A brief tool to assess capacity to consent for medical care among homeless individuals with problematic substance use: study protocol

Background

Public health care increasingly uses outreach models to engage individuals who are marginalized, many of whom misuse substances. Problematic substance use, together with marginalization from the health care system, among homeless adults makes it difficult to assess their capacity to consent to medical care. Tools have been developed to assess capacity to consent; however, these tools are lengthy and unsuitable for outreach settings. The primary objective of this study is to develop, validate, and pilot a brief but sensitive screening instrument which can be used to guide clinicians in assessing capacity to consent in outreach settings. The goal of this paper is to outline the protocol for the development of such a tool.

Methods/Design

A brief assessment tool will be developed and compared to the MacArthur Competency Assessment Tool for Treatment (MacCAT-T). As list of 36 possible questions will be created by using qualitative data from clinician interviews, as well as concepts from the literature. This list will be rated by content experts according to the extent that it corresponds to the test objectives. The instrument will be validated with 300 homeless adult volunteers who self-report problematic substance use. Participants will be assessed for capacity using the MacCAT-T and the new instrument. A combination of Classical Test Theory and advanced psychometric methods will be used for the psychometric analysis. Corrected Item-Total correlation will be examined to identify items that discriminate poorly. Guided exploratory factor analysis will be conducted on the final selection of items to confirm the assumptions for a unidimensional polytomous Rasch model. If unidimensionality is confirmed, an unstandardized Cronbach Alpha will be calculated. If multi-dimensionality is detected, a multidimensional Rasch analysis will be conducted. Results from the new instrument will be compared to the total score from the MacCAT-T by using Pearson’s correlation test. The new instrument will then be piloted in real-time by street outreach clinicians to determine the acceptability and usefulness of the new instrument.

Discussion

This research will build on the existing knowledge about assessing capacity to consent and will contribute new knowledge about assessing individuals whose judgment is impaired by substance use.     

Psychometric validation of the revised Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life instrument

The revised Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) quality of life (QoL) instrument has been updated and expanded to provide more complete and accurate coverage of human immune deficiency virus/ acquired immune deficiency syndrome (HIV/AIDS)-related QoL. Factor analysis and the Rasch measurement model were used to determine a new subscale structure for the FAHI. The content of these subscales, including physical well-being (ten items, = 0.91), function and global well-being (13 items, = 0.86), emotional well-being/living with HIV (10 items, = 0.82), social well-being (eight items, = 0.73), and cognitive functioning (three items; = 0.75), reflect both general illness- and HIV/AIDS-specific QoL concerns: a total QoL score can also be calculated for the FAHI (44 items, =0.91). Psychometric evaluation revealed good internal consistency reliability for the FAHI and its subscales. In addition, construct validity, known groups validity and sensitivity to change were demonstrated by significant associations between the FAHI and additional indicators of functional status, psychological symptoms, stress and illness severity. In summary, the FAHI is a psychometrically sound instrument that captures multiple important dimensions of HIV/AIDS-related QoL. It is brief, easy to administer and score, has been translated into nine languages other than English and is appropriate for use in clinical trials and clinical practice.     

Validation of the WHOQOL-BREF quality of life questionnaire for general use in New Zealand: confirmatory factor analysis and Rasch analysis

Purpose

The present study validated the abbreviated version of the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire for general use in New Zealand.

Methods

A random postal sample from the national electoral roll was used, and 808 questionnaires were returned. Psychometric properties of the instrument were assessed, including tests of the four-domain factor structure using confirmatory factor analysis and Rasch analysis.

Results

Goodness-of-fit from the confirmatory factor analysis were good, and the overall conclusion of the Rasch analysis supported the confirmatory factor analysis (CFA) findings after dealing with problems of threshold ordering, local dependency, and differential item functioning (DIF).

Conclusions

The WHOQOL-BREF is valid for general use in New Zealand. In the future work, the WHOQOL-BREF domain scores should either be analyzed using non-parametric statistics or data should be fitted to the Rasch model to derive interval person estimates.     

