Do Patient-Reported Quality-of-Life (QoL) Scales Provide an Adequate Assessment of Patients with Cryptoglandular Anal Fistulae? A Systematic Review of Measurement Instruments and Their Content Validity
Round 1
Reviewer 1 Report
Thank you for this really interesting paper. In my oppinion QoL is underrespresented in treatment of perianal fistulae, as you´ve also mentioned. It is very good to assess the quality of the methods of measurement of QoL. There are many different ways to treat perianal fistulae, but as you´ve also stated, the impact of our treatment on the individual remains unclear and should be included in the decision making process.
I think this paper cleary shows the lack of suitable methods to measure the QoL in this patient collective and shows the importance of further research in this field!
Author Response
We thank you for your valuable feedback, we hope that publication of this paper will further highlight the importance and inadequacy of QoL measurement in this complex patient cohort.
Reviewer 2 Report
Dear Author
thnks for the opportunity to review you paper. The issue of QoL in fistula patients is extremely important and accordingly to your conclusion, the instruments available lack of quality. One comment arise in evaluating your work: you mention a relevant reference (line 43 and 237) as article in press. Such reference appears as a relevant issue, therefore it could be better to cite it in full once the article is published. Alternatively the reference may be indicated in the reference list, at least as follows: journal name, year, in press.
Author Response
We thank you for your feedback. This paper has now been published online ahead of print and has been appropriately referenced in the text (see tracked changes).
Reviewer 3 Report
Though it is a nicely conducted study and a lot of effort has gone into writing the manuscript, I feel that it's a bit premature for a systematic review on this topic.
Author Response
We thank reviewer 3 for taking the time to assess this manuscript. A number of patients with cryptoglandular anal fistula will suffer from complex and chronic disease, meaning that assessing the outcome of treatment in binary ‘success vs failure’ terms is overly simplistic and inadequate, given that many treatments in these cases will be focused on improving symptoms and QoL. As such, we feel that this systematic review of QoL measurement instruments is important and timely given the enduring impact of having a fistula on QoL in such cases, but also because of the emphasis placed on measuring QoL as a core outcome of fistula treatment (1). Current methods of measurement are hugely variable and ultimately meaningless if they lack basic content validity, therefore an investigation such as this is key to highlighting ways in which we can improve research in this field. It is also a necessary first step in the process of developing a new instrument for measuring quality of life in this crucial area, and for developing a core measurement set, which will help researchers to improve the assessment of outcomes in fistula research.
Reviewer 4 Report
The aim of the study is clear and the study design is good, but the lack of elegible papers is very relevant (only 2/731) and the results are not very solid.
Considering these aspects, in my opinion, it would be preferable to modify the article in an editorial.
Author Response
We thank you for taking the time to review this manuscript. We agree that the lack of eligible papers limits this review and we have expanded on this in the discussion. However, given that QoL has been identified as a core outcome that should be reported in all studies of anal fistula treatment (1), this paper is important in identifying the lack of validated measurement instruments available, which is a key step in determining a Core Measurement Set for cryptoglandular anal fistula. We believe that the systematic methods employed in identifying the available instruments is relevant and useful to all researchers involved in planning and executing studies of fistula treatment, ensuring that the selection of future measurement instruments, including for other patient reported outcomes such as symptoms and patient satisfaction, is done based on high quality studies of the relevant measurement properties.
- Iqbal N, Machielsen AJHM, Kimman ML, Kane G, Woodcock R, Grossi U, et al. AFCOS: The Development of a Cryptoglandular Anal Fistula Core Outcome Set. Ann Surg. 2022 Jul;Jul 11:Epub ahead of print.
Round 2
Reviewer 3 Report
Can be accepted
