Evidence on the measurement properties of health-related quality of life instruments is largely missing in patients with low back pain: A systematic review
Open accessAbstract
OBJECTIVE To synthesize the measurement properties of six health-related quality of life instruments (Short Form 36 [SF-36], Short Form 12 [SF-12], EuroQol 5D-3L [EQ-5D-3L], EuroQol 5D-5L [EQ-5D-5L], Nottingham Health Profile (NHP), and Patient-Reported Outcome Measurement Information System Global Health [PROMIS-GH-10]) in patients with low back pain (LBP). STUDY DESIGN AND SETTING Six electronic databases (MEDLINE, EMBASE, CINAHL, PsycINFO, SportDiscus, and Google Scholar) were searched (July 2017). Studies assessing any measurement property in nonspecific LBP patients were included. Two reviewers independently screened the articles and assessed the risk of bias (COSMIN checklist). Consensus-based criteria were used to rate measurement properties results as sufficient, insufficient, or inconsistent; a modified GRADE approach was adopted for evidence synthesis. RESULTS High quality evidence was found for insufficient construct validity of SF-36 summary scores, and EQ-5D-3L utility and visual analogue scale scores. Moderate evidence was found for sufficient construct validity of SF-12 physical summary score and inconsistent responsiveness of EQ-5D-3L utility score. Very low quality evidence was found on each instrument's content validity; very low to low evidence underpinned the other assessed measurement properties. EQ-5D-5L, NHP and PROMIS Global Health-10 were not evaluated in LBP patients. CONCLUSION Documentation of the measurement properties of health-related quality of life instruments in LBP is incomplete. Future clinimetric studies should prioritize content validity.
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Written from the paper’s full text.
TL;DR
This systematic review found that measurement properties of health-related quality of life instruments in low back pain are largely understudied, with very low quality evidence for content validity across six instruments. High-quality evidence indicated insufficient construct validity for SF-36 summary scores and EQ-5D-3L utility/VAS scores, while EQ-5D-5L, NHP, and PROMIS-GH-10 had little or no LBP-specific evaluation.
Key findings
- From 4,809 records, 95 full texts were retrieved, 26 were eligible, and 9 more were found by citation tracking, yielding 35 included studies; 17 reported instrument development and 18 assessed other measurement properties.
- High quality evidence showed insufficient construct validity for SF-36 physical and mental summary scores and for EQ-5D-3L utility and visual analogue scale scores.
- Moderate evidence showed sufficient construct validity for the SF-12 physical summary score and inconsistent responsiveness for the EQ-5D-3L utility score; content validity for each instrument was supported by very low quality evidence.
- The abstract reports EQ-5D-5L, NHP, and PROMIS-GH-10 were not evaluated in LBP patients; the results note one NHP construct validity study in which 37 of 48 hypotheses were met (77%), with low quality evidence.
Methods
- Systematic review conducted according to COSMIN guidance and PRISMA, with a protocol registered in PROSPERO (CRD42015020021).
- Six electronic databases (MEDLINE, EMBASE, CINAHL, PsycINFO, SportDiscus, Google Scholar) were searched in July 2017; studies were included if they assessed a measurement property in adults with nonspecific LBP or samples with at least 75% nonspecific LBP.
- Two reviewers independently screened studies and assessed risk of bias with the COSMIN checklist; consensus-based criteria rated results as sufficient, insufficient, or inconsistent, and a modified GRADE approach rated quality of evidence.
Limitations
- The paper states that evidence syntheses pooled studies from different cultures, countries, and languages, and that the search strategy targeted LBP rather than instrument development studies in generic populations.
- The paper states that the reviewed instruments predate current COSMIN standards and that EQ-5D-5L and PROMIS-GH-10 were developed later, so fewer LBP studies exist for them.
- Evident from the text: no included studies assessed cross-cultural validity for any instrument, and content validity evidence was very low and often based only on reviewers’ ratings because development studies lacked patient involvement and cognitive interviews.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
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Cites
Statistics
Claims the paper makes
0 of 34 cited sources checked · 0 supported · 0 flagged
- Findingown data
Very low quality evidence was found on each instrument's content validity in patients with low back pain.
“Very low quality evidence was found on each instrument's content validity; very low to low evidence underpinned the other assessed measurement properties.”
Quote in the paperSubstantial claim - Findingown data
Moderate quality evidence indicates inconsistent responsiveness of the EQ-5D-3L utility score in patients with low back pain.
“Moderate evidence was found for sufficient construct validity of SF-12 physical summary score and inconsistent responsiveness of EQ-5D-3L utility score.”
- Also stated in: § 3.3.3. Other measurement properties · plain
“There was moderate quality evidence for inconsistent responsiveness of the utility score (Table 3), as results were largely inconsistent across studies (Appendix 3).”
