Reviewer's report
Title:Patient-centered factors associated with hepatitis C treatment: a qualitative
study
Version:2Date:6 February 2015
Reviewer: Sheryl Szeinbach
Reviewer's report:
Overall, the focus group study via telephone interviews was appropriate. The
investigators obtained useful information from the interviews for use in a larger
and more extensive study.
Major:
Background information is helpful, but the study needs a stronger foundation. For
example, there appears to be no theoretical background for the research? Was
some type of model used to develop the study? How was the interview guide
developed?
What qualitative research approach was used in the study? Were guidelines for
outcomes research followed? For example, The FDA patient-reported outcomes
guidelines would provide a foundation for the research presented. How did the
investigators go from the items and dimensions to a conceptual model?
How was content validity assessed in the study? What studies have already been
performed in this area? Did a literature review guide the development of
questions for use in the study?
How was this information from the literature used to develop the interview guide
for the study?
Was item saturation reached? This would let us know that enough individuals
were sampled.
More information is needed about these patients regarding their separation into
groups. What were the selection criteria? Why were they assigned to the groups
from a clinical standpoint? More detail is needed.
At what point was the instrument for the study developed?
Was cognitive debriefing used to assess content and face validity?
What other limitations exist with patients selected from the VA? Age?
Conceptual framework as presented is very confusing. There are what appear to
be items and dimensions with arrows everywhere. Are these factors? Was a
factor analysis performed? What is the proposed causal relationship among
these items and dimensions? Standard nomenclature for reporting conceptual
frameworks should be used. The overall conceptualization process is missing
from the development of the conceptual framework. For example,
shared-decision making is mentioned throughout the manuscript, yet there is no
mention of shared decision making in the conceptual framework. It is not clear
how the dimensions are related conceptually - conceptualization is also important
for study validation.
Minor
Line – 41 – typo than # that; several other minor edits are needed throughout the
manuscript
Summary
However, preliminary results from this study do provide a framework for future
research. The research question “Little work has been done to examine and
understand the factors that patients consider in making the decision to pursue or
forego CHC treatment” is a very important question. How can this research
project continue? As a suggestion, a more extensive development of the criteria
by which these patients are assigned to these three groups is needed, along with
a more substantial study background in theory and methods for the research.
Also, what about patients who start therapy then stop? What about patients who
complete therapy?
Using the outcome and clinical measures from this study and from the literature,
suggest performing a MANOVA along with the estimation of effect size, which
would inform us of the importance of group differences, and may provide more
insight as to why patients with HCV undergo or refuse treatment.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
received funding from Abbvie in the past five years in this area - not currently
working on a project in this area -- all papers have been published -- no papers in
this area under review -
Reviewer's report
Title:Patient-centered factors associated with hepatitis C treatment: a qualitative
study
Version:2Date:6 February 2015
Reviewer: Sheryl Szeinbach
Reviewer's report:
Overall, the focus group study via telephone interviews was appropriate. The
investigators obtained useful information from the interviews for use in a larger
and more extensive study.
Major:
Background information is helpful, but the study needs a stronger foundation. For
example, there appears to be no theoretical background for the research? Was
some type of model used to develop the study? How was the interview guide
developed?
What qualitative research approach was used in the study? Were guidelines for
outcomes research followed? For example, The FDA patient-reported outcomes
guidelines would provide a foundation for the research presented. How did the
investigators go from the items and dimensions to a conceptual model?
How was content validity assessed in the study? What studies have already been
performed in this area? Did a literature review guide the development of
questions for use in the study?
How was this information from the literature used to develop the interview guide
for the study?
Was item saturation reached? This would let us know that enough individuals
were sampled.
More information is needed about these patients regarding their separation into
groups. What were the selection criteria? Why were they assigned to the groups
from a clinical standpoint? More detail is needed.
At what point was the instrument for the study developed?
Was cognitive debriefing used to assess content and face validity?
What other limitations exist with patients selected from the VA? Age?
