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Using cross-cultural input to adapt the Functional Assessment of Chronic Illness Therapy (FACIT) scales.

Cross-cultural quality of life measurement and psychosocial assessment in oncology have become reality with the translation and international validation of quality of life questionnaires. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, under development since 1987, produced its 4th version in November 1997. The FACIT system includes the Functional Assessment of Cancer Therapy (FACT), the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) and the Functional Assessment of Multiple Sclerosis (FAMS). These questionnaires were developed in North America and, to date, many have been translated into almost 30 languages. One of the strengths of this ongoing translation project is its use of input from patients, linguists, psychologists and physicians internationally to assure that the wording of Version 4 is more cross-culturally relevant and more sensitive to measuring the psychosocial impact of illness in cultures outside the United States. Statistical analysis, aggregation of patient comments, and comments from linguists and users of the translated versions are used as needed to revise item wording to ensure clarity and consistency across languages. A 'decentering' approach is also used to adapt the source (English language) document in response to problems encountered during its translation.

Chronic Disease↗

The Clinician-Administered Rating Scale for Mania (CARS-M): development, reliability, and validity.

There are currently seven rating scales available to assess manic symptomatology. All, however, have some limitations that could restrict their clinical and research utility. To resolve these deficiencies the Clinician-Administered Rating Scale for Mania (CARS-M) was developed and normed on 96 patients with mixed diagnoses during baseline and following treatment. Interrater reliability was established across multiple raters viewing 14 videotaped interviews and comparing agreement among individual items and total scores. Test-retest reliability was assessed on 36 patients twice during baseline. The mean intraclass correlation coefficient among five raters across items for each of the 14 patients was 0.81, and for total scores 0.93. Principal components analysis of items revealed two factors: mania, and psychosis. Test-retest reliability was significant for both factors (range = 0.78 to 0.95). Internal validity, comparing each item with its respective total factor score, revealed significant correlations for all items. Correlation of CARS-M total scores with mania rating scale (MRS) total scores was 0.94. Results indicate the CARS-M is both a reliable and valid measure of the severity of manic symptomatology, which incorporates a number of methodological improvements leading to greater precision and clinical utility.

Adolescent↗

Genetic variation in the mitochondrial enzyme carbamyl-phosphate synthetase I predisposes children to increased pulmonary artery pressure following surgical repair of congenital heart defects: a validated genetic association study.

Increased pulmonary artery pressure (PAP) can complicate the postoperative care of children undergoing surgical repair of congenital heart defects. Endogenous NO regulates PAP and is derived from arginine supplied by the urea cycle. The rate-limiting step in the urea cycle is catalyzed by a mitochondrial enzyme, carbamoyl-phosphate synthetase I (CPSI). A well-characterized polymorphism in the gene encoding CPSI (T1405N) has previously been implicated in neonatal pulmonary hypertension. A consecutive modeling cohort of children (N=131) with congenital heart defects requiring surgery was prospectively evaluated to determine key factors associated with increased postoperative PAP, defined as a mean PAP>20 mmHg for at least 1h during the 48h following surgery measured by an indwelling pulmonary artery catheter. Multiple dimensionality reduction (MDR) was used to both internally validate observations and develop optimal two-variable through five-variable models that were tested prospectively in a validation cohort (N=41). Unconditional logistic regression analysis of the modeling cohort revealed that age (OR=0.92, p=0.01), CPSI T1405N genotype (AC vs. AA: OR=4.08, p=0.04, CC vs. AA: OR=5.96, p=0.01), and Down syndrome (OR=5.25, p=0.04) were independent predictors of this complex phenotype. MDR predicted that the best two-variable model consisted of age and CPSI T1405N genotype (p<0.001). This two-variable model correctly predicted 73% of the outcomes from the validation cohort. A five-variable model that added race, gender and Down's syndrome was not significantly better than the two-variable model. In conclusion, the CPSI T1405N genotype appears to be an important new factor in predicting susceptibility to increased PAP following surgical repair of congenital cardiac defects in children.

Carbamoyl-Phosphate Synthase (Ammonia)↗

[Validation study of the 10-channel Sidas 2010 registration unit for diagnosis of sleep-related respiratory disorders].

