Chapter 16 · Measurement, agreement and diagnosis
Can you trust a questionnaire score?
Scores and indices, Cronbach's alpha, test-retest reliability and the types of validity.
Read first: Data collection, Bias, confounding and validity
The problem first
You are a second-year MD resident. Your thesis needs a fatigue score for patients on haemodialysis, and no questionnaire exists in your patients' language, so you write five questions yourself and score each from 0 to 4.
You give it to ten patients, run “Reliability Analysis” in SPSS and write “the questionnaire was validated, Cronbach's alpha 0.71”. At the pre-submission seminar, the professor of Community Medicine asks one question.
“Your alpha is 0.71. How do you know the questionnaire measures fatigue at all?”
Start here
What is the difference between an indicator, an index and a score?
Fatigue, quality of life and disability cannot be measured with one instrument reading. You measure them by asking several questions and combining the answers into a number.
Building a scoring system
- Define the construct. Write in one or two sentences what the score should measure, in which patients, and for what purpose (diagnosis, severity, change over time).
- Write the items. From the literature, patients and clinicians. Each item asks about one thing.
- Choose the response format. Yes or no, or ordered categories such as 0 to 4.
- Decide the weights. Equal weights (every item 0 to 4, then add) are the usual choice. Unequal weights need a reason, for example points taken from the coefficients of a regression model.
- Add the items into a total, and decide how to handle missing answers before you collect the data.
- Test the score: content validity, a pretest with patients, then reliability and validity in a new sample.
Does every score need Cronbach's alpha? No. COSMIN distinguishes two kinds of instrument. In a reflective model the construct shows itself in the items, so the items should correlate (fatigue makes a patient tired, slow and unable to concentrate). In a formative model the items are not supposed to be correlated (a checklist of risk factors that together form a risk score). Analyses of internal structure, including alpha, apply only to reflective scales.
Two types of Likert data
Is one Likert item a scale?
No. A Likert item is one statement with ordered answers. A Likert scale is the sum or mean of several such items that measure the same construct.
| Feature | Likert item | Likert scale |
|---|---|---|
| What it is | One statement with ordered answers (never to always) | The sum or mean of several items on one construct |
| Type of data | Ordinal | Usually analysed as a measurement (interval data) |
| Summary | Counts and percentages for each answer, or the median | Mean and SD, or median and IQR if skewed |
| Tests | Rank tests or chi-square | Parametric tests are commonly used (Norman 2010) |
| Reliability | Cannot be assessed on its own with alpha | Alpha or omega for each unidimensional scale |
Opinion differs on single Likert items: some authors treat Likert data as interval, others as ordinal. Norman (2010) reviewed studies going back to the 1930s and concluded that parametric methods can be used with Likert scale data without giving wrong answers. When you analyse single items, say which approach you used.
Comparison
What is the difference between a reliable and a valid questionnaire?
Reliable means the questionnaire gives the same result when nothing has changed. Valid means it measures the construct it claims to measure. A scale can be reliable and still measure the wrong thing.
| Feature | Reliability | Validity |
|---|---|---|
| Question | Do repeated measurements give the same result? | Does it measure what it claims to measure? |
| When it fails | Repeated results scatter | Results are consistently off target, or reflect another construct |
| Needs a reference standard? | No | Criterion validity does. Content and construct validity do not |
| COSMIN measurement properties | Internal consistency, reliability (for example test-retest and inter-rater), measurement error | Content (including face), construct (structural, hypotheses testing, cross-cultural), criterion |
| Typical statistics | Alpha, omega, ICC, kappa | CVI, correlations with other measures, AUC, factor analysis |
Reliability
In what ways can a questionnaire be reliable?
Three questions, three kinds of study. Do the items agree with each other? Does the patient get the same score next week? Do two raters give the same score?
Internal consistency
How does Cronbach's alpha work?
If all items measure fatigue, a patient who scores high on one item tends to score high on the others. Their scores then vary together, and the total varies more than the items would if they were unrelated.
α = k ÷ (k − 1) × [1 − (sum of the item variances) ÷ (variance of the total score)]
- k
- number of items
- item variance
- the variance of each item across patients
- variance of the total
- the variance of the patients’ total scores. When items correlate, this is much larger than the sum of the item variances
The same idea written with correlations gives the standardised alpha, which SPSS reports next to Cronbach's alpha. If the two differ, the items differ in spread or in how strongly they reflect the construct:
standardised α = k × r̄ ÷ [1 + (k − 1) × r̄]
- r̄
- the mean correlation between all pairs of items
Related coefficients
- Kuder-Richardson 20 (KR-20): for yes or no items, Cronbach's alpha is equivalent to KR-20.
- Split-half reliability: the items are divided into two halves and the two half-scores are correlated. Because each half is shorter, the Spearman-Brown formula estimates the reliability of the full-length test: rfull = 2r ÷ (1 + r). Alpha is the mean of all possible split-half reliabilities, corrected for test length.
