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Purpose <p>The Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire&#xa0;measures constipation-specific quality of life; however, how small changes in the PAC-QOL scales are clinically meaningful for the prevention of opioid-induced constipation (OIC) is unknown. This study aimed to determine the minimal important change (MIC) of the PAC-QOL scales for the prevention of OIC in patients initiating opioids for cancer pain.</p> Methods <p>MICs were calculated using data from a multicenter, randomized controlled trial of naldemedine for OIC prevention. MICs for the PAC-QOL overall scale and satisfaction subscale scores were calculated using an anchor-based method with two anchors, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL) constipation scale and the Bowel Function Index (BFI), as well as a distribution-based method.</p> Results <p>A total of 77 patients were analyzed. The optimal cut-points for the MICs in the overall scale and satisfaction subscale based on two anchors were 0.14 and 0.20 for the QLQ-C15-PAL and 0.41 and 1.80 for the BFI, respectively. A 0.5 standard deviation and 1 standard error of measurement for the PAC-QOL were 0.26 and 0.22 for the overall scale and 0.46 and 0.53 for the satisfaction subscale, respectively.</p> Conclusion <p>The MIC values for the PAC-QOL scales for OIC prevention ranged from 0.14 to 0.41 for the overall scale and from 0.20 to 1.80 for the satisfaction subscale. These findings enable the assessment of the preventive effect of interventions for OIC in patients initiating opioids for cancer pain.</p>

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Establishing the minimal important change for Patient Assessment of Constipation Quality of Life questionnaire for the prevention of opioid-induced constipation in patients with cancer pain

  • 期刊论文

  • 发表日期：

    2025年11月28日

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  • Takahiro Higashibata,
  • Shunsuke Oyamada,
  • Jun Hamano,
  • Takaomi Kessoku,
  • Tatsuya Morita,
  • Takuhiro Yamaguchi

摘要

Purpose

The Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire measures constipation-specific quality of life; however, how small changes in the PAC-QOL scales are clinically meaningful for the prevention of opioid-induced constipation (OIC) is unknown. This study aimed to determine the minimal important change (MIC) of the PAC-QOL scales for the prevention of OIC in patients initiating opioids for cancer pain.

Methods

MICs were calculated using data from a multicenter, randomized controlled trial of naldemedine for OIC prevention. MICs for the PAC-QOL overall scale and satisfaction subscale scores were calculated using an anchor-based method with two anchors, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL) constipation scale and the Bowel Function Index (BFI), as well as a distribution-based method.

Results

A total of 77 patients were analyzed. The optimal cut-points for the MICs in the overall scale and satisfaction subscale based on two anchors were 0.14 and 0.20 for the QLQ-C15-PAL and 0.41 and 1.80 for the BFI, respectively. A 0.5 standard deviation and 1 standard error of measurement for the PAC-QOL were 0.26 and 0.22 for the overall scale and 0.46 and 0.53 for the satisfaction subscale, respectively.

Conclusion

The MIC values for the PAC-QOL scales for OIC prevention ranged from 0.14 to 0.41 for the overall scale and from 0.20 to 1.80 for the satisfaction subscale. These findings enable the assessment of the preventive effect of interventions for OIC in patients initiating opioids for cancer pain.