A lot depends on how much prior research has been done in your area. If you are looking at a well studied area, such as patient satisfaction or quality of life, then you may well be able to adapt existing questionnaires without patient input. Alternatively, if you are looking something that is condition-specific or that applies to a unique group of patients, then it would be highly advisable to get their input.

Hello Ankur Sharma,

I think you would like to read this paper written by Tsang, Royse, and Terkawi (2017).

Hope this can help,

Best,

Riangga

Article Guidelines for developing, translating, and validating a que...

Hi Riangga,

Thanks for the nice article provided by you. I also wanted to know that is it fine to make a research group and let them formulate the item pool. or is it important that the item pool be collected through thematic analysis of interviews or focus groups of the patients?

Regards.

Ankur.

Hello Ankur,

In my humble opinion, i think it wouldn't be a problem if only the researcher formulate the item pool that would be included in the questionnaire.

But, in the other hands. Including the patients i think would provide useful information and enrich the list on the item pool.

So, if possible.. i would suggest you to develop the questionnaire using the second choice, because you'll get a better understanding about patients' experience.

Best,

Riangga.

The quality of a questionnaire you’re constructing will - in the end - depend in part upon the quality of items you initially generate.  For example, a factor analysis can not show a dimension if you don’t have items that tap the dimension.  You’ll have trouble interpreting the results if a question confuses participants or is interpreted differently by different participants.  It’s certainly not necessary to have those from the population of participants help you generate items.  But it could be helpful.  For example, it could help you find wording that’s more like how your participants ‘speak’ rather than having jargon.  I’m not a medical doctor, so I don’t have experience asking patients.  But I study children’s development and it’s definitely been helpful when kids and teens have told me their ideas in their own words, that I’ve been able to structure as items on questionnaires.  Best wishes designing your instrument, Ankur. ~ Kevin

Thanks Kevin. I am being increasingly convinced that population participation in item generation is not necessary as long as the constructs can be confirmed. However, defining these constructs explicitly and through scientific evidence should invariably be an important part of questionnaire development.

Hello Ankur,

I think that Kevin Grobman provides some really helpful advice above. In my experience, an academic research group could well not be aware of some aspects of a topic that patients themselves experience or find important. In fact, I think that it demonstrates a degree of arrogance when some people assume they know how others think. Also, as Kevin suggests, it is good to reflect the language of prospective participants. That could be particularly important for such things as participant rapport and, ultimately, the quality of the data that are collected.

I would consider getting perspectives from as many groups as might be able to offer relevant insights: a research group, a patient group, a provider group . . .

All the best with your research,

Robert.

Hi Robert,

Thanks for guiding. Even I am of an opinion that patient experience and guidance should be paramount in item generation for patient perception questionnaire. However, is there any document, guideline or research paper that recommends patient participation as a preferred method of item generation?

Thanks.

Ankur

Hello again, Ankur, Sorry, but offhand I can't think of a REALLY good reference for you that would be extra pertinent, but here are some quick thoughts. Last year, a former student of mine contacted me with a catch-up hello (about 15 years since I had taught her), and told me she was in now in England doing her PhD with women who had cancer. She said that she gained all kinds of insights from those women that she was completely unable to acquire from her academic colleagues. That was what prompted me to write my response to you above.

I think that the article that Riangga has suggested to you in the first response up above might have some good ideas in it, and about 10 years ago I wrote an article about instrument development in the area of podiatry that might be of some help, particularly because it has a "medical slant". It was published in the Journal of the American Podiatric Medical Association in 2009 under my name. I think that copyright restrictions prevent me from putting a copy on ResearchGate, but if you email me at my personal address ([email protected]) I could probably send you a PDF copy with that being above board.

One other thing: I think that there are a number of good books dealing with survey design that could be useful for you. I have included some of them in the reference list of my article above. One of them is the following:

ADAY LA, CORNELIUS LJ: Designing and Conducting Health Surveys: A Comprehensive Guide, 3rd Ed, Jossey

Bass, San Francisco, 2006.

I hope that's helpful. Email me if you would like to check out the possibility of me sending you a copy of my article.

Robt.

Thanks Robert, for the immense help that you are providing me. I have emailed you a request for the article. I appreciate you sharing your thoughts.

Regards.

Ankur

Hi Ankur,

The American Food and Drug Administration (FDA) released guidelines for PRO construction in 2009. They suggest that patient input should be used for item generation. I agree with Robert and his ex-student that it is difficult to guess what patient's are going to say about their experiences and it is good to ask them.

The guidelines can be found here:

https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf

I hope this is helpful,

Joe.

Yes it is important to involve patients for item generation. Depending upon the nature and type of illness you can perform individual interviews or focus group. Because sometimes in focus group the suggestibility factor is high. But it is very important to add patient's perspective.

A lot depends on how much prior research has been done in your area. If you are looking at a well studied area, such as patient satisfaction or quality of life, then you may well be able to adapt existing questionnaires without patient input. Alternatively, if you are looking something that is condition-specific or that applies to a unique group of patients, then it would be highly advisable to get their input.

Thanks Dr. Morgan for the new insight. I feel that your answer clarifies many things regarding need of patient involvement in item generation. However, even though patient perceptions about satisfaction and quality of life have been extensively researched, is it still possible that patient satisfaction and quality of life constructs depend on entirely different factors for a new healthcare process or a product, that has not been researched before? Because if it is so, then patient involvement for such a measure should becomes imperative!?

Dear Najam,

Thanks for your answer. Among interview and focus groups, is some method more advantageous over the other? Or is there any evidence that if both are to be used, which one should succeed the other? Like interview before focus groups?

Thanks.

Ankur.