- Corrected item-total correlation (item-rest correlation): the correlation of each item with the sum of the other items. Items below 0.30 are candidates for revision or deletion (Boateng 2018).
- Alpha if item deleted: the alpha of the scale without that item. If it is higher than the scale's alpha, the item adds less than it takes away.
Interactive
Add items, change their correlation and delete an unrelated item, and watch alpha change
Try this: the unrelated item (r = 0.1) keeps alpha at 0.69. Read its "alpha if item deleted", then set it to "Not included". Next, move the number of related items to 20 and watch alpha rise although the correlation between items has not changed.
Teaching model: every related item correlates r with every other related item, all items have the same spread, and alpha is calculated from the correlations.
More items → higher alpha
Higher correlation → higher alpha
Below 0.70, the value COSMIN uses for sufficient internal consistency.
| Item | Corrected item-total correlation | Alpha if item deleted |
|---|---|---|
| Each of the 6 related items | 0.44 | 0.65 |
| The unrelated item | 0.15 (below 0.30) | 0.72 (higher than 0.69) |
Deleting the unrelated item raises alpha from 0.69 to 0.72. Deleting any related item lowers it to 0.65.
Red dot: the current scale with the unrelated item. Ring: the same scale without it.
A common misreading
Does a high alpha prove that the items measure one thing?
No. Internal consistency is a necessary but not sufficient condition for unidimensionality. A questionnaire that mixes two different topics can still have a high alpha, especially if it is long.
Tavakol and Dennick (2011) note that a multidimensional test does not necessarily have a lower alpha than a unidimensional one, and that alpha should be calculated for each concept, not for a whole test that covers several. The COSMIN Risk of Bias checklist (Mokkink 2018) states that alpha can be interpreted as a measure of internal consistency only when the scale or subscale is unidimensional, and COSMIN recommends checking structural validity with factor analysis first. Factor analysis is explained in the multivariate methods chapter.
Interactive
Mix two unrelated topics in one questionnaire and watch alpha stay high
Try this: keep the correlation between topics at 0.10. Alpha for the whole questionnaire is 0.79, although the two topics barely relate. Then raise the items per topic to 10 and watch alpha for all 20 items rise further.
Teaching model: a questionnaire that mixes, say, fatigue items (topic A) with sleep items (topic B). Each shaded square is the correlation between two items; darker means higher.
More items → higher alpha
Cannot exceed the correlation within a topic
The first two principal components account for 35% and 25% of the total variance. The second eigenvalue is 2.50, above 1 (Kaiser's criterion, used for example in the KOOS paper below), which points to a second dimension. Alpha does not show it.
Comparison
What does McDonald's omega add?
Alpha assumes that every item measures the construct equally strongly (the tau-equivalent model). Omega uses the factor loading of each item, so items may differ in how strongly they reflect the construct.
ω = (Σλ)² ÷ [(Σλ)² + Σθ]
- λ (lambda)
- factor loading of each item on the single factor (standardised)
- θ (theta)
- error variance of each item, 1 − λ² for standardised items
Teaching example. Five standardised items with loadings 0.8, 0.8, 0.7, 0.6 and 0.3: Σλ = 3.2 and Σθ = 2.78, so ω = 3.2² ÷ (3.2² + 2.78) = 10.24 ÷ 13.02 = 0.79. Alpha calculated from the correlations these loadings produce is 0.77. With five equal loadings of 0.7, alpha and omega are the same, 0.83.
| Feature | Cronbach's alpha | McDonald's omega |
|---|---|---|
| Assumes | Equal loadings (tau-equivalence), one dimension, uncorrelated errors | One dimension (for omega total from one factor), uncorrelated errors. Loadings may differ |
| Calculated from | Item variances and the total variance, or inter-item correlations | A factor model: loadings and error variances |
| When loadings are unequal | Tends to underestimate reliability | Uses the actual loadings |
| Software | Every package | jamovi, R (psych, jmv), and the Omega model listed in the SPSS version 31 documentation |
| Report | For each unidimensional scale or subscale | The same, with the factor model you used |
McNeish (2018) and Dunn and colleagues (2014) review the problems with alpha and recommend omega and related coefficients. Neither coefficient replaces checking the dimensions with factor analysis.
Reliability over time and between raters
Does the score stay the same when the patient has not changed?
Give the questionnaire twice to patients whose condition should not change in between, and compare the two scores. This is test-retest reliability. The same comparison between two raters is inter-rater reliability.
The interval must be short enough that the condition does not change, since real change lowers test-retest reliability (Boateng 2018), and long enough that patients do not simply remember their previous answers. The KOOS study below used 1 to 2 weeks.
Teaching example: why a correlation is not enough
Made-up totals for 8 stable patients on day 0 (12, 8, 15, 5, 10, 14, 7, 11) and day 14 (13, 8, 14, 6, 11, 15, 6, 12). Pearson r = 0.97. The ICC for absolute agreement, two-way random effects, single measurement, is 0.96 (95% CI 0.85 to 0.99).