Conceptual framework as presented is very confusing. There are what appear to
be items and dimensions with arrows everywhere. Are these factors? Was a
factor analysis performed? What is the proposed causal relationship among
these items and dimensions? Standard nomenclature for reporting conceptual
frameworks should be used. The overall conceptualization process is missing
from the development of the conceptual framework. For example,
shared-decision making is mentioned throughout the manuscript, yet there is no
mention of shared decision making in the conceptual framework. It is not clear
how the dimensions are related conceptually - conceptualization is also important
for study validation.
Minor
Line – 41 – typo than # that; several other minor edits are needed throughout the
manuscript
Summary
However, preliminary results from this study do provide a framework for future
research. The research question “Little work has been done to examine and
understand the factors that patients consider in making the decision to pursue or
forego CHC treatment” is a very important question. How can this research
project continue? As a suggestion, a more extensive development of the criteria
by which these patients are assigned to these three groups is needed, along with
a more substantial study background in theory and methods for the research.
Also, what about patients who start therapy then stop? What about patients who
complete therapy?
Using the outcome and clinical measures from this study and from the literature,
suggest performing a MANOVA along with the estimation of effect size, which
would inform us of the importance of group differences, and may provide more
insight as to why patients with HCV undergo or refuse treatment.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
received funding from Abbvie in the past five years in this area - not currently
working on a project in this area -- all papers have been published -- no papers in
this area under review -
Please review this paper.
user
Reviewer's report
Title:Patient-centered factors associated with hepatitis C treatment: a qualitative
study
Version:2Date:6 February 2015
Reviewer: Sheryl Szeinbach
Reviewer's report:
Overall, the focus group study via telephone interviews was appropriate. The
investigators obtained useful information from the interviews for use in a larger
and more extensive study.
Major:
Background information is helpful, but the study needs a stronger foundation. For
example, there appears to be no theoretical background for the research? Was
some type of model used to develop the study? How was the interview guide
developed?
What qualitative research approach was used in the study? Were guidelines for
outcomes research followed? For example, The FDA patient-reported outcomes
guidelines would provide a foundation for the research presented. How did the
investigators go from the items and dimensions to a conceptual model?
How was content validity assessed in the study? What studies have already been
performed in this area? Did a literature review guide the development of
questions for use in the study?
How was this information from the literature used to develop the interview guide
for the study?
Was item saturation reached? This would let us know that enough individuals
were sampled.
More information is needed about these patients regarding their separation into
groups. What were the selection criteria? Why were they assigned to the groups
from a clinical standpoint? More detail is needed.
At what point was the instrument for the study developed?
Was cognitive debriefing used to assess content and face validity?
What other limitations exist with patients selected from the VA? Age?
Conceptual framework as presented is very confusing. There are what appear to
be items and dimensions with arrows everywhere. Are these factors? Was a
factor analysis performed? What is the proposed causal relationship among
these items and dimensions? Standard nomenclature for reporting conceptual
frameworks should be used. The overall conceptualization process is missing
from the development of the conceptual framework. For example,
shared-decision making is mentioned throughout the manuscript, yet there is no
mention of shared decision making in the conceptual framework. It is not clear
how the dimensions are related conceptually - conceptualization is also important
for study validation.
Minor
Line – 41 – typo than # that; several other minor edits are needed throughout the
manuscript
Summary
However, preliminary results from this study do provide a framework for future
research. The research question “Little work has been done to examine and
understand the factors that patients consider in making the decision to pursue or
forego CHC treatment” is a very important question. How can this research
project continue? As a suggestion, a more extensive development of the criteria
by which these patients are assigned to these three groups is needed, along with
a more substantial study background in theory and methods for the research.
Also, what about patients who start therapy then stop? What about patients who
complete therapy?
Using the outcome and clinical measures from this study and from the literature,
suggest performing a MANOVA along with the estimation of effect size, which
would inform us of the importance of group differences, and may provide more
insight as to why patients with HCV undergo or refuse treatment.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
received funding from Abbvie in the past five years in this area - not currently
working on a project in this area -- all papers have been published -- no papers in
this area under review -
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