Evidence map›Paper›PMID 41313456›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2025

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.

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

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Beyond a single threshold: deepening the methodology for minimal important change in OIC prevention.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Takahiro HigashibataDepartment of Palliative and Supportive Care, Institute of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan. higashibata.takahiro.na@ms.hosp.tsukuba.ac.jp.
Shunsuke OyamadaDepartment of Biostatistics, Japanese Organisation for Research and Treatment of Cancer (JORTC) Data Center, Tokyo, Japan.
Jun HamanoDepartment of Palliative and Supportive Care, Institute of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.
Takaomi KessokuDepartment of Gastroenterology, International University Health and Welfare Graduate School of Medicine, Narita, Japan.
Tatsuya MoritaDepartment of Palliative and Supportive Care, Seirei Mikatahara General Hospital, Hamamatsu, Japan.
Takuhiro YamaguchiDivision of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.

Funding

Grant for Research Advancement on Palliative Medicine, Japanese Society for Palliative Medicine No. 192
6 · The paper itself

Abstract

purposeThe 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.

methodsMICs 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.

resultsA 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.

conclusionThe 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.

Indexed as

Analgesics, OpioidCancer PainConstipationOpioid-Induced ConstipationQuality of LifeAdultAgedFemaleHumansMaleMiddle AgedNaltrexoneSurveys and QuestionnairesAnalgesics, OpioidnaldemedineNaltrexoneCancer painMinimal important changeOpioid-induced constipationPAC-QOL

Identifiers

PMID41313456

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.