M
- Status
F
Faith1960
Guest
I’m afraid that the studies (and there have been several) are right.I could forget about the previous studies prior to 2006, those studies seem flawed, but the 2006 Harvard study seems to be, as someone wrote in an article about this, the final word on prayer studies. It can’t be criticised for being flawed and it was the biggest, longest, most comprehensive study done on prayer.
M
Mystical_Seeker
Guest
So maybe prayer doesn’t “work” according to their formula. No problem. 
It’s still making the assumption that they can “catch God in the act” by using a careful experimental setup. If God can be reduced to a formula, then God would be constrained by our imagination of how He may behave. And if we can’t catch Him with our mathematics then we can’t assume that since He doesn’t play the way we expected, He must not play at all.
This doesn’t prove anything. If they had shown a positive result and the result was repeatable, that is evidence that they have found something. But we can only prove a negative when we have some way to know that we are even measuring it right. God is a pretty complicated fish to assume that He is automatically going to take some intellectual “bait” we offer and let us reel Him in.
MS
It’s still making the assumption that they can “catch God in the act” by using a careful experimental setup. If God can be reduced to a formula, then God would be constrained by our imagination of how He may behave. And if we can’t catch Him with our mathematics then we can’t assume that since He doesn’t play the way we expected, He must not play at all.
This doesn’t prove anything. If they had shown a positive result and the result was repeatable, that is evidence that they have found something. But we can only prove a negative when we have some way to know that we are even measuring it right. God is a pretty complicated fish to assume that He is automatically going to take some intellectual “bait” we offer and let us reel Him in.
MS
F
Faith1960
Guest
Will they ever be able to prove He doesnt answer prayer in future repeatable studies?So maybe prayer doesn’t “work” according to their formula. No problem.
It’s still making the assumption that they can “catch God in the act” by using a careful experimental setup. If God can be reduced to a formula, then God would be constrained by our imagination of how He may behave. And if we can’t catch Him with our mathematics then we can’t assume that since He doesn’t play the way we expected, He must not play at all.
This doesn’t prove anything. If they had shown a positive result and the result was repeatable, that is evidence that they have found something. But we can only prove a negative when we have some way to know that we are even measuring it right. God is a pretty complicated fish to assume that He is automatically going to take some intellectual “bait” we offer and let us reel Him in.
MS
M
Mystical_Seeker
Guest
I don’t think it’s possible, unless they are able to prove an example where prayer was answered, so we know we are looking for the right phenomenon.
One thing I’ve heard that is kind of interesting, is that there are these huge fancy random number generators all over the world. Supposedly when huge human events take place, like 9/11, the numbers start showing correlations to some huge mathematical certainty. In other words, “randomness” in the wake of a human trauma, begins to show some patterns for a while.
This kind of thing gives me hope that we will be able to measure some of the effects of human emotion, which is kind of like when everybody has a prayer. Of course who knows what is going on with the random number generators at this point, but it does show that our world is a little more complicated and sneaky about how it acts, every time we get better at measuring.
F
Faith1960
Guest
I don’t have any idea about that, but thanks for your patience with me in this thread.
M
Mystical_Seeker
Guest
NP. I enjoy your questions, because they are good questions and I’m confident you are sincere about your desire to know what’s really going on. When the “best and brightest” among us do a study that seems to be an honest attempt at finding something and the results are, “nothing was found,” we want to think they knew what they were doing. But they are in a place where science and religion have been separated for however many centuries and they have different methods of exploration.
Plus, what I often find is that headlines and articles about a study often take a snippet of the result out of context and then write headlines that sound “more interesting” than what was actually found. Like if a scientist says, “our study found no statistically significant beneficial effect in those who were prayed for,” the headlines will come screaming “New Study: Prayer does Not Work.” That grabs more attention than “no connection was found.”
That seems to me, to be the most common way science gets twisted to become sensantionalistic. Someone with an agenda takes what is said and shapes it into what fits their preconceived notion, or what they think will sell newspapers in an increasingly noisy world where ideas have to work hard to even be noticed. Plus you have one journalist will do it and others will copy-cat without ever checking the source.
MS
M
Mystical_Seeker
Guest
The study was published in 2006, in American Heart Journal. I have a university database with access to those journals so I’ll see what I can find without getting to bogged down with it (because I should be working on homework don’t you know). I’ll grab a couple things and put them here and you can review them yourself.
Here is one article I don’t quite understand, but it gives you and idea of one possible objection to the conclusion of the studies:
Letter to the editor by Dr. Adam H. Skolnick
Skolnick, Adam HView Profile. The American Heart Journal152.4 (Oct 2006): e39.
Abstract
Chronic obstructive pulmonary disease is an independent risk factor for postoperative pulmonary complications and may contribute, when added to other unmeasured baseline pulmonary conditions, to the increased incidence of the composite end point of “any pulmonary complication” in group 1 compared with group 3 (23.2% vs 27.1%).2 The increased risk of any cardiac complication may be accounted for by the significantly higher use of 3-vessel coronary artery bypass graft among those in group 3 with complications (59.6% vs 50.7%) as demonstrated in Fig. 3B.
