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The development of a new measure of quality of life in the management of gastro-oesophageal reflux disease: the Reflux questionnaire

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Abstract

Introduction

This paper reports on the development of a new measure of health-related quality of life for use among patients with gastro-oesophageal reflux disease (GORD), funded as part of the REFLUX trial. This is a large UK multi centre trial that aims to compare the clinical and cost effectiveness of minimal access surgery with best medical treatment for patients with GORD within the NHS.

Method

Potential items were identified via a series of interviews and focus groups carried out with patients who were receiving/had received medical or surgical treatment for GORD. The final measure consisted of 31 items covering 7 categories (Heartburn; Acid reflux; Wind; Eating and swallowing; Bowel movements; Sleep; Work, physical and social activities). The measure produced two outputs: a quality of life score (RQLS) and five Reflux symptom scores. Reliability (internal consistency), criterion validity with the SF-36 and, sensitivity to change in terms of relationship with reported change in prescribed medication were assessed amongst a sample of 794 patients recruited into the trial.

Results

The measure was shown to be internally consistent, to show criterion validity with the SF-36 and sensitive to changes in patients use of prescribed medication at baseline and 3 month follow-up.

Discussion

The Reflux questionnaire is a new self-administered questionnaire for use amongst patients with GORD. Initial findings suggest that the new measure is valid, reliable, acceptable to respondents and simple to administer in both a clinical and research context.

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Acknowledgements

We thank the NHS R&D Health Technology Assessment programme for grant support of the Reflux Trial. We also thank all who took part in this study and gave generously of their time and views. The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Executive Department of Health. The views expressed are the authors’, not necessarily the funders’.

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Correspondence to Susan Macran.

Appendices

Appendix: The Reflux Questionnaire

For the following questions, please put a cross in the box which best describes how often your symptoms have occurred and the effect they have had on your quality of life.

Section A – Heartburn

  1. A1.

    In the last 2 weeks, how often have you experienced heartburn (a burning sensation which moves up from your chest to your throat)?

    • \( \hbox{Not at all }\hskip 90pt \square\)

    • \( \hbox{Once a week }\hskip 78.5pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24pt \square\)

    • \( \hbox{Most days }\hskip 88pt \square\)

    • \( \hbox{Every day }\hskip 89pt \square\)

  2. A2.

    In the last 2 weeks, how often have you experienced any discomfort or pain in your chest?

    • \( \hbox{Not at all }\hskip 90pt \square\)

    • \( \hbox{Once a week }\hskip 79pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24.5pt \square\)

    • \( \hbox{Most days }\hskip 88pt \square\)

    • \( \hbox{Every day }\hskip 89pt \square\)

  3. A3.

    In the last 2 weeks, how much has the heartburn or discomfort/pain in your chest affected your quality of life?

    • \( \hbox{Not at all }\hskip 89.9pt \square\)

    • \( \hbox{A little } \hskip 100.9pt \square\)

    • \( \hbox{Moderately }\hskip 83.5pt \square\)

    • \( \hbox{A lot } \hskip 107.9pt \square\)

    • \( \hbox{Extremely }\hskip 89pt \square\)

Section B – Acid Reflux

  1. B1.

    In the last 2 weeks, how often have you experienced acid reflux and/or had an acid taste in your mouth?

    • \( \hbox{Not at all }\hskip 89.9pt \square\)

    • \( \hbox{Once a week }\hskip 78.8pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24pt \square\)

    • \( \hbox{Most days }\hskip 87.7pt \square\)

    • \( \hbox{Every day }\hskip 89.5pt \square\)

  2. B2.

    In the last 2 weeks, how often have you been sick (vomited)?

    • \( \hbox{Not at all }\hskip 90.1pt \square\)

    • \( \hbox{Once a week }\hskip 78.8pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24pt \square\)

    • \( \hbox{Most days }\hskip 87.7pt \square\)

    • \( \hbox{Every day }\hskip 90pt \square\)

  3. B3.

    In the last 2 weeks, how often have you regurgitated (brought up) quantities of liquid or solids into your mouth?

    • \( \hbox{Not at all }\hskip 90pt \square\)

    • \( \hbox{Once a week }\hskip 79pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24.5pt \square\)

    • \( \hbox{Most days }\hskip 88pt \square\)

    • \( \hbox{Every day }\hskip 89pt \square\)

  4. B4.

    In the last 2 weeks, how often have you experienced a feeling of nausea (without actually being sick or regurgitating)?