UNLABELLED: We developed in cooperation with F. D. Stott, Oxford, the Mobile 10-Channel Unit SIDAS 10, a recording instrument for diagnosing sleep-related breathing disorders, to cope with the large number of patients requiring to be diagnosed. Studies that have already been published prove the clinical worth of this instrument that has been conceived as a mobile unit for the diagnosis of sleep-related breathing disorders outside a conventional sleep laboratory. To test the validity of this unit the present study was designed as a comparative study of conventional polygraphs versus SIDAS recordings. METHOD: 20 unselected patients (18 men, 2 women), average age 54.8 (34-65) years, body mass index (BMI) 29.8 (20.2-46.2) kg/m2, were examined parallel for one night in the sleep laboratory. We compared the breathing a) recorded with nasal airflow, oesophageal pressure, oxygen saturation and b) with induction plethysmography, ITP (a non-invasive recording of intrathoracic pressure variations), nasal airflow and pulse oxymetry via SIDAS 2010. The writeouts were evaluated visually according to internationally valid criteria. RESULTS: We found 10 patients with an apnoea index (AI) > 10/h (mean AI 53.2), 4 patients with AI between 5 and 10/h (mean AI 6.4) and 6 patients with an AI < 5/h (mean AI 3.4). 5835 apnoeas and hypopnoeas were evaluated. The statistical analyses yielded the following results: equal classification of central apnoeas in 87%, of obstructive apnoeas in 90% and of mixed apnoeas in 92% of the cases; on the whole, 10% more hypopnoeas were classified in the SIDAS recordings.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Validation and adaptation of a nomogram for predicting the survival of patients with extremity soft tissue sarcoma using a three-grade system.

BACKGROUND: A nomogram for predicting long term tumor-specific death in patients with soft tissue sarcoma (STS) was developed at the Memorial Sloan-Kettering Cancer Center (MSKCC). METHODS: To assess the performance of the MSKCC nomogram, 642 consecutive patients with extremity STS who underwent surgery over a 20-year span at a single referral center were analyzed. Nomogram predictions were based on tumor size, depth, site, patient age, histologic subtype, and grade. The latter, at variance with the system in use at the MSKCC, was classified as Grade 1-3 according to the French Federation of Cancer Centers Sarcoma Group (FNCLCC) system. The statistical approach used for nomogram performance assessment was that of "validation by calibration" proposed by Van Houwelingen. RESULTS: Graphic comparison of observed and predicted sarcoma-specific survival curves showed that predictions by the nomogram were quite accurate, within 10% of actual survival for all prognostic strata. Statistical analysis showed that such predictions could be improved by employing approximately 25% shrinkage to achieve good calibration. The contribution of histologic grade was highly significant in both univariate analysis (P < 0.001) and multivariate analysis (P < 0.001), and a survival trend across the 3 grade categories was observed. Based on those findings, a nomogram that included the FNCLCC histologic grade classification was produced. CONCLUSIONS: Results of the current study confirmed that the MSKCC nomogram is a valuable tool for individual prognostic assessment. A nomogram that included the FNCLCC histologic grade classification was proposed and was validated internally.

Adolescent↗

Instruments for measuring body image in breast cancer patients: a systematic review of measurement properties.

PURPOSE: To evaluate the psychometric properties of PROMs for measuring body image in breast cancer patients. METHODS: In December 2024, a psychometric systematic review was performed in the nine databases. The COSMIN checklist was employed to evaluate the methodological quality and psychometric properties of the included body image measures. The&#xa0;level of evidence was assessed using the GRADE framework, and final recommendations were formulated for the scale. RESULTS: Thirty-eight articles evaluating fifteen PROMs were included in this review. Structural validity, internal consistency, and hypothesis testing had been most frequently evaluated. Measurement error had not been assessed for all PROMs. Twelve instruments show potential application value but require further research. The BAS-BC, PSPP, and ASI-R are not recommended for use, as these instruments do not meet the strict COSMIN thresholds for full recommendation. CONCLUSION: The BIS can be recommended as a temporary screening tool for assessing body image outcome in clinical practice. The BIRS can be tentatively advised for measuring specific postoperative body image changes. However, further comprehensive studies are required to validate the psychometric properties of existing PROMs.

