A pain assessment scale for population-based studies: Development and validation of the Pain Module of the Standard Evaluation Questionnaire

The objectives of this study were to develop and validate a tool for assessing pain in population-based observational studies and to develop three subscales for back/neck, upper extremity and lower extremity pain. Based on a literature review, items were extracted from validated questionnaires and reviewed by an expert panel. The initial questionnaire consisted of a pain manikin and 34 items relating to (i) intensity of pain in different body regions (7 items), (ii) pain during activities of daily living (18 items) and (iii) various pain modalities (9 items). Psychometric validation of the initial questionnaire was performed in a random sample of the German-speaking Swiss population. Analyses included tests for reliability, correlation analysis, principal components factor analysis, tests for internal consistency and validity. Overall, 16,634 of 23,763 eligible individuals participated (70%). Test-retest reliability coefficients ranged from 0.32 to 0.97, but only three coefficients were below 0.60. Subscales were constructed combining four items for each of the subscales. Item-total coefficients ranged from 0.76 to 0.86 and Cronbach's alpha were 0.75 or higher for all subscales. Correlation coefficients between subscales and three validated instruments (WOMAC, SPADI and Oswestry) ranged from 0.62 to 0.79. The final Pain Standard Evaluation Questionnaire (SEQ Pain) included 28 items and the pain manikin and accounted for the multidimensionality of pain by assessing pain location and intensity, pain during activity, triggers and time of onset of pain and frequency of pain medication. It was found to be reliable and valid for the assessment of pain in population-based observational studies.

A parent-completed respiratory questionnaire for 1-year-old children: repeatability

BACKGROUND AND AIMS: There are few standardised questionnaires for the assessment of respiratory symptoms in preschool children. We have developed and tested the short-term repeatability of a postal questionnaire on respiratory symptoms for 1-year-old children. METHODS: A newly developed postal questionnaire for the assessment of wheeze and other respiratory symptoms was sent to parents of a population-based random sample of 4300 children aged 12-24 months. After an interval of 3 months, a random sample of 800 respondents received the questionnaire a second time. The responses were compared using Cohen's kappa (kappa) to assess agreement corrected for chance. RESULTS: The first questionnaire was returned by 3194 (74%) families, the second one by 460/800 (58%). Repeatability was excellent (kappa 0.80-0.96) for questions on household characteristics, environmental exposures and family history, good (kappa 0.61-0.80) for questions on prevalence, severity and treatment of wheeze, and moderate (kappa 0.39-0.66) for chronic cough and upper respiratory symptoms. CONCLUSIONS: This short postal questionnaire designed for use in population-based studies has excellent repeatability for family and household characteristics and good repeatability for questions on wheeze. Short-term changes in symptom status might be responsible for variable answers on recent chronic cough and upper respiratory symptoms. Overall, the questionnaire is a valuable instrument for community-based research on respiratory symptoms in 1 to 2-year-old children.

Family satisfaction in the intensive care unit: cross-cultural adaptation of a questionnaire

PURPOSE: Family needs and expectations are often unmet in the intensive care unit (ICU), leading to dissatisfaction. This study assesses cross-cultural adaptability of an instrument evaluating family satisfaction in the ICU. MATERIALS AND METHODS: A Canadian instrument on family satisfaction was adapted for German language and central European culture and then validated for feasibility, validity, internal consistency, reliability, and sensitivity. RESULTS: Content validity of a preliminary translated version was assessed by staff, patients, and next of kin. After adaptation, content and comprehensibility were considered good. The adapted translation was then distributed to 160 family members. The return rate was 71.8%, and 94.4% of questions in returned forms were clearly answered. In comparison with a Visual Analogue Scale, construct validity was good for overall satisfaction with care (Spearman rho = 0.60) and overall satisfaction with decision making (rho = 0.65). Cronbach alpha was .95 for satisfaction with care and .87 for decision-making. Only minor differences on repeated measurements were found for interrater and intrarater reliability. There was no floor or ceiling effect. CONCLUSIONS: A cross-cultural adaptation of a questionnaire on family satisfaction in the ICU can be feasible, valid, internally consistent, reliable, and sensitive.