Using the Rasch Model to Validate and Enhance the Interpretation of the Functional Assessment of Cancer Therapy–Kidney Symptom Index—Disease-Related Symptoms Scale

Objectives:  The Functional Assessment of Cancer Therapy–Kidney Symptom Index—Disease-Related Symptoms (FKSI-DRS) was developed to assess patients' kidney-cancer-related symptoms. The Rasch rating scale, a one-parameter logistic item response model, may enhance FKSI-DRS interpretation and validate its measurement properties.
Methods:  We applied the Rasch model to FKSI-DRS data from a randomized phase 3 trial in which first-line sunitinib therapy showed superiority to interferon-alfa in patients with metastatic renal cell carcinoma. Of 750 enrolled patients, 668 patients completed the questionnaire on cycle 1, day 28 and were evaluated in the current study. The nine FKSI-DRS items were analyzed to enhance interpretation of the summary score by using an item characteristic curve that related score to probability of reporting specific symptoms.
Results:  The Rasch model fitted the FKSI-DRS well: 8 of 9 items had acceptable infit and outfit statistics (<1.5, >0.5); item difficulty spanned a wide range (−3.23 to 1.64 logits); and the five response categories performed adequately. The item characteristic curve offered enhanced interpretation of FKSI-DRS: For example, an FKSI-DRS score of 27 (mean baseline score for total sample) indicated a 47% chance of reporting "no" to "lack of energy," although a two-point difference between sunitinib and interferon-alfa, averaged across all assessments (29 vs. 27), corresponded to sunitinib achieving a 28% increase (13% absolute difference) in the probability of reporting "no" to "lack of energy" (60% vs. 47%).
Conclusions:  Data suggest that the FKSI-DRS is an adequate measure of symptom status in patients with metastatic renal cell carcinoma. The Rasch model supports its validation and enhances its interpretation.     

Adaptation of the Nottingham Health Profile: a simple measure to assess quality of life

The aim of the present study was to evaluate the psychometric properties of the Brazilian version of the Nottingham Health Profile (NHP), a generic instrument for quality of life assessment. This NHP was translated to Portuguese, following recommended methodology, and applied to 215 subjects, being 170 community elderly (66.3 +/- 8.5 years), 30 chronic stroke survivors (56.4 +/- 10.9 years), and 15 parkinsonians (59.6 +/- 10.2 years). The data was analysed by Rasch analysis. Out of the 38 items of NHP, only two items (5%) did not fit the statistical model, indicating that the items collaborated to measure a unidimensional construct. However, some items of NHP were very easy for the elderly, stroke survivors and Parkinsonians, characterizing a ceiling effect, which could limit the use of the scale for individuals with higher levels of ability. The results, in spite of indicating that the instrument fits the Rasch statistical model for this sample, indicate a need for revision of the items, in order to make the questionnaire more clinically useful.     

Acromegaly Quality of Life Questionnaire (AcroQoL)

Acromegaly is a chronic disease with an important impact on patients, Health Related Quality of Life (HRQoL). The ability to effectively measure Health Related Quality of Life is central to describing the impacts of disease or treatment upon the patient, therefore the importance of having a disease specific questionnaire for acromegaly. For the development of the AcroQoL questionnaire different sources of information were used: first a literature search was performed to identify relevant papers describing the impact of acromegaly in HRQoL, second the main domains of impact on HRQoL were identified by 10 experts endocrinologists, and third ten in-depth semi-structured interviews were conducted in acromegalic patients to identify domains and items related to the self-perceived impact of acromegaly in patients' life. After a proper qualitative analysis a preliminary 38 item questionnaire was obtained. Rasch analysis concluded with a final 22 item questionnaire. The measurement properties (validity and reliability) of the resulting final questionnaire were tested and compared using standard procedures (Cronbach's Alpha and item-total correlation). The evaluation of the item parameters confirmed the construct validity of the new instrument. Responsiveness to change was assessed in a small sample of 32 acromegalic patients with active disease in Spain who were administered the AcroQoL and the generic questionnaire EuroQoL 5-D. The results showed a statistically significant relationship between all the dimensions of AcroQoL and the VAS (visual analogic scale) of EQ-5D. An improvement in the global score of AcroQoL was related to a global improvement in the VAS of the EQ-5D.     

