Screening Accuracy and Clinical Application of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA)

Background

The Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a promising questionnaire for the early detection of psychosocial problems in toddlers. The screening accuracy and clinical application were evaluated.

Methods

In a community sample of 2-year-olds (N = 2060), screening accuracy of the BITSEA Problem scale was examined regarding a clinical CBCL1.5-5 Total Problem score. For the total population and subgroups by child’s gender and ethnicity Receiver Operating Characteristic (ROC) curves were calculated, and across a range of BITSEA Problem scores, sensitivity, specificity, likelihood ratio’s, diagnostic odds ratio and Youden’s index. Clinical application of the BITSEA was examined by evaluating the relation between the scale scores and the clinical decision of the child health professional.

Results

The area under the ROC curve (95% confidence interval) of the Problem scale was 0.97(0.95–0.98), there were no significant differences between subgroups. The association between clinical decision and BITSEA Problem score (B = 2.5) and Competence score (B = −0.7) was significant (p<0.05).

Conclusions

The results indicate that the BITSEA Problem scale has good discriminative power to differentiate children with and without psychosocial problems. Referred children had less favourable scores compared to children that were not referred. The BITSEA may be helpful in the early detection of psychosocial problems.     

Screening for Autism Spectrum Disorders with the Brief Infant-Toddler Social and Emotional Assessment

Objective

Using parent-completed questionnaires in (preventive) child health care can facilitate the early detection of psychosocial problems and psychopathology, including autism spectrum disorders (ASD). A promising questionnaire for this purpose is the Brief Infant-Toddler Social and Emotional Assessment (BITSEA). The screening accuracy with regard to ASD of the BITSEA Problem and Competence scales and a newly calculated Autism score were evaluated.

Method

Data, that was collected between April 2010 and April 2011, from a community sample of 2-year-olds (N = 3127), was combined with a sample of preschool children diagnosed with ASD (N = 159). For the total population and for subgroups by child''s gender, area under the Receiver Operating Characteristic (ROC) curve was examined, and across a range of BITSEA Problem, Competence and Autism scores, sensitivity, specificity, positive and negative likelihood ratio''s, diagnostic odds ratio and Youden''s index were reported.

Results

The area under the ROC curve (95% confidence interval, [95%CI]) of the Problem scale was 0.90(0.87–0.92), of the Competence scale 0.93(0.91–0.95), and of the Autism score 0.95(0.93–0.97). For the total population, the screening accuracy of the Autism score was significantly better, compared to the Problem scale. The screening accuracy of the Competence scale was significantly better for girls (AUC = 0.97; 95%CI = 0.95–0.98) than for boys (AUC = 0.91; 95%CI = 0.88–0.94).

Conclusion

The results indicate that the BITSEA scales and newly calculated Autism score have good discriminative power to differentiate children with and without ASD. Therefore, the BITSEA may be helpful in the early detection of ASD, which could have beneficial effects on the child''s development.     

TOPICOP?: A New Scale Evaluating Topical Corticosteroid Phobia among Atopic Dermatitis Outpatients and Their Parents

Background

The fear of using topical corticosteroids, usually called topical corticophobia, is a frequent concern for atopic dermatitis patients and/or their parents. Assessing patients’ atopic dermatitis and their parents’ topical corticosteroid phobia is an essential step to improving adherence to treatment. Because topical corticophobia appears to be a complex phenomenon, its evaluation by binary responses (yes/no) is too simplistic. Thus, a scale is needed, which is capable of identifying the subtleties of topical corticosteroid phobia.

Objectives

To develop and validate a scale, TOPICOP©, measuring worries and beliefs about topical corticosteroids among atopic dermatitis outpatients and their parents.

Methods

An initial statistical validation of TOPICOP was carried out, collecting qualitative data about patients’ topical corticophobia behaviors and beliefs using focus-group methodology. Then, 208 outpatients or their parents from five French centers completed a self-administered questionnaire built from focus-group results. The scale-development process comprised an explanatory principal component analysis, Cronbach’s α-coefficients and structural equation modeling.

Results

The validated questionnaire comprised 12 items, covering two important dimensions relative to “worries” (6 items) and “beliefs” (6 items). Psychometric properties showed that items had very good communality (>0.60) within their own dimension. The final two-factor solution accounted for 47.3% of the variance. Cronbach’s α-coefficients were, respectively, 0.79 and 0.78. Structural equation modeling strongly supported the possibility of calculating a global score.