Assessment of quality of life in patients with uncontrolled vs. controlled acromegaly using the Acromegaly Quality of Life Questionnaire (AcroQoL)

Acromegaly is a chronic disease with an important impact on quality of life. An acromegaly disease-generated quality of life questionnaire (AcroQoL) has recently been developed. We aimed to confirm reliability, construct validity and disease-specificity of the AcroQoL questionnaire. Second, we investigated the effect of remission status on health-related quality of life (HRQoL) in patients with acromegaly.

Validation of the LittlEARS((R)) Auditory Questionnaire in children with normal hearing

OBJECTIVES: With more children receiving cochlear implants during infancy, there is a need for validated assessments of pre-verbal and early verbal auditory skills. The LittlEARS Auditory Questionnaire is presented here as the first module of the LittlEARS test battery. The LittlEARS Auditory Questionnaire was developed and piloted to assess the auditory behaviour of normal hearing children and hearing impaired children who receive a cochlear implant or hearing aid prior to 24 months of age. This paper presents results from two studies: one validating the LittlEARS Auditory Questionnaire on children with normal hearing who are German speaking and a second validating the norm curves found after adaptation and administration of the questionnaire to children with normal hearing in 15 different languages. METHODS: Scores from a group of 218 German and Austrian children with normal hearing between 5 days and 24 months of age were used to create a norm curve. The questionnaire was adapted from the German original into English and then 15 other languages to date. Regression curves were found based on parental responses from 3309 normal hearing infants and toddlers. Curves for each language were compared to the original German validation curve. RESULTS: The results of the first study were a norm curve which reflects the age-dependence of auditory behaviour, reliability and homogeneity as a measure of auditory behaviour, and calculations of expected and critical values as a function of age. Results of the second study show that the regression curves found for all the adapted languages are essentially equal to the German norm curve, as no statistically significant differences were found. CONCLUSIONS: The LittlEARS Auditory Questionnaire is a valid, language-independent tool for assessing the early auditory behaviour of infants and toddlers with normal hearing. The results of this study suggest that the LittlEARS Auditory Questionnaire could also be very useful for documenting children's progress with their current amplification, providing evidence of the need for implantation, or highlighting the need for follow-up in other developmental areas.

Coping resources in a sample of chronic low back pain patients: Evaluation of the questionnaire for back pain

BACKGROUND The coping resources questionnaire for back pain (FBR) uses 12 items to measure the perceived helpfulness of different coping resources (CRs, social emotional support, practical help, knowledge, movement and relaxation, leisure and pleasure, spirituality and cognitive strategies). The aim of the study was to evaluate the instrument in a clinical patient sample assessed in a primary care setting. SAMPLE AND METHODS The study was a secondary evaluation of empirical data from a large cohort study in general practices. The 58 participating primary care practices recruited patients who reported chronic back pain in the consultation. Besides the FBR and a pain sketch, the patients completed scales measuring depression, anxiety, resilience, sociodemographic factors and pain characteristics. To allow computing of retested parameters the FBR was sent to some of the original participants again after 6 months (90% response rate). We calculated consistency and retest reliability coefficients as well as correlations between the FBR subscales and depression, anxiety and resilience scores to account for validity. By means of a cluster analysis groups with different resource profiles were formed. Results. RESULTS For the study 609 complete FBR baseline data sets could be used for statistical analysis. The internal consistency scores ranged fromα=0.58 to α=0.78 and retest reliability scores were between rTT=0.41 and rTT=0.63. Correlation with depression, fear and resilience ranged from r=-0.38 to r=0.42. The cluster analysis resulted in four groups with relatively homogenous intragroup profiles (high CRs, low spirituality, medium CRs, low CRs). The four groups differed significantly in fear and depression (the more inefficient the resources the higher the difference) as well as in resilience (the more inefficient the lower the difference). The group with low CRs also reported permanent pain with no relief. The groups did not otherwise differ. CONCLUSIONS The FBR is an economic instrument that is suitable for practical use e.g. in primary care practices to identify strengths and deficits in the CRs of chronic pain patients that can then be specified in face to face consultation. However, due to the rather low reliability, the use of subscales for profile differentiation and follow-up measurement in individual diagnoses is limited.