    • \( \hbox{Not at all }\hskip 91pt \square\)

    • \( \hbox{Once a week }\hskip 79.4pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24.5pt \square\)

    • \( \hbox{Most days }\hskip 87.9pt \square\)

    • \( \hbox{Every day }\hskip 89pt \square\)

  5. B5.

    In the last 2 weeks, how often have you wanted to be sick but physically been unable to?

    • \( \hbox{Not at all }\hskip 90.5pt \square\)

    • \( \hbox{Once a week }\hskip 79pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24.2pt \square\)

    • \( \hbox{Most days }\hskip 88pt \square\)

    • \( \hbox{Every day }\hskip 89pt \square\)

  6. B6.

    In the last 2 weeks, how much have these reflux symptoms affected your quality of life?

    • \( \hbox{Not at all }\hskip 90.5pt \square\)

    • \( \hbox{A little } \hskip 101.5pt \square\)

    • \( \hbox{Moderately }\hskip 84pt \square\)

    • \( \hbox{A lot } \hskip 108.8pt \square\)

    • \( \hbox{Extremely }\hskip 90pt \square\)

Section C – Wind

  1. C1.

    In the last 2 weeks, how often have you experienced a lot of wind from the lower bowel?

    • \( \hbox{Not at all }\hskip 90.5pt \square\)

    • \( \hbox{Once a week }\hskip 79pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24.2pt \square\)

    • \( \hbox{Most days }\hskip 88pt \square\)

    • \( \hbox{Every day }\hskip 90pt \square\)

  2. C2.

    In the last 2 weeks, how often have you experienced a lot of burping/belching?

    • \( \hbox{Not at all }\hskip 91pt \square\)

    • \( \hbox{Once a week }\hskip 79.8pt \square\)

    • \( \hbox{Two or three times a week }\hskip 25pt \square\)

    • \( \hbox{Most days }\hskip 87.7pt \square\)

    • \( \hbox{Every day }\hskip 89pt \square\)

  3. C3.

    In the last 2 weeks, how often have you experienced bloatedness and/or a feeling of trapped wind, in your stomach?

    • \( \hbox{Not at all }\hskip 90.5pt \square\)

    • \( \hbox{Once a week }\hskip 79pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24pt \square\)

    • \( \hbox{Most days }\hskip 87pt \square\)

    • \( \hbox{Every day }\hskip 88pt \square\)

  4. C4.

    In the last 2 weeks, how often have you experienced loud gurgling noises from your stomach?

    • \( \hbox{Not at all }\hskip 90pt \square\)

    • \( \hbox{Once a week }\hskip 78pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24.4pt \square\)

    • \( \hbox{Most days }\hskip 87pt \square\)

    • \( \hbox{Every day }\hskip 88pt \square\)

  5. C5.

    In the last 2 weeks, how much have these wind problems affected your quality of life?

    • \( \hbox{Not at all }\hskip 89pt \square\)

    • \( \hbox{A little } \hskip 100pt \square\)

    • \( \hbox{Moderately }\hskip 83pt \square\)

    • \( \hbox{A lot } \hskip 107pt \square\)

    • \( \hbox{Extremely }\hskip 88pt \square\)

Section D – Eating and Swallowing

  1. D1.

    In the last 2 weeks, how often have you experienced difficulty swallowing food or have you actually choked on food?

    • \( \hbox{Not at all }\hskip 90pt \square\)

    • \( \hbox{Once a week }\hskip 78pt \square\)

    • \( \hbox{Two or three times a week }\hskip 23pt \square\)

    • \( \hbox{Most days }\hskip 86.5pt \square\)

    • \( \hbox{Every day }\hskip 86.8pt \square\)

  2. D2.

    In the last 2 weeks, how often have your eating habits been restricted because of your condition? Examples might be eating more slowly, having smaller portions or eating different foods.

    • \( \hbox{Not at all }\hskip 88pt \square\)

    • \( \hbox{Once a week }\hskip 77.8pt \square\)

    • \( \hbox{Two or three times a week }\hskip 22pt \square\)

    • \( \hbox{Most days }\hskip 86.5pt \square\)

    • \( \hbox{Every day }\hskip 86.8pt \square\)

  3. D3.

    In the last 2 weeks, how much have these problems with eating affected your quality of life?

    • \( \hbox{Not at all }\hskip 87pt \square\)

    • \( \hbox{A little }\hskip 99pt \square\)

    • \( \hbox{Moderately }\hskip 82pt \square\)

    • \( \hbox{A lot } \hskip 105pt \square\)

    • \( \hbox{Extremely }\hskip 87pt \square\)

Section E – Bowel Movements

  1. E1.

    In the last 2 weeks, how often have you experienced diarrhoea and/or loose stools?

