Development of a questionnaire for measurement of vision-related quality of life

PURPOSE: To define vision-related quality of life, to outline the development of a vision-specific quality of life instrument and to present the characteristics of a 10-item 'core' questionnaire. METHOD: A standard method included: 1. Generation of relevant issues by individual interviews with 38 visually impaired adults, consultation with 37 professionals and support workers and literature review. 2. Operationalisation, involving 58 ophthalmic patients. 3. Pre-testing, to maximise face validity and content validity, involving 184 individuals with a variety of different visual problems and social backgrounds. 4. Adoption of a modular approach to item selection. 5. Formal piloting in 92 individuals to establish reliability and construct validity. RESULTS: More than 232 items were tested of which 139 were considered suitable for a final question pool or 'parent' questionnaire (the VQOL). From this parent questionnaire individual items or groups of items can be selected. Ten broadly applicable items referring to physical, social and psychological issues were selected for the core questionnaire (the VCM1). The VCM1 has high reliability (alpha = 0.93) and validity. CONCLUSIONS: Any self-reported problem relating to vision may constitute a quality of life issue. A modular approach to item selection may provide the flexibility to investigate vision-related quality of life in a wide range of clinical settings, allowing detailed assessment of specific problems and also cross-study comparisons where appropriate.     

Development of a disease-specific health-related quality of life questionnaire for sleep apnea

The Calgary Sleep Apnea Quality of Life Index (SAQLI) was developed to record key elements of the disease that are important to patients. All items felt to influence the quality of life of these patients were identified. Final questionnaire items were selected by interviewing 113 patients with sleep apnea and 50 snorers who rated each item on whether it was a problem and the importance of it to their overall quality of life. Items for the final questionnaire were selected based on the rank order of the frequency ximportance product. The rank ordering was similar across strata of disease severity and between sexes. The Calgary SAQLI has 35 questions organized into four domains: daily functioning, social interactions, emotional functioning, and symptoms. A fifth domain, treatment-related symptoms, can be added for clinical intervention trials to record the possible negative impacts of treatment. The SAQLI has a high degree of internal consistency, face validity as judged by content experts and patients, and construct validity as shown by its positive correlations with the SF-36 and the improvement in scores in patients successfully completing a 4-wk trial of continuous positive airway pressure. It includes items shown to be important to patients with sleep apnea and is designed as a measure of outcome in clinical trials in sleep apnea. Flemons WW, Reimer MA. Development of a disease-specific health-related quality of life questionnaire for sleep apnea.     

Validation of a telephone questionnaire for Parkinson''s disease

Unfractionated as well as low-molecular-weight heparins (LMWH) are known to cause an increase in blood levels of tissue factor pathway inhibitor (TFPI). To study the effect of a newly developed supersulfated LMWH (IK-SSH, Iketon Farmaceutici) on TFPI concentrations in human plasma, the compound was injected into volunteers at doses of 0.14, 0.33 and 0.66 mg/kg intravenously or 0.33, 0.66 and 1.0 mg/kg subcutaneously. At certain known times blood was drawn and plasma levels of both total and free TFPI were measured using enzyme-linked immunosorbent assay methodology. Baseline plasma concentrations of TFPI were 72.2+/-3.1 ng/ml for total and 10.8+/-0.8 ng/ml for free TFPI. Intravenous or subcutaneous injection of IK-SSH led to a strong and long-lasting rise in TFPI levels which were increased more than 5-fold for total TFPI and more than 30-fold for free TFPI. Maximum TFPI levels were reached 5-10 min after intravenous and 60 min after subcutaneous administration. IK-SSH caused prolongation of ex-vivo clotting times in the APTT and Heptest assay, whereas thrombin time was not affected. Anticoagulant actions of IK-SSH showed a significant correlation to plasma concentrations of TFPI and they are thought to be based at least partially on the release of TFPI from vascular sites.     

An improved questionnaire for assessing quality of life after acute myocardial infarction

This paper reports our experience with the use of an improved self-administered questionnaire for assessing quality of life (QOL) after acute myocardial infarction. The modified questionnaire significantly increased the proportion of patients able to answer all questions from 84%-92%. The additional questions in the improved questionnaire increased the total variance explained by the Emotional, Physical and Social QOL factors from 65.8%-66.5%. Internal consistency and construct validity were assessed and found to be high. Overall, we have found that this improved questionnaire is easy to administer and that it possesses desirable properties of validity and reliability.     