Conclusions

TOPICOP© is the first scale aimed at assessing topical corticophobia in adult patients and parents of children with eczema. TOPICOP® has excellent psychometric properties and should be easy to use in everyday clinical practice for clinicians and researchers. Further studies are needed to confirm our results and validate TOPICOP© in other cultures.     

Assessing Attitudes towards Statistics among Medical Students: Psychometric Properties of the Serbian Version of the Survey of Attitudes Towards Statistics (SATS)

Background

Medical statistics has become important and relevant for future doctors, enabling them to practice evidence based medicine. Recent studies report that students’ attitudes towards statistics play an important role in their statistics achievements. The aim of the study was to test the psychometric properties of the Serbian version of the Survey of Attitudes Towards Statistics (SATS) in order to acquire a valid instrument to measure attitudes inside the Serbian educational context.

Methods

The validation study was performed on a cohort of 417 medical students who were enrolled in an obligatory introductory statistics course. The SATS adaptation was based on an internationally accepted methodology for translation and cultural adaptation. Psychometric properties of the Serbian version of the SATS were analyzed through the examination of factorial structure and internal consistency.

Results

Most medical students held positive attitudes towards statistics. The average total SATS score was above neutral (4.3±0.8), and varied from 1.9 to 6.2. Confirmatory factor analysis validated the six-factor structure of the questionnaire (Affect, Cognitive Competence, Value, Difficulty, Interest and Effort). Values for fit indices TLI (0.940) and CFI (0.961) were above the cut-off of ≥0.90. The RMSEA value of 0.064 (0.051–0.078) was below the suggested value of ≤0.08. Cronbach’s alpha of the entire scale was 0.90, indicating scale reliability. In a multivariate regression model, self-rating of ability in mathematics and current grade point average were significantly associated with the total SATS score after adjusting for age and gender.

Conclusion

Present study provided the evidence for the appropriate metric properties of the Serbian version of SATS. Confirmatory factor analysis validated the six-factor structure of the scale. The SATS might be reliable and a valid instrument for identifying medical students’ attitudes towards statistics in the Serbian educational context.     

Development of the Japanese 15D Instrument of Health-Related Quality of Life: Verification of Reliability and Validity among Elderly People

Objective

The 15D is a self-administered questionnaire for assessment of health-related quality of life, which contains 15 questions with 5 response options each. This study was conducted to evaluate the reliability and validity of the Japanese 15D.

Methods

The subjects were 430 community-dwelling elderly people. Each item of the 15D was scored on a 5-point Likert scale, with level 1 being the best, score 1. Reliability was assessed by determination of the internal consistency and test-retest reliability. Criterion-based validity was assessed using the Japanese version of the Nottingham Health Profile (NHP) and Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG index). Acceptability was assessed by inquiring about the time required to complete the questionnaire and the burden felt in responding to it.

Results

The answers of 423 individuals who responded to all items were analyzed. The median time required to complete the questionnaire was 5.0 minutes, and the proportion of subjects who indicated that the questionnaire was easy to complete was 98.3%. The Cronbach’s alpha coefficients for all 15 items in the 2 surveys were 0.793 and 0.792, respectively. The intraclass correlation coefficients for the 15 items ranged from 0.44 to 0.72. In the relationship between the 15D and the NHP, the correlation coefficients between the corresponding domains were higher than those between non-corresponding domains. The prevalence of disability in higher-level functional capacity was higher in the “level 2 to 5” group than in the “level 1” group.

Conclusions

The Japanese version of the 15D showed sufficient internal consistency and moderate repeatability. Because of the short time required to complete the Japanese 15D and the significant relationships between the scores on the 15D and the NHP, and between the 15D and higher-level functional capacity, the acceptability and validity of the Japanese 15D were considered to be sufficient.     

Childhood Internalizing and Externalizing Problems Predict the Onset of Clinical Panic Attacks over Adolescence: The TRAILS Study

Background

Panic attacks are a source of individual suffering and are an independent risk factor for later psychopathology. However, much less is known about risk factors for the development of panic attacks, particularly during adolescence when the incidence of panic attacks increases dramatically. We examined whether internalizing and externalizing problems in childhood predict the onset of panic attacks in adolescence.