Full Text
To the Editor:
I am writing in response to the study by Benson et al, which found that patients who were informed that they were to receive intercessory prayer (group 3) had a higher incidence (58.6% vs 52.5%) of any post-coronary artery bypass graft complication compared with those who were unaware (group 1). 1 Before assuming that knowledge of the good wishes of others accounts for the difference in any complication between the two groups, it is essential to examine possible confounding factors, as well as the types of complications measured. When analyzing the incidence of any complication, the authors assumed that the 6 patients in group 3 and 2 patients in group 1 who were lost to follow-up had a complication; this appears to bias the study against those in group 3 with respect to the overall complication rate. The mortality within 30 days, readmission rate, and operative complication rate were actually lower in group 3. The increase in “any complication” may be driven by the increase in any pulmonary or any cardiac complication. At baseline, although not reaching statistical significance, those in group 1 had a 10% prevalence of chronic obstructive pulmonary disease compared with 13% of those in group 3. Chronic obstructive pulmonary disease is an independent risk factor for postoperative pulmonary complications and may contribute, when added to other unmeasured baseline pulmonary conditions, to the increased incidence of the composite end point of “any pulmonary complication” in group 1 compared with group 3 (23.2% vs 27.1%). 2 The increased risk of any cardiac complication may be accounted for by the significantly higher use of 3-vessel coronary artery bypass graft among those in group 3 with complications (59.6% vs 50.7%) as demonstrated in Fig. 3B. We must use caution when drawing conclusions from composite end points, such as any complication, when hard end points such as 30-day mortality suggest a different interpretation of the data. Before attributing differences between groups to the intervention tested, we must ensure that the randomization and modified intent-to-treat analysis was successful at eliminating potential confounding factors.
Here is one article I don’t quite understand, but it gives you and idea of one possible objection to the conclusion of the studies:
Letter to the editor by Dr. Adam H. Skolnick
Skolnick, Adam HView Profile. The American Heart Journal152.4 (Oct 2006): e39.
Abstract
Chronic obstructive pulmonary disease is an independent risk factor for postoperative pulmonary complications and may contribute, when added to other unmeasured baseline pulmonary conditions, to the increased incidence of the composite end point of “any pulmonary complication” in group 1 compared with group 3 (23.2% vs 27.1%).2 The increased risk of any cardiac complication may be accounted for by the significantly higher use of 3-vessel coronary artery bypass graft among those in group 3 with complications (59.6% vs 50.7%) as demonstrated in Fig. 3B.
Full Text
To the Editor:
I am writing in response to the study by Benson et al, which found that patients who were informed that they were to receive intercessory prayer (group 3) had a higher incidence (58.6% vs 52.5%) of any post-coronary artery bypass graft complication compared with those who were unaware (group 1). 1 Before assuming that knowledge of the good wishes of others accounts for the difference in any complication between the two groups, it is essential to examine possible confounding factors, as well as the types of complications measured. When analyzing the incidence of any complication, the authors assumed that the 6 patients in group 3 and 2 patients in group 1 who were lost to follow-up had a complication; this appears to bias the study against those in group 3 with respect to the overall complication rate. The mortality within 30 days, readmission rate, and operative complication rate were actually lower in group 3. The increase in “any complication” may be driven by the increase in any pulmonary or any cardiac complication. At baseline, although not reaching statistical significance, those in group 1 had a 10% prevalence of chronic obstructive pulmonary disease compared with 13% of those in group 3. Chronic obstructive pulmonary disease is an independent risk factor for postoperative pulmonary complications and may contribute, when added to other unmeasured baseline pulmonary conditions, to the increased incidence of the composite end point of “any pulmonary complication” in group 1 compared with group 3 (23.2% vs 27.1%). 2 The increased risk of any cardiac complication may be accounted for by the significantly higher use of 3-vessel coronary artery bypass graft among those in group 3 with complications (59.6% vs 50.7%) as demonstrated in Fig. 3B. We must use caution when drawing conclusions from composite end points, such as any complication, when hard end points such as 30-day mortality suggest a different interpretation of the data. Before attributing differences between groups to the intervention tested, we must ensure that the randomization and modified intent-to-treat analysis was successful at eliminating potential confounding factors.
M
Mystical_Seeker
Guest
Another reply in the same journal, critical of the interpretation of the results:
Controlling the independent variables in the clinical study of prayer: The devil is in the details
Burks, Eric J. The American Heart Journal152.4 (Oct 2006): e41-e42.
Abstract
…]although this study overcomes some of the statistical hurdles that encumbered prior studies on prayer and medicine, the failure of the authors to rigorously control their independent variables invalidates their comparison of this with prior studies and so does little to advance our understanding of the medical application of intercessory prayer.
Full Text
To the editor:
I was intrigued by this, the sixth study of intercessory prayer and its effect on cardiac patient outcomes. Although the earliest 2 studies showed a positive impact of prayer on outcome, they have been criticized for suboptimal methods of data analysis, nonstandard methods of randomization and allocation concealment, and untested outcome measures. 1,2 Conversely, 3 subsequent studies showed no effect related to prayer, but lacked the statistical power to prove this.3-5 It is with this introduction that the current study was designed to overcome these obstacles with the largest and most statistically powerful study to date in this area.6 The conclusions were that intercessory prayer had no beneficial clinical effect, within the 10% magnitude the study was powered to detect, in patients undergoing coronary artery bypass graft. Indeed, one arm of the study in which prayer was knowingly administered had a worse outcome than those who received none at all. These authors conclude that the findings in this study are inconsistent with that of the previous smaller studies.