Now suppose every day-14 score is 3 points higher, because the questionnaire was read out differently. Pearson r stays at 0.97. The ICC for absolute agreement falls to 0.66 (95% CI −0.03 to 0.94), because the patients no longer get the same score. The ICC forms, and the Bland-Altman limits of agreement, are covered in the ICC and Bland-Altman chapter. For categories and grades, use kappa or weighted kappa (kappa chapter).
Reading an ICC: Koo and Li (2016) suggest, based on the 95% CI of the estimate, values below 0.5 as poor, 0.5 to 0.75 moderate, 0.75 to 0.9 good and above 0.90 excellent. There are 10 forms of ICC, so the form must be stated.
Decide
Which reliability statistic do you need?
Answer the questions about your study.
What do you want to show about the questionnaire?
Which reliability statistic: all possible answers
- Structural validity first: COSMIN recommends evaluating structural validity (factor analysis) before internal consistency, because alpha can be interpreted only for a unidimensional scale or subscale.
- Kuder-Richardson 20 (KR-20): For yes or no items, Cronbach's alpha is the same as KR-20. Report it for each subscale.
- Cronbach's alpha, with McDonald's omega: Report alpha for each subscale, with corrected item-total correlations and alpha if item deleted. Add omega when the items load unequally on the factor.
- Intraclass correlation coefficient (test-retest): Use an ICC for absolute agreement, state the model, type and definition, and give the 95% CI. A Pearson correlation ignores a systematic change between occasions.
- Intraclass correlation coefficient (inter-rater): Each patient is scored by two or more raters. Choose the ICC form from the design: the same raters for every patient or not, and whether the raters are a sample of possible raters.
- Cohen's kappa (weighted kappa for ordered categories): Kappa corrects the percentage agreement for the agreement expected by chance. COSMIN accepts an ICC or weighted kappa of 0.70 or more for reliability.
Validity
Does the questionnaire measure what it claims to measure?
Validity is not shown by one statistic. It is built from several kinds of evidence, collected before and after the questionnaire is given to patients.
Face validity
The degree to which respondents or end users judge that the items are appropriate to the construct and the purpose of the assessment. It is assessed with the target population, for example in cognitive interviews, and COSMIN counts it as part of content validity.
Content validity and the content validity index (CVI)
Experts rate how relevant each item is to the construct, on a 4-point scale from 1 (not relevant) to 4 (highly relevant). A rating of 3 or 4 counts as relevant.
I-CVI = number of experts rating the item 3 or 4 ÷ number of experts
- S-CVI/Ave
- the mean of the I-CVIs of all items
- S-CVI/UA
- the proportion of items rated 3 or 4 by every expert (universal agreement)
Polit and Beck (2006) recommend, for excellent content validity, an I-CVI of 1.00 with 3 to 5 experts or at least 0.78 with 6 to 10 experts, and an S-CVI/Ave of 0.90 or higher. The two scale-level indices can give different values, so state which one you report.
Interactive
Change the experts' ratings and watch the item and scale content validity indices change
Try this: item 5 (poor appetite) has an I-CVI of 0.50. Change two of its ratings of 2 to 3 and watch the item and the scale-level indices change.
Teaching example, made-up ratings: six experts rate a draft five-item fatigue scale. 1 = not relevant, 4 = highly relevant. A rating of 3 or 4 counts as relevant.
| Item | E1 | E2 | E3 | E4 | E5 | E6 | I-CVI |
|---|---|---|---|---|---|---|---|
| 1. Tired during the day | 1.00 | ||||||
| 2. Needs to rest after small tasks | 1.00 | ||||||
| 3. Hard to concentrate | 0.83 | ||||||
| 4. Everyday tasks take more effort | 1.00 | ||||||
| 5. Poor appetite | 0.50 |
1 item below an I-CVI of 0.78: Poor appetite. Revise or drop, then ask the experts again. The S-CVI/Ave is below 0.90. Report which scale-level index you used, because the two can differ.
Validity
How do you show criterion and construct validity?
Criterion validity compares the questionnaire with a gold standard. Construct validity checks whether the scores relate to other measures, and differ between groups, in the ways you predicted before collecting the data.
Criterion validity
- Concurrent: the questionnaire and the gold standard are measured at the same time or shortly after, such as a depression questionnaire against a psychiatrist's interview. Report a correlation, or sensitivity, specificity and the AUC.
- Predictive: the score predicts a later outcome, such as a frailty score and readmission within a year.
- COSMIN rates criterion validity as sufficient when the correlation with the gold standard, or the AUC, is 0.70 or more.
Construct validity
- Structural validity: factor analysis shows whether the items form the dimensions (subscales) the authors intended.
- Convergent validity: scores correlate strongly with a measure of a similar construct. COSMIN's generic hypothesis is a correlation of 0.50 or more.
- Discriminant validity: scores correlate weakly with measures of unrelated constructs (COSMIN: below 0.30). Related but dissimilar constructs should correlate 0.30 to 0.50.
