Methodological Quality of PROMs in Psychosocial Consequences of Colorectal Cancer Screening: A Systematic Review

Gram, Emma Grundtvig; Rogvi, Jessica á; Agerbeck, Anders Heiberg; Martiny, Frederik; Bie, Anne Katrine Lykke; Brodersen, John

doi:10.2147/prom.s394247

Cited by 4 publications

(4 citation statements)

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“…Future research could perform a more rigorous examination of the quality of questionnaire measures identified by the present review through application of the COSMIN Risk of Bias tool, as has been done in comparable and relevant research in the colorectal cancer screening field. 36 There is need to bring together experts (academic, public, patient, healthcare professional) in cancer screening harms, emotional processing, and scale measurement methodology to reach agreement on what to measure (outcomes) and how to measure it (outcome measures). 31 Existing relevant psychological theories could be utilised, such as those related to emotional response and processing (e.g.…”

Section: Discussionmentioning

confidence: 99%

“…While appropriate guidelines were used to inform the specific psychometric properties by which outcome questionnaire measures were characterised, we did not undertake an assessment of the methodological quality of questionnaires, as is advocated by COSMIN. Future research could perform a more rigorous examination of the quality of questionnaire measures identified by the present review through application of the COSMIN Risk of Bias tool, as has been done in comparable and relevant research in the colorectal cancer screening field 36 …”

Section: Discussionmentioning

confidence: 99%

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Emotion constructs and outcome measures following false positive breast screening test results: A systematic review of reporting clarity and selection rationale

Long,

Hindmarch,

Martindale

et al. 2024

Psycho-Oncology

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Objective(i) To systematically identify constructs and outcome measures used to assess the emotional and mood impact of false positive breast screening test results; (ii) to appraise the reporting clarity and rationale for selecting constructs and outcome measures.MethodsDatabases (MEDLINE, CINAHL, PsycINFO) were systematically searched from 1970. Studies using standardised and non‐standardised outcome measures to evaluate the emotion or mood impact of false positive breast screening test results were eligible. A 15‐item coding scheme was devised to appraise articles on clarity and rationale for selected constructs and measures.ResultsForty‐seven articles were identified. The most investigated constructs were general anxiety and depression and disease‐specific anxiety and worry. Twenty‐two standardised general outcome questionnaire measures and three standardised disease‐specific outcome questionnaire measures were identified. Twenty articles used non‐standardised scales/items. Reporting of constructs and outcome measures was generally clear, but rationales for their selection were lacking. Anxiety was typically justified, but justification for depression was almost always absent. Practical and psychometric justification for selecting outcome measures was lacking, and theoretical rationale was absent.ConclusionsHeterogeneity in constructs and measures, coupled with unclear rationale for these, impedes a thorough understanding of why there are emotional effects of false positive screening test results. This may explain the repeated practice of investigating less relevant outcomes such as depression. There is need to develop a consensual conceptual model of and standardised approach to measuring emotional impact from cancer screening test results, to address heterogeneity and other known issues of interpreting an inconsistent evidence base.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Emotion constructs and outcome measures following false positive breast screening test results: A systematic review of reporting clarity and selection rationale

Long,

Hindmarch,

Martindale

et al. 2024

Psycho-Oncology

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“…The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist was developed to evaluate the quality of Patient-Reported Outcome Measures (PROMs) in systematic reviews [ 19 ]. A systematic review assessing quality of PROMs in the evaluation of psychosocial consequences in colorectal cancer reported that 90% of PROMs lacked content validity according to the COSMIN checklist [ 20 ].…”

Section: Introductionmentioning

confidence: 99%

Validation of the psychosocial consequences of screening in lung cancer questionnaire in the international lung screen trial Australian cohort