Quality of life in chronic inflammatory bowel diseases. Validation of a questionnaire and first French data]

One hundred and seventy patients with Graves' disease underwent thyroidectomy between 1987 and 1994 (10.5% of all thyroidectomies performed in the same period). Female/male ratio was 9/1; mean age 55.2 years and average period between diagnosis and surgical treatment 5.3 years. The average thyroid weight was 230 g (range 90-950 g). Thyroidectomy was subtotal in 110 and total in 60 patients, 5 of which had been previously treated elsewhere from 5 to 33 years before. Malignancy was incidentally found in 2.35% of patients. The complication rate resulted higher in total thyroidectomies than in subtotal procedures (bleeding 0.9% vs 5.4%, transient hypoparathyroidism 4.5% vs 12.7%, recurrent nerve lesion 0.45% vs 2.72%) however the differences were not statistically significant; this probably because both the procedures were carried out with the same technique for parathyroid gland and recurrent nerve safety. The need of repeated surgery increased the risk. In opposition to total thyroidectomy, subtotal thyroidectomy does not doom to complete and permanent replacement therapy (96.4% of hypothyroidism at 2 months, 72.6% at 4 years), but in this series it failed to achieve remission in 2 patients who maintained a mild hyperthyroidism and in one more patient who developed a relapse 4 years later. Serum TSI meaning is not clear, but preoperative positivity suggests a wider resection and postoperative persistence a closer follow-up by functional assessment. In conclusion surgical procedures for Graves' disease range from subtotal to total thyroidectomy but for a safe outcome the choice depends more on the intraoperative troubles of each single case than on theoretic advantages.     

Evaluating health-related quality of life in patients with facial acne: development of a self-administered questionnaire for clinical trials

Although psychosocial aspects of skin diseases are well known, disease-specific questionnaires validated for use in clinical trials are not available to assess the impact of facial acne on health-related quality of life or to evaluate therapeutic change. Development of such an instrument was undertaken and included item generation, reduction and pilot-testing phases. By interviewing acne subjects and dermatologists and literature review, 168 possible items were identified. Next, 165 acne subjects identified which items affected them and rated importance on a 5-point scale. Reduction to a brief questionnaire was performed by evaluating patient-perceived importance and factor analysis; four domains were identified (self-perception, role-emotional, role-social, acne symptoms). After pilot-testing for comprehension in acne subjects, further revisions were made to improve clarity and applicability. The resulting instrument takes 10 minutes to complete, and consists of 24 questions assessing how acne affected certain aspects of patients' lives during the past week on a 7-point scale. Thus, an instrument with excellent content validity was developed to assess health-related quality of life in patients with facial acne, and is comprised of statistically meaningful items of importance to patients. Other measurement characteristics are being assessed in a recently initiated study to evaluate test-retest reliability and responsiveness to therapy.     

The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30

While quality of life (QOL) assessment is becoming more common, interpreting the results remains problematic. This paper demonstrates an approach to developing clinically-based interpretations for QOL outcomes, using the QLQ-C30 as an example. The results from 14 published QLQ-C30 studies which group patients by performance status, weight loss, toxicity, extent or severity of disease are collated. Groups with lower clinical status generally have worse QOL. The largest differences are between performance status groups, and the smallest differences are between groups of patients with local disease and those with metastases. The physical and role scores have the largest ranges of means across patient groups, and show the largest differences between clinical groups, while the cognitive and emotional scores have the smallest ranges of means and differences. Sicker groups have larger score standard deviations than healthier groups. Relatively large and small means and differences, and corresponding effect sizes, are presented. Collectively, the results provide a sense of the relative sizes of means and of differences, and of the types of clinical groups which give rise to them, thereby providing clinically-based benchmarks by which to interpret QLQ-C30 results.     

Evaluation of the RFIPC, a disease-specific health-related quality of life questionnaire, in Swedish patients with ulcerative colitis

BACKGROUND: We wanted to characterize a Swedish version of the Rating Form of Inflammatory Bowel Disease Patient Concerns (RFIPC) with regard to validity, reliability, and responsiveness. METHODS: Two hundred and three consecutive patients with ulcerative colitis were studied. Health-related quality of life (HRQOL) was measured with the disease-specific questionnaire, the RFIPC, and a general questionnaire, the Sickness Impact Profile (SIP). Concerns about general well-being were also reported. Disease activity was measured by means of symptom cards, laboratory tests, and two clinical indices for disease activity. RESULTS: Test-retest reliability using Spearman's r (rs) was 0.79, and internal consistency measured with Cronbach's alpha was 0.95. RFIPC had a fair correlation with concerns about general well-being (rs = 0.69, P < 0.001). There was also a stronger correlation with another measure of HRQOL, the overall SIP score (rs = 0.43), than with measures of disease activity such as stool frequency (rs = 0.28) and sigmoidoscopic grading (NS). The group of patients in relapse had a higher RFIPC sum score than patients in remission (P = 0.001). Measures of HRQOL had a low correlation with disease activity and did not respond to changes in disease activity. CONCLUSION: The Swedish version of the RFIPC is a valid and reliable measure of HRQOL. The SIP and the RFIPC have a good discriminative ability between groups of patients in remission and in relapse. However, they do not seem to be useful in predicting the disease activity or change in disease activity over time in the individual patient.     

A new short practical quality of life