I challenge the scientific validity of such a claim. I have no doubts regarding the dependent variables, relating to outcome measures, population size, or statistical analysis; rather I think it is relevant to point out the independent variables, relating to intercessory prayer, that have been overlooked in the comparison of this with prior studies. Table I summarizes the salient features regarding the intercessors of prayer and the populations being studied. In the earliest studies, which showed prayer positively influenced clinical outcomes, intercessors were individually chosen based on definitions of either “born again” Christians (according to John 3:3) 1 or those confessing a belief in God who answers prayer and is willing and able to heal the sick.2 In both cases, “manifestations of an active Christian life” were required such as daily devotional prayer and regular Christian fellowship with a local church to be qualified as an intercessor of prayer.
The remaining studies showed prayer to have no clinical effect, but based on quite different definitions of intercessors. Some studies chose intercessors from local religious groups and community interest meetings.3 The MANTRA studies similarly chose organizations rather than individuals, but focused on attaining religious diversity to include Buddhist, Jewish, Christian, Muslim, and Native American religious groups.4,5 In the current study, it would appear religious groups were targeted and selected based on their ability to receive the prayer list by facsimile, post the list in a central location by 7:15 pm EST, and to have at least one person pray for the patient by midnight. 6,7 Only 3 organizations agreed to participate, including 2 Catholic churches and 1 Protestant church. The authors do not explain the number or diversity of organizations they targeted or the reasons why so few were willing to participate.
Should we assume that anyone is qualified to perform intercessory prayer? Does it matter which religious affiliation the intercessor is committed to, if any? Regardless of our personal opinions about these questions, the fact remains that they have not been scientifically addressed. Although some may scoff at the notion of being scientifically rigorous in a religious matter, the purpose of this study was to scientifically prove or discredit the prayer hypothesis and this requires careful accounting of all the variables when interpreting the results. For example, it is very likely that the coronary artery bypass graft procedure would have deleterious effects on patient outcome if performed by a pathologist, but we would not so readily dismiss the utility of this procedure because we know it can be effective when performed by a cardiothoracic surgeon. Indeed, others have already commented on the scientifically naive assumptions made about prayer in this current study. 8
Even if we dismiss the above objections to this study, we must ask whether it is even possible to test the hypothesis of prayer and its effect on medical outcome. Several reviews of this topic have already been published.9,10 Central to the debate is the Judeo-Christian belief that God should not be put to the test, as per the Old Testament command “Do not put the Lord your God to the test” (Deuteronomy 6:16, New International Version), which is then repeated in the New Testament by Jesus Christ (Luke 4:12). If one assumes that faithfulness is a requirement for a successful intercessor, then it has to be questioned if those willing to participate in such a study are qualified for the role of intercessor. It is my opinion that such a study cannot be performed by faithful Christians because their beliefs would inherently contradict participation.
In conclusion, although this study overcomes some of the statistical hurdles that encumbered prior studies on prayer and medicine, the failure of the authors to rigorously control their independent variables invalidates their comparison of this with prior studies and so does little to advance our understanding of the medical application of intercessory prayer.
Controlling the independent variables in the clinical study of prayer: The devil is in the details
Burks, Eric J. The American Heart Journal152.4 (Oct 2006): e41-e42.
Abstract
…]although this study overcomes some of the statistical hurdles that encumbered prior studies on prayer and medicine, the failure of the authors to rigorously control their independent variables invalidates their comparison of this with prior studies and so does little to advance our understanding of the medical application of intercessory prayer.
Full Text
To the editor:
I was intrigued by this, the sixth study of intercessory prayer and its effect on cardiac patient outcomes. Although the earliest 2 studies showed a positive impact of prayer on outcome, they have been criticized for suboptimal methods of data analysis, nonstandard methods of randomization and allocation concealment, and untested outcome measures. 1,2 Conversely, 3 subsequent studies showed no effect related to prayer, but lacked the statistical power to prove this.3-5 It is with this introduction that the current study was designed to overcome these obstacles with the largest and most statistically powerful study to date in this area.6 The conclusions were that intercessory prayer had no beneficial clinical effect, within the 10% magnitude the study was powered to detect, in patients undergoing coronary artery bypass graft. Indeed, one arm of the study in which prayer was knowingly administered had a worse outcome than those who received none at all. These authors conclude that the findings in this study are inconsistent with that of the previous smaller studies.
I challenge the scientific validity of such a claim. I have no doubts regarding the dependent variables, relating to outcome measures, population size, or statistical analysis; rather I think it is relevant to point out the independent variables, relating to intercessory prayer, that have been overlooked in the comparison of this with prior studies. Table I summarizes the salient features regarding the intercessors of prayer and the populations being studied. In the earliest studies, which showed prayer positively influenced clinical outcomes, intercessors were individually chosen based on definitions of either “born again” Christians (according to John 3:3) 1 or those confessing a belief in God who answers prayer and is willing and able to heal the sick.2 In both cases, “manifestations of an active Christian life” were required such as daily devotional prayer and regular Christian fellowship with a local church to be qualified as an intercessor of prayer.
The remaining studies showed prayer to have no clinical effect, but based on quite different definitions of intercessors. Some studies chose intercessors from local religious groups and community interest meetings.3 The MANTRA studies similarly chose organizations rather than individuals, but focused on attaining religious diversity to include Buddhist, Jewish, Christian, Muslim, and Native American religious groups.4,5 In the current study, it would appear religious groups were targeted and selected based on their ability to receive the prayer list by facsimile, post the list in a central location by 7:15 pm EST, and to have at least one person pray for the patient by midnight. 6,7 Only 3 organizations agreed to participate, including 2 Catholic churches and 1 Protestant church. The authors do not explain the number or diversity of organizations they targeted or the reasons why so few were willing to participate.