Quote in the paperSubstantial claim - Also stated in: § 3.3.3. Other measurement properties · plain
- Findingown data
Moderate quality evidence indicates sufficient construct validity of the SF-12 physical summary score in patients with low back pain.
“Moderate evidence was found for sufficient construct validity of SF-12 physical summary score and inconsistent responsiveness of EQ-5D-3L utility score.”
- Also stated in: § 3.2.3. Other measurement properties · plain
“Moderate quality evidence (downgraded for risk of bias) (Appendix 2) of sufficient construct validity was found for PCS”
Quote in the paperSubstantial claim - Also stated in: § 3.2.3. Other measurement properties · plain
- Findingreasoning
Correlations of SF-36 and EQ-5D-3L scores with other instruments are not as expected in patients with low back pain.
“Caution should be used in assuming the validity of the SF-36 and EQ-5D-3L scores in patients with LBP, as there is high quality evidence suggesting that correlations of these scores with other instruments are not as expected.”
Quote in the paperSubstantial claim - Findingown data
High quality evidence indicates insufficient construct validity of SF-36 summary scores in patients with low back pain.
“High quality evidence was found for insufficient construct validity of SF-36 summary scores, and EQ-5D-3L utility and visual analogue scale scores.”
- Also stated in: § 3.1.3. Other measurement properties · plain
“High quality evidence of insufficient construct validity was found for both PCS and MCS scores (Table 3).”
Quote in the paperSubstantial claim - Also stated in: § 3.1.3. Other measurement properties · plain
- Findingown data
High quality evidence indicates insufficient construct validity of EQ-5D-3L utility and VAS scores in patients with low back pain.
“High quality evidence was found for insufficient construct validity of SF-36 summary scores, and EQ-5D-3L utility and visual analogue scale scores.”
- Also stated in: § 3.3.3. Other measurement properties · plain
“High quality evidence for insufficient construct validity (Appendix 2) was found for utility and VAS scores (Table 3).”
Quote in the paperSubstantial claim - Also stated in: § 3.3.3. Other measurement properties · plain
- Findingown data
Very low to low quality evidence underpinned the other assessed measurement properties in patients with low back pain.
“Very low quality evidence was found on each instrument's content validity; very low to low evidence underpinned the other assessed measurement properties.”
Quote in the paperSubstantial claim - Findingcitation
Low quality evidence for inconsistent results for EQ-5D-3L domain scores.
“For the domain scores, low quality evidence (due to risk of bias) was found for inconsistent results (Table 3) because two studies of doubtful quality reported inconsistent results [45,57].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [45] Eker, 2007, The relationship between EQ-5D and SF-36 instruments in patients with low back pain, Fizyoterapi Rehabilitasyon
Not checked in the free run.
- cites [57] Mueller, 2013, Comparison of the EuroQOL-5D with the Oswestry Disability Index, back and leg pain scores in patients with degenerative lumbar spine pathology, Spine source
Not checked in the free run.
- Findingnone given
No studies assessed SF-12 test-retest reliability.
“No studies assessed SF-12 testeretest reliability.”
Quote in the paperNot a substantial claim - Findingcitation
Diaz-Arribas et al. was the only study assessing SF-12 measurement error.
“Diaz-Arribas et al. [53] (doubtful quality) was the only study assessing measurement error.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [53] Diaz-Arribas, 2017, Minimal clinically important difference in quality of life for patients with low back pain, Spine source
Not checked in the free run.
- Findingnone given
Cross-cultural validity was not assessed for any instrument.
“Cross-cultural validity was not assessed for any instrument.”
Quote in the paperNot a substantial claim - Findingcitation
The EQ-5D-5L development was rated inadequate because a clear description of the construct to be measured was not provided as it referred to the development of the EQ-5D-3L.
“One article reported information on the development of the EQ-5D-5L [30] and was rated as inadequate because a clear description of the construct to be measured was not provided as it referred to the development of the EQ-5D-3L (Table 1).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [30] Herdman, 2011, Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L), Qual Life Res source
Not checked in the free run.
- Findingown data
Low quality evidence of inconsistent construct validity for SF-12 MCS.
“although low quality evidence (risk of bias and inconsistent results) of inconsistent construct validity for MCS (Table 3).”
Quote in the paperSubstantial claim - Findingown data
No studies assessed responsiveness of EQ-5D-3L domain scores.
“No studies assessed the responsiveness of the domain scores.”
Quote in the paperNot a substantial claim - Findingown data
No studies evaluated SF-12 structural validity.
“No studies evaluated the SF-12 structural and crosscultural validity.”
Quote in the paperNot a substantial claim - Findingcitation
One study of inadequate quality found Cronbach's alpha = 0.80 for the SF-36 total scale.
“One study [47] evaluated internal consistency of the total scale in a study of inadequate quality (Cronbach's alpha 5 0.80).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [47] Bronfort, 1999, Responsiveness of general health status in chronic low back pain: a comparison of the COOP charts and the SF-36, Pain source
Not checked in the free run.