First results on the mandatory notification of dog bite injuries in Switzerland: a questionnaire survey among physicians and veterinarians

In order to expedite targeted interventions, mandatory notification of treated dog bite injuries for Swiss physicians and veterinarians was implemented in 2006. Since the number of notified cases was much lower than expected, the validity of the annually produced statistics with respect to the real situation in Switzerland was discussed controversially. In this study a questionnaire survey among physicians and veterinarians was carried out to evaluate the amount of and reasons for non-compliance with the mandatory notification. 81 % of the physicians and 97 % of the veterinarians reported the treatment of dog bite injuries in the year 2009. Among those, 60 % of the physicians and 41 % of the veterinarians indicated notification of less than 50 % of the treated cases. Our results indicate that the most relevant cases for targeted interventions seem to be notified, but that the statistical analyses have to be interpreted carefully.

The HeartQoL: Part II. Validation of a new core health-related quality of life questionnaire for patients with ischemic heart disease

Background: Evaluation of health-related quality of life (HRQL) is important in improving the quality of patient care. The aim of this study was to determine the psychometric properties of the HeartQoL in patients with ischemic heart disease (IHD), specifically angina, myocardial infarction (MI), or ischemic heart failure. Methods: Data for the interim validation of the HeartQoL questionnaire were collected in (a) a cross-sectional survey and (b) a prospective substudy of patients undergoing either a percutaneous coronary intervention (PCI) or referred to cardiac rehabilitation (CR) and were then analyzed to determine the reliability, validity, and responsiveness of the HeartQoL questionnaire. Results: We enrolled 6384 patients (angina, n = 2111, 33.1%; MI, n = 2351, 36.8%; heart failure, n = 1922, 30.1%) across 22 countries speaking 15 languages in the cross-sectional study and 730 patients with IHD in the prospective substudy. The HeartQoL questionnaire comprises 14-items with physical and emotional subscales and a global score (range 0–3 (poor to better HRQL). Cronbach’s α was consistently ≥0.80; convergent validity correlations between similar HeartQoL and SF-36 subscales were significant (r ≥ 0.60, p < 0.001); discriminative validity was confirmed with predictor variables: health transition, anxiety, depression, and functional status. HeartQoL score changes following either PCI or CR were significant (p < 0.001) with effect sizes ranging from 0.37–0.64. Conclusion: The HeartQoL questionnaire is reliable, valid, and responsive to change allowing clinicians and researchers to (a) assess baseline HRQL, (b) make between-diagnosis comparisons of HRQL, and (c) evaluate change in HRQL in patients with angina, MI, or heart failure with a single IHD-specific HRQL instrument.

The HeartQoL: Part I. Development of a new core health-related quality of life questionnaire for patients with ischemic heart disease

Background: Evaluation of health-related quality of life (HRQL) is important in improving the quality of patient care. Methods: The HeartQoL Project, with cross-sectional and longitudinal phases, was designed to develop a core ischemic heart disease (IHD) specific HRQL questionnaire, to be called the HeartQoL, for patients with angina, myocardial infarction (MI), or ischemic heart failure. Patients completed a battery of questionnaires and Mokken scaling analysis was used to identify items in the HeartQoL questionnaire. Results: We enrolled 6384 patients (angina, n = 2111, 33.1%; MI, n = 2351, 36.8%; heart failure, n = 1922, 30.1%) across 22 countries and 15 languages. The HeartQoL questionnaire comprises 14-items with 10-item physical and 4-item emotional subscales which are scored from 0 (poor HRQL) to 3 (better HRQL) with a global score if needed. The mean baseline HeartQoL global score was 2.2 (±0.5) in the total group and was different (p < 0.001) by diagnosis (MI, 2.4 ± 0.5; angina, 2.2 ± 0.6; and heart failure, 2.1 ± 0.6). Conclusion: The HeartQoL questionnaire, with global and subscale scores, has the potential to allow clinicians and researchers to (a) assess baseline HRQL, (b) make between-diagnosis comparisons of HRQL, and (c) evaluate change in HRQL in patients with angina, MI, or heart failure with a single IHD-specific HRQL instrument.