Method

This study is part of the TRacking Adolescents’ Individual Lives Survey (TRAILS), a Dutch longitudinal population cohort study (N = 1,584). Internalizing and Externalizing Problems were collected using the Youth Self-Report (YSR) and the parent-report Child Behavior Checklist (CBCL) at baseline (age 10–12). At age 18–20, DSM-IV defined panic attacks since baseline were assessed with the Composite International Diagnostic Interview (CIDI). We investigated whether early adolescent Internalizing and Externalizing Problems predicted panic attacks between ages 10–20 years, using survival analysis in univariate and multivariate models.

Results

There were N = 314 (19.8%) cases who experienced at least one DSM-IV defined panic attack during adolescence and N = 18 (1.2%) who developed panic disorder during adolescence. In univariate analyses, CBCL Total Problems, Internalizing Problems and three of the eight syndrome scales predicted panic attack onset, while on the YSR all broad-band problem scales and each narrow-band syndrome scale predicted panic attack onset. In multivariate analyses, CBCL Social Problems (HR 1.19, p<.05), and YSR Thought Problems (HR 1.15, p<.05) and Social Problems (HR 1.26, p<.01) predicted panic attack onset.

Conclusion

Risk indicators of panic attack include the wide range of internalizing and externalizing problems. Yet, when adjusted for co-occurring problem behaviors, Social Problems were the most consistent risk factor for panic attack onsets in adolescence.     

Development of Two Barthel Index-Based Supplementary Scales for Patients with Stroke

Background

The Barthel Index (BI) assesses actual performance of activities of daily living (ADL). However, comprehensive assessment of ADL functions should include two other constructs: self-perceived difficulty and ability.

Objective

The aims of this study were to develop two BI-based Supplementary Scales (BI-SS), namely, the Self-perceived Difficulty Scale and the Ability Scale, and to examine the construct validity of the BI-SS in patients with stroke.

Method

The BI-SS was first developed by consultation with experts and then tested on patients to confirm the clarity and feasibility of administration. A total of 306 participants participated in the construct validity study. Construct validity was investigated using Mokken scale analysis and analyzing associations between scales. The agreement between each pair of the scales’ scores was further examined.

Results

The Self-perceived Difficulty Scale consisted of 10 items, and the Ability Scale included 8 items (excluding both bladder and bowel control items). Items in each individual scale were unidimensional (H≥0.5). The scores of the Self-perceived Difficulty and Ability Scales were highly correlated with those of the BI (rho = 0.78 and 0.90, respectively). The scores of the two BI-SS scales and BI were significantly different from each other (p<.001). These results indicate that both BI-SS scales assessed unique constructs.

Conclusions

The BI-SS had overall good construct validity in patients with stroke. The BI-SS can be used as supplementary scales for the BI to comprehensively assess patients’ ADL functions in order to identify patients’ difficulties in performing ADL tasks, plan intervention strategies, and assess outcomes.     

A clinical in-hospital prognostic score for acute exacerbations of COPD

Background

The use of a severity score to help orientation decisions could improve the efficiency of care for acute exacerbations of COPD (AECOPD). We previously developed a score (‘2008 score’, based on age, dyspnea grade at steady state and number of clinical signs of severity) predicting in-hospital mortality in patients with AECOPD visiting emergency departments (EDs). External validity of this score remained to be assessed.

Objectives

To test the predictive properties of the ‘2008 score’ in a population of patients hospitalized in medical respiratory wards for AECOPD, and determine whether a new score specifically derived from this population would differ from the previous score in terms of components or predictive performance.

Methods

Data from a cohort study in 1824 patients hospitalized in a medical ward for an AECOPD were analyzed. Patients were categorized using the 2008 score and its predictive characteristics for in-hospital mortality rates were assessed. A new score was developed using multivariate logistic regression modeling in a randomly selected derivation population sample followed by testing in the remaining population (validation sample). Robustness of results was assessed by case-by-case validation.

Results

The 2008 score was characterized by a c-statistic at 0.77, a sensitivity of 69% and a specificity of 76% for prediction of in-hospital mortality. The new score comprised the same variables plus major cardiac comorbidities and was characterized by a c-statistic of 0.78, a sensitivity of 77% and specificity of 66%.

Conclusions

A score using simple clinical variables has robust properties for predicting the risk of in-hospital death in patients hospitalized for AECOPD. Adding cardiac comorbidities to the original score increased its sensitivity while decreasing its specificity.