- Findingreasoning
Very low quality evidence of sufficient content validity for SF-12.
“There was very low quality evidence of sufficient content validity (based on the reviewers' ratings only) (Table 3).”
Quote in the paperNot a substantial claim - Findingcitation
SF-36 structural validity results on the unidimensionality of the two component scores were inconsistent based on low quality evidence.
“Considering that the general health subscale is supposed to load on the MCS, these results on the unidimensionality of the two component scores were considered inconsistent based on low quality evidence.”
Quote in the paperNot a substantial claim - Findingown data
Low quality evidence was present for insufficient responsiveness of SF-12 MCS.
“although low quality evidence (because of risk of bias) was present for insufficient responsiveness of the MCS (Table 3).”
Quote in the paperNot a substantial claim - Findingown data
Very low quality evidence of sufficient relevance and comprehensibility for EQ-5D-3L.
“There was very low quality evidence of sufficient relevance and comprehensibility and very low quality evidence of insufficient comprehensiveness (Table 3).”
Quote in the paperSubstantial claim - Findingown data
Low quality evidence of inconsistent responsiveness for SF-36 PCS and MCS scores.
“Low quality evidence (due to risk of bias and inconsistency) of inconsistent responsiveness was found for PCS and MCS scores (Table 3).”
Quote in the paperNot a substantial claim - Findingown data
No studies evaluated SF-12 cross-cultural validity.
“No studies evaluated the SF-12 structural and crosscultural validity.”
Quote in the paperNot a substantial claim - Findingown data
Low quality evidence for inconsistent responsiveness of EQ-5D-3L VAS score.
“Low quality evidence (because of risk of bias and inconsistency) was found for inconsistent responsiveness of the VAS score (Table 3).”
Quote in the paperNot a substantial claim - Findingcitation
Two studies of very good quality found Cronbach's alpha >0.70 for seven of eight SF-36 subscales in each study.
“Two studies [48,52] of very good quality assessed the internal consistency of the subscales, finding a Cronbach's alpha O0.70 for seven of eight subscales in each study.”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [48] Bullinger, 1995, German translation and psychometric testing of the SF-36 health survey: preliminary results from the IQOLA project. International quality of life assessment, Soc Sci Med source
Not checked in the free run.
- cites [52] Zwingmann, 1998, Short Form-36 Health Survey (SF-36): psychometrische analysen der deutschen Version bei Rehabilitanden mit chronischen Rückenschmerzen, Diagnostica
Not checked in the free run.
- Findingown data
Measurement error was not evaluated for SF-36.
“No studies assessed testeretest reliability of PCS, MCS, and total score; likewise, measurement error was not evaluated.”
Quote in the paperNot a substantial claim - Findingcitation
Sufficient responsiveness was found for the SF-36 total score (low quality evidence), based on one study with an area under the curve >0.70.
“Sufficient responsiveness was found for the SF-36 total score (low quality evidence, Table 3), based on one study [47] with an area under the curve O0.70.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [47] Bronfort, 1999, Responsiveness of general health status in chronic low back pain: a comparison of the COOP charts and the SF-36, Pain source
Not checked in the free run.
- Findingcitation
For SF-36 subscales, hypotheses could not be tested in three studies because only overall effect sizes were reported.
“For the subscales, hypotheses could not be tested in three studies [50e52] because only overall effect sizes were reported;”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [50e52]
Not checked in the free run.
- Findingreasoning
Very low quality evidence of sufficient content validity for SF-36.
“Because no additional content validity studies were found, solely the reviewers' ratings counted for the evidence synthesis, leading to very low quality evidence of sufficient content validity (Table 3).”
Quote in the paperSubstantial claim - Findingown data
Very low quality evidence of insufficient comprehensiveness for EQ-5D-3L.
“There was very low quality evidence of sufficient relevance and comprehensibility and very low quality evidence of insufficient comprehensiveness (Table 3).”
Quote in the paperNot a substantial claim - Findingown data
Low quality evidence of sufficient construct validity for SF-36 total score.
“For the total score, there was low quality evidence (due to risk of bias) of sufficient construct validity (Table 3).”
Quote in the paperNot a substantial claim - Findingown data
Sufficient test-retest reliability was found for SF-36 subscales (low quality evidence).
“In one study of doubtful quality (Table 4), sufficient testeretest reliability was found for the subscales (low quality evidence).”
Quote in the paperNot a substantial claim - Findingown data
No studies assessed test-retest reliability of SF-36 PCS, MCS, and total score.
“No studies assessed testeretest reliability of PCS, MCS, and total score; likewise, measurement error was not evaluated.”
Quote in the paperSubstantial claim - Findingown data
Test-retest reliability and measurement error were not assessed for EQ-5D-3L in any study.