Rasch analysis of the Western Ontario McMaster (WOMAC) Osteoarthritis Index: results from community and arthroplasty samples

BACKGROUND AND OBJECTIVE: This study is based on secondary analysis of Western Ontario McMaster Osteoarthritis Index (WOMAC) data from a community sample over 55 years and total hip or knee arthroplasty samples presurgery and 1-year postoperative. METHODS: The WOMAC data were evaluated by Rasch analysis. Data were considered to fit the Rasch mathematical model for the pain and physical dimensions of the WOMAC if unidimensionality was confirmed by principle component analysis of the subscale and the residuals from the Rasch analysis, infit and outfit statistics were in the range of 0.80 to 1.20; if there was no differential item functioning based on gender or hip vs. knee subjects; and, if there was stability of the item logits across the three data samples. RESULTS: A three-item pain dimension (excluding night pain and pain on standing) and a 14-item physical dimension (excluding heavy domestic duties, getting in and out of the bath and getting on and off the toilet) fit the Rasch model based on these criteria. CONCLUSION: In evaluating existing health status questionnaires using Rasch methodology, it is important to evaluate relevant patient samples and longitudinal data when the measure is intended to evaluate change in status. By these criteria, a modified WOMAC questionnaire fits the Rasch model and has interval-level scaling properties.     

Feasibility and psychometric properties of the German 12-item WHO Disability Assessment Schedule (WHODAS 2.0) in a population-based sample of patients with myocardial infarction from the MONICA/KORA myocardial infarction registry

Background

The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) provides a standardized assessment of functioning and disability in individuals with any kind of disease. So far, data on feasibility and psychometric properties of the 12-item WHODAS 2.0 in patients with acute myocardial infarction (AMI) are not available. Thus, the objective of this study was to investigate feasibility and psychometric properties of this questionnaire in a population-based sample of persons with AMI.

Methods

The sample consisted of 2077 persons (age 35-85 years) with AMI from the population-based MONICA/KORA Myocardial Infarction Registry, Augsburg, Germany, who responded to a postal follow-up survey in 2011. Feasibility was assessed by the number of missing WHODAS 2.0 items and analyzed using multivariate logistic regression modeling. Psychometric properties were determined using Rasch analysis. It included testing of unidimensionality, monotonicity and local independency, Partial Credit Model (PCM) fitting, and testing for Differential Item Functioning (DIF). Concurrent validity was tested by a linear additive model predicting the WHODAS disability score based on a number of independent variables.

Results

For 96% of the subjects, the WHODAS disability score could be computed. Incomplete questionnaires were significantly more common in older persons (Odds ratio (OR) 1.03, 95% confidence interval (CI) 1.01-1.05) and persons with bad/very bad self-rated health (OR 2.55, 95% CI 1.28-5.06). The assumptions of Rasch modeling were fulfilled. The PCM revealed disordered thresholds for nine of the 12 items. However, it was possible to achieve a correct order of thresholds by collapsing the five response options to three. The item thresholds covered the whole range of the continuum, indicating that items are appropriate to differentiate between persons across the whole continuum of disability. No DIF was detected for any of the tested variables such as age, sex, and education. Significantly higher disability scores were found in persons with comorbidities and impaired overall health status, confirming concurrent validity.

Conclusions

The 12-item WHODAS 2.0 is a feasible, nonbiased, and valid instrument for application in persons with AMI. Shortcomings refer to unordered thresholds of most items. Further studies are required in order to confirm these findings.

     

Usefulness of EQ-5D for evaluation of health-related quality of life in young adults with first-episode psychosis

Purpose

To evaluate the psychometric properties of the EQ-5D and the usefulness of this instrument in psychiatric practice as a measure of health-related quality of life (HRQoL) in a sample of young adults with first-episode psychosis.

Methods

The validity of individual questionnaire items is studied using an Item Response/Latent Trait Theory modeling approach. Sensitivity of response patterns on EQ-5D items to particular diagnostic subtypes of psychosis is investigated using a finite mixture modeling approach through latent class analysis. Finally, a structural equation modeling framework is used to study differential item functioning via a multigroup approach.

Results

Results suggest that the data closely correspond to the Rasch Rating Scale Model, and therefore that EQ-5D latent scores are equal interval measures. Despite comprising relatively few items, the instrument yields reliable measures of HRQoL for group comparisons and cost-effectiveness evaluation, but EQ-5D score is too imprecise for the assessment of HRQoL for clinical purposes at the individual level. A significant relationship was found between EQ-5D responses and type of psychosis due to inclusion of item anxiety/depression in EQ-5D. Two items (anxiety/depression, functioning in usual activities) showed an ethnicity bias.