    • \( \hbox{Not at all }\hskip 88.4pt \square\)

    • \( \hbox{Once a week }\hskip 78pt \square\)

    • \( \hbox{Two or three times a week }\hskip 23pt \square\)

    • \( \hbox{Most days }\hskip 86.5pt \square\)

    • \( \hbox{Every day }\hskip 88pt \square\)

  2. E2.

    In the last 2 weeks, how often have you experienced constipation and/or hard stools?

    • \( \hbox{Not at all }\hskip 89pt \square\)

    • \( \hbox{Once a week }\hskip 78pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24pt \square\)

    • \( \hbox{Most days }\hskip 86.5pt \square\)

    • \( \hbox{Every day }\hskip 88pt \square\)

  3. E3.

    In the last 2 weeks, how often have you felt an urgent need to have a bowel movement ?

    • \( \hbox{Not at all }\hskip 88.5pt \square\)

    • \( \hbox{Once a week }\hskip 77.8pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24pt \square\)

    • \( \hbox{Most days }\hskip 86.5pt \square\)

    • \( \hbox{Every day }\hskip 88pt \square\)

  4. E4.

    In the last 2 weeks, how often have you had a feeling of not emptying your bowels?

    • \( \hbox{Not at all }\hskip 89pt \square\)

    • \( \hbox{Once a week }\hskip 78pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24pt \square\)

    • \( \hbox{Most days }\hskip 86.5pt \square\)

    • \( \hbox{Every day }\hskip 88pt \square\)

  5. E5.

    In the last 2 weeks, how much have these bowel problems affected your quality of life?

    • \( \hbox{Not at all }\hskip 89pt \square\)

    • \( \hbox{A little } \hskip 100pt \square\)

    • \( \hbox{Moderately }\hskip 82pt \square\)

    • \( \hbox{A lot } \hskip 106.5pt \square\)

    • \( \hbox{Extremely }\hskip 88pt \square\)

Section F – Sleep

  1. F1.

    In the last 2 weeks, how often have you experienced difficulty in lying down to sleep?

    • \( \hbox{Not at all }\hskip 88.85pt \square\)

    • \( \hbox{Once a week }\hskip 77.7pt \square\)

    • \( \hbox{Two or three times a week }\hskip 23pt \square\)

    • \( \hbox{Most nights }\hskip 80.7pt \square\)

    • \( \hbox{Every night }\hskip 82pt \square\)

  2. F2.

    In the last 2 weeks, how often have you experienced difficulty getting to sleep because of your reflux symptoms?

    • \( \hbox{Not at all }\hskip 88.5pt \square\)

    • \( \hbox{Once a week }\hskip 77pt \square\)

    • \( \hbox{Two or three times a week }\hskip 22.5pt \square\)

    • \( \hbox{Most nights }\hskip 80pt \square\)

    • \( \hbox{Every night }\hskip 81.4pt \square\)

  3. F3.

    In the last 2 weeks, how often have you been woken up because of your reflux symptoms?

    • \( \hbox{Not at all }\hskip 89pt \square\)

    • \( \hbox{Once a week }\hskip 78pt \square\)

    • \( \hbox{Two or three times a week }\hskip 24pt \square\)

    • \( \hbox{Most nights }\hskip 81pt \square\)

    • \( \hbox{Every night }\hskip 83pt \square\)

  4. F4.

    In the last 2 weeks, how much have these sleep related problems affected your quality of life?

    • \( \hbox{Not at all }\hskip 89pt \square\)

    • \( \hbox{A little } \hskip 100pt \square\)

    • \( \hbox{Moderately }\hskip 83pt \square\)

    • \( \hbox{A lot } \hskip 107pt \square\)

    • \( \hbox{Extremely }\hskip 88pt \square\)

Section G – Work, Physical and Social Activities

For the following section, please put a cross in the box which best applies to you.

  1. G1.

    In the last 2 weeks, have your reflux symptoms affected you at work (paid or voluntary)?

    • \( \hbox{Not applicable (I do not do} \quad \hskip 1pt \hbox{paid or voluntary work) }\hskip 33pt \square\)

    • \( \hbox{No, my symptoms} \quad \hskip 1pt \hbox{do}\ \hbox{not affect me }\hskip 62.5pt \square\)

    • \( \hbox{Yes, my symptoms have} \quad \hskip 1pt \hbox{affected me but I still work }\hskip 20.7pt \square\)

    • \( \hbox{Yes, I have worked less often} \quad \hskip 1pt \hbox{because of my symptoms }\hskip 29.5pt \square\)

    • \( \hbox{Yes, I have not worked in the} \quad \hskip 1pt \hbox{last 2\,weeks because} \quad \hskip 1pt \hbox{of my symptoms }\hskip 59pt \square\)

    • \( \hbox{I no longer work} \quad \hskip 1pt \hbox{because of my symptoms }\hskip 29pt \square\)

  2. G2.

    In the last 2 weeks, have your reflux symptoms affected your ability to perform less strenuous activities (such as going for a gentle walk, shopping or housework)?