Female↗

A prediction model for metachronous colorectal cancer: development and validation.

BACKGROUND: Being able to estimate the risk of metachronous disease in a patient with colorectal cancer (CRC) could enable risk-appropriate surveillance. The aim of this study was to develop a risk-prediction model to estimate individual 10-year risk of metachronous disease following a CRC diagnosis. METHODS: A population-based cohort of patients with CRC was recruited soon after diagnosis between 1997 and 2012 from the United States, Canada, and Australia. Cox regression with the least absolute shrinkage and selection operator penalization was used to identify factors that predicted the risk of a new primary CRC diagnosed at least 1 year after the initial CRC diagnosis. Potential predictors included demography, anthropometry, lifestyle factors, comorbidities, personal and family cancer history, medication use, age at diagnosis, and pathological features of the first CRC. Internal validation through bootstrapping was used to evaluate the discrimination and calibration. RESULTS: We included 6085 CRC cases; 138 (2.3%) of these cases were diagnosed with metachronous disease over a median of 12&#x2009;years (IQR&#x2009;=&#x2009;5-17&#x2009;years). Metachronous CRC risk was predicted by body mass index; smoking status; level of physical activity; family history of cancer and synchronous CRC; stage, grade, histological type, and DNA mismatch repair status; and age at diagnosis of the first CRC. The model was valid with a C statistic of 0.65 (95% CI&#x2009;=&#x2009;0.63 to 0.68) and a calibration slope of 0.873 (SD = 0.087). CONCLUSIONS: Metachronous CRC can be predicted with reasonable accuracy using a prediction model that consists of clinical variables collected as part of routine practice.

Humans↗

[Assessment of a modified Hospital Emergency Appropriateness Evaluation Protocol].

BACKGROUND AND OBJECTIVE: Hospital Emergency inappropriate attendances need to be evaluated, including emergencies that can be solved in primary care. The study aim was to validate a Hospital Emergency Appropriateness Evaluation Protocol (HEAEP) having into account patient health care setting. MATERIAL AND METHOD: An HEAEP with explicit criteria was developed. We randomly chose 100 emergency medical records among all patients attended at the Granada Hospital Ruiz de Alda in the first quarter of 2000. Records were evaluated by six emergency specialists to compare results provided by the HEAEP. RESULTS: The HEAEP identified as appropriate all attendances so classified by experts. As inappropriate, HEAEP only pointed out 69% of the emergency visits considered as inappropriate by experts. CONCLUSIONS: The modified HEAEP shown a good internal validity and high reproducibility. The main advantage is to point out as inappropriate emergency attendances that can be solved in primary care.

Adolescent↗

A simplified Indian Diabetes Risk Score for screening for undiagnosed diabetic subjects.

AIM: The aim of this study was to develop and validate a simplified Indian Diabetes Risk Score for detecting undiagnosed diabetes in India. METHODS: The risk score was derived from the Chennai Urban Rural Epidemiology Study (CURES), an ongoing epidemiological study on a representative population of Chennai. Phase 1 of CURES recruited 26,001 individuals, of whom every tenth subject was requested to participate in Phase 3 for screening for diabetes using World Health Organization (WHO) 2 hour venous plasma glucose criteria [i.e. > or = 200 mg/dl]. The response rate was 90.4% (2350/2600). The Indian Diabetes Risk Score [IDRS] was developed based on results of multiple logistic regression analysis. Internal validation was performed on the same data. RESULTS: IDRS used four risk factors: age, abdominal obesity, family history of diabetes and physical activity. Beta co-efficients were derived based on a multiple logistic regression analysis using undiagnosed diabetes as the dependent variable. The beta co-efficients were modified so as to obtain a maximum possible score of 100. Receiver Operating Characteristic [ROC] curves were constructed to identify the optimum value of IDRS for detecting diabetes by WHO consulting group criteria. Area under the curve for ROC was 0.698 (95% confidence interval (CI): 0.663-0.733). An IDRS value > or = 60 had the optimum sensitivity (72.5%) and specificity (60.1%) for determining undiagnosed diabetes with a positive predictive value of 17.0%, negative predictive value of 95.1%, and accuracy of 61.3%. CONCLUSION: This simplified Indian Diabetes Risk Score is useful for identifying undiagnosed diabetic subjects in India and could make screening programmes more cost effective.