Conclusions

Psychometric evidence confirmed the EQ-5D to be a valid, interval measure that is scalable according to Rasch principles.     

Derivation and testing of an interval-level score for measuring locomotor disability in epidemiological studies of middle and old age

Purpose

Locomotor disability is prevalent in middle and old age and although interval-level measurement instruments have been developed that relate to locomotor disability, there is currently no brief, interval-level score developed specifically to measure the severity of locomotor disability in the general population. We aimed to create such a score from five items of the SF-36 Physical Functioning subscale (PF-10): three walking- and two stair-climbing-related, and assess the scoring mechanism’s measurement properties.

Methods

Data were collected from postal surveys of adults aged 50 years and over. The walking and stair-climbing items were formed into two super-items to remove response dependency. The Rasch measurement model was used to form an interval-level score and fit to this model was assessed. The scoring mechanism was applied to three external data sets and fit to the Rasch model was assessed. Repeatability, construct validity, and responsiveness of the new interval scale were examined.

Results

Overall, the fit of the super-items to the Rasch model was good, with little evidence of misfit. Our analyses broadly support the generalisability, repeatability, construct validity, and responsiveness of this new interval-level score.

Conclusions

An interval-level score for locomotor disability was created from five items of the PF-10 completed in a general population of adults aged 50 years and over. Further work is needed to assess the generalisability of this Rasch score to other populations and to determine a clinically meaningful change score.     

Reliability,validity and responsiveness of the Greek MacDQoL individualized measure of the impact of macular degeneration on quality of life

Purpose

To assess the psychometric properties of the Greek Macular Disease-Dependent Quality of Life Questionnaire (MacDQoL).

Methods

The MacDQoL was translated in Greek and administered to 191 patients with neovascular age-related macular degeneration (AMD). To assess validity, all patients completed the Greek SF-12 health survey and underwent vision measurements. For test–retest reliability, a subset of twenty participants completed the MacDQoL twice, 2 weeks apart. Responsiveness was assessed on 102 patients who completed the MacDQoL at a follow-up visit, 1 year later. Rasch analysis was used to assess the Greek MacDQoL’s response category functioning, precision, unidimensionality, targeting and differential item functioning.

Results

Internal and test–retest reliability of the average weighted impact (AWI) was 0.952 and 0.97, respectively. Test–retest reliability of MacDQoL items ranged from 0.78 to 0.99. Principal component analysis revealed three subscales (activities, embarrassment and family life), which were also confirmed by confirmatory factor analysis. Rasch analysis revealed poor functionality of response categories and that was resolved by collapsing response categories and using the impairment scores only. In terms of convergent validity, the AWI and revised MacDQoL scales showed significant correlations with SF-12 summary scales (ρ = 0.21–0.30) and vision assessments (ρ = 0.31–0.46). Poorer AMD-related QoL at 1-year follow-up was associated with deterioration in distance visual acuity and worse eye near visual acuity.

Conclusions

The Greek MacDQoL is a reliable, valid and sensitive to change in vision instrument for assessing AMD patients’ perceptions of QoL. However, Rasch analysis revealed that its multiplicative rating scale is flawed. Scientific measurement was restored with a number of revisions to the questionnaire.

     

The EORTC breast cancer-specific quality of life questionnaire (EORTC QLQ-BR23): Translation and validation study of the Iranian version

The objective of this study was to test the reliability and validity of the Iranian version of the European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). The English-language version of the questionnaire was translated into Persian (Iranian language) and its final form was approved by the EORTC Study Group on Quality of Life and then it was used in this study. The questionnaire was administered at two points in time to a consecutive sample of 168 newly diagnosed breast cancer patients and almost all of them (99%) found the questions easy to understand and acceptable. Cronbach's coefficient for multi-item scales (to test reliability) ranged from 0.63 to 0.95 at baseline and from 0.75 to 0.92 at follow-up administration of the questionnaire. Validity analysis was performed using known-groups' comparison analysis. The results showed that all functional and symptom scales discriminated between sub-groups of patients differing in clinical status as defined by their performance status and disease stage. In addition, all functional and symptoms scales detected change over time, as a function of changes in patients' performance status. In general, the findings of this study indicated that the Iranian version of the EORTC QLQ-BR23 is a reliable and valid supplementary measure of the quality of life in breast cancer patients and can be used in clinical trials and studies of outcome research in oncology.     