“Testeretest reliability and measurement error were not assessed in any study.”
Quote in the paperSubstantial claim - Findingown data
Low quality evidence of inconsistent construct validity for SF-36 subscales.
“Low quality evidence (due to risk of bias and inconsistent results across studies) of inconsistent construct validity was found for the subscales (Table 3).”
Quote in the paperSubstantial claim - Findingown data
There was high quality evidence only of insufficient construct validity of SF-36 physical and mental summary scores, and EQ-5D-3L utility and VAS scores.
“There was high quality evidence only of insufficient construct validity of SF-36 physical and mental summary scores, and EQ-5D-3L utility and VAS scores.”
- Also stated in: § 4. Discussion · plain
“The most important finding regarding the other measurement properties assessed in this review is the insufficient construct validity of the SF-36 PCS and MCS scores and of the EQ-5D-3L utility and VAS scores.”
Quote in the paperSubstantial claim - Also stated in: § 4. Discussion · plain
- Findingcitation
Four articles and one report included information on the development of the PROMIS-GH-10.
“Four articles and one report included information on the PROMIS-GH-10 development [27,66e69].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [27,66e69]
Not checked in the free run.
- Findingown data
Reviewers rated EQ-5D-5L content validity for patients with low back pain as sufficient for relevance and comprehensibility (very low quality evidence).
“The reviewers rated the EQ-5D-5L content validity for patients with LBP as sufficient for relevance and comprehensibility (very low quality evidence), and as insufficient for comprehensiveness (very low quality) (Table 3).”
Quote in the paperNot a substantial claim - Findingown data
Reviewers rated EQ-5D-5L content validity for patients with low back pain as insufficient for comprehensiveness (very low quality evidence).
“The reviewers rated the EQ-5D-5L content validity for patients with LBP as sufficient for relevance and comprehensibility (very low quality evidence), and as insufficient for comprehensiveness (very low quality) (Table 3).”
Quote in the paperSubstantial claim - Findingreasoning
It is unclear which HRQoL instrument performs best in patients with low back pain.
“It is unclear which performs best in patients with LBP.”
Quote in the paperSubstantial claim - Findingown data
There are no studies on the cross-cultural validity of the HRQoL instruments included in this review.
“because there are no studies on the cross-cultural validity of these instruments (Table 3)”
Quote in the paperSubstantial claim - Findingown data
No studies were found on the internal structure, reliability, and/or responsiveness of the Nottingham Health Profile in patients with low back pain.
“No studies were found on the internal structure, reliability, and/or responsiveness of the NHP in patients with LBP.”
Quote in the paperSubstantial claim - Findingown data
No studies assessed the content validity of the Nottingham Health Profile.
“No studies assessed the content validity.”
Quote in the paperNot a substantial claim - Findingown data
There was very low quality evidence of sufficient content validity of the PROMIS-GH-10 based solely on the reviewers' ratings.
“There was very low quality evidence of sufficient content validity based solely on the reviewers' ratings (Table 3).”
Quote in the paperNot a substantial claim - Findingown data
No studies assessed the measurement properties of EQ-5D-5L in patients with low back pain.
“No studies assessed the measurement properties of this instrument in patients with LBP.”
Quote in the paperSubstantial claim - Findingown data
Evidence related to the measurement properties of HRQoL instruments in patients with low back pain is inconclusive.
“Evidence related to the measurement properties of HRQoL instruments in patients with LBP is inconclusive (Table 3).”
Quote in the paperSubstantial claim - Findingcitation
The development of the Nottingham Health Profile was rated inadequate because patients were not involved in the concept elicitation study.
“Three studies reported the development of the NHP [35,64,65], which was rated as inadequate because patients were not involved in the concept elicitation study (Table 1).”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [35] Hunt, 1980, The development of a subjective health indicator, Sociol Health Illn source
Not checked in the free run.
- cites [64] Hunt, 1981, The Nottingham Health Profile: subjective health status and medical consultations, Soc Sci Med A
Not checked in the free run.
- cites [65] Hunt, 1980, A quantitative approach to perceived health status: a validation study, J Epidemiol Community Health source
Not checked in the free run.
- Findingown data
This systematic review highlights the scarcity of high quality evidence on the measurement properties of SF-36, SF-12, EQ-5D-3L, EQ-5D-5L, NHP, and PROMIS-GH-10 in patients with low back pain.
“This systematic review highlights the scarcity of high quality evidence on the measurement properties of SF-36, SF-12, EQ-5D-3L, EQ-5D-5L, NHP, and PROMIS-GH-10 in patients with LBP.”
Quote in the paperSubstantial claim - Findingown data
The structural validity of HRQoL instruments in patients with low back pain has not been sufficiently investigated for the SF-36.
