Can we do better? A qualitative study in the East of England investigating patient experience and acceptability of using the faecal immunochemical test in primary care

Objectives The faecal immunochemical test (FIT) is increasingly used in UK primary care to triage patients presenting with symptoms and at different levels of colorectal cancer risk. Evidence is scarce on patients’ views of using FIT in this context. We aimed to explore patients’ care experience and acceptability of using FIT in primary care. Design A qualitative semi-structured interview study. Interviews were conducted via Zoom between April and October 2020. Transcribed recordings were analysed using framework analysis. Setting East of England general practices. Participants Consenting patients (aged ≥40 years) who presented in primary care with possible symptoms of colorectal cancer, and for whom a FIT was requested, were recruited to the FIT-East study. Participants were purposively sampled for this qualitative substudy based on age, gender and FIT result. Results 44 participants were interviewed with a mean age 61 years, and 25 (57%) being men: 8 (18%) received a positive FIT result. Three themes and seven subthemes were identified. Participants’ familiarity with similar tests and perceived risk of cancer influenced test experience and acceptability. All participants were happy to do the FIT themselves and to recommend it to others. Most participants reported that the test was straightforward, although some considered it may be a challenge to others. However, test explanation by healthcare professionals was often limited. Furthermore, while some participants received their results quickly, many did not receive them at all with the common assumption that ‘no news is good news’. For those with a negative result and persisting symptoms, there was uncertainty about any next steps. Conclusions While FIT is acceptable to patients, elements of communication with patients by the healthcare system show potential for improvement. We suggest possible ways to improve the FIT experience, particularly regarding communication about the test and its results.


GENERAL COMMENTS
Thank you for letting me review this manuscript titled: It tis an interesting paper and I find similarities to the research we have conducted here in Sweden.
Can we do better? A qualitative study investigating patient experience and acceptability of using the faecal immunochemical test in primary care Background Relevant to reflect upon: Are the relevant concepts and aspects of the study defined here? For whom are you writing this? Do you need to include any more information, for instance regarding colorectal cancer? I would suggest to expand the background based on these questions. What does NICE stand for? Please explain abbreviations throughout the manuscript. It would be good to put describe the health care system in the UK. Help the reader to grasp the context both regarding health care sector and this part of England. Who do you want to address this paper to? I would suggest formulating a clearer rational. Do we need more of this type of research and why? What is new?

Aim
The aim it to explore FIT experience and acceptability. How is acceptability defined? How is acceptability addressed in the interview guide? Please see further under Methods. Methods It´s good that COREQ is acknowledged. My major concern here is that a deductive analysis seems to have been conducted. That is not, however, visible in the design description. It is not clear how the analysis process has been conducted so I would like to see a more detailed description. It could be in the format of a visual presentation about the process, adding on to the text. Results "Many", "several", "most" participants are frequently used. Is this relevant for a qualitative paper? Isn´t it the variation that should be in focus? I would suggest decreasing number of citations in the result section. My impression now is that the section is very much a description of the different citations and that is not my view on how a qualitative result should be structured. How is the deductive perspective visible here? Discussion It is stated here that three well-established theoretical models were used but I don´t see how. The authors state that the models complemented each other but how is that shown to the reader? Please see under method. What about the section on COVID? How is it going to be addressed? Do you have such solid evidence as to be able to come up with all those recommendations or are they based on other research as well? I miss a more detailed discussion regarding strengths and limitations. I miss a Conclusion.

REVIEWER
Nepogodiev, Dmitri University of Birmingham, Academic Department of Surgery REVIEW RETURNED 17-Mar-2023

GENERAL COMMENTS
This is a well executed study that has been transparently reported with clear recommendations for clinical practice.
Unfortunately, it is not possible to address the study's main limitation, which is that the patients interviewed were all white and disproportionately had degree-level qualifications and higher socioeconomic status. It is well documented that bowel screening uptake is significantly lower in populations with lower socioeconomic status and in ethnic minorities, so it is a missed opportunity to not have included a more diverse patient sample to explore potential inequalities within symptomatic patient groups. Could the authors comment on what they did find in terms of differences between socioeconomic groups? The need for further research in to socioeconomic and ethnic group inequalities using both qualitative and quantitative methods should be highlighted as a future research priority (box 1).
Please add to main manuscript that you have used COREQ.