Electronic supplementary material

The online version of this article (doi:10.1186/s12931-014-0099-9) contains supplementary material, which is available to authorized users.     

Development and Validation of a Severity Scale for Leprosy Type 1 Reactions

Objectives

To develop a valid and reliable quantitative measure of leprosy Type 1 reactions.

Methods

A scale was developed from previous scales which had not been validated. The face and content validity were assessed following consultation with recognised experts in the field. The construct validity was determined by applying the scale to patients in Bangladesh and Brazil who had been diagnosed with leprosy Type 1 reaction. An expert categorized each patient''s reaction as mild or moderate or severe. Another worker applied the scale. This was done independently. In a subsequent stage of the study the agreement between two observers was assessed.

Results

The scale had good internal consistency demonstrated by a Cronbach''s alpha >0.8. Removal of three items from the original scale resulted in better discrimination between disease severity categories. Cut off points for Type 1 reaction severities were determined using Receiver Operating Characteristic curves. A mild Type 1 reaction is characterized using the final scale by a score of 4 or less. A moderate reaction is a score of between 4.5 and 8.5. A severe reaction is a score of 9 or more.

Conclusions

We have developed a valid and reliable tool for quantifying leprosy Type 1 reaction severity and believe this will be a useful tool in research of this condition, in observational and intervention studies, and in the comparison of clinical and laboratory parameters.     

Comparison of Alternative Evidence Summary and Presentation Formats in Clinical Guideline Development: A Mixed-Method Study

Background

Best formats for summarising and presenting evidence for use in clinical guideline development remain less well defined. We aimed to assess the effectiveness of different evidence summary formats to address this gap.

Methods

Healthcare professionals attending a one-week Kenyan, national guideline development workshop were randomly allocated to receive evidence packaged in three different formats: systematic reviews (SRs) alone, systematic reviews with summary-of-findings tables, and ‘graded-entry’ formats (a ‘front-end’ summary and a contextually framed narrative report plus the SR). The influence of format on the proportion of correct responses to key clinical questions, the primary outcome, was assessed using a written test. The secondary outcome was a composite endpoint, measured on a 5-point scale, of the clarity of presentation and ease of locating the quality of evidence for critical neonatal outcomes. Interviews conducted within two months following completion of trial data collection explored panel members’ views on the evidence summary formats and experiences with appraisal and use of research information.

Results

65 (93%) of 70 participants completed questions on the prespecified outcome measures. There were no differences between groups in the odds of correct responses to key clinical questions. ‘Graded-entry’ formats were associated with a higher mean composite score for clarity and accessibility of information about the quality of evidence for critical neonatal outcomes compared to systematic reviews alone (adjusted mean difference 0.52, 95% CI 0.06 to 0.99). There was no difference in the mean composite score between SR with SoF tables and SR alone. Findings from interviews with 16 panelists indicated that short narrative evidence reports were preferred for the improved clarity of information presentation and ease of use.

Conclusions

Our findings suggest that ‘graded-entry’ evidence summary formats may improve clarity and accessibility of research evidence in clinical guideline development.

Trial Registration

Controlled-Trials.com ISRCTN05154264     

Psychometrics of the Short Form 36 Health Survey Version 2 (SF-36v2) and the Quality of Life Scale for Drug Addicts (QOL-DAv2.0) in Chinese Mainland Patients with Methadone Maintenance Treatment

Objective

To test psychometrics of the Short Form 36 Health Survey version 2 (SF-36v2) and the Quality of Life Scale for Drug Addicts (QOL-DAv2.0) in Chinese mainland patients with methadone maintenance treatment (MMT).

Methods

A total of 1,212 patients were recruited from two MMT clinics in Xi’an, China. Reliability was estimated with Cronbach’s α and intra-class correlation (ICC). Convergent and discriminant validity was assessed using multitrait-multimethod correlation matrix. Sensitivity was measured with ANOVA and relative efficiency. Responsiveness was evaluated by pre-post paired-samples t-test and standardized response mean based on the patients’ health status changes following 6-month period.