    • \( \hbox{Not applicable (I do not perform } \quad \hskip 1pt \hbox{these activities, though this} \quad \hskip 1pt \hbox{is not due to my} \quad \hskip 1pt \hbox{reflux symptoms) }\hskip 74pt \square\)

    • \( \hbox{No, my symptoms do not} \quad \hskip 1pt \hbox{affect me } \hskip 108.5pt \square\)

    • \( \hbox{Yes, my symptoms have} \quad \hskip 1pt \hbox{affected} \hbox{me but I still perform these} \quad \hskip 1pt \hbox{activities as often as ever }\hskip 50pt \square\)

    • \( \hbox{Yes, I perform these activities} \quad \hskip 1pt \hbox{less often because of my symptoms } \hskip 10pt \square\)

    • \( \hbox{Yes, I have not performed} \quad \hskip 1pt \hbox{these activities in the last two weeks }\hskip 6pt \square\)

    • \( \hbox{I no longer perform these activities} \quad \hskip 1pt \hbox{at all because of my symptoms }\hskip 26pt \square\)

  3. G3.

    In the last 2 weeks, have your reflux symptoms affected your ability to perform strenuous activities (such as brisk walking or swimming)?

    • \( \hbox{Not applicable (I do not perform} \quad \hskip 1pt \hbox{these activities, though this is not} \quad \hskip 1pt \hbox{due to my reflux symptoms) }\hskip 37.5pt \square\)

    • \( \hbox{No, my symptoms do not affect me }\hskip 9.6pt \square\)

    • \( \hbox{Yes, my symptoms have affected} \quad \hskip 1pt \hbox{me but I still perform these activities} \quad \hskip 1pt \hbox{as often as ever }\hskip 86.7pt \square\)

    • \( \hbox{Yes, I perform these activities} \quad \hskip 1pt \hbox{less often because of my symptoms } \hskip 11pt \square\)

    • \( \hbox{Yes, I have not performed} \quad \hskip 1pt \hbox{these activities in the last two weeks }\hskip 07pt \square\)

    • \( \hbox{I no longer perform these activities} \quad \hskip 1pt \hbox{ at all because of my symptoms }\hskip 24pt \square\)

  4. G4.

    In the last 2 weeks, have you found that your reflux symptoms have affected any of your social activities (such as going out for meals, going out for drinks or socialising with other people)?

    • \( \hbox{Not applicable (I do not perform these} \quad \hskip 1pt \hbox{activities, though this is} \quad \hskip 1pt \hbox{not due to my reflux symptoms) }\hskip 20pt \square\)

    • \( \hbox{No, my symptoms do not affect me }\hskip 8pt \square\)

    • \( \hbox{Yes, my symptoms have affected} \quad \hskip 1pt \hbox{me but I still perform these} \quad \hskip 1pt \hbox{activities as often as ever }\hskip 50pt \square\)

    • \( \hbox{Yes, I perform these activities} \quad \hskip 1pt \hbox{less often because of my symptoms } \hskip 10pt \square\)

    • \( \hbox{Yes, I have not performed these activities} \quad \hskip 1pt \hbox{in the last two weeks }\hskip 65pt \square\)

    • \( \hbox{I no longer perform these} \quad \hskip 1pt \hbox{activities at all because of} \quad \hskip 1pt \hbox{my symptoms }\hskip 92pt \square\)

  5. G5.

    In the last 2 weeks, how much has the effect of your symptoms on your work, physical or social activities affected your quality of life?

    • \( \hbox{Not at all } \hskip 110pt \square\)

    • \( \hbox{A little } \hskip 121pt \square\)

    • \( \hbox{Moderately } \hskip 103pt \square\)

    • \( \hbox{A lot } \hskip 127.5pt \square\)

    • \( \hbox{Extremely } \hskip 110pt \square\)

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Macran, S., Wileman, S., Barton, G. et al. The development of a new measure of quality of life in the management of gastro-oesophageal reflux disease: the Reflux questionnaire. Qual Life Res 16, 331–343 (2007). https://doi.org/10.1007/s11136-006-9005-3

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