Reviewer comments
Author response Reviewer 1 Aim The aim is to explore FIT experience and acceptability. This is still not addressed in connection to the aim: How is acceptability defined? How is acceptability addressed in the interview guide? Please see further under Methods Following our previous revisions, we have now moved our definition of acceptability into the Introduction (paragraph 4).
"Acceptability is defined as a multi-faceted construct comprising affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and selfefficacy 19 " The questions in the interview topic guide were broad to encompass constructs within Sekhon et al's theoretical framework of acceptability (TFA). We have added our response here again for information: Within the interview topic guide, questions were broad to both encompass constructs of Sekhon's TFA, whilst also leaving scope for participants to talk about other issues regarding FIT that they felt were important. For example, affective attitude was investigated by asking questions such as "How did you feel when the GP suggested having a FIT-poo test?" and "How did you feel following the test?". Burden was explored through questions such as "How did you feel about doing the testphysically, emotionally?". Intervention coherence was investigated by asking "How would you explain the test to someone else?" The question "How was the FIT-poo test introduced and explained" was designed to shed light on both the care experience and the construct of perceived effectiveness. We did not have questions focusing specifically on ethicality and opportunity costswhile answers to openended questions could have still approached issues relevant to these, we found that these constructs were less relevant to the participants' experiences.

Methods
My major concern here is that a deductive analysis seems to have been conducted. That is not, however, visible in the design description. It is not clear how the analysis process has been conducted so I would like to see a more detailed description. It could be in the format of a visual presentation about the process, adding on to the text.
New comment: This is still a concern to me, what is the design of this study? To me, a qualitative study is not enough as a description of the design. I would also like to see a rational for the use of Acceptability much earlier in the manuscript, preferably in the background. Why is this concept relevant and what is included in these conceptual models.
Regarding addressing the rationale for the use of acceptability earlier on in the manuscript, we have now added a definition to the Introduction, see above. Furthermore, we have brief explained why the concept is relevant (Introduction, paragraph 4): "It is a necessary condition for the effectiveness of an intervention or test; from the patient perspective, if a test is considered acceptable, patients are more likely to adhere to the proposed investigation which in turn results in improved clinical outcomes 19,20 ." This is a qualitative interview study which used a framework approach for data analysis. This is a widely used and accepted research design, particularly in applied health research. We have now tried to clarify our approach to data analysis, which we interpreted as the key issue raised by the reviewer.
We have adopted the framework method/approach for data analysis; this is a tool that allows for both inductive and deductive approaches (Gale et al,ref 33). In this study, we adopted an inductive approach, also as described by Gale et al: themes were generated from the data through open coding, and were then refined taking into account our research question and adopted definition of acceptability. This information has been added to Methods, Data analysis, paragraph 1: "Verbatim transcripts were checked, anonymised and analysed using framework analysis 33 . This allows for both inductive and deductive approaches. An inductive approach was adopted for data analysis, influenced by our research question and specific definitions of acceptability 33 ." We have also moved information regarding the theoretical models used into a new Box 'Theoretical Models' found after the Methods, Data analysis section. We have added information about what is included in the models, and provided references that have detailed descriptions for each of them. It is stated here that three well-established theoretical models were used but I don´t see how. The authors state that the models complemented each other but how is that shown to the reader? Please see under method. I would like to see a more detailed description of As per the comments above, we would prefer not to focus too much on the theory as this was used for a specific step of the analysis to help conceptualise the themes, rather than driving the overall analysis. We have provided references with comprehensive descriptions of the constructs within the TFA (reference 19, Sekhon et al) and definitions for care experience the models to be able to follow the discussion and to grasp the authors statements.
(reference 28, Forster et al) that can now be found in Box 1.

Discussion
What about the section on COVID? How is it going to be addressed?
As before, we thought carefully about whether to add findings related to COVID within the main results section. We found that whilst COVID was an important factor in how patients presented to their GP, it did not appear to have an impact on acceptability and experience of using FIT. However, we do consider it is important as background information and for this reason it was included as supplementary data to provide context to the study. We believe that including it within the main results section would deviate from the aims of the study and distract the reader from its main messages. Therefore, we would prefer to keep it as supplementary data. We trust this is appropriate.

Discussion
Do you have such solid evidence as to be able to come up with all those recommendations or are they based on other research as well? I'm hesitant.
We do believe that the recommendations are either informed by the results or link clearly to the UK healthcare setting.
We have highlighted this further by adding additional information within the Discussion, Implications for research, practice and policy, paragraph 1.
"Building on our findings and published literature, alongside considerations on what is feasible within the UK context, we have developed recommendations for research, practice and policy to improve both the FIT experience and patient safety (Box 2)."