“The structural validity (second measurement property to consider when selecting an instrument [7]) of HRQoL instruments in patients with LBP has not been sufficiently investigated for the SF-36 (Table 3).”
Quote in the paperSubstantial claim - Findingreasoning
There was very low quality evidence for sufficient content validity of the Nottingham Health Profile, as rated by the reviewers.
“There was very low quality evidence for sufficient content validity, as rated by the reviewers (Table 3).”
Quote in the paperNot a substantial claim - Findingown data
There is very low quality evidence for the content validity of the six instruments (SF-36, SF-12, EQ-5D-3L, EQ-5D-5L, NHP, PROMIS-GH-10) in patients with low back pain.
“Foremost, there is very low quality evidence for the content validity of these six instruments in patients with LBP (Table 3).”
Quote in the paperSubstantial claim - Findingnone given
The six instruments assessed in this review were developed without patient input.
“The six instruments assessed in this review were developed without patient input (Table 1).”
Quote in the paperSubstantial claim - Findingnone given
There is no evidence showing whether it is appropriate to translate findings on measurement properties from generic populations to populations with specific health conditions and between health conditions.
“The HRQoL instruments assessed in this review have been assessed in several other populations [14], but, up to now, there is no evidence showing whether it is appropriate to translate findings on measurement properties from generic populations to populations with specific health conditions and between health conditions.”
Quote in the paperSubstantial claim - Findingown data
No studies assessing the measurement properties of the PROMIS-GH-10 in patients with low back pain were retrieved.
“No studies assessing the measurement properties of the PROMIS-GH-10 in patients with LBP were retrieved.”
Quote in the paperSubstantial claim - Interpretationown data
Documentation of the measurement properties of health-related quality of life instruments in low back pain is incomplete.
“Documentation of the measurement properties of health-related quality of life instruments in LBP is incomplete.”
Quote in the paperSubstantial claim - Interpretationreasoning
The measurement properties of health-related quality of life instruments have been only marginally investigated in patients with low back pain.
“The measurement properties of HRQoL instruments have been only marginally investigated in patients with LBP.”
Quote in the paperSubstantial claim - Premisereasoning
It remains unclear how valid, reliable, and responsive these instruments are in patients with low back pain.
“However, it remains unclear how valid, reliable, and responsive these instruments are in patients with LBP.”
Quote in the paperSubstantial claim - Premisecitation
Three reviews have attempted to summarize the measurement properties of health-related quality of life instruments in patients with low back pain.
“Three reviews have attempted to summarize the measurement properties of HRQoL instruments in patients with LBP [15e17].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [15e17]
Not checked in the free run.
- Premisecitation
The three previous reviews had significant and important methodological weaknesses, such as failure to account for risk of bias in the evidence synthesis.
“Two were narrative reviews [16,17], two focused on utility scores [15,17], and all had significant and important methodological weaknesses, such as failure to account for risk of bias in the evidence synthesis [18,19].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [18] Higgins, 2011
Not checked in the free run.
- cites [19] Katikireddi, 2015, How do systematic reviews incorporate risk of bias assessments into the synthesis of evidence? A methodological study, J Epidemiol Community Health source
Not checked in the free run.
- May combine two claims. 20
- Classified as probably not a substantial claim. 23
May combine two claims.
Findingown dataEQ-5D-5L, NHP and PROMIS Global Health-10 were not evaluated in patients with low back pain.
“EQ-5D-5L, NHP and PROMIS Global Health-10 were not evaluated in LBP patients.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown data18 other included studies evaluated measurement properties.
“Among the other 18 included studies, three evaluated the SF-36 and the EQ-5D-3L simultaneously”
Quote in the paperNot a substantial claimMay combine two claims.
FindingcitationThe only study assessing SF-12 internal consistency was of very good quality and found Cronbach's alpha 0.77 and 0.80 for PCS and MCS scores.
“The only study [54] assessing internal consistency was of very good quality and found Cronbach's alpha equal to 0.77 and 0.80 for PCS and MCS scores, respectively.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [54] Luo, 2003, Reliability, validity, and responsiveness of the short form 12-item survey (SF-12) in patients with back pain, Spine source
Not checked in the free run.
May combine two claims.
Findingnone givenNo studies tested structural validity, internal consistency, or cross-cultural validity of EQ-5D-3L in patients with low back pain.
“No studies tested structural validity, internal consistency, or cross-cultural validity in patients with LBP.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataThe EQ-5D-3L development was rated inadequate because no patients were involved, no clear definition of the construct was provided, and no cognitive interview study was performed.
“The EQ-5D-3L development was rated inadequate because no patients were involved in the instrument development, no clear definition of the construct to be measured was provided, and no cognitive interview study was performed (Table 1).”
Quote in the paperNot a substantial claimMay combine two claims.
FindingcitationThe SF-12 development was considered inadequate as no patients were involved and no cognitive interview study was performed.