Results

Cronbach’s α of the SF-36v2 physical and mental summary components were 0.80 and 0.86 (eight scales range 0.73–0.92) and the QOL-DAv2.0 was 0.96 (four scales range: 0.80–0.93). ICC of the SF-36v2 two components were 0.86 and 0.85 (eight scales range: 0.72–0.87) and the QOL-DAv2.0 was 0.94 (four scales range: 0.88–0.92). Convergent validity was lower between the two instruments (γ <0.70) while discriminant validity was acceptable within each instrument. Sensitivity was satisfied in self-evaluated health status (both instruments) and average daily methadone dose (SF-36v2 physical functioning and vitality scales; QOL-DAv2.0 except psychology scale). Responsiveness was acceptable in the improved health status change (SF-36v2 except vitality scale; QOL-DAv2.0 except psychology and symptoms scales) and deteriorated health status change (SF-36v2 except vitality, social functioning and mental health scales; QOL-DAv2.0 except society scale).

Conclusions

The SF-36v2 and the QOL-DAv2.0 are valid tools and can be used independently or complementary according to different emphases of health-related quality of life evaluation in patients with MMT.     

Evaluation of Construct and Criterion Validity for the ‘Liverpool Osteoarthritis in Dogs’ (LOAD) Clinical Metrology Instrument and Comparison to Two Other Instruments

Objective

To test the ‘Liverpool Osteoarthritis in Dogs’ (LOAD) questionnaire for construct and criterion validity, and to similarly test the Helsinki Chronic Pain Index (HCPI) and the Canine Brief Pain Inventory (CBPI).

Design

Prospective Study.

Animals

222 dogs with osteoarthritis.

Procedure

Osteoarthritis was diagnosed in a cohort of dogs on the basis of clinical history and orthopedic examination. Force-platform analysis was performed and a “symmetry index” for peak vertical force (PVF) was calculated. Owners completed LOAD, CBPI and HCPI instruments. As a test of construct validity, inter-instrument correlations were calculated. As a test of criterion validity, the correlations between instrument scores and PVF symmetry scores were calculated. Additionally, internal consistency of all instruments was calculated and compared to those previously reported. Factor analysis is reported for the first time for LOAD, and is compared to that previously reported for CBPI and HCPI.

Results

Significant moderate correlations were found between all instruments, implying construct validity for all instruments. Significant weak correlations were found between LOAD scores and PVF symmetry index, and between CBPI scores and PVF symmetry index.

Conclusion and Clinical Relevance

LOAD is an owner-completed clinical metrology instrument that can be recommended for the measurement of canine osteoarthritis. It is convenient to use, validated and, as demonstrated here for the first time, has a correlation with force-platform data.     

Development and Validation of the Chinese Attitudes to Starting Insulin Questionnaire (Ch-ASIQ) for Primary Care Patients with Type 2 Diabetes

Objectives

To develop and evaluate the psychometric properties of a Chinese questionnaire which assesses the barriers and enablers to commencing insulin in primary care patients with poorly controlled Type 2 diabetes.

Research Design and Method

Questionnaire items were identified using literature review. Content validation was performed and items were further refined using an expert panel. Following translation, back translation and cognitive debriefing, the translated Chinese questionnaire was piloted on target patients. Exploratory factor analysis and item-scale correlations were performed to test the construct validity of the subscales and items. Internal reliability was tested by Cronbach’s alpha.

Results

Twenty-seven identified items underwent content validation, translation and cognitive debriefing. The translated questionnaire was piloted on 303 insulin naïve (never taken insulin) Type 2 diabetes patients recruited from 10 government-funded primary care clinics across Hong Kong. Sufficient variability in the dataset for factor analysis was confirmed by Bartlett’s Test of Sphericity (P<0.001). Using exploratory factor analysis with varimax rotation, 10 factors were generated onto which 26 items loaded with loading scores > 0.4 and Eigenvalues >1. Total variance for the 10 factors was 66.22%. Kaiser-Meyer-Olkin measure was 0.725. Cronbach’s alpha coefficients for the first four factors were ≥0.6 identifying four sub-scales to which 13 items correlated. Remaining sub-scales and items with poor internal reliability were deleted. The final 13-item instrument had a four scale structure addressing: ‘Self-image and stigmatization’; ‘Factors promoting self-efficacy; ‘Fear of pain or needles’; and ‘Time and family support’.

Conclusion

The Chinese Attitudes to Starting Insulin Questionnaire (Ch-ASIQ) appears to be a reliable and valid measure for assessing barriers to starting insulin. This short instrument is easy to administer and may be used by healthcare providers and researchers as an assessment tool for Chinese diabetic primary care patients, including the elderly, who are unwilling to start insulin.     