Discussion
The conclusion needs to be justified in the result section.
We are unsure of which parts of the conclusion are not justified in the results section. Results show that patients find FIT acceptable, that those with previous knowledge or experience of similar tests were happy to do the test, and that despite poor experience of care acceptability was high. Results also show that communication with patients was not always optimal, giving scope for improvement. We are also aware that there are certain groups that our study did not include and we have suggested future studies to include these populations. Thanks, the background has improved and I´m satisfied with the new version.

Aim
The aim it to explore FIT experience and acceptability. This is still not addressed in connection to the aim: How is acceptability defined? How is acceptability addressed in the interview guide? Please see further under Methods. Methods It´s good that COREQ is acknowledged. My major concern here is that a deductive analysis seems to have been conducted. That is not, however, visible in the design description. It is not clear how the analysis process has been conducted so I would like to see a more detailed description. It could be in the format of a visual presentation about the process, adding on to the text. New comment: This is still a concern to me, what is the design of this study? To me, a qualitative study is not enough as a description of the design. I would also like to see a rational for the use of Acceptability much earlier in the manuscript, preferably in the background. Why is this concept relevant and what is included in these conceptual models. Results "Many", "several", "most" participants are frequently used. Is this relevant for a qualitative paper? Isn´t it the variation that should be in focus? I would suggest decreasing number of citations in the result section. My impression now is that the section is very much a description of the different citations and that is not my view on how a qualitative result should be structured. It is better now, thank you. Still, how is the deductive perspective visible? Discussion It is stated here that three well-established theoretical models were used but I don´t see how. The authors state that the models complemented each other but how is that shown to the reader? Please see under method. I would like to see a more detailed description of the models to be able to follow the discussion and to grasp the authors statements.
What about the section on COVID? How is it going to be addressed? Do you have such solid evidence as to be able to come up with all those recommendations or are they based on other research as well? Im hesitant.
The conclusion needs to be justified in the result section.

Reviewer comments
Author response Reviewer 1 Aim The aim is to explore FIT experience and acceptability. This is still not addressed in connection to the aim: How is acceptability defined? How is acceptability addressed in the interview guide? Please see further under Methods Following our previous revisions, we have now moved our definition of acceptability into the Introduction (paragraph 4).

"Acceptability is defined as a multi-faceted construct comprising affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and selfefficacy 19 "
The questions in the interview topic guide were broad to encompass constructs within Sekhon et al's theoretical framework of acceptability (TFA). We have added our response here again for information: Within the interview topic guide, questions were broad to both encompass constructs of Sekhon's TFA, whilst also leaving scope for participants to talk about other issues regarding FIT that they felt were important. For example, affective attitude was investigated by asking questions such as "How did you feel when the GP suggested having a FIT-poo test?" and "How did you feel following the test?". Burden was explored through questions such as "How did you feel about doing the testphysically, emotionally?". Intervention coherence was investigated by asking "How would you explain the test to someone else?" The question "How was the FIT-poo test introduced and explained" was designed to shed light on both the care experience and the construct of perceived effectiveness. We did not have questions focusing specifically on ethicality and opportunity costswhile answers to openended questions could have still approached issues relevant to these, we found that these constructs were less relevant to the participants' experiences.

Methods
My major concern here is that a deductive analysis seems to have been conducted. That is not, however, visible in the design description. It Regarding addressing the rationale for the use of acceptability earlier on in the manuscript, we have now added a definition to the Introduction, see above. Furthermore, we have brief is not clear how the analysis process has been conducted so I would like to see a more detailed description. It could be in the format of a visual presentation about the process, adding on to the text.
New comment: This is still a concern to me, what is the design of this study? To me, a qualitative study is not enough as a description of the design. I would also like to see a rational for the use of Acceptability much earlier in the manuscript, preferably in the background. Why is this concept relevant and what is included in these conceptual models.
explained why the concept is relevant (Introduction, paragraph 4): "It is a necessary condition for the effectiveness of an intervention or test; from the patient perspective, if a test is considered acceptable, patients are more likely to adhere to the proposed investigation which in turn results in improved clinical outcomes 19,20 ." This is a qualitative interview study which used a framework approach for data analysis. This is a widely used and accepted research design, particularly in applied health research. We have now tried to clarify our approach to data analysis, which we interpreted as the key issue raised by the reviewer.
We have adopted the framework method/approach for data analysis; this is a tool that allows for both inductive and deductive approaches (Gale et al,ref 33). In this study, we adopted an inductive approach, also as described by Gale et al: themes were generated from the data through open coding, and were then refined taking into account our research question and adopted definition of acceptability. This information has been added to Methods, Data analysis, paragraph 1: "Verbatim transcripts were checked, anonymised and analysed using framework analysis 33 . This allows for both inductive and deductive approaches. An inductive approach was adopted for data analysis, influenced by our research question and specific definitions of acceptability 33 ." We have also moved information regarding the theoretical models used into a new Box 'Theoretical Models' found after the Methods, Data analysis section. We have added information about what is included in the models, and provided references that have detailed descriptions for each of them.