“The SF-12 was derived from the SF-36 using regression methods [33]; its development was considered inadequate as no patients were involved, and no cognitive interview study was performed (Table 1).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [33] Ware, 1996, A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity, Med Care source
Not checked in the free run.
May combine two claims.
Findingown dataThe SF-36 development was considered of inadequate quality because no patients were involved and no cognitive interview study was performed.
“The SF-36 development was considered of inadequate quality because no patients were involved, and no cognitive interview study was performed (Table 1).”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingreasoning35 studies were included in the review.
“therefore, 35 studies were included (Fig. 1).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown data17 included articles presented information on the development of the instruments.
“Seventeen of the included articles presented information on the development of the instruments (Table 1).”
Quote in the paperNot a substantial claimMay combine two claims.
FindingcitationIn Suarez-Almazor et al., inconsistent results were found (very low quality evidence) as 11 of 32 hypotheses were met (34%).
“in the study by Suarez-Almazor et al. [46], inconsistent results were found (very low quality evidence due to risk of bias and imprecision) as 11 of 32 hypotheses were met (34%) (Table 3).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [46] Suarez-Almazor, 2000, Use of health status measures in patients with low back pain in clinical settings. Comparison of specific, generic and preference-based instruments, Rheumatology (Oxford) source
Not checked in the free run.
May combine two claims.
Findingown dataMIC values were larger than the smallest detectable change values, providing low quality evidence for sufficient measurement error for SF-12 PCS and MCS.
“The MIC values presented in this study were larger than the smallest detectable change values (Table 4), providing low quality evidence for sufficient measurement error for both PCS and MCS.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Findingnone givenThere is no evidence clearly indicating the best way to synthesize evidence on instrument measurement properties.
“splitting the results of these studies may be considered equally contentious as there is no evidence clearly indicating the best way to synthesize evidence on instrument measurement properties.”
Quote in the paperSubstantial claimMay combine two claims.
FindingreasoningAll other properties of any instrument were underpinned by lower quality evidence or not assessed.
“All other properties of any instrument were underpinned by lower quality evidence or not assessed.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Findingnone givenIt remains unclear if HRQoL can be adequately expressed using the total score of a multidimensional instrument or only by the subscale scores.
“HRQoL definitions usually highlight the multidimensional nature of the domain, but it remains unclear if HRQoL can be adequately expressed using the total score of a multidimensional instrument or only by the subscales scores.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataConstruct validity and responsiveness were the most often assessed properties, mainly for SF-36, SF-12, and EQ-5D-3L.
“Construct validity and responsiveness were the most often assessed properties, mainly for SF-36, SF-12, and EQ-5D-3L.”
Quote in the paperNot a substantial claimMay combine two claims.
FindingcitationOne study assessed the construct validity of the Nottingham Health Profile subscales compared to the SF-36 subscales, providing low quality evidence of sufficient construct validity, with 37 of 48 hypotheses met (77%).
“One study [48] assessed the construct validity of its subscales as compared to the SF-36 subscales, providing low quality evidence (due to risk of bias, Table 3) of sufficient construct validity as 37 of 48 hypotheses were met (77%, Appendix 2).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [48] Bullinger, 1995, German translation and psychometric testing of the SF-36 health survey: preliminary results from the IQOLA project. International quality of life assessment, Soc Sci Med source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown dataEight articles on instrument development were found with the initial search and the remaining nine through citation tracking.
“nevertheless, eight articles on the instruments development were found with the initial search and the remaining nine through citation tracking (Figure 1).”
Quote in the paperNot a substantial claimMay combine two claims.
FindingcitationThe development of the PROMIS-GH-10 was rated inadequate because patients were not specifically involved in selecting the most relevant (sub)domains to be included in the instrument, despite patients' involvement in developing PROMIS items.
“Development was rated inadequate because, despite patients' involvement in developing PROMIS items [69], they were not specifically involved in selecting the most relevant (sub)domains to be included in this instrument (Table 1).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [69] DeWalt, 2007, Evaluation of item candidates: the PROMIS qualitative item review, Med Care source
Not checked in the free run.
May combine two claims.
FindingcitationOnly the EQ-5D-3L version has been assessed in patients with low back pain and not the EQ-5D-5L.
“Regarding the EQ-5D, it should be underlined that only the EQ-5D-3L version has been assessed in patients with LBP and not the EQ-5D-5L [30].”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataModerate quality evidence was found for SF-12 PCS score inconsistent construct validity and EQ-5D utility score inconsistent responsiveness.
“Moderate quality evidence was found for SF-12 PCS score inconsistent construct validity and EQ-5D utility score inconsistent responsiveness (Table 3).”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationcitationBecause no studies assessed the unidimensionality of SF-36 subscales, internal consistency results cannot provide evidence in support of this measurement property.