- Known-groups validity: scores differ between groups that should differ.
- COSMIN rates hypotheses testing as sufficient when at least 75% of the results agree with the hypotheses stated in advance.
Interactive
Lower the reliability of the scale and watch its correlation with the criterion fall
Measurement error in either measure lowers the correlation you observe. This is why a questionnaire with poor reliability cannot show strong criterion or convergent validity.
observed r = true r × √(reliability of the scale × reliability of the criterion)
Rearranged from Spearman's correction for attenuation, in which the disattenuated correlation equals the observed correlation divided by the square root of the product of the two reliabilities.
Try this: lower the reliability of the new scale from 0.70 to 0.40 and watch the correlation with the criterion fall, although the true relationship stays at 0.80.
Teaching simulation: 150 patients. The new questionnaire is compared with a criterion measure. Both contain measurement error.
Less reliable → lower observed correlation
0.80 × √(0.70 × 0.90) = 0.63 · highest correlation these reliabilities allow: √(0.70 × 0.90) = 0.79
Cross-cultural adaptation
Can you translate a questionnaire and use it straight away?
No. A translation can change the meaning of an item, and an item that suits one culture may not suit another. The questionnaire is adapted in stages, and its measurement properties are tested again in the new population.
- Two independent forward translations are combined into one version, which is translated back into the original language without sight of the original, so that differences in meaning become visible.
- An expert committee reviews all versions and reports, and produces the pre-final version.
- The pre-final version is tested in 30 to 40 people from the target population, to check that the items are understood and acceptable.
- COSMIN treats the translation process itself as not a measurement property. The pilot test after translation counts as part of content validity (comprehensibility), and cross-cultural validity is assessed by testing whether items behave the same way in different groups (measurement invariance, differential item functioning).
- Then test internal consistency, reliability and validity in the new population, as for a new questionnaire.
The formula
Worked example: alpha, item statistics and the item to drop
Made-up teaching data: 10 patients answer the resident's five fatigue items, each scored 0 to 4.
| Patient | Tired | Rest | Focus | Effort | Appetite | Total |
|---|---|---|---|---|---|---|
| 1 | 3 | 2 | 0 | 2 | 1 | 8 |
| 2 | 0 | 0 | 0 | 0 | 3 | 3 |
| 3 | 1 | 3 | 4 | 3 | 1 | 12 |
| 4 | 4 | 3 | 4 | 3 | 1 | 15 |
| 5 | 3 | 1 | 2 | 2 | 2 | 10 |
| 6 | 2 | 2 | 2 | 2 | 3 | 11 |
| 7 | 2 | 0 | 2 | 3 | 1 | 8 |
| 8 | 4 | 3 | 3 | 2 | 2 | 14 |
| 9 | 4 | 2 | 4 | 4 | 4 | 18 |
| 10 | 3 | 2 | 2 | 3 | 2 | 12 |
- Item variances: tired 1.82, rest 1.29, focus 2.23, effort 1.16, appetite 1.11. Sum = 7.61.
- Totals: 8, 3, 12, 15, 10, 11, 8, 14, 18, 12. Variance of the totals = 17.66.
- α = 5 ÷ 4 × (1 − 7.61 ÷ 17.66) = 1.25 × 0.569 = 0.71.
- Standardised alpha, from the mean inter-item correlation of 0.31, is 0.69. It differs from 0.71 because the items differ in spread (focus 2.23, effort 1.16).
| Item | Corrected item-total correlation | Alpha if item deleted |
|---|---|---|
| Tired during the day | 0.58 | 0.61 |
| Needs rest after small tasks | 0.55 | 0.63 |
| Hard to concentrate | 0.71 | 0.54 |
| Everyday tasks take more effort | 0.68 | 0.59 |
| Poor appetite | −0.08 | 0.83 |
- The appetite item correlates −0.08 with the rest of the scale, below 0.30, and alpha rises to 0.83 without it. Appetite is affected by dialysis for reasons other than fatigue, so the item probably belongs to a different construct.
- Four items: sum of item variances 6.50, variance of the totals 17.21. α = 4 ÷ 3 × (1 − 6.50 ÷ 17.21) = 0.83, 95% CI 0.55 to 0.95.
- The confidence interval is wide because only 10 patients answered. Deleting an item on data from 10 patients is a decision for a pilot, to be confirmed in the main sample.
α (5 items) = 0.71 → delete appetite → α (4 items) = 0.83
Computed in Python with pingouin 0.6.1 and NumPy.
In a real paper
Reliability and validity reported in two published questionnaire studies
Paradowski PT, Kęska R, Witoński D. Validation of the Polish version of the Knee injury and Osteoarthritis Outcome Score (KOOS) in patients with osteoarthritis undergoing total knee replacement. BMJ Open. 2015;5(7):e006947.
doi:10.1136/bmjopen-2014-006947 · PMID 26141301 · Free full text (PMC4499743)
The study: A prospective cohort of 68 patients with end-stage knee osteoarthritis having total knee replacement in Łódź, Poland. The Polish KOOS, adapted in an earlier study, was completed before surgery, at 1 to 2 years, and again 1 to 2 weeks later. The authors needed internal consistency, test-retest reliability, factor analysis and hypotheses about correlations with the SF-36 to show that the translated score could be used.