"Box 1. Theoretical models
Three theoretical models, listed below, were used to help inform and conceptualize the themes during data analysis. These models were chosen to underpin important complementary but distinctive aspects of the cancer diagnostic pathway 35,36  It is stated here that three well-established theoretical models were used but I don´t see how. The authors state that the models complemented each other but how is that shown to the reader? Please see under method. I would like to see a more detailed description of the models to be able to follow the discussion and to grasp the authors statements.
As per the comments above, we would prefer not to focus too much on the theory as this was used for a specific step of the analysis to help conceptualise the themes, rather than driving the overall analysis. We have provided references with comprehensive descriptions of the constructs within the TFA (reference 19, Sekhon et al) and definitions for care experience (reference 28, Forster et al) that can now be found in Box 1.

Discussion
What about the section on COVID? How is it going to be addressed?
As before, we thought carefully about whether to add findings related to COVID within the main results section. We found that whilst COVID was an important factor in how patients presented to their GP, it did not appear to have an impact on acceptability and experience of using FIT. However, we do consider it is important as background information and for this reason it was included as supplementary data to provide context to the study. We believe that including it within the main results section would deviate from the aims of the study and distract the reader from its main messages. Therefore, we would prefer to keep it as supplementary data. We trust this is appropriate.

Discussion
Do you have such solid evidence as to be able to come up with all those recommendations or are they based on other research as well? I'm hesitant.
We do believe that the recommendations are either informed by the results or link clearly to the UK healthcare setting.
We have highlighted this further by adding additional information within the Discussion, Implications for research, practice and policy, paragraph 1.
"Building on our findings and published literature, alongside considerations on what is feasible within the UK context, we have developed recommendations for research, practice and policy to improve both the FIT experience and patient safety (Box 2)."

Discussion
The conclusion needs to be justified in the result section.
We are unsure of which parts of the conclusion are not justified in the results section. Results show that patients find FIT acceptable, that those with previous knowledge or experience of similar tests were happy to do the test, and that despite poor experience of care acceptability was high. Results also show that communication with patients was not always optimal, giving scope for improvement. We are also aware that there are certain groups that our study did not include and we have suggested future studies to include these populations. Thanks, the background has improved and I´m satisfied with the new version.

Aim
The aim it to explore FIT experience and acceptability. This is still not addressed in connection to the aim: How is acceptability defined? How is acceptability addressed in the interview guide? Please see further under Methods.

Methods
It´s good that COREQ is acknowledged.
My major concern here is that a deductive analysis seems to have been conducted. That is not, however, visible in the design description. It is not clear how the analysis process has been conducted so I would like to see a more detailed description. It could be in the format of a visual presentation about the process, adding on to the text.
New comment: This is still a concern to me, what is the design of this study? To me, a qualitative study is not enough as a description of the design.
I would also like to see a rational for the use of Acceptability much earlier in the manuscript, preferably in the background. Why is this concept relevant and what is included in these conceptual models 230530: Ok now.

Results
"Many", "several", "most" participants are frequently used. Is this relevant for a qualitative paper? Isn´t it the variation that should be in focus? I would suggest decreasing number of citations in the result section. My impression now is that the section is very much a description of the different citations and that is not my view on how a qualitative result should be structured.
It is better now, thank you. Still, how is the deductive perspective visible?

Discussion
It is stated here that three well-established theoretical models were used but I don´t see how. The authors state that the models complemented each other but how is that shown to the reader? Please see under method. I would like to see a more detailed description of the models to be able to follow the discussion and to grasp the authors statements. What about the section on COVID? How is it going to be addressed? Do you have such solid evidence as to be able to come up with all those recommendations or are they based on other research as well? Im hesitant. The conclusion needs to be justified in the result section.