“According to recent COSMIN guidance [24], because no studies assessed the unidimensionality of the SF-36 subscales, these results cannot provide evidence in support of this measurement property.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [24] Prinsen, 2018, COSMIN guideline for systematic reviews of patient-reported outcome measures, Qual Life Res source
Not checked in the free run.
May combine two claims.
InterpretationcitationThis SF-12 internal consistency study does not represent evidence on this measurement property because the unidimensionality of these scores was not assessed in any study.
“This study does not represent evidence on this measurement property because the unidimensionality of these scores was not assessed in any study [24].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [24] Prinsen, 2018, COSMIN guideline for systematic reviews of patient-reported outcome measures, Qual Life Res source
Not checked in the free run.
Classified as probably not a substantial claim.
Study design and conductnone givenConsensus-based criteria were used to rate measurement properties results as sufficient, insufficient, or inconsistent.
“Consensus-based criteria were used to rate measurement properties results as sufficient, insufficient, or inconsistent; a modified GRADE approach was adopted for evidence synthesis.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationA priori hypotheses were formulated by the review team to evaluate construct validity and responsiveness.
“A priori hypotheses were formulated by the review team to evaluate the results of studies on construct validity and responsiveness, based on the results of a previous systematic review on instruments for LBP [40].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [40] Chiarotto, 2016, Roland-Morris disability questionnaire and Oswestry Disability Index: which has better measurement properties for measuring physical functioning in nonspecific low back pain? Systematic review and meta-analysis, Phys Ther source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationFor content validity, results of each study were rated by two reviewers independently against 10 established criteria.
“For content validity, the results of each study were rated by two reviewers (A.C. and C.B.T.) independently against 10 established criteria: five on relevance, one on comprehensiveness, and four on comprehensibility [25].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [25] Terwee, 2018, COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study, Qual Life Res source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenPotentially eligible full-texts were screened independently by two reviewers.
“Potentially eligible full-texts were also screened independently by two reviewers (A.C. and R.W.O.).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenTwo reviewers independently screened the articles.
“Two reviewers independently screened the articles and assessed the risk of bias (COSMIN checklist).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationA modified GRADE approach was adopted for evidence synthesis.
“The quality of evidence for each measurement property was rated according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach [42] adapted for this type of review”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [42] Guyatt, 2008, GRADE: an emerging consensus on rating quality of evidence and strength of recommendations, BMJ source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenInclusion criteria were applied by two reviewers independently to titles and abstracts.
“Inclusion criteria were applied by two reviewers (A.C. and S.J.K.) independently to titles and abstracts retrieved with the searches.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataData on patients' characteristics and results were extracted by one reviewer, and a random 25% was double checked by a second reviewer.
“For every study, data on patients' characteristics and results were extracted by one reviewer (A.C.), and a random 25% of the extracted information, stratified per instrument, was double checked by a second reviewer (R.W.O.).”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Study design and conductcitationRisk of bias was assessed with the COSMIN checklist.
“The risk of bias of the studies on the other measurement properties was also assessed with the COSMIN risk of bias checklist [23].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [23] Mokkink, 2018, COSMIN risk of bias checklist for systematic reviews of patient-reported outcome measures, Qual Life Res source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataThe protocol was registered a priori in PROSPERO.
“The protocol was registered a priori in PROSPERO (https:// www.crd.york.ac.uk/prospero/), number CRD42015020021.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationThis study was conducted according to current guidance on systematic reviews of patient-reported outcome measures.
“This study was conducted according to current guidance on systematic reviews of patient-reported outcome measures [7,21,23e25].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [7,21,23e25]
Not checked in the free run.
Classified as probably not a substantial claim.
PremisecitationContent validity is considered by clinimetric and psychometric experts as the first measurement property to consider when selecting an instrument.
“Content validity is considered by clinimetric and psychometric experts as the first measurement property to consider when selecting an instrument [7,25].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [7] Prinsen, 2016, How to select outcome measurement instruments for outcomes included in a “Core Outcome Set”–a practical guideline, Trials source
Not checked in the free run.
- cites [25] Terwee, 2018, COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study, Qual Life Res source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductreasoningAnother potential limitation of this review is that the search strategy was designed to identify studies on patients with low back pain without specifically targeting the development studies of the instruments that were conducted in generic populations.
“Another potential limitation of this review is that the search strategy was designed to identify studies on patients with LBP (Appendix 1), without specifically targeting the development studies of the instruments that were conducted in generic populations”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenA potential limitation of this review is that the evidence syntheses were performed lumping together studies from different cultures, countries, and languages.
“A potential limitation is that the evidence syntheses were performed lumping together studies from different cultures, countries, and languages.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
PremisecitationThe SF-36 was not endorsed because it was considered too long for inclusion in every clinical trial, and the EQ-5D because it provided scores that cannot be pooled with the other instruments' scores.