Should we assume that anyone is qualified to perform intercessory prayer? Does it matter which religious affiliation the intercessor is committed to, if any? Regardless of our personal opinions about these questions, the fact remains that they have not been scientifically addressed. Although some may scoff at the notion of being scientifically rigorous in a religious matter, the purpose of this study was to scientifically prove or discredit the prayer hypothesis and this requires careful accounting of all the variables when interpreting the results. For example, it is very likely that the coronary artery bypass graft procedure would have deleterious effects on patient outcome if performed by a pathologist, but we would not so readily dismiss the utility of this procedure because we know it can be effective when performed by a cardiothoracic surgeon. Indeed, others have already commented on the scientifically naive assumptions made about prayer in this current study. 8
Even if we dismiss the above objections to this study, we must ask whether it is even possible to test the hypothesis of prayer and its effect on medical outcome. Several reviews of this topic have already been published.9,10 Central to the debate is the Judeo-Christian belief that God should not be put to the test, as per the Old Testament command “Do not put the Lord your God to the test” (Deuteronomy 6:16, New International Version), which is then repeated in the New Testament by Jesus Christ (Luke 4:12). If one assumes that faithfulness is a requirement for a successful intercessor, then it has to be questioned if those willing to participate in such a study are qualified for the role of intercessor. It is my opinion that such a study cannot be performed by faithful Christians because their beliefs would inherently contradict participation.
In conclusion, although this study overcomes some of the statistical hurdles that encumbered prior studies on prayer and medicine, the failure of the authors to rigorously control their independent variables invalidates their comparison of this with prior studies and so does little to advance our understanding of the medical application of intercessory prayer.
M
Mystical_Seeker
Guest
And another criticism, that appeared in the same issue as the original study. It appears the “scientific community” is not as impressed with the study as those who widely report it as being valid:
(Part 1 of 3)
From efficacy to safety concerns: A STEP forward or a step back for clinical research and intercessory prayer?: The Study of Therapeutic Effects of Intercessory Prayer (STEP)
Krucoff, Mitchell WView Profile; Crater, Suzanne W; Lee, Kerry LView Profile. The American Heart Journal151.4 (Apr 2006): 762-764.
Abstract
…]attribution is antithetical to the very definition of what α error and statistical certainty imply: that the worse outcomes are almost certainly related to the therapy and not the play of chance. Literally, from the analysis plan, this “harm” is measured relative to the double-blinded prayer cohort (Group 3, prayer and certain vs Group 1, prayer and uncertain), although Group 1 itself had worse absolute rates of complications than the standard care, Group 2 (no prayer, uncertain).
In a randomized single-center study of prayer in coronary care unit patients, Harris et al6 were supported by the hospital institutional review board (IRB) to conduct the study without obtaining informed consent from patients.
Full Text
Historically one is inclined to look upon science and religion as irreconcilable antagonistsc… I maintain that cosmic religious feeling is the strongest and noblest incitement to scientific research…" Einstein, A. The World as I See It
Systematic study of intangible "noetic1 " or "frontier2 " healing methods such as intercessory prayer, defined as "widely practiced therapeutics with no plausible mechanism,2 " is an area of great public and scientific interest, as well as of great controversy.3,4 . Although prayer is one of the most ancient of healing practices, the scientific literature studying prayer is still quite young. In this issue of the journal, Benson et al report the sixth and largest prospective, randomized, placebo-controlled study of distant prayer scardiovascular patients 1,5-8 in the STEP.
It is not surprising that so much of the study of healing effects of prayer would be pursued in the “high tech” world of cardiovascular care,9 as heart disease invariably faces patients, families, and loved ones with the immediate prospect of death, myocardial infarction, and stroke, either from the disease or from the procedures associated with its treatment. In this setting, the cultural practices of patients, families, and medical staff frequently include the personal use of prayer or solicitation of prayer with therapeutic intention from other devotees. Previous trials include 3 studies in coronary care unit populations 5-7 and 2 in percutaneous coronary intervention populations.1,8 STEP is the first report of distant intercessory prayer in patients undergoing coronary artery bypass surgery.
In the absence of mechanistic insight, attention to the quality of clinical trials science used for the study of an emotionally and culturally charged “therapy” such as intercessory prayer10 becomes critical to the interpretability of study findings and to the utility of such findings to the practice of medicine. In this regard, the STEP investigators are to be congratulated for reporting a large, prospective multicenter study using classic clinical end points (as defined by the Society of Thoracic Surgeons database), with rigorous quality control in the study’s conduct and a thoughtful and rigorous statistical analysis plan including sensitivity analyses for missing data. The STEP study is unequivocally a landmark in the peer review literature on this topic.
A few study design questions can, nonetheless, be raised. “Constraints on how intercessory prayer was provided” excluded all but a handful of prayer groups and may have affected the actual prayers performed by those groups. As the authors point out, although on the one hand this gave rigor to the prayer method used, it may also have impacted the quality of the prayer itself and leaves open questions about the generalizability of the STEP findings relative to other intercessory prayer approaches.