QUOTE-HIV: an instrument for assessing quality of HIV care from the patients' perspective

Background: An HIV-specific version of the QUOTE questionnaire was developed to measure the quality of care of patients infected with HIV from the patients' perspective. The consistency and validity of the questionnaire was assessed.

Methods: Focus group discussions were held to select aspects for inclusion in the questionnaire that are important to patients with HIV. Item and inter-item analysis, factor analysis, and reliability analysis were performed to test the internal consistency and validity of the questionnaire.

Results: Twenty seven items (13 generic and 14 HIV specific) were used in the QUOTE-HIV questionnaire. Separate factor analyses of the generic and HIV specific aspects indicated that each loaded onto a single factor. The internal consistency of the total questionnaire was good (Cronbach's alpha &ge;0.80). Feasibility of the questionnaire was shown by the diversity of importance and performance scores for general practitioners as well as for HIV specialists and AIDS nursing consultants.

Conclusion: The QUOTE-HIV questionnaire is a useful instrument for measuring the quality of care from the perspective of HIV infected patients.

     

An evaluation of the structural validity of the shoulder pain and disability index (SPADI) using the Rasch model

Purpose

The shoulder pain and disability index (SPADI) has been extensively evaluated for its psychometric properties using classical test theory (CTT). The purpose of this study was to evaluate its structural validity using Rasch model analysis.

Methods

Responses to the SPADI from 1030 patients referred for physiotherapy with shoulder pain and enrolled in a prospective cohort study were available for Rasch model analysis. Overall fit, individual person and item fit, response format, dependence, unidimensionality, targeting, reliability and differential item functioning (DIF) were examined.

Results

The SPADI pain subscale initially demonstrated a misfit due to DIF by age and gender. After iterative analysis it showed good fit to the Rasch model with acceptable targeting and unidimensionality (overall fit Chi-square statistic 57.2, p?=?0.1; mean item fit residual 0.19 (1.5) and mean person fit residual 0.44 (1.1); person separation index (PSI) of 0.83. The disability subscale however shows significant misfit due to uniform DIF even after iterative analyses were used to explore different solutions to the sources of misfit (overall fit (Chi-square statistic 57.2, p?=?0.1); mean item fit residual 0.54 (1.26) and mean person fit residual 0.38 (1.0); PSI 0.84).

Conclusions

Rasch Model analysis of the SPADI has identified some strengths and limitations not previously observed using CTT methods. The SPADI should be treated as two separate subscales. The SPADI is a widely used outcome measure in clinical practice and research; however, the scores derived from it must be interpreted with caution. The pain subscale fits the Rasch model expectations well. The disability subscale does not fit the Rasch model and its current format does not meet the criteria for true interval-level measurement required for use as a primary endpoint in clinical trials. Clinicians should therefore exercise caution when interpreting score changes on the disability subscale and attempt to compare their scores to age- and sex-stratified data.

     

Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer

Background

The Health-Related Quality of Life (HRQoL) assessment in atrial fibrillation (AF) patients has traditionally been carried out in a poorly standardised fashion, or via the use of non disease-specific HRQoL questionnaires. The development of a HRQoL questionnaire with a good measuring performance will allow for a standardised assessment of the impact of this disease on the patient's daily living.

Methods

A bibliography review was conducted to identify the most relevant domains of daily living in AF patients. Subsequently, a focus group was created with the aid of cardiologists, and 17 patients were interviewed to identify the most-affected HRQoL domains. A qualitative analysis of the interview answers was performed, which was used to develop a pilot questionnaire administered to a 112-patient sample. Based on patient responses, an analysis was carried out following the statistical procedures defined by the Classical Test Theory (CTT) and the Item Response Theory (IRT). Reliablility was assessed via Cronbach's coefficient alpha and item-total score correlations. A factorial analysis was performed to determine the number of domains. For each domain, a Rasch analysis was carried out, in order to reduce and stand hierarchically the questionnaire items.