Adult↗

Impact of pediatric epilepsy on the family: a new scale for clinical and research use.

PURPOSE: There is no brief, global instrument available that specifically measures the psychosocial impact of pediatric epilepsy on the family. An 11-item scale was created for parents' use to evaluate the influence of epilepsy on the major aspects of their family and child's life. This will be a helpful tool both in the clinical setting and as an outcome measure for research studies. METHODS: Mothers rated their child's quality of life on a visual analogue scale (1-6) and completed the Impact of Pediatric Epilepsy Scale (IPES), which assesses the impact on academic achievement, participation in activities, health, relationships with family and with peers and siblings, social activities, self-esteem, and the caregiver's hopes for their child's future adapted from the scale developed by Jacoby. External validation was determined by comparison of the IPES with physicians' reports of the characteristics of the child's epilepsy and neurological limitations and parents' ratings on the Family Environment Scale or Parenting Stress Index. In addition, each school-aged child completed the Piers-Harris Children's Self-Concept Scale, Brother-Sister Questionnaire, and Loneliness Scale. Teachers of children completed the Academic Performance Rating Scale. Seven days later, retest reliability of the IPES was evaluated. RESULTS: Ninety-seven mothers of children aged 2-16 years completed the IPES and the appropriate family and age-related questionnaires. Internal validation on the IPES yielded a Cronbach's a for the scale of 0.92. A significant Pearson's correlation indicated that total scores were consistent over time (r = 0.81). Spearman's correlations for the individual items were also significant, ranging from 0.48 to 0.78. Significant Spearman's correlations also indicated that quality of life was negatively related to impact on each of the 11 items of psychosocial function. Children with IPES scores above the median differed in some psychosocial aspects from those who scored below. Their parents were more stressed, their siblings were more respectful, they had lower self-esteem, and they experienced more emotional problems. Total impact was also significantly related to seizure frequency, total number of medications taken, number of visits to a physician in the previous year, and number of nights spent in hospital for neurological reasons. CONCLUSIONS: The IPES is an accurate, acceptable, and quick measurement tool that reflects the way in which childhood epilepsy has an impact on the child and on family life. It may be helpful in routine clinical care and may be useful in the research setting to find ways to improve the lives of children with epilepsy.

Adolescent↗

Factor structure and reliability of the Hungarian version of the Illness Intrusiveness Scale: invariance across North American and Hungarian dialysis patients.

OBJECTIVES: The objectives of this study were to compare the factor structure and to assess the reliability of the Hungarian version of the Illness Intrusiveness Rating Scale (IIRS), testing internal validity and employing simultaneous confirmatory factor analysis (SCFA) in two large samples of North American versus Hungarian patients with end-stage renal disease (ESRD). METHODS: Translation was conducted according to current recommendations. Following pilot testing, 365 maintenance haemodialysis patients completed the scale. Hungarian data were compared with IIRS data from North American ESRD patients undergoing maintenance hemodialysis to evaluate item bias (Group x Item ANOVA). RESULTS: Confirmatory factor analyses indicated a good fit between the previously hypothesized three-factor model ("relationships and personal development", "intimacy", and "instrumental" life domains) of the original English version and the Hungarian translation. Although statistically significant (P<.05), the effect size for the Groups x Items interaction was not substantial. Internal consistency was very good (Cronbach's alpha=.80) for the total score, and, although somewhat lower than ideal, it was still in the acceptable range for the subscales (.64-.67). These numbers are similar to values reported for the original English version. Test-retest reliability was also acceptable. CONCLUSION: The Hungarian translation of the IIRS has the same three-dimensional factor structure as the original English-language version does. Furthermore, it is sufficiently reliable for research applications. These features satisfy important requirements of cultural equivalence.

Cost of Illness↗

Measuring the outcome of health resort programs.