The primary analytic plan also represents some fundamental trade-offs, as is almost always the case in clinical trial planning. As the authors carefully explain, their prospective plan compared Group 1 (prayer but uncertain) versus Group 2 (no prayer but uncertain) and independently compared Group 1 (prayer but uncertain) with Group 3 (prayer and certain). This structure allows a single feature to be assessed for efficacy in each comparison: the effect of adding prayer in a double-blind (Group 1 vs Group 2) and the effect of certainty versus uncertainty in patients receiving intercessory prayer (Group 1 vs Group 3). The trade-offs of adopting this analytic plan, however, especially in light of the data, are relatively unexplored in discussion by the authors, and although rethinking the analysis plan after the data have been examined may be fatally biased, some discussion of the absence of even secondary analyses of all exposure to prayer versus placebo or a 3-way comparison model across the studied groups might have been helpful to readers.
continued …
(Part 1 of 3)
From efficacy to safety concerns: A STEP forward or a step back for clinical research and intercessory prayer?: The Study of Therapeutic Effects of Intercessory Prayer (STEP)
Krucoff, Mitchell WView Profile; Crater, Suzanne W; Lee, Kerry LView Profile. The American Heart Journal151.4 (Apr 2006): 762-764.
Abstract
…]attribution is antithetical to the very definition of what α error and statistical certainty imply: that the worse outcomes are almost certainly related to the therapy and not the play of chance. Literally, from the analysis plan, this “harm” is measured relative to the double-blinded prayer cohort (Group 3, prayer and certain vs Group 1, prayer and uncertain), although Group 1 itself had worse absolute rates of complications than the standard care, Group 2 (no prayer, uncertain).
In a randomized single-center study of prayer in coronary care unit patients, Harris et al6 were supported by the hospital institutional review board (IRB) to conduct the study without obtaining informed consent from patients.
Full Text
Historically one is inclined to look upon science and religion as irreconcilable antagonistsc… I maintain that cosmic religious feeling is the strongest and noblest incitement to scientific research…" Einstein, A. The World as I See It
Systematic study of intangible "noetic1 " or "frontier2 " healing methods such as intercessory prayer, defined as "widely practiced therapeutics with no plausible mechanism,2 " is an area of great public and scientific interest, as well as of great controversy.3,4 . Although prayer is one of the most ancient of healing practices, the scientific literature studying prayer is still quite young. In this issue of the journal, Benson et al report the sixth and largest prospective, randomized, placebo-controlled study of distant prayer scardiovascular patients 1,5-8 in the STEP.
It is not surprising that so much of the study of healing effects of prayer would be pursued in the “high tech” world of cardiovascular care,9 as heart disease invariably faces patients, families, and loved ones with the immediate prospect of death, myocardial infarction, and stroke, either from the disease or from the procedures associated with its treatment. In this setting, the cultural practices of patients, families, and medical staff frequently include the personal use of prayer or solicitation of prayer with therapeutic intention from other devotees. Previous trials include 3 studies in coronary care unit populations 5-7 and 2 in percutaneous coronary intervention populations.1,8 STEP is the first report of distant intercessory prayer in patients undergoing coronary artery bypass surgery.
In the absence of mechanistic insight, attention to the quality of clinical trials science used for the study of an emotionally and culturally charged “therapy” such as intercessory prayer10 becomes critical to the interpretability of study findings and to the utility of such findings to the practice of medicine. In this regard, the STEP investigators are to be congratulated for reporting a large, prospective multicenter study using classic clinical end points (as defined by the Society of Thoracic Surgeons database), with rigorous quality control in the study’s conduct and a thoughtful and rigorous statistical analysis plan including sensitivity analyses for missing data. The STEP study is unequivocally a landmark in the peer review literature on this topic.
A few study design questions can, nonetheless, be raised. “Constraints on how intercessory prayer was provided” excluded all but a handful of prayer groups and may have affected the actual prayers performed by those groups. As the authors point out, although on the one hand this gave rigor to the prayer method used, it may also have impacted the quality of the prayer itself and leaves open questions about the generalizability of the STEP findings relative to other intercessory prayer approaches.
The primary analytic plan also represents some fundamental trade-offs, as is almost always the case in clinical trial planning. As the authors carefully explain, their prospective plan compared Group 1 (prayer but uncertain) versus Group 2 (no prayer but uncertain) and independently compared Group 1 (prayer but uncertain) with Group 3 (prayer and certain). This structure allows a single feature to be assessed for efficacy in each comparison: the effect of adding prayer in a double-blind (Group 1 vs Group 2) and the effect of certainty versus uncertainty in patients receiving intercessory prayer (Group 1 vs Group 3). The trade-offs of adopting this analytic plan, however, especially in light of the data, are relatively unexplored in discussion by the authors, and although rethinking the analysis plan after the data have been examined may be fatally biased, some discussion of the absence of even secondary analyses of all exposure to prayer versus placebo or a 3-way comparison model across the studied groups might have been helpful to readers.
continued …
M
Mystical_Seeker
Guest
continued …
Defining other features of the study cohort might also have been revealing. Patients enrolled in the double-blinded arms might still be inclined to guess or even believe they know what their treatment assignment actually was. In elective percutaneous coronary intervention patients enrolled in a double-blinded prayer study, about two thirds of patients not actually assigned prayer believed that they were. 8 In STEP, documentation of what patients were actually assigned versus what they believed they were assigned in Groups 1 and 2 (uncertain prayer and uncertain no prayer, respectively) might have provided insight into the possible role of a placebo effect.
With excellent clinical science, overall, and a handful of design criticisms inevitable in clinical studies, the most striking element of the STEP report is in the interpretation of the study results showing significantly worsened outcomes in one of the experimental arms. While presenting these results clearly and noting them in discussion, the investigators take an almost casual approach toward any explanation, stating only that it “may have been a chance finding.” It is rather unusual to attribute a statistically significant result in the primary end point of a prospective, multicenter randomized trial to “chance.” In fact, such attribution is antithetical to the very definition of what α error and statistical certainty imply: that the worse outcomes are almost certainly related to the therapy and not the play of chance. If the results had shown benefit rather than harm, would we have read the investigators’ conclusion that this effect “may have been a chance finding,” with absolutely no other comments, insight, or even speculation?