“The Cronbach's α was from 0.90 to 0.92 for all subscales, indicating excellent internal consistency. The test–retest reliability at follow-up was excellent, with ICCs ranging from 0.81 to 0.86 for all KOOS subscales.”
Alpha was calculated separately for each KOOS subscale, not for the whole questionnaire, and every subscale gave 0.90 to 0.92. The same patients, 1 to 2 years after surgery, completed KOOS twice, 1 to 2 weeks apart. The ICC (two-way random effects, absolute agreement) between the two occasions was 0.81 to 0.86 across subscales. The authors had set 0.80 as acceptable for groups and above 0.90 for individual patients.
| Reported | Value | What it means |
|---|---|---|
| Patients | 68 | A small sample for factor analysis. The authors did an exploratory analysis for this reason |
| Cronbach's α, each subscale | 0.90 to 0.92 | At the upper limit of 0.90 suggested by Tavakol and Dennick. Look at the items for repetition |
| ICC, test-retest | 0.81 to 0.86 | Above 0.80 (acceptable for groups), below 0.90 (individual use) |
| Retest interval | 1 to 2 weeks | Measured 1 to 2 years after surgery |
| Floor or ceiling effect | more than 15% | The authors’ rule: more than 15% of patients at the lowest or highest possible score |
- Alpha is given per subscale, which is correct for a multidimensional questionnaire.
- The ICC form is stated (two-way random, absolute agreement) with a 95% CI.
- The translation process was described in an earlier paper, so read that paper before accepting content validity.
- The hypotheses about correlations with the SF-36 were set in advance.
Sidiq M, Ramachandran A, Janakiraman B, Kashoo FZ, Chahal A, Singh J, et al. Adaption and psychometric evaluation of the Hindi version of Neck Disability Index in the rural population of Northern India: a cross cultural study. F1000Res. 2023;12:1599 (version 2).
doi:10.12688/f1000research.142451.2 · PMID 39282515 · Free full text (PMC11393535)
The study: The 10-item Neck Disability Index was translated and adapted into Hindi, pretested with 30 people, and then given to 211 participants with neck pain in rural northern India to test reliability, factor structure and correlation with the Hindi version of another neck pain questionnaire. It shows common reporting problems.
“The test-retest reliability of the NDI-Hi version was determined by calculating Cronbach’s alpha with an alpha value of > 0.7 (deemed acceptable), > 0.8 (considered good), and > 0.9 (considered excellent) to grade the internal consistency”
The sentence uses the name test-retest reliability for Cronbach's alpha, which measures internal consistency at one sitting. Test-retest reliability needs two administrations and an ICC, which the paper reports separately. The grading also calls any alpha above 0.9 excellent, although a value that high may mean the items repeat each other.
| Reported | Value | What it means |
|---|---|---|
| Cronbach's alpha, 10 items | 0.962 | Above 0.95. Deleting any one item leaves alpha at 0.95 or 0.96, so no single item explains the high value |
| Corrected item-total correlations | 0.75 to 0.93 | Very high, consistent with overlapping items |
| ICC, test-retest (results section) | 0.893 | The abstract gives 0.87 |
| Alpha in the discussion | 0.89 | Differs from the 0.962 in the results |
| Retest interval | 48 hours (abstract), seven days (results) | The paper gives two different intervals |
- Check that each reliability name matches the statistic used.
- Check that numbers in the abstract, results and discussion agree.
- An alpha above 0.95 in a 10-item scale calls for a look at item redundancy.
- Check that the ICC model, type and definition are stated (Koo and Li 2016).
Software
How to run it
Menu paths and function names below are taken from the current IBM SPSS, CRAN and jamovi documentation.
IBM SPSS Statistics
Internal consistency
Analyze > Scale > Reliability Analysis...
Items: move the scale items (not the total)
Model: Alpha (Omega is also listed in the version 31 documentation)
Statistics...: Descriptives for > Scale if item deleted
Inter-Item > Correlations
Test-retest or inter-rater reliability
Analyze > Scale > Reliability Analysis...
Items: score at time 1, score at time 2 (or rater 1, rater 2)
Statistics...: Intraclass correlation coefficient
Model: Two-Way Random Type: Absolute AgreementFor yes or no items, the alpha that SPSS reports is equivalent to KR-20. “Scale if item deleted” gives the corrected item-total correlation and alpha if item deleted. The ICC options are Two-Way Mixed, Two-Way Random and One-Way Random, with Consistency or Absolute Agreement.
