What Happens After Health Coaching? Observational Study 1 Year Following a Randomized Controlled Trial

Anjana E. Sharma; Rachel Willard-Grace; Danielle Hessler; Thomas Bodenheimer; David H. Thom

doi:10.1370/afm.1924

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Author Response: Clarification to "What Happens After Health Coaching? Observational Study 1 Year Following a Randomized Conrolled Trial"
Anjana E. Sharma

Published on: 15 August 2016
What Happens After health Coaching? Observational Study 1 Year Following a Randomized Controlled Trial - comment on the article by Sharma et al.
Ahlam El Moussaoui

Published on: 21 July 2016

Published on: (15 August 2016)
Page navigation anchor for Author Response: Clarification to "What Happens After Health Coaching? Observational Study 1 Year Following a Randomized Conrolled Trial"
Author Response: Clarification to "What Happens After Health Coaching? Observational Study 1 Year Following a Randomized Conrolled Trial"
Anjana E. Sharma, Clinical Fellow
Other Contributors:
We are grateful to our colleagues for their close review of our paper and their comments.
We agree that offering a limited amount of health coaching to the subgroup of usual care patients did impair our statistical ability to compare the usual care group against the intervention group. As our colleagues mention, this was primarily an ethical decision as well as a way to thank the safety net sites for their partici...
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We are grateful to our colleagues for their close review of our paper and their comments.
We agree that offering a limited amount of health coaching to the subgroup of usual care patients did impair our statistical ability to compare the usual care group against the intervention group. As our colleagues mention, this was primarily an ethical decision as well as a way to thank the safety net sites for their participation in the study; as part of a pragmatic clinical trial this was a concession we made for the benefit of our participants.
We did compare the intervention arm against the usual care arm as part of our descriptive analysis; this between-arm analysis was not significant and was not the primary goal of this follow-up study, and therefore was not included in the final version of the manuscript. We apologize that the description of the statistical methods was not clear in this aspect.
Regarding the issue of multiple comparisons: we did not provide a correction for multiple comparisons for several reasons. First and most simply, this was not performed at the 12 month analysis so that performing it in the follow-up would have been inconsistent and potentially confusing. Second, the measures in question are not conceptually distinct; our primary outcome measure is a composite measure of achieving goal of either A1c, SBP or LDL and all the other outcomes tested were based on change for one or more of these three variables. Our analysis focused on the primary outcome and then reported results for the secondary, component measures. Third, the use of Bonferoni adjustment to the p-value threshold for significance is controversial where outcomes are being tested individually (as opposed to testing the hypothesis that any outcome is significant) [ref] With respect to our findings in change of hemoglobin A1c, we observed a decline in mean A1c of 0.6%, which is clinically significant such that applying additional correction would not be worth the increased chance of type 2 error.
Ref: Perneger TV. What's wrong with Bonferroni adjustments. BMJ. 1998 Apr 18;316(7139):1236-8.
Competing interests: None declared
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Competing Interests: None declared.
Published on: (21 July 2016)
Page navigation anchor for What Happens After health Coaching? Observational Study 1 Year Following a Randomized Controlled Trial - comment on the article by Sharma et al.
What Happens After health Coaching? Observational Study 1 Year Following a Randomized Controlled Trial - comment on the article by Sharma et al.
Ahlam El Moussaoui, Medical Student
Other Contributors:
With interest we read the 1 year follow-up study by Sharma et al. that evaluated the maintenance of improved cardiovascular risk factors following a health coaching intervention(1). Since little is known about persistence of beneficial effects of health coaching, this study was of great relevance. The authors concluded that all clinical outcomes persisted 1 year after completion of the health coaching intervention, exce...
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With interest we read the 1 year follow-up study by Sharma et al. that evaluated the maintenance of improved cardiovascular risk factors following a health coaching intervention(1). Since little is known about persistence of beneficial effects of health coaching, this study was of great relevance. The authors concluded that all clinical outcomes persisted 1 year after completion of the health coaching intervention, except for HbA1c. However, after reading the author conclusions some questions remained.
First, to answer the main question as stated above it would have been sufficient to investigate the 1-year follow-up effects of the health coaching arm from the initial conducted RCT. However, the authors also included the usual-care arm in this follow-up study. In this usual-care arm, a non-randomized subgroup of participants who did not reach their clinical goals at the end of the original RCT received 6 months of limited health coaching after termination of the initial RCT. We understand that from an ethical perspective this option was offered to all usual care patients who didn't succeed yet. However, this impairs the comparison between the two groups regarding whether there are differences in the persistence of clinical outcomes between participants who reached this in the health coaching arm versus those who reached this in the usual care arm after 24 months. Question arises why the study team decided to do so.
Secondly, the authors mention they aim to describe the natural history of patients within each arm after the RCT and will not compare differences between both RCT arms again. Yet, in the statistical analysis the authors do mention that the two study arms were evaluated using McNemar's X2 test for differences and a 2-sample independent t-test for continuous outcomes between study arms, in contrary to what they stated before. No data of these analyses are shown in the results.
Finally, the findings in table 2 show a significant difference in HbA1c (mean and at goal) between 12 and 24 months, which means that participants dropped from their goal after 24 months. However, the authors did not take multiple testing into account. For example, a Bonferroni correction could have been executed on the 8 outcomes of table 2. In that case, HbA1c would not differ significantly from 12 months since the p value would be 0.006 (0.05 / 8). This leads to the conclusion that participants were still at goal for their HbA1c after 24 months. Naturally, this is a much more favorable outcome.
We would be interested in the authors' thoughts on these comments.
Reference 1. Sharma AE, Willard-Grace R, Hessler D, Bodenheimer T, Thom DH. What Happens After Health Coaching? Observational Study 1 Year Following a Randomized Controlled Trial. Ann Fam Med. 2016 May;14(3):200-7.
Competing interests: None declared
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Competing Interests: None declared.