A more straightforward interpretation might have been that patients who were asked to hide a clinical study treatment assignment from their bedside staff and “who were certain that intercessors would pray for them had a higher rate of complications,” that is, that this construct appears to do harm. Literally, from the analysis plan, this “harm” is measured relative to the double-blinded prayer cohort (Group 3, prayer and certain vs Group 1, prayer and uncertain), although Group 1 itself had worse absolute rates of complications than the standard care, Group 2 (no prayer, uncertain). Secondary analyses of the data that might help try to understand whether the stress on the patient in the preoperative period was the key detrimental factor or whether it was the intercessory prayer per se that may be unsafe in this patient population were not performed. If space constraints limited the opportunity to present secondary analyses, at least some indication of their potential might have been commented upon.
Compared with the very high level of study design, conduct, and analysis, the STEP investigators’ interpretation of the study results appears to reflect more the cultural bias that healing prayer could only seriously be explored for effectiveness, not for safety issues. Culturally, “harm” resulting from prayer is generally ascribed to overtly “negative” prayer, such as hateful prayer, voodoo, spells, or other black magic. 11 Positively intended intercessory prayer is considered a priori to be only capable of doing good, if it does anything at all. But this cultural dichotomy is medically problematic and ethically unacceptable in the setting of a clinical trial performing structured experimentation on human subjects. Particularly in the absence of mechanistic insight, outcome researchers must be vigilant in asking the question of whether a well-intentioned, loving, heartfelt healing prayer might inadvertently harm or kill vulnerable patients in certain circumstances. Although the STEP data do not actually prove that prayer had an untoward effect on coronary artery bypass graft patients, to simply write off significantly worse outcomes in one of the experimental arms as the play of chance is in striking contrast to all the other measures the STEP coordinating center and investigators took to ensure the safety of participating patients and quality of the study data. Thus, although the STEP investigators used every appropriate means of protection of the human subjects who participated in their study, the casual approach to the question of safety in the final data interpretation promotes a dangerously ambiguous message to investigators who might be inclined to do research in this area in the future.
In the study of noetic therapies and, perhaps most particularly, in the study of intercessory prayer, unique issues of personal sensitivity, underlying assumptions on the part of the investigators, and ethical obligations abound.9 Approaching a patient to participate in a prayer study before a procedure could inadvertently alarm a patient, “You mean I’m so sick that I might need prayer?” Even the assumption that standard clinical outcome measures are appropriate end points for studies of prayer must be carefully examined; for instance, many prayers for the sick contain the implicit objective of easing the passage of the spirit out of the body, an outcome which, by Society of Thoracic Surgeons definition, would be coded as death.
continued …
Defining other features of the study cohort might also have been revealing. Patients enrolled in the double-blinded arms might still be inclined to guess or even believe they know what their treatment assignment actually was. In elective percutaneous coronary intervention patients enrolled in a double-blinded prayer study, about two thirds of patients not actually assigned prayer believed that they were. 8 In STEP, documentation of what patients were actually assigned versus what they believed they were assigned in Groups 1 and 2 (uncertain prayer and uncertain no prayer, respectively) might have provided insight into the possible role of a placebo effect.
With excellent clinical science, overall, and a handful of design criticisms inevitable in clinical studies, the most striking element of the STEP report is in the interpretation of the study results showing significantly worsened outcomes in one of the experimental arms. While presenting these results clearly and noting them in discussion, the investigators take an almost casual approach toward any explanation, stating only that it “may have been a chance finding.” It is rather unusual to attribute a statistically significant result in the primary end point of a prospective, multicenter randomized trial to “chance.” In fact, such attribution is antithetical to the very definition of what α error and statistical certainty imply: that the worse outcomes are almost certainly related to the therapy and not the play of chance. If the results had shown benefit rather than harm, would we have read the investigators’ conclusion that this effect “may have been a chance finding,” with absolutely no other comments, insight, or even speculation?
A more straightforward interpretation might have been that patients who were asked to hide a clinical study treatment assignment from their bedside staff and “who were certain that intercessors would pray for them had a higher rate of complications,” that is, that this construct appears to do harm. Literally, from the analysis plan, this “harm” is measured relative to the double-blinded prayer cohort (Group 3, prayer and certain vs Group 1, prayer and uncertain), although Group 1 itself had worse absolute rates of complications than the standard care, Group 2 (no prayer, uncertain). Secondary analyses of the data that might help try to understand whether the stress on the patient in the preoperative period was the key detrimental factor or whether it was the intercessory prayer per se that may be unsafe in this patient population were not performed. If space constraints limited the opportunity to present secondary analyses, at least some indication of their potential might have been commented upon.
Compared with the very high level of study design, conduct, and analysis, the STEP investigators’ interpretation of the study results appears to reflect more the cultural bias that healing prayer could only seriously be explored for effectiveness, not for safety issues. Culturally, “harm” resulting from prayer is generally ascribed to overtly “negative” prayer, such as hateful prayer, voodoo, spells, or other black magic. 11 Positively intended intercessory prayer is considered a priori to be only capable of doing good, if it does anything at all. But this cultural dichotomy is medically problematic and ethically unacceptable in the setting of a clinical trial performing structured experimentation on human subjects. Particularly in the absence of mechanistic insight, outcome researchers must be vigilant in asking the question of whether a well-intentioned, loving, heartfelt healing prayer might inadvertently harm or kill vulnerable patients in certain circumstances. Although the STEP data do not actually prove that prayer had an untoward effect on coronary artery bypass graft patients, to simply write off significantly worse outcomes in one of the experimental arms as the play of chance is in striking contrast to all the other measures the STEP coordinating center and investigators took to ensure the safety of participating patients and quality of the study data. Thus, although the STEP investigators used every appropriate means of protection of the human subjects who participated in their study, the casual approach to the question of safety in the final data interpretation promotes a dangerously ambiguous message to investigators who might be inclined to do research in this area in the future.