R
library(psych)
a <- alpha(items) # items: data frame, one column per item
a$total$raw_alpha # Cronbach's alpha (std.alpha = standardised)
a$alpha.drop # alpha if each item is dropped
a$item.stats$r.drop # correlation of each item with the other items
ICC(retest) # retest: one column per occasion or rater
# ICC2 = two-way random, absolute agreement, single
library(jmv) # the jamovi analyses in R
reliability(data, vars = c("tired", "rest", "focus", "effort"),
omegaScale = TRUE, alphaItems = TRUE, omegaItems = TRUE,
itemRestCor = TRUE)jamovi
Analyses tab: Factor → Reliability Analysis. Move the items across. The options give Cronbach's α and McDonald's ω for the scale, and for each item the α and ω if the item is dropped and the item-rest correlation. Reverse-scored items can be listed so they are recoded before the analysis.
Reporting
How to report it
Report each measurement property with the statistic, its confidence interval, the sample and the form of the analysis.
- How the items were developed or translated, with the guideline followed.
- Content validity: the number of experts, the rating scale, the I-CVIs and which S-CVI you report.
- Structural validity: the factor analysis and the number of factors retained.
- Internal consistency: alpha (and omega) for each unidimensional scale or subscale, with the 95% CI, item-total correlations and any items removed, with the reason.
- Reliability: the software and the ICC model, type and definition (Koo and Li 2016), the 95% CI, the interval between occasions and why patients were considered stable.
- Validity: the hypotheses stated in advance and the proportion confirmed, or the correlation or AUC against the criterion.
A sentence you can adapt (teaching numbers):
The five draft items were answered by 10 patients on haemodialysis. The appetite item had a corrected item-total correlation of −0.08 and was removed, which raised Cronbach's α from 0.71 to 0.83 (95% CI 0.55 to 0.95) for the remaining four items. In 8 stable patients who completed the scale twice, 14 days apart, test-retest reliability was ICC 0.96 (95% CI 0.85 to 0.99), two-way random effects, absolute agreement, single measurement. Analyses were done in Python (pingouin 0.6.1).
Reporting guidance: GRRAS (Guidelines for Reporting Reliability and Agreement Studies, Kottner 2011) proposes 15 issues to address when reliability and agreement are reported. The COSMIN Risk of Bias checklist (Mokkink 2018) lists the design requirements and preferred statistical methods for each measurement property, and the COSMIN criteria (Prinsen 2018) define sufficient results.
By specialty
Questionnaire reliability and validity by specialty
An English questionnaire on health-seeking behaviour is to be used in Tamil in a rural block.
Follow the cross-cultural adaptation stages (forward translation, synthesis, back-translation, expert committee, pretest), then test reliability and validity in the new population.
A new 20-item anxiety questionnaire reports Cronbach's alpha of 0.94.
An alpha above 0.90 may mean some items repeat each other. Check the inter-item correlations and the content before calling it excellent.
A quality-of-life questionnaire for heart failure has physical, emotional and social subscales, and the thesis reports one alpha for all 30 items.
Report alpha for each subscale. A long, multidimensional questionnaire can have a high overall alpha.
A knee function score is given to patients 1 to 2 weeks apart, with no treatment in between, to check test-retest reliability.
Use an ICC for absolute agreement with its 95% CI, and state the form. Patients must be stable between the two occasions.
Two nurses score the same neonates on a pain scale from video recordings.
This is inter-rater reliability. Use an ICC for the total score, or weighted kappa if the result is a grade.
A resident builds a patient-satisfaction questionnaire from items she thinks are important.
Ask content experts to rate each item's relevance and calculate the CVI, then pretest with patients to check that they understand the items.
A screening questionnaire for postnatal depression is compared with a psychiatrist's diagnostic interview on the same day.
This is concurrent criterion validity. Report sensitivity, specificity and the AUC against the interview.
A disease-severity score is expected to be higher in patients admitted for the disease than in outpatients.
This is known-groups validity. State the expected difference before collecting the data, then test it.
Common myths
Common mistaken beliefs
Myth: An alpha of 0.95 means an excellent questionnaire.
An alpha above 0.90 may mean that items repeat the same question, and a maximum of 0.90 has been recommended (Tavakol and Dennick 2011).
Myth: A high alpha shows that the items measure one thing.
A multidimensional test does not necessarily have a lower alpha. Check the dimensions with factor analysis first, then report alpha for each subscale.
Myth: Alpha is a fixed property of the questionnaire.
Streiner (2003) lists this as a myth. Alpha depends on the sample, so report it for your own patients.
Myth: Alpha always lies between 0 and 1.
Streiner (2003) also lists this as a myth. Alpha can be negative, for example when a reverse-worded item has not been recoded.
Myth: A high correlation between test and retest proves reliability.
In the teaching example, adding 3 points to every retest score left Pearson r at 0.97 while the ICC for absolute agreement fell from 0.96 to 0.66.
Myth: A translated questionnaire keeps the validity of the original.
It needs cross-cultural adaptation, a pretest, and new testing of reliability and validity in the target population.