OBJECTIVE: To evaluate the metric properties and practicability of valid, internationally available outcome instruments in the special setting of health resort programs. METHODS: A cohort study in a convenience sample of patients with low back pain, upper back pain, conditions of the lower extremities, and conditions of the upper extremities was conducted. Their functioning and health were assessed before and after a health resort program by the disease-specific North American Spine Society (NASS) instruments Lumbar NASS and Cervical NASS; WOMAC Osteoarthritis Index; Disabilities of Arm, Shoulder and Hand Questionnaire; and the general instrument, Medical Outcome Study Short Form-36 (SF-36). RESULTS: Completeness on the scale level ranged between 1% and 10%. Criterion validity of condition-specific instruments was confirmed by stronger associations of the pain and function scales to the Physical Health component of the SF-36 (r = -0.59 to -0.79, p < 0.001 for all scales) than to the Mental Health component (r = -0.11, NS, to r = -0.42, p < 0.001). Reliability (Cronbach's alpha coefficient) was higher than 0.8 for all scales of condition-specific instruments and for 6 of 8 SF-36 scales. Floor and ceiling effects ranged between 0% and 7%. The condition-specific instruments demonstrated a good responsiveness with an effect size ranging between 0.28 and 0.55 and with a standardized response mean between 0.32 and 0.94. The responsiveness of most SF-36 scales was similar, but the Physical Function scale showed a lower responsiveness than the condition-specific scales. CONCLUSION: The evaluated instruments can be recommended for use in clinical trials that assess the outcome of health resort programs.

Aged↗

Development and validation of a prediction model for strokes after coronary artery bypass grafting.

BACKGROUND: A prospective study of patients undergoing coronary artery bypass graft surgery (CABG) was conducted to identify patient and disease factors related to the development of a perioperative stroke. A preoperative risk prediction model was developed and validated based on regionally collected data. METHODS: We performed a regional observational study of 33,062 consecutive patients undergoing isolated CABG surgery in northern New England between 1992 and 2001. The regional stroke rate was 1.61% (532 strokes). We developed a preoperative stroke risk prediction model using logistic regression analysis, and validated the model using bootstrap resampling techniques. We assessed the model's fit, discrimination, and stability. RESULTS: The final regression model included the following variables: age, gender, presence of diabetes, presence of vascular disease, renal failure or creatinine greater than or equal to 2 mg/dL, ejection fraction less than 40%, and urgent or emergency. The model significantly predicted (chi(2) [14 d.f.] = 258.72, p < 0.0001) the occurrence of stroke. The correlation between the observed and expected strokes was 0.99. The risk prediction model discriminated well, with an area under the relative operating characteristic curve of 0.70 (95% CI, 0.67 to 0.72). In addition, the model had acceptable internal validity and stability as seen by bootstrap techniques. CONCLUSIONS: We developed a robust risk prediction model for stroke using seven readily obtainable preoperative variables. The risk prediction model performs well, and enables a clinician to estimate rapidly and accurately a CABG patient's preoperative risk of stroke.

Adult↗

Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report.

OBJECTIVES: A growing number of prospective clinical trials include economic end points. Recognizing the variation in methodology and reporting of these studies, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) chartered the Task Force on Good Research Practices: Randomized Clinical Trials-Cost-Effectiveness Analysis. Its goal was to develop a guidance document for designing, conducting, and reporting cost-effectiveness analyses conducted as a part of clinical trials. METHODS: Task force cochairs were selected by the ISPOR Board of Directors. Cochairs invited panel members to participate. Panel members included representatives from academia, the pharmaceutical industry, and health insurance plans. An outline and a draft report developed by the panel were presented at the 2004 International and European ISPOR meetings, respectively. The manuscript was then submitted to a reference group for review and comment. RESULTS: The report addresses issues related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members agreed that trials should be designed to evaluate effectiveness (rather than efficacy), should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. Analyses should be guided by an analysis plan and hypotheses. An incremental analysis should be conducted with an intention-to-treat approach. Uncertainty should be characterized. Manuscripts should adhere to established standards for reporting results of cost-effectiveness analyses. CONCLUSIONS: Trial-based cost-effectiveness studies have appeal because of their high internal validity and timeliness. Improving the quality and uniformity of these studies will increase their value to decision makers who consider evidence of economic value along with clinical efficacy when making resource allocation decisions.

Advisory Committees↗

Further development of the Liverpool Infant Distress Scale.