In the study of noetic therapies and, perhaps most particularly, in the study of intercessory prayer, unique issues of personal sensitivity, underlying assumptions on the part of the investigators, and ethical obligations abound.9 Approaching a patient to participate in a prayer study before a procedure could inadvertently alarm a patient, “You mean I’m so sick that I might need prayer?” Even the assumption that standard clinical outcome measures are appropriate end points for studies of prayer must be carefully examined; for instance, many prayers for the sick contain the implicit objective of easing the passage of the spirit out of the body, an outcome which, by Society of Thoracic Surgeons definition, would be coded as death.
continued …
M
Mystical_Seeker
Guest
continued …
In a randomized single-center study of prayer in coronary care unit patients, Harris et al6 were supported by the hospital institutional review board (IRB) to conduct the study without obtaining informed consent from patients. The concern leading to this design element was a deep and thoughtful one: patient awareness that a study of prayer was ongoing might profoundly change the spiritual landscape being studied. The IRB was duly consulted, and the study design was approved based on the IRB’s conclusion that this therapy “could not possibly do harm.” Although for personal or cultural practices assumptions of Divine benevolence may be both relevant and satisfactory, for clinical research, such an assumption could only be considered scientifically naive as in the history of medicine there has never been a healing remedy that was actually effective without having potential side effects or toxicities.
Rigorous thinking is not an indictment of prayer or prayer’s potential healing power. Rather, it is respect for the complex, redundant, and relatively frail aspects of human physiology in the setting of coronary revascularization. In medical school, almost 30 years ago, we were taught to define health as a state of equilibrium and to understand disease as a fundamental disequilibrium. Protocol addition of an influence we do not mechanistically understand into a physiologic or even “mind-body-spirit” disequilibrium such as heart disease obliges open minded clarity in interpreting the results, even if the results are not what we intend or expect. Both ethically and scientifically, this approach should be no different for the clinical study of intercessory prayer than for any other novel therapeutic.
In STEP, the safety of patients and related ethical obligations to study subjects were conducted, like so much of the study methodology, at the very highest level. Informed consent was required, and data and safety monitoring board oversight was provided. The data, on the other hand, proved to be counterintuitive. The assumption imbedded in the analysis plan was that blinded prayer would be effective and unblinded prayer even more effective, with expected complication rates of 50% in the standard care group, 40% in the blinded prayer group, and 30% in the unblinded prayer group–exactly the opposite of what was actually observed. In the interpretation of obviously counterintuitive findings as “what may have been chance,” the STEP investigators have allowed cultural presumption to undermine scientific objectivity. Leading researchers such as the STEP team should be underlining the imperative that mechanistically undefined “frontier” therapy research–even well intentioned intercessory prayer–must be scrutinized for safety issues at an equal or even higher level than efficacy measures if medically important and useful knowledge in this arena is to truly step forward.
So it seems the scientific community is not as impressed with the results as those who gleefully throw around headlines and sound bites.
MS
In a randomized single-center study of prayer in coronary care unit patients, Harris et al6 were supported by the hospital institutional review board (IRB) to conduct the study without obtaining informed consent from patients. The concern leading to this design element was a deep and thoughtful one: patient awareness that a study of prayer was ongoing might profoundly change the spiritual landscape being studied. The IRB was duly consulted, and the study design was approved based on the IRB’s conclusion that this therapy “could not possibly do harm.” Although for personal or cultural practices assumptions of Divine benevolence may be both relevant and satisfactory, for clinical research, such an assumption could only be considered scientifically naive as in the history of medicine there has never been a healing remedy that was actually effective without having potential side effects or toxicities.
Rigorous thinking is not an indictment of prayer or prayer’s potential healing power. Rather, it is respect for the complex, redundant, and relatively frail aspects of human physiology in the setting of coronary revascularization. In medical school, almost 30 years ago, we were taught to define health as a state of equilibrium and to understand disease as a fundamental disequilibrium. Protocol addition of an influence we do not mechanistically understand into a physiologic or even “mind-body-spirit” disequilibrium such as heart disease obliges open minded clarity in interpreting the results, even if the results are not what we intend or expect. Both ethically and scientifically, this approach should be no different for the clinical study of intercessory prayer than for any other novel therapeutic.
In STEP, the safety of patients and related ethical obligations to study subjects were conducted, like so much of the study methodology, at the very highest level. Informed consent was required, and data and safety monitoring board oversight was provided. The data, on the other hand, proved to be counterintuitive. The assumption imbedded in the analysis plan was that blinded prayer would be effective and unblinded prayer even more effective, with expected complication rates of 50% in the standard care group, 40% in the blinded prayer group, and 30% in the unblinded prayer group–exactly the opposite of what was actually observed. In the interpretation of obviously counterintuitive findings as “what may have been chance,” the STEP investigators have allowed cultural presumption to undermine scientific objectivity. Leading researchers such as the STEP team should be underlining the imperative that mechanistically undefined “frontier” therapy research–even well intentioned intercessory prayer–must be scrutinized for safety issues at an equal or even higher level than efficacy measures if medically important and useful knowledge in this arena is to truly step forward.