Bonney,

Brodersen,

Siersma

et al. 2024

Health Qual Life Outcomes

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Background Evaluation of psychosocial consequences of lung cancer screening with LDCT in high-risk populations has generally been performed using generic psychometric instruments. Such generic instruments have low coverage and low power to detect screening impacts. This study aims to validate an established lung cancer screening-specific questionnaire, Consequences Of Screening Lung Cancer (COS-LC), in Australian-English and describe early results from the baseline LDCT round of the International Lung Screen Trial (ILST). Methods The Danish-version COS-LC was translated to Australian-English using the double panel method and field tested in Australian-ILST participants to examine content validity. A random sample of 200 participants were used to assess construct validity using Rasch item response theory models. Reliability was assessed using classical test theory. The COS-LC was administered to ILST participants at prespecified timepoints including at enrolment, dependent of screening results. Results Minor linguistic alterations were made after initial translation of COS-LC to English. The COS-LC demonstrated good content validity and adequate construct validity using psychometric analysis. The four core scales fit the Rasch model, with only minor issues in five non-core scales which resolved with modification. 1129 Australian-ILST participants were included in the analysis, with minimal psychosocial impact observed shortly after baseline LDCT results. Conclusion COS-LC is the first lung cancer screening-specific questionnaire to be validated in Australia and has demonstrated excellent psychometric properties. Early results did not demonstrate significant psychosocial impacts of screening. Longer-term follow-up is awaited and will be particularly pertinent given the announcement of an Australian National Lung Cancer Screening Program. Trial registration NCT02871856.

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“…Colorectal Cancer Screening (CRCS) can, like any other screening program, cause unintended harm, including physical and psychosocial harm [ 1 , 2 ]. Evidence has shown that the categorization of the unintended harms of CRCS lacks consensus [ 3 ]. However, there is an agreement that the most serious type of harm in CRCS is physical harms [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

The risk of bleeding and perforation from sigmoidoscopy or colonoscopy in colorectal cancer screening: A systematic review and meta-analyses

Kindt,

Martiny,

Gram

et al. 2023

PLoS ONE

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Introduction Physical harm from Colorectal Cancer Screening tends to be inadequately measured and reported in clinical trials. Also, studies of ongoing Colorectal Cancer Screening programs have found more frequent and severe physical harm from screening procedures, e.g., bleeding and perforation, than reported in previous trials. Therefore, the objectives of the study were to systematically review the evidence on the risk of bleeding and perforation in Colorectal Cancer Screening. Design Systematic review with descriptive statistics and random-effects meta-analyses. Methods We systematically searched five databases for studies investigating physical harms related to Colorectal Cancer Screening. We assessed the internal and the external validity using the ROBINS-I tool and the GRADE approach. Harm estimates was calculated using mixed Poisson regression models in random-effect meta-analyses. Results We included 89 studies. Reporting and measurement of harms was inadequate in most studies. In effect, the risk of bias was critical in 97.3% and serious in 98.3% of studies. All GRADE ratings were very low. Based on severe findings with not-critical risk of bias and 30 days follow-up, the risk of bleedings per 100,000 people screened were 8 [2;24] for sigmoidoscopy, 229 [129;408] for colonoscopy following fecal immunochemical test, 68 [39;118] for once-only colonoscopy, and 698 [443;1045] for colonoscopy following any screening tests. The risk of perforations was 88 [56;138] for colonoscopy following fecal immunochemical test and 53 [25;112] for once-only colonoscopy. There were no findings within the subcategory severe perforation with long-term follow-up for colonoscopy following any screening tests and sigmoidoscopy. Discussion Harm estimates varied widely across studies, reporting and measurement of harms was mostly inadequate, and the risk of bias and GRADE ratings were very poor, collectively leading to underestimation of harm. In effect, we consider our estimates of perforation and bleeding as conservative, highlighting the need for better reporting and measurement in future studies. Trial registration PROSPERO registration number: CRD42017058844.

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Methodological Quality of PROMs in Psychosocial Consequences of Colorectal Cancer Screening: A Systematic Review

Cited by 4 publications

References 71 publications

Emotion constructs and outcome measures following false positive breast screening test results: A systematic review of reporting clarity and selection rationale

Emotion constructs and outcome measures following false positive breast screening test results: A systematic review of reporting clarity and selection rationale

Validation of the psychosocial consequences of screening in lung cancer questionnaire in the international lung screen trial Australian cohort

The risk of bleeding and perforation from sigmoidoscopy or colonoscopy in colorectal cancer screening: A systematic review and meta-analyses

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