“On the other hand, the SF-36 was not endorsed because it was considered too long for inclusion in every clinical trial, and the EQ-5D because it provided scores that cannot be pooled with the other instruments' scores (i.e., SF12 and PROMIS-GH-10) [26].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [26] Chiarotto, 2018, Core outcome measurement instruments for clinical trials in non-specific low back pain, Pain source
Not checked in the free run.
May combine two claims.
PremisecitationNone of the HRQoL instruments met the prespecified 67% cutoff for consensus in an international Delphi process to endorse core instruments for low back pain clinical trials, although the SF-12 came close.
“The results of this systematic review informed an international and multidisciplinary Delphi process to endorse core instruments for LBP clinical trials; however, none of the HRQoL instruments met the prespecified 67% cutoff for consensus (although the SF-12 came close) [26].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [26] Chiarotto, 2018, Core outcome measurement instruments for clinical trials in non-specific low back pain, Pain source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe EQ-5D-5L has shown improved validity in other populations.
“This newer version has shown improved validity in other populations [75].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [75] Janssen, 2013, Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study, Qual Life Res source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe international consortium overseeing the core set initiative for low back pain decided to recommend the SF-12 and the PROMIS-GH-10 for HRQoL.
“To improve measurement standardization, the international consortium overseeing the core set initiative for LBP decided to recommend the SF-12 and the PROMIS-GH-10 for HRQoL, as they both provide PCS and MCS scores, and the PROMIS-GH-10 represents a free of charge option [26].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [26] Chiarotto, 2018, Core outcome measurement instruments for clinical trials in non-specific low back pain, Pain source
Not checked in the free run.
The authors state this as an assumption.
The SF-12 measures the same construct and has the same target population and context of use as the SF-36.
“Not reported; assumed same of SF-36”
The authors state this as an assumption.
The EQ-5D-5L measures the same construct and has the same target population and context of use as the EQ-5D-3L.
“Not reported; assumed same of EQ-5D-3L”
The paper relies on this without support.
The EQ-5D-5L and PROMIS-GH-10 were developed 10 to 20 years later than the other instruments.
“given that the EQ-5D-5L and PROMIS-GH-10 were developed 10 to 20 years later than the other instruments”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Current tools specific for back pain or musculoskeletal conditions are scarce for assessing health related quality of life.
“Nevertheless, we recognise that current tools specific for back pain or musculoskeletal conditions are scarce for assessing health related quality of life.30 124”
From Psychological interventions for chronic, non-specific low back pain: systematic review with network meta-analysis (2022) · cites this paper as [124]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
SF-12 PCS construct validity receives opposing ratings
MajorThe discussion calls the SF-12 PCS construct validity inconsistent, whereas the results rate it sufficient. Both describe the evidence as moderate quality.
“Moderate quality evidence was found for SF-12 PCS score inconsistent construct validity and EQ-5D utility score inconsistent responsiveness (Table 3).”
“Moderate quality evidence (downgraded for risk of bias) (Appendix 2) of sufficient construct validity was found for PCS”
Abstract says the NHP was not evaluated in LBP patients
MinorThe abstract says the NHP was not evaluated, but the results describe a study of its construct validity in patients with LBP.
“EQ-5D-5L, NHP and PROMIS Global Health-10 were not evaluated in LBP patients.”
“One study [48] assessed the construct validity of its subscales as compared to the SF-36 subscales, providing low quality evidence (due to risk of bias, Table 3) of sufficient construct validity as 37 of 48 hypotheses were met (77%, Appendix 2).”
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- Authors
- Chiarotto, A., Terwee, C. B., Kamper, S. J., Boers, M., & Ostelo, R. W.
- Affiliations
- Amsterdam Public Health (NL)
- The University of Sydney (AU)
- Corresponding author
- Chiarotto, Alessandro
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2018-10
- Volume
- 102
- Pages
- 23-37
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W2804655732
- Semantic Scholar
- 4c6fb85f5f849078fb8dd35a2fa6c61b79c7e451
- Cited by
- 69
- References
- 87
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 13 · 2023: 9 · 2022: 10 · 2021: 16 · 2020: 5 · 2019: 7 · 2018: 1
- FWCI
- 0.85
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Pure Amsterdam UMC (submittedVersion)
- VU Research Portal (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- EUROSPINE
- Topics
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Medical Practices and Rehabilitation
- Keywords
- low back pain, health-related quality of life, measurement properties, SF-36, SF-12, EQ-5D-3L, EQ-5D-5L, Nottingham Health Profile, construct validity, content validity, responsiveness, utility scores
- MeSH terms
- Patient Reported Outcome Measures, Female, Humans, Male, Psychometrics, Quality of Life, Research Design, Low Back Pain, Evidence-Based Medicine
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-10.
Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-10.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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