Why this matters to you
Five consequences of using a questionnaire without testing it
Protocol sent back
A research committee will ask how a self-made or translated questionnaire was developed and tested before it can measure your primary outcome.
A thesis result nobody can interpret
If the score is unreliable, real differences between groups are hidden by measurement error and correlations with other measures are lower than they should be.
Questions you cannot answer at the viva
"The questionnaire was validated, alpha 0.71" does not answer "validated against what?".
Misreading papers
A paper that reports only alpha has shown internal consistency, not validity, and a very high alpha may reflect repeated items.
Wrong decisions for patients
A screening score that has not been compared with a diagnostic standard can label healthy people as ill, or miss people who need treatment.
History
History of reliability and validity measurement
- 1904
C. Spearman
Published "The proof and measurement of association between two things", the source of the correction for attenuation: a correlation lowered by measurement error, corrected using the reliabilities of the two measures.
- 1910
Spearman and Brown
In two papers in the same issue of the British Journal of Psychology, gave the Spearman-Brown formula, which shows how reliability increases as a test is lengthened.
- 1932
Rensis Likert
Introduced the Likert-type scale in a monograph on the method of summated ratings for measuring attitudes.
- 1937
Kuder and Richardson
Published "The theory of the estimation of test reliability" in Psychometrika. Their KR-20 coefficient is the form of alpha for yes or no items.
- 1951
Lee Cronbach
Published "Coefficient alpha and the internal structure of tests" in Psychometrika, to measure the internal consistency of a test or scale.
- 1955
L. J. Cronbach and P. E. Meehl
Published "Construct validity in psychological tests".
- 1959
D. T. Campbell and D. W. Fiske
Described convergent and discriminant validation with the multitrait-multimethod matrix.
- 1986
M. R. Lynn
Published "Determination and quantification of content validity". Polit and Beck (2006) recommend its criteria for item-level CVIs.
- 2000
Beaton, Bombardier, Guillemin and Ferraz
Published guidelines for the cross-cultural adaptation of self-report measures.
- 2010
COSMIN group (Lidwine Mokkink and colleagues)
Reached international consensus, in a Delphi study with 43 experts, on the taxonomy, terminology and definitions of measurement properties.
- 2011
Jan Kottner and colleagues
Proposed the Guidelines for Reporting Reliability and Agreement Studies (GRRAS), 15 issues to address.
Guidelines
Guidance on questionnaire measurement properties
Internal consistency is sufficient with “At least low evidence for sufficient structural validity AND Cronbach's alpha(s) ≥ 0.70 for each unidimensional scale or subscale”. Reliability is sufficient with “ICC or weighted Kappa ≥ 0.70”. Criterion validity: correlation with gold standard or AUC ≥ 0.70. An earlier criterion of alpha below 0.95 was deleted because it applies to the development of a new instrument, not to evaluating an existing one.
Structural validity is evaluated before internal consistency, because evidence for unidimensionality is a prerequisite for interpreting Cronbach's alpha. The translation process is not a measurement property, and the pilot test after translation is part of content validity.
Six stages: initial translation, synthesis of translations, back-translation, expert committee review, testing of the pre-final version (30 to 40 people), and submission of the documentation to the developers or a coordinating committee.
For excellent content validity: I-CVIs of 1.00 with 3 to 5 experts, or at least 0.78 with 6 to 10 experts, and an S-CVI/Ave of 0.90 or higher. State which scale-level method was used.
Report the software and the ICC "model", "type" and "definition". Interpret using the 95% CI: below 0.5 poor, 0.5 to 0.75 moderate, 0.75 to 0.9 good, above 0.90 excellent.
Fifteen issues to address when reliability and agreement are reported, arranged under the headings usually used in publications.
Reading a paper
Six checks on a questionnaire study
- Was the questionnaire developed or translated by a stated method, with expert review and a pretest in the target population?
- Was the factor structure checked before alpha was reported, and is alpha given for each subscale?
- Is an alpha above 0.90 explained, or could items be repeating each other?
- For test-retest or inter-rater reliability, is the ICC form stated, with a 95% CI and the interval between occasions?
- Were hypotheses for construct validity stated before the data were collected, and how many were confirmed?
- Do the numbers in the abstract, results and discussion agree, and does each reliability name match the statistic used?
Why is it called that?
Word surgery
“Reliable”
Trustworthy, dependable, can be relied on to be right.
Gives the same result when the measurement is repeated and nothing has changed. A reliable questionnaire can be consistently wrong.
“Valid”
Legally acceptable, or a sound argument.
Measures the construct it claims to measure, shown by several kinds of evidence, not by one number.
“Scale”
A weighing machine, or the marks on a ruler.
A set of items whose answers are added or averaged into one score for one construct.
Reliable: the same result again. Valid: the right thing measured. Alpha: the items agree with each other. Test-retest ICC: the patient agrees with the earlier score. Inter-rater ICC or kappa: the raters agree with each other.
Valid
Latin validus: "strong, effective", from valere "be strong"
A valid score is well supported by evidence that it measures the intended construct.