Results

By way of the bibliography review and the expert focus group, 10 domains were identified. The patient interviews allowed for the identification of 286 items that later were downsized to 40 items. The resultant preliminary questionnaire was administered to a 112-patient sample (pilot study). The Rasch analysis led to the definition of two domains, comprising 7 and 11 items respectively, which corresponded to the psychological and physical domains (18 items total), thereby giving rise to the initial AF-QoL-18 questionnaire. Cronbach's coefficient alpha was acceptable (0.91).

Conclusion

An initial HRQoL questionnaire, AFQoL-18, has been developed to assess HRQoL in AF patients.     

Performance of a new, HIV/AIDS-targeted quality of life (HAT-QoL) instrument in asymptomatic seropositive individuals

Objective: to evaluate the psychometric performance of a new human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS)-targeted quality of life (QoL) instrument in asymptomatic HIV-seropositive individuals. Methods: 201 urban and rural, HIV-seropositive subjects were recruited to complete a 76-item pilot QoL measure developed using content provided in group process by seropositive individuals. Questionnaire responses from the full sample (n=201) were used to identify dimensions and to reduce the number of items to 42. The responses to the retained items were then analysed for the asymptomatic subsample (n=106). Results: 9 multi-item dimensions were identified: overall function (OF), sexual function (SF), disclosure worries (DW), health worries (HW), financial worries (FW), HIV mastery (HM), life satisfaction (LS), medication concerns (MC) and provider trust (PT). The responses by asymptomatic subjects (74% male, 64% non-White and 63% homosexual/bisexual) revealed no substantial floor or ceiling effects, except for the PT dimension (where 44% were found to have scored the highest score). The internal consistency coefficients (Cronbach's alphas) were between 0.80 and 0.89 for six dimensions. The coefficients were lower for the SF (0.52), HM (0.67) and MC (0.48) dimensions. Construct validity assessments, using self-reported HIV disease-severity and sociodemographic variables, revealed some significant relationships (p0.05) for all dimensions except SF, MC and PT. Conclusions: the results suggested that five dimensions (OF, DW, HW, FW and LS) from the new instrument have good psychometric properties for asymptomatic HIV-seropositive individuals. These dimensions may be useful in the study of asymptomatic, seropositive individuals' QoL. Four dimensions (SF, HM, MC and PS) require additional refinement for this subpopulation.     

Estimating the Efficacy of Receiving Treatment in Randomized Clinical Trials with Noncompliance

Analysis of a randomized trial is problematic when there is noncompliance with the treatment assignment. An intent-to-treat (ITT) analysis estimates the effect of randomization rather than the effect for those who actually receive the treatment. An alternative to the ITT is the as treated analysis, in which subjects are classified by the treatment actually received. However, the as treated analysis is also flawed since confounders are likely to be associated with switching treatment.We propose the use of an instrumental variable estimate (using the randomization as the instrument) in combination with propensity score adjustment. In addition, we consider the assumptions implicit in the instrumental variable methodology.These methods are illustrated with data from the Multimodal Treatment of ADHD (MTA) Study of treatment efficacy for children with attention deficit hyperactivity disorder. We show how the addition of the propensity score adjustment to the instrumental variable analysis uncovers some surprising results concerning the children who were assigned to behavioral therapy only but switched to medication.     

Awareness and Attitude of the General Public Toward HIV/AIDS in Coastal Karnataka

Objective:

To assess the awareness and attitude of the general public toward people living with HIV/AIDS (PLWHA) in Mangalore, a city in Coastal Karnataka.

Design:

Community-based cross-sectional study.

Materials and Methods:

The study population included 630 individuals aged 18 years and above. The information was collected using a semi structured pre-tested questionnaire. The questionnaire consisted of 24 questions regarding awareness of the modes of transmission of HIV/AIDS (nine questions) and questions to assess the attitude toward People Living With HIV/AIDS (PLWHA) (15 questions). Statistical package SPSS version 11.5 was used, Chi-square test was conducted and P < 0.05 was considered as statistically significant.

Results:

About one-third of the study population thought that one could get infected by merely touching an HIV positive individual. Approximately 45% stated that they would dismiss their maid on finding out her HIV positive status. About 54% were willing to undergo the HIV test. The respondents with less than secondary school education had a discriminatory attitude toward HIV positive people, with regard to them deserving to suffer, dismissing a HIV positive maid, hesitating to sit next to a HIV positive person in the bus, divorcing the infected spouse, and willingness to get tested for HIV, which was found to be statistically significant.