So it seems the scientific community is not as impressed with the results as those who gleefully throw around headlines and sound bites.
MS
F
Faith1960
Guest
Wow! Thanks for all the info!continued …
In a randomized single-center study of prayer in coronary care unit patients, Harris et al6 were supported by the hospital institutional review board (IRB) to conduct the study without obtaining informed consent from patients. The concern leading to this design element was a deep and thoughtful one: patient awareness that a study of prayer was ongoing might profoundly change the spiritual landscape being studied. The IRB was duly consulted, and the study design was approved based on the IRB’s conclusion that this therapy “could not possibly do harm.” Although for personal or cultural practices assumptions of Divine benevolence may be both relevant and satisfactory, for clinical research, such an assumption could only be considered scientifically naive as in the history of medicine there has never been a healing remedy that was actually effective without having potential side effects or toxicities.
Rigorous thinking is not an indictment of prayer or prayer’s potential healing power. Rather, it is respect for the complex, redundant, and relatively frail aspects of human physiology in the setting of coronary revascularization. In medical school, almost 30 years ago, we were taught to define health as a state of equilibrium and to understand disease as a fundamental disequilibrium. Protocol addition of an influence we do not mechanistically understand into a physiologic or even “mind-body-spirit” disequilibrium such as heart disease obliges open minded clarity in interpreting the results, even if the results are not what we intend or expect. Both ethically and scientifically, this approach should be no different for the clinical study of intercessory prayer than for any other novel therapeutic.
In STEP, the safety of patients and related ethical obligations to study subjects were conducted, like so much of the study methodology, at the very highest level. Informed consent was required, and data and safety monitoring board oversight was provided. The data, on the other hand, proved to be counterintuitive. The assumption imbedded in the analysis plan was that blinded prayer would be effective and unblinded prayer even more effective, with expected complication rates of 50% in the standard care group, 40% in the blinded prayer group, and 30% in the unblinded prayer group–exactly the opposite of what was actually observed. In the interpretation of obviously counterintuitive findings as “what may have been chance,” the STEP investigators have allowed cultural presumption to undermine scientific objectivity. Leading researchers such as the STEP team should be underlining the imperative that mechanistically undefined “frontier” therapy research–even well intentioned intercessory prayer–must be scrutinized for safety issues at an equal or even higher level than efficacy measures if medically important and useful knowledge in this arena is to truly step forward.
So it seems the scientific community is not as impressed with the results as those who gleefully throw around headlines and sound bites.
MS
F
Faith1960
Guest
Ill have to re-read it a few times; a lot of it was over my head.
F
Faith1960
Guest
Is what he or she trying to say, in English, that the patients had various pre conditions that could contribute to post operative complications BitTorrent figured in the study, or…?
F
Faith1960
Guest
*but werent figured into the study?
M
Mystical_Seeker
Guest
Yes, I think something like that.
It sounds like he’s saying there are too many explanations available for the results, that would skew the results enough that they aren’t meaningful.
Confounding variables are what they sound like. They are variables that cannot be controlled but they influence the outcome. The groups of patients were not enough alike to have confidence other things didn’t factor in.
Also I think he’s saying that if they had used the 30 day survival rate or other measures that might be a little more meaningful than “any complications” their results may have favored the group that did receive the prayers.
So if I’m reading this right, and I’m not an expert, it sounds like he’s saying that not only did the experiment fail to control significant factors, but the measurement they used that showed that the prayed-for group was worse off, was not a meaningful measure. I’d take that to mean that somebody might be prayed for and have a complication, but it doesn’t kill them or land them back into the hospital like some of the other complications.
I’m a beginning psych student, so I just know a little bit of the jargon and have access to the database. I wish I had figure 3B it refers to … I might see if I can find that.
F
Faith1960
Guest
Pope Francis was just talking about evolution, not prayer studies, but I took one thing he said about that as an answer to my prayer. I’d been praying for God to help me with this problem I’d been having regarding prayer studies and today I read that he made the comment that God is not a magician
with a magic wand – I took that as,a sign that He doesn’t sit around granting all our prayers just because,we ask.
with a magic wand – I took that as,a sign that He doesn’t sit around granting all our prayers just because,we ask.
M
Mystical_Seeker
Guest
I agree.
Apparently perfect love, including hating your enemy, logically connects with God not particularly favoring the just. I wonder what this says about intercessory prayer?
Matt 5:43-48
“You have heard that it was said, ‘You shall love your neighbor and hate your enemy.’ But I say to you, love your enemies, and pray for those who persecute you that you may be children of your heavenly Father, for he makes his sun rise on the bad and the good, and causes rain to fall on the just and the unjust. For if you love those who love you, what recompense will you have? Do not the tax collectors do the same? And if you greet your brothers only, what is unusual about that? Do not the pagans do the same? So be perfect, just as your heavenly Father is perfect."
It doesn’t exactly address whether somebody is praying, but whether somebody is “worthy” to pray is another mental formula that wants to try finding a place in the mind. Are my prayers as good as someone else’s? What if I pray for rain and my neighbor prays for sun?
I suggest there are too many possibilities for we human minds to grasp, given how little we know about any particular rules God “follows” regarding prayer.
MS
F
Faith1960
Guest
You meant dark spiritual p.owers would not want unbelieving people to experience first-hand the power of God" right?
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