Reliable
rely + -able: "that may be relied on"
In measurement, a reliable score is one you can rely on to be repeated.
Criterion
Greek kriterion: "means for judging, standard", from krites "judge"
Criterion validity judges the questionnaire against a standard.
Construct
Latin construere: "pile up together, build"
A construct, such as fatigue or quality of life, is built in the mind from observations and cannot be measured directly.
Consistency
Latin consistere: "stand firm", from com "together" + sistere "to place"
Internal consistency: the items agree with each other.
Questionnaire
French questionnaire: "list of formal questions" (in English from 1901)
A list of questions answered by the respondent.
Index
Latin index: "forefinger, pointer", from indicare "to point out"
An index combines measurements into one number that points to a characteristic.
Scale
Latin scala: "ladder, flight of stairs"
A series of steps, hence a standard of measurement.
Exam answers
Model answer outlines
Validation of questionnaire
MD Community Medicine 2023- Definition: validation is collecting evidence that a questionnaire measures the intended construct (validity) with little measurement error (reliability) in the population where it will be used.
- Define the construct, the target population and the purpose. Decide whether the model is reflective (items should correlate) or formative.
- Item generation from literature, patients and experts. Choose the response format (yes or no, Likert 0 to 4) and the scoring.
- Content validity: experts rate relevance on a 4-point scale. I-CVI = experts rating 3 or 4 ÷ number of experts. Aim for I-CVI ≥ 0.78 (6 to 10 experts) and S-CVI/Ave ≥ 0.90.
- Face validity and pretest: cognitive interviews with the target population on understanding and wording.
- Translation, if needed (Beaton 2000): forward translation, synthesis, back-translation, expert committee, pretest in 30 to 40 people, submission of reports.
- Pilot and item analysis: corrected item-total correlations (below 0.30: revise or drop), alpha if item deleted, floor and ceiling effects.
- Structural validity: exploratory or confirmatory factor analysis to confirm the dimensions.
- Reliability: internal consistency with Cronbach's alpha or McDonald's omega per subscale (≥ 0.70, above 0.90 suggests redundancy). Test-retest reliability with the ICC for absolute agreement in stable patients. Inter-rater reliability with the ICC or kappa.
- Validity: criterion validity (concurrent or predictive) against a gold standard: correlation or AUC ≥ 0.70. Construct validity by hypotheses stated in advance: convergent (r ≥ 0.50 with similar measures), discriminant (r below 0.30 with unrelated measures), known-groups differences. At least 75% of hypotheses confirmed.
- Responsiveness: the ability to detect change over time, and interpretability.
- Reporting: COSMIN taxonomy and criteria, and GRRAS for reliability studies.
Short note: Cronbach's alpha
- Measures internal consistency: how far the items of one scale vary together. Developed by Lee Cronbach in 1951.
- α = k ÷ (k − 1) × (1 − Σ item variances ÷ variance of total). Standardised α = k r̄ ÷ [1 + (k − 1) r̄].
- Rises with the number of items and the mean inter-item correlation. Equivalent to KR-20 for yes or no items.
- Interpretation: ≥ 0.70 acceptable (COSMIN, with evidence of unidimensionality). Above 0.90 may suggest redundant items.
- Limitations: assumes equal loadings (tau-equivalence) and one dimension, depends on the sample, can be negative, is not evidence of validity. Omega relaxes the equal-loadings assumption.
- Worked example: 5 items, 10 patients, α = 0.71. Dropping an item with item-total correlation −0.08 gives α = 0.83.
Short note: types of validity
| Type | Question it answers | How it is shown |
|---|---|---|
| Face | Do respondents find the items appropriate? | Cognitive interviews with the target population |
| Content | Are the items relevant to, and do they cover, the construct? | Expert ratings, CVI |
| Criterion: concurrent | Does it agree with a gold standard now? | Correlation, sensitivity, specificity, AUC |
| Criterion: predictive | Does it predict a later outcome? | Regression, AUC |
| Construct: structural | Do the items form the intended dimensions? | Factor analysis |
| Construct: convergent and discriminant | Does it correlate with similar measures and not with unrelated ones? | Correlations against hypotheses (≥ 0.50 and below 0.30) |
| Construct: known-groups | Does it differ between groups that should differ? | t-test or ANOVA against a stated hypothesis |
| Cross-cultural | Do items behave the same way in different groups? | Measurement invariance, differential item functioning |
The one thing to remember
Alpha shows that the items agree with each other, nothing more. Validity needs expert review, factor analysis, and hypotheses about other measures that are stated in advance and then tested.
Worked examples, the CVI ratings and the interactive elements use made-up teaching data. Every statistic was computed in Python (NumPy, SciPy 1.15, pingouin 0.6.1).
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Past papers
TNMGRMU questions on reliability and validity of scales
Questions from MD, MS, DM, MCh and Ph.D. papers that this chapter helps you answer. Tap a sitting to open the university's own question paper.
- ×1Validation of questionnaire