Conclusion:

Stigma among the general public was mostly due to fear of contracting the illness. Stigma does exist to significant degrees among the educated people, which was suggested by about 45% of the participants being willing to undergo the HIV test. There is a need for greater attempts toward making information regarding HIV/AIDS available to every individual of the society.     

Development and validation of a patient-reported questionnaire assessing systemic therapy induced diarrhea in oncology patients

Background

Systemic therapy-induced diarrhea (STID) is a common side effect experienced by more than half of cancer patients. Despite STID-associated complications and poorer quality of life (QoL), no validated assessment tools exist to accurately assess STID occurrence and severity to guide clinical management. Therefore, we developed and validated a patient-reported questionnaire (STIDAT).

Methods

The STIDAT was developed using the FDA iterative process for patient-reported outcomes. A literature search uncovered potential items and questions for questionnaire construction used by oncology clinicians to develop questions for the preliminary instrument. The instrument was evaluated on its face validity and content validity by patient interviews. Repetitive, similar and different themes uncovered from patient interviews were implemented to revise the instrument to the version used for validation. Patients starting high-risk STID treatments were monitored using the STIDAT, bowel diaries and EORTC QLQ-C30. The STIDAT was evaluated for construct validity using exploratory factor analysis (EFA) using minimal residual method with Promax rotation, reliability and consistency. A weighted scoring system was developed and a receiver-operating characteristic (ROC) curve evaluated the tool’s ability to detect STID occurrence. Median scores and variability were analysed to determine how well it differentiates between diarrhea severities. A post-hoc analysis determined how diarrhea severity impacted QoL of cancer patients.

Results

Patients defined diarrhea based on presence of watery stool. The STIDAT assessed patient’s perception of having diarrhea, daily number of bowel movements, daily number of diarrhea episodes, antidiarrheal medication use, the presence of urgency, abdominal pain, abdominal spasms or fecal incontinence, patient’s perception of diarrhea severity, and QoL. These dimensions were sorted into four clusters using EFA – patient’s perception of diarrhea, frequency of diarrhea, fecal incontinence and abdominal symptoms. Cronbach’s alpha was 0.78; kappa ranged from 0.934–0.952, except for abdominal spasms (κ = 0.0455). The positive predictive value was 96.4%, with the minimum score of 1.35 predicting a positive STID occurrence. Patients with moderate or severe diarrhea experience significant decreases in QoL compared to those with no diarrhea.

Conclusions

This is the first patient-reported questionnaire that accurately predicts the occurrence and severity of diarrhea in oncology patients via assessing several bowel habit dimensions.

     

Evaluation properties of the French version of the OUT-PATSAT35 satisfaction with care questionnaire according to classical and item response theory analyses

Purpose

The present study investigates the properties of the French version of the OUT-PATSAT35 questionnaire, which evaluates the outpatients’ satisfaction with care in oncology using classical analysis (CTT) and item response theory (IRT).

Methods

This cross-sectional multicenter study includes 692 patients who completed the questionnaire at the end of their ambulatory treatment. CTT analyses tested the main psychometric properties (convergent and divergent validity, and internal consistency). IRT analyses were conducted separately for each OUT-PATSAT35 domain (the doctors, the nurses or the radiation therapists and the services/organization) by models from the Rasch family. We examined the fit of the data to the model expectations and tested whether the model assumptions of unidimensionality, monotonicity and local independence were respected.

Results

A total of 605 (87.4 %) respondents were analyzed with a mean age of 64 years (range 29–88). Internal consistency for all scales separately and for the three main domains was good (Cronbach’s α 0.74–0.98). IRT analyses were performed with the partial credit model. No disordered thresholds of polytomous items were found. Each domain showed high reliability but fitted poorly to the Rasch models. Three items in particular, the item about “promptness” in the doctors’ domain and the items about “accessibility” and “environment” in the services/organization domain, presented the highest default of fit. A correct fit of the Rasch model can be obtained by dropping these items. Most of the local dependence concerned items about “information provided” in each domain. A major deviation of unidimensionality was found in the nurses’ domain.

Conclusions

CTT showed good psychometric properties of the OUT-PATSAT35. However, the Rasch analysis revealed some misfitting and redundant items. Taking the above problems into consideration, it could be interesting to refine the questionnaire in a future study.