The Liverpool Infant Distress Scale (LIDS) was initially designed to assess behaviours reflecting pain in neonates following surgery. This paper reports a further development of the validity and reliability of LIDS and its use as a measure of neonatal behaviour. In the first stage of validity testing the LIDS scores of infants prior to administration of analgesia were compared to LIDS scores postanalgesia. Significantly lower scores were recorded following analgesia. The second stage of validity testing compared LIDS scores of a control group of neonates with those undergoing surgery, each over 43 hours. A significantly lower score on LIDS was found for the control group of infants compared to the surgical group, providing support for validity. Internal consistency was high, providing support for reliability. By providing detailed description of neonatal behaviours LIDS may assist nurses in the identification and objective quantification of neonatal behaviour, the context of which will govern intervention. The efficacy of such interventions may also be measured using LIDS.

Female↗

Subfertility guidelines in Europe: the quantity and quality of intrauterine insemination guidelines.

BACKGROUND: International collaboration could facilitate systematic development of guidelines to regulate and improve clinical practice. To promote European collaboration in guideline development in reproductive medicine, insight into existing subfertility guidelines in Europe is essential. The study aim was to explore the number and quality of clinical practice guidelines on homologous intrauterine insemination (IUI) in Europe. METHODS: To identify IUI guidelines in Europe, electronic databases and Internet were systematically searched and key experts on assisted reproduction in 25 European countries were questioned. The quality of IUI guidelines was systematically assessed with the internationally validated Appraisal of Guidelines for Research and Evaluation (AGREE) Instrument. Qualitative methods were used to appraise IUI guideline recommendations and references. RESULTS: National guidelines on IUI are available in four of 25 European countries. The quality of IUI guidelines in Europe is moderate to high, but the recommendations and references differ considerably. CONCLUSIONS: The number of IUI guidelines in Europe is surprisingly small, and differences in their recommendations and references are considerable. To overcome these deficiencies in clinical guidance on IUI care in Europe, a central body with expertise in up-to-date guideline development methodology and sufficient resources could be established in Europe for central selection and international exchange of evidence to support guideline recommendations.

Europe↗

Beyond the Hamilton depression scores in long-term treatment of manic-melancholic patients: prediction of recurrence of depression by quality of life measurements.

This study should be considered as a pilot study to investigate the applicability and validity of quality of life scales in manic-melancholic patients in long-term, prophylactic treatment. The quality of life instruments included the SmithKline Beecham Quality of Life (SBQOL) scale, the PCASEE questionnaire (a modified paper-and-pencil version of the computerized SBQOL), the Psychological General Well-Being (PGWB) scale, and the Medical Outcomes Study (SF-36) scale. The patients (n = 23) fulfilled the DSM-IV criteria of bipolar or recurrent depressive disorders. They were investigated in a symptom-free period (HAM-D < 14) and again 4 weeks later. The results showed that the quality of life scales had an adequate applicability and internal validity. Furthermore, at first visit a factor analysis identified two factors of which the quality of life scales loaded on the first factor (positive well-being) and the Hamilton scales loaded on the second factor (negative well-being). At the second visit, only one, general, factor emerged, because some of the patients had relapsed. Those patients with a relapse had low quality of life scores at the first visit indicating that the quality of life scales can predict recurrence of depression.

Adult↗

[Psychometric evaluation of an instrument measuring motivation].

McEwen's Health Motivation Assessment Inventory (HMAI) (1993) tool was developed to assess the motivation of patients with coronary artery disease to initiate and sustain healthy habits. Because of its measurement difficulties, it was modified and translated into French. The purpose of this methodological study was to examine the psychometric properties (content validity, internal consistency, and test-retest reliability) of the modified HMAI on 255 normal subjects. The average proportions of the items, rated congruent by the three raters, were 0.99 for clarity and 0.95 for relevancy. The final Cronbach's alpha coefficients for the six subscales ranged from 0.08 to 0.67. Confirmatory factor analysis provided evidence that the majority of the items were moderately independent of each other. Also, temporal stability coefficients ranged from 0.49 to 0.81. Finally, the modified HMAI was found to be free of social desirability bias. Although the modified HMAI appears to be a promising tool for future research, further refinement is needed to improve its validity.

Bias↗