Questionnaire-based study to assess the association between management practices and mastitis within tie-stall and free-stall dairy housing systems in Switzerland.

BACKGROUND Prophylactic measures are key components of dairy herd mastitis control programs, but some are only relevant in specific housing systems. To assess the association between management practices and mastitis incidence, data collected in 2011 by a survey among 979 randomly selected Swiss dairy farms, and information from the regular test day recordings from 680 of these farms was analyzed. RESULTS The median incidence of farmer-reported clinical mastitis (ICM) was 11.6 (mean 14.7) cases per 100 cows per year. The median annual proportion of milk samples with a composite somatic cell count (PSCC) above 200,000 cells/ml was 16.1 (mean 17.3) %. A multivariable negative binomial regression model was fitted for each of the mastitis indicators for farms with tie-stall and free-stall housing systems separately to study the effect of other (than housing system) management practices on the ICM and PSCC events (above 200,000 cells/ml). The results differed substantially by housing system and outcome. In tie-stall systems, clinical mastitis incidence was mainly affected by region (mountainous production zone; incidence rate ratio (IRR) = 0.73), the dairy herd replacement system (1.27) and farmers age (0.81). The proportion of high SCC was mainly associated with dry cow udder controls (IRR = 0.67), clean bedding material at calving (IRR = 1.72), using total merit values to select bulls (IRR = 1.57) and body condition scoring (IRR = 0.74). In free-stall systems, the IRR for clinical mastitis was mainly associated with stall climate/temperature (IRR = 1.65), comfort mats as resting surface (IRR = 0.75) and when no feed analysis was carried out (IRR = 1.18). The proportion of high SSC was only associated with hand and arm cleaning after calving (IRR = 0.81) and beef producing value to select bulls (IRR = 0.66). CONCLUSIONS There were substantial differences in identified risk factors in the four models. Some of the factors were in agreement with the reported literature while others were not. This highlights the multifactorial nature of the disease and the differences in the risks for both mastitis manifestations. Attempting to understand these multifactorial associations for mastitis within larger management groups continues to play an important role in mastitis control programs.

Exploring the validity and reliability of a questionnaire for evaluating virtual patient design with a special emphasis on fostering clinical reasoning

Background: The design of Virtual Patients (VPs) is essential. So far there are no validated evaluation instruments for VP design published. Summary of work: We examined three sources of validity evidence of an instrument to be filled out by students aimed at measuring the quality of VPs with a special emphasis on fostering clinical reasoning: (1) Content was examined based on theory of clinical reasoning and an international VP expert team. (2) Response process was explored in think aloud pilot studies with students and content analysis of free text questions accompanying each item of the instrument. (3) Internal structure was assessed by confirmatory factor analysis (CFA) using 2547 student evaluations and reliability was examined utilizing generalizability analysis. Summary of results: Content analysis was supported by theory underlying Gruppen and Frohna’s clinical reasoning model on which the instrument is based and an international VP expert team. The pilot study and analysis of free text comments supported the validity of the instrument. The CFA indicated that a three factor model comprising 6 items showed a good fit with the data. Alpha coefficients per factor were 0,74 - 0,82. The findings of the generalizability studies indicated that 40-200 student responses are needed in order to obtain reliable data on one VP. Conclusions: The described instrument has the potential to provide faculty with reliable and valid information about VP design. Take-home messages: We present a short instrument which can be of help in evaluating the design of VPs.