Psychometric Properties of the Japanese Version of the STarT Back Tool in Patients with Low Back Pain

Background and Objective

The STarT Back Tool uses prognostic indicators to classify patients with low back pain into three risk groups to guide early secondary prevention in primary care. The present study aimed to evaluate the psychometric properties of the Japanese version of the tool (STarT-J).

Methods

An online survey was conducted among Japanese patients with low back pain aged 20–64 years. Reliability was assessed by examining the internal consistency of the overall and psychosocial subscales using Cronbach’s alpha coefficients. Spearman’s correlation coefficients were used to evaluate the concurrent validity between the STarT-J total score/psychosocial subscore and standard reference questionnaires. Discriminant validity was evaluated by calculating the area under the curves (AUCs) for the total and psychosocial subscale scores against standard reference cases. Known-groups validity was assessed by examining the relationship between low back pain-related disability and STarT-J scores.

Results

The analysis included data for 2000 Japanese patients with low back pain; the mean (standard deviation [SD]) age was 47.7 (9.3) years, and 54.1% were male. The mean (SD) STarT-J score was 2.2 (2.1). The Cronbach’s alpha coefficient was 0.75 for the overall scale and 0.66 for the psychosocial subscale. Spearman’s correlation coefficients ranged from 0.30 to 0.59, demonstrating moderate to strong concurrent validity. The AUCs for the total score ranged from 0.65 to 0.83, mostly demonstrating acceptable discriminative ability. For known-groups validity, participants with more somatic symptoms had higher total scores. Those in higher STarT-J risk groups had experienced more low back pain-related absences.

Conclusions

The overall STarT-J scale was internally consistent and had acceptable concurrent, discriminant, and known-groups validity. The STarT-J can be used with Japanese patients with low back pain.     

Validation of the IHE Cohort Model of Type 2 Diabetes and the Impact of Choice of Macrovascular Risk Equations

Background

Health-economic models of diabetes are complex since the disease is chronic, progressive and there are many diabetic complications. External validation of these models helps building trust and satisfies demands from decision makers. We evaluated the external validity of the IHE Cohort Model of Type 2 Diabetes; the impact of using alternative macrovascular risk equations; and compared the results to those from microsimulation models.

Methods

The external validity of the model was analysed from 12 clinical trials and observational studies by comparing 167 predicted microvascular, macrovascular and mortality outcomes to the observed study outcomes. Concordance was examined using visual inspection of scatterplots and regression-based analysis, where an intercept of 0 and a slope of 1 indicate perfect concordance. Additional subgroup analyses were conducted on ‘dependent’ vs. ‘independent’ endpoints and microvascular vs. macrovascular vs. mortality endpoints.

Results

Visual inspection indicates that the model predicts outcomes well. The UKPDS-OM1 equations showed almost perfect concordance with observed values (slope 0.996), whereas Swedish NDR (0.952) and UKPDS-OM2 (0.899) had a slight tendency to underestimate. The R ² values were uniformly high (>0.96). There were no major differences between ‘dependent’ and ‘independent’ outcomes, nor for microvascular and mortality outcomes. Macrovascular outcomes tended to be underestimated, most so for UKPDS-OM2 and least so for NDR risk equations.

Conclusions

External validation indicates that the IHE Cohort Model of Type 2 Diabetes has predictive accuracy in line with microsimulation models, indicating that the trade-off in accuracy using cohort simulation might not be that large. While the choice of risk equations was seen to matter, each were associated with generally reasonable results, indicating that the choice must reflect the specifics of the application. The largest variation was observed for macrovascular outcomes. There, NDR performed best for relatively recent and well-treated patients, while UKPDS-OM1 performed best for the older UKPDS cohort.     

Development of a Multimorbidity Illness Perceptions Scale (MULTIPleS)

Background

Illness perceptions are beliefs about the cause, nature and management of illness, which enable patients to make sense of their conditions. These perceptions can predict adjustment and quality of life in patients with single conditions. However, multimorbidity (i.e. patients with multiple long-term conditions) is increasingly prevalent and a key challenge for future health care delivery. The objective of this research was to develop a valid and reliable measure of illness perceptions for multimorbid patients.

Methods

Candidate items were derived from previous qualitative research with multimorbid patients. Questionnaires were posted to 1500 patients with two or more exemplar long-term conditions (depression, diabetes, osteoarthritis, coronary heart disease and chronic obstructive pulmonary disease). Data were analysed using factor analysis and Rasch analysis. Rasch analysis is a modern psychometric technique for deriving unidimensional and intervally-scaled questionnaires.

Results

Questionnaires from 490 eligible patients (32.6% response) were returned. Exploratory factor analysis revealed five potential subscales ‘Emotional representations’, ‘Treatment burden’, ‘Prioritising conditions’, ‘Causal links’ and ‘Activity limitations’. Rasch analysis led to further item reduction and the generation of a summary scale comprising of items from all scales. All scales were unidimensional and free from differential item functioning or local independence of items. All scales were reliable, but for each subscale there were a number of patients who scored at the floor of the scale.

Conclusions

The MULTIPleS measure consists of five individual subscales and a 22-item summary scale that measures the perceived impact of multimorbidity. All scales showed good fit to the Rasch model and preliminary evidence of reliability and validity. A number of patients scored at floor of each subscale, which may reflect variation in the perception of multimorbidity. The MULTIPleS measure will facilitate research into the impact of illness perceptions on adjustment, clinical outcomes, quality of life, and costs in patients with multimorbidity.     

Assessing the Assessment in Emergency Care Training

Objective

Each year over 1.5 million health care professionals attend emergency care courses. Despite high stakes for patients and extensive resources involved, little evidence exists on the quality of assessment. The aim of this study was to evaluate the validity and reliability of commonly used formats in assessing emergency care skills.

Methods

Residents were assessed at the end of a 2-week emergency course; a subgroup was videotaped. Psychometric analyses were conducted to assess the validity and inter-rater reliability of the assessment instrument, which included a checklist, a 9-item competency scale and a global performance scale.

Results

A group of 144 residents and 12 raters participated in the study; 22 residents were videotaped and re-assessed by 8 raters. The checklists showed limited validity and poor inter-rater reliability for the dimensions “correct” and “timely” (ICC = .30 and.39 resp.). The competency scale had good construct validity, consisting of a clinical and a communication subscale. The internal consistency of the (sub)scales was high (α = .93/.91/.86). The inter-rater reliability was moderate for the clinical competency subscale (.49) and the global performance scale (.50), but poor for the communication subscale (.27). A generalizability study showed that for a reliable assessment 5–13 raters are needed when using checklists, and four when using the clinical competency scale or the global performance scale.

Conclusions

This study shows poor validity and reliability for assessing emergency skills with checklists but good validity and moderate reliability with clinical competency or global performance scales. Involving more raters can improve the reliability substantially. Recommendations are made to improve this high stakes skill assessment.     

‘The Words Will Pass with the Blowing Wind’: Staff and Parent Views of the Deferred Consent Process,with Prior Assent,Used in an Emergency Fluids Trial in Two African Hospitals

Objective

To document and explore the views and experiences of key stakeholders regarding the consent procedures of an emergency research clinical trial examining immediate fluid resuscitation strategies, and to discuss the implications for similar trials in future.

Methods

A social science sub-study of the FEAST (Fluid Expansion As Supportive Therapy) trial. Interviews were held with trial team members (n = 30), health workers (n = 15) and parents (n = 51) from two purposively selected hospitals in Soroti, Uganda, and Kilifi, Kenya.

Findings

Overall, deferred consent with prior assent was seen by staff and parents as having the potential to protect the interests of both patients and researchers, and to avoid delays in starting treatment. An important challenge is that the validity of verbal assent is undermined when inadequate initial information is poorly understood. This concern needs to be balanced against the possibility that full prior consent on admission potentially causes harm through introducing delays. Full prior consent also potentially imposes worries on parents that clinicians are uncertain about how to proceed and that clinicians want to absolve themselves of any responsibility for the child’s outcome (some parents’ interpretation of the need for signed consent). Voluntariness is clearly compromised for both verbal assent and full prior consent in a context of such vulnerability and stress. Further challenges in obtaining verbal assent were: what to do in the absence of the household decision-maker (often the father); and how medical staff handle parents not giving a clear agreement or refusal.

Conclusion

While the challenges identified are faced in all research in low-income settings, they are magnified for emergency trials by the urgency of decision making and treatment needs. Consent options will need to be tailored to particular studies and settings, and might best be informed by consultation with staff members and community representatives using a deliberative approach.