STABILITY (Symptomatic Review during Biologic Therapy) of Inflammatory Bowel Disease Patients Receiving Infusion Therapy Improves Clinical Outcomes

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

Thank you for asking me to review this paper. While it is well known that patients do better if given more attention, and specifically, by their clinician, the paper adds to an important body of knowledge. The paper is straight forward, however, there is one important issue to address by either data or discussion in the limitations. How do the authors know that it was their intervention that improved the patients overall condition? Before and after implies they had medical intervention(s) and it might just be therapy? Can the authors look at this aspect and report their findings? If not, they have to address adequately in a limitations paragraph. 

Author Response

Thank you for your thorough review which highlighted important issues which are part of our study. We appreciate the feedback and the opportunity to clarify and improve this work. 

The reviewer correctly points out the need to distinguish that our 'conversational' interactions/interventions provided the treating physicians with information to provide medical treatments the patients may not have received otherwise. We discuss how the patients would make infusion appointments but often missed other appointments and the possibility that meetings at the infusion clinic may have 'caught' gaps in the therapy which would ordinarily have been found at a scheduled, but often skipped, meeting with the patients regular physician. We would point out that conversations between the physicians and patients during the infusion led to medical interventions that likely influenced the patients' outcomes. We compared the medical history before and after this intervention and found improvements in outcomes using paired t-tests. We did not have an equivalent cohort where there was no patient interaction and no revision of patient care planning based on the conversation. We now acknowledge this as a limitation of the study.

 To provide a clearer context for interpreting our findings and acknowledging the complexity of patient care, we now include a discussion in the limitations section addressing this as a potential confounding factors, and whether therapies and other medical interventions that were newly introduced at the time of this study could be drivers of this improved response., that could have contributed to the observed improvements. 

Reviewer 2 Report

Comments and Suggestions for Authors

see file attached

Comments for author File: Comments.pdf

Author Response

Thank you for your thorough review which highlighted important issues which are part of our study. We appreciate the feedback and the opportunity to clarify and improve this work. 

1. ABSTRACT: very long and confusing.
2. INTRODUCTION: the introduction is confusingly structured. The background is not sufficiently structured. The objective of the study is not clearly stated.
3. In the introduction the authors report that “ Historically, these patients would see only the infusion nurse during their treatments, and the GI physician was only called per patient request or if they were visibly ill and the nurse felt they needed to see the physician”. In my opinion, it is normal and good clinical practice to evaluate a patient by a doctor before the infusion to decide on any
   changes to the therapeutic plan. To my knowledge, this is an approach that is normally and routinely applied in pediatric and adult centers. If the authors know that this is not normal clinical practice they should report the data and these could justify the purpose of this study.

Clarifying the Historical Context: This statement in our introduction reflects the specific historical context of our clinical setting. While it may indeed be a standard practice in many centers to have a physician evaluate patients before infusion, this was not consistently implemented in our practice until the intervention described in the study. In order to clarify this point, we have revised the introduction to clearly state that this historical practice was specific to our setting and may not reflect broader clinical norms.

1. STATISTICS: not reported. We regret for not stating this clearly. We used paired t-tests to compare clinical findings before and after STABILITY.
2. MATERIALS AND METHODS: it is not clear what the STABILITY approach consists of and whether and how it differs from a normal clinical evaluation. What does it mean: “ very brief reviews of symptoms”?. It is not clear how the severity of the disease is assessed while there are validated scores such as MAYO and CDAI as the authors themselves report in the discussion. Detailed patient data is lacking.
3. RESULTS: the data reported are confounding and redundant.
4. DISCUSSION: not a single reference is reported in the entire discussion.
5. CONCLUSIONS: the conclusions become an extension of the discussion with health economics considerations.
6. FURTHERMORE: no tables or figures in the entire paper. 

The reviewer correctly points out the need to distinguish that our 'conversational' interactions / interventions provided the treating physicians with information to provide medical treatments the patients may not have received otherwise. We now point out that conversations between the physicians and patients during the infusion are not typical and we agree as suggested by the reviewer that this likely led to medical interventions that likely beneficilly influenced the patients' outcomes. We compared the medical history before and after this intervention and found improvements in outcomes using paired t-tests. We did not have an equivalent cohort where there was no patient interaction and no revision of patient care planning based on the conversation. We do now acknowledge this as a limitation of the study.

To provide a clearer context for interpreting our findings and acknowledging the complexity of patient care, we now include a discussion in the limitations section addressing this as a potential confounding factors, and whether therapies and other medical interventions that were newly introduced at the time of this study could be drivers of this improved response., that could have contributed to the observed improvements. 

Reviewer 3 Report

Comments and Suggestions for Authors

The manuscript by Kelli Morgan et al., entitled “STABILITY (Symptomatic Review during Biologic Therapy) in Inflammatory Bowel Disease Patients Receiving Infusion Therapy Improves Clinical Outcomes” is presented for review.

 

            The presented manuscript addresses correlation between increased physician-patient communication (STABILITY approach) during the drug administration and inflammatory bowel disease (e.g. ulcerative colitis; UC, and Crohn’s disease; CD) patient outcomes. In total, 111 IBD patients (18UC and 93CD) who were receiving certolizumab as an injectable biologic have been evaluated. IBD-relevant patient data, endoscopic evaluation (i.e., colonoscopy), serum inflammatory markers (C-reactive peptide, erythrocyte sedimentation rate) and fecal calprotectin levels were used to assess disease severity in IBD patients. Patient biological sex was also considered in the study.

 

The findings of this study indicate a statistically significant reduction in disease activity and hospitalizations, in both male and female IBD groups (including CD and UC) and in CD patients (including male and female CD patients) after STABILITY. The above changes were associated with lower although not significantly different levels of inflammatory biomarkers which were detected in IBD patients after STABILITY.

Important finding of the study is that 72% of patients felt improvement during biologic therapy with STABILITY and 77% of the respondents described increased optimism about managing their condition and a better quality of life after STABILITY. In addition, 48% of patients reported decreased ED visits since the initiation of STABILITY.

 

It is this reviewer’s opinion that the manuscript is very timely, addresses important clinical problem, and may have a profound impact to the overall patient care system. The results are novel and well discussed. The manuscript is well written as was easy to follow.

As such, there are no major concerns with the manuscript.

 

Points for consideration:

 

1. It would be helpful to the reader if the results would be presented in Tables.

Author Response

We appreciate the positive impressions of our report and would like to respond to the criticisms raised by this reviewer that the data be reported in  tabular form. This has now been accomplished as suggested by several reviewers.