for the study (1:1:1 allocation ratio).

Baseline continuous variables were compared using analysis of variance, and baseline and outcome categorical variables were compared using the χ2 test. Risk ratios and 95% CIs were used for the comparison of group 1 (uncertain, with intercessory prayer) versus group 2 (uncertain, no intercessory prayer) and for group 3 (Certain, Intercessory Prayer) versus group 1 (uncertain, with intercessory prayer). A multivariate logistic-regression model (stepwise algorithm) was used to evaluate whether baseline covariates, other than study group, were associated with occurrence of complication and to assess consistency of the unadjusted and final model. Prespecified covariates were included, and variables retained in the final models had a P value of .05 or less. Statistical analyses were performed using SAS 6.12, Cary, NC, and SPSS 11.0, Chicago, IL.

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