Evidence map›Paper›PMID 33865400›Full record

ArticleHealth and quality of life outcomes2021

Validity and responsiveness of EQ-5D-5L and SF-6D in patients with health complaints attributed to their amalgam fillings: a prospective cohort study of patients undergoing amalgam removal.

Admassu N Lamu, Lars Björkman, Harald J Hamre, Terje Alræk, Frauke Musial, Bjarne Robberstad

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Health and quality of life outcomes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01682278 (Amalgam Removal in Patients With Health Complaints Attributed to Amalgam Restorations), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
5.6field-weighted citation impact, top 4% of its field
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.

NCT01682278 completednot on this map

Amalgam Removal in Patients With Health Complaints Attributed to Amalgam Restorations: A Prospective Cohort Study

TypeobservationalSponsorNORCE Norwegian Research Centre ASRan2012 to 2021Enrolled118ConditionsHealth Complaints Attributed to Dental Amalgam RestorationsArmsRemoval of dental amalgam restorations
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. A systematic review of minimum important changes for generic multi-attribute utility instruments and recommendations for their estimation.The European journal of health economics : HEPAC : health economics in prevention and care · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Admassu N LamuSection for Ethics and Health Economics, Department of Global Public Health and Primary Care, Faculty of Health Sciences, University of Bergen, 5020, Bergen, Norway. admassu.lamu@uib.no.ORCID http://orcid.org/0000-0001-6638-421X
Lars BjörkmanDental Biomaterials Adverse Reaction Unit, NORCE Norwegian Research Centre AS, Bergen, Norway.
Harald J HamreInstitute for Applied Epistemology and Medical Methodology, University of Witten/Herdecke, Freiburg, Germany.
Terje AlrækNational Research Center in Complementary and Alternative Medicine, NAFKAM, Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.
Frauke MusialNational Research Center in Complementary and Alternative Medicine, NAFKAM, Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.
Bjarne RobberstadSection for Ethics and Health Economics, Department of Global Public Health and Primary Care, Faculty of Health Sciences, University of Bergen, 5020, Bergen, Norway.
UiT The Arctic University of Norway · NOUniversity of Bergen · NONORCE Research AS · NOWitten/Herdecke University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEvidence of health utility changes in patients who suffer from longstanding health complaints attributed to dental amalgam fillings are limited. The change in health utility outcomes enables calculating quality-adjusted life-year (QALY) and facilitates the comparison with other health conditions. The purpose of this study was to estimate the validity and responsiveness of the EQ-5D-5L and SF-6D utilities following removal of dental amalgam fillings in patients with health complaints attributed to their amalgam fillings, and examine the ability of these instruments to detect minimally important changes over time.

methodsPatients with medically unexplained physical symptoms, which they attributed to dental amalgam restorations, were recruited to a prospective cohort study in Norway. Two health state utility instruments, EQ-5D-5L and SF-6D, as well as self-reported general health complaints (GHC-index) and visual analogue scale (EQ-VAS) were administered to all patients (n = 32) at baseline and at follow-up. The last two were used as criteria measures. Concurrent and predictive validities were examined using correlation coefficients. Responsiveness was assessed by the effect size (ES), standardized response mean (SRM), and relative efficiency. Minimally important change (MIC) was examined by distribution and anchor-based approaches.

resultsConcurrent validity of the EQ-5D-5L was similar to that of SF-6D utility. EQ-5D-5L was more responsive than SF-6D: the ES were 0.73 and 0.58 for EQ-5D-5L and SF-6D, respectively; SRM were 0.76 and 0.67, respectively. EQ-5D-5L was more efficient than SF-6D in detecting changes, but both were less efficient compared to criteria-based measures. The estimated MIC of EQ-5D-5L value set was 0.108 and 0.118 based on distribution and anchor-based approaches, respectively. The corresponding values for SF-6D were 0.048 and 0.064, respectively.

conclusionsIn patients with health complaints attributed to dental amalgam undergoing amalgam removal, both EQ-5D-5L and SF-6D showed reasonable concurrent and predictive validity and acceptable responsiveness. The EQ-5D-5L utility appears to be more responsive compared to SF-6D. Trial registration The research was registered at ClinicalTrials.gov., NCT01682278. Registered 10 September 2012, https://clinicaltrials.gov/ct2/show/NCT01682278 .

Indexed as

Health Status IndicatorsQuality of LifeAdultAgedChronic PainCohort StudiesDental AmalgamFemaleHumansMaleMercuryMiddle AgedNorwayProspective StudiesPsychometricsSurveys and QuestionnairesDental AmalgamMercuryEQ-5D-5LMinimally important changeResponsivenessSF-6DUtilityValidity

Identifiers

PMID33865400
PMCPMC8052827
OpenAlexW3154834401

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.