Validity of the newly developed 4-item ANXiety-scale in patients with an implantable cardioverter defibrillator: A 12-month follow-up study

Q: What are the key findings of this study?

The 4-item ANX4 scale demonstrated high internal consistency (α=0.894) and significantly predicted lower physical (β=-0.276, p<0.001) and mental (β=-0.551, p<0.001) health status at 12 months.

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Anxiety symptoms in patients with an implantable cardioverter defibrillator (ICD) (n=288). Intervention: 4-item Anxiety Scale (ANX4) baseline score. Primary outcome: Mental and physical health status (SF-12 MCS and PCS) at 12 months post ICD implantation and psychometric validity of ANX4 (β = -0.551 (mental health); β = -0.276 (physical health); Cronbach's α = 0.894, p=<0.001).

Q: What does this research mean for the field?

The 4-item Anxiety Scale (ANX4) is a reliable and valid measure of anxiety in ICD patients that independently predicts poorer physical and mental health status at 12-month follow-up. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Johan Denollet; Susanne S. Pedersen; F.E. Warnaars; Mirela Habibović

doi:10.1016/j.jpsychores.2020.110106

April 2, 2020Journal of Psychosomatic ResearchOpen Access

Validity of the newly developed 4-item ANXiety-scale in patients with an implantable cardioverter defibrillator: A 12-month follow-up study

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Key result

Brief ANX4 anxiety scale predicts worse 12-month mental and physical health in ICD patients.

β = -0.551 (mental health); β = -0.276 (physical health); Cronbach's α = 0.894
P<0.001
n=288

Why the study?

Subclinical anxiety symptoms in ICD patients are associated with impaired health status, ventricular tachyarrhythmias, and mortality, prompting the evaluation of the validity and predictive value of the new 4-item Anxiety Scale (ANX4).

Is the newly developed 4-item Anxiety Scale (ANX4) a valid measure of anxiety symptoms and does it predict physical and mental health status 12 months after ICD implantation?

Study Design

Type

Cohort (n=288)

Multicenter

Yes

Structured PICO

Is the newly developed 4-item Anxiety Scale (ANX4) a valid measure of anxiety symptoms and does it predict physical and mental health status 12 months after ICD implantation?

P

Population

288 first-time implanted ICD patients (mean age 58 years, 81.3% male) across 6 Dutch hospitals evaluated at baseline, with a subsample of 212 followed for 12 months.

E

Exposure

Baseline anxiety assessment using the newly developed brief 4-item Anxiety Scale (ANX4)

C

Comparator

Existing generic anxiety measures (STAI-S, GAD-7, HADS-A), disease-specific ICD Patient Concerns questionnaire (ICDC), and depression subscale (HADS-D) for construct validity

O

Outcome

Psychometric validity (factor structure, internal consistency, convergent/divergent validity) at baseline and physical and mental health status measured by the Short-Form Health Survey 12 (SF-12 Physical Component Summary [PCS] and Mental Component Summary [MCS]) at 12 months post ICD implantationpatient reported

Main Result

Effect estimate: β = -0.551 (mental health); β = -0.276 (physical health); Cronbach's α = 0.894

p-value: p=<0.001

Limitations

Relatively small sample of patients and high dropout rate at 12 months limiting generalizability
Data collected as part of the WEBCARE online behavioral trial, introducing potential selection bias toward more motivated patients
Database did not allow for robust examination of divergent validity against constructs unrelated to anxiety, depression, and quality of life
Validation was performed at a single baseline time point, precluding assessment of test-retest reliability
Relatively small sample size and high dropout rate at 12-month follow-up (125/340 excluded due to missing SF-12 data)
Potential selection bias towards more motivated patients with internet skills due to recruitment from the WEBCARE trial
Lack of constructs unrelated to anxiety, depression, and quality of life for a more robust divergent validity assessment
Single time-point administration of ANX4 prevented evaluation of test-retest reliability

Implication

The brief 4-item ANX4 is a reliable, valid tool free of somatic confounding that takes under two minutes to administer and identifies ICD patients at risk for poor 12-month physical and mental health status.

Abstract

BACKGROUND: Subclinical anxiety symptoms are associated with risk of impaired mental and physical health status, ventricular tachyarrhythmias and mortality, in patients with an implantable cardioverter defibrillator (ICD). This study evaluates the validity of the brief and new 4-item Anxiety Scale (ANX4) and its predictive value in relation to health status 12-months post ICD implantation. METHODS: A total of 288 ICD patients completed the ANX4 questionnaire. Factor analysis was performed to assess the validity of the scale. In a subsample of N = 212 patients, regression analysis was performed to assess questionnaires' predictive value of health status at 12-months follow-up. RESULTS: Analyses of the ANX4 revealed a one-factor structure with a high internal consistency (α = 0.894). The ANX4 correlated significantly with existing generic and disease specific measures of anxiety symptoms STAI-S (r = 0.62), GAD-7 (r = 0.58), HADS-A (r = 0.66) and ICD related concerns (ICDC) (r = 0.44). Baseline anxiety symptoms were associated with lower levels of physical (β = -0.276; p < .001) and mental (β = -0.551; p < .001) health status 12-months post ICD implantation, adjusting for demographic and clinical variables. CONCLUSIONS: The 4-item ANX4 shows to be a valid measure of anxiety symptoms in ICD patients and predicts physical and mental health status up to 12 months follow-up. Further studies are warranted to replicate these findings, determine the cut-off score for clinical relevant symptoms, and whether the ANX4 can be used in other populations.

Discussion

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Cite This Study

Denollet et al. (2020) conducted a cohort in Anxiety symptoms in patients with an implantable cardioverter defibrillator (ICD) (n=288). 4-item Anxiety Scale (ANX4) baseline score was evaluated on Mental and physical health status (SF-12 MCS and PCS) at 12 months post ICD implantation and psychometric validity of ANX4 (β = -0.551 (mental health); β = -0.276 (physical health); Cronbach's α = 0.894, p=<0.001). The 4-item ANX4 scale demonstrated high internal consistency (α=0.894) and significantly predicted lower physical (β=-0.276, p<0.001) and mental (β=-0.551, p<0.001) health status at 12 months.

synapsesocial.com/papers/6a71c56cc2d7c30908271e48 https://doi.org/10.1016/j.jpsychores.2020.110106

Topics

Cardiac device therapy

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Validity of the newly developed 4-item ANXiety-scale in patients with an implantable cardioverter defibrillator: A 12-month follow-up study

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Topics

Validity of the newly developed 4-item ANXiety-scale in patients with an implantable cardioverter defibrillator: A 12-month follow-up study

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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