Background <p>The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) questionnaire is a patient-reported outcome measure designed to assess pulmonary arterial hypertension (PAH) symptoms and impacts in clinical trials. It includes recall periods of 24&#xa0;h for symptoms and 7&#xa0;days for impacts. The PAH-SYMPACT for use in Clinical Practice (SYMPACT-CP) is an adaptation of the PAH-SYMPACT in which the recall period for symptoms has been revised to 7&#xa0;days, a timeframe more appropriate for clinical practice settings. The PAH-SYMPACT was psychometrically validated previously. As such, this study focused on assessing whether patients with PAH can use the SYMPACT-CP appropriately to rate their symptoms over the 7-day range, and it explored their perspectives on the utility and feasibility of completing the questionnaire as part of routine clinical assessments.</p> Methods <p>This was a cross-sectional, noninterventional, qualitative study involving one-on-one telephone interviews with English-speaking adults (≥ 18&#xa0;years) living in the US diagnosed with PAH. Participants were provided copies of the SYMPACT-CP to review, and interviews were subsequently conducted using a semi-structured guide including concept elicitation and cognitive interviewing sections. Transcripts were coded using a coding framework based on the interview guide.</p> Results <p>Fifteen participants were interviewed (mean age, 49.9&#xa0;years; <i>n</i> = 13 female, <i>n</i> = 13 White). Most (<i>n</i> = 12) stated that they thought about the last 7 calendar days or the “last week” when asked to interpret the 7-day recall period and all but one (<i>n</i> = 14) could easily remember their symptoms over this period. All 15 participants reported that it would be easy to fill out the SYMPACT-CP prior to a clinic visit with their physician or other healthcare provider (HCP), and most (<i>n</i> = 14) felt it would be useful in the management of their disease. Participants felt that breathing difficulties (<i>n</i> = 11), followed by swelling (<i>n</i> = 4), feeling lightheaded, dizzy, or faint (<i>n</i> = 3), and heart palpitations/heart fluttering (<i>n</i> = 3) were the most important symptoms to share with their HCPs.</p> Conclusions <p>The SYMPACT-CP is valid to assess symptoms and impacts of PAH in clinical practice. Compared with the PAH-SYMPACT, it provides a consistent 7-day recall period for symptoms and impacts and may improve symptom monitoring and disease management during clinical appointments.</p>

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Validation of the Pulmonary Arterial Hypertension-Symptoms and Impact for Clinical Use (SYMPACT-CP): a qualitative interview study

  • Stacy Davis,
  • Anne Skalicky,
  • Amélie Beaudet,
  • Bjorn Bayer,
  • Leah Kleinman

摘要

Background

The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) questionnaire is a patient-reported outcome measure designed to assess pulmonary arterial hypertension (PAH) symptoms and impacts in clinical trials. It includes recall periods of 24 h for symptoms and 7 days for impacts. The PAH-SYMPACT for use in Clinical Practice (SYMPACT-CP) is an adaptation of the PAH-SYMPACT in which the recall period for symptoms has been revised to 7 days, a timeframe more appropriate for clinical practice settings. The PAH-SYMPACT was psychometrically validated previously. As such, this study focused on assessing whether patients with PAH can use the SYMPACT-CP appropriately to rate their symptoms over the 7-day range, and it explored their perspectives on the utility and feasibility of completing the questionnaire as part of routine clinical assessments.

Methods

This was a cross-sectional, noninterventional, qualitative study involving one-on-one telephone interviews with English-speaking adults (≥ 18 years) living in the US diagnosed with PAH. Participants were provided copies of the SYMPACT-CP to review, and interviews were subsequently conducted using a semi-structured guide including concept elicitation and cognitive interviewing sections. Transcripts were coded using a coding framework based on the interview guide.

Results

Fifteen participants were interviewed (mean age, 49.9 years; n = 13 female, n = 13 White). Most (n = 12) stated that they thought about the last 7 calendar days or the “last week” when asked to interpret the 7-day recall period and all but one (n = 14) could easily remember their symptoms over this period. All 15 participants reported that it would be easy to fill out the SYMPACT-CP prior to a clinic visit with their physician or other healthcare provider (HCP), and most (n = 14) felt it would be useful in the management of their disease. Participants felt that breathing difficulties (n = 11), followed by swelling (n = 4), feeling lightheaded, dizzy, or faint (n = 3), and heart palpitations/heart fluttering (n = 3) were the most important symptoms to share with their HCPs.

Conclusions

The SYMPACT-CP is valid to assess symptoms and impacts of PAH in clinical practice. Compared with the PAH-SYMPACT, it provides a consistent 7-day recall period for symptoms and impacts and may improve symptom monitoring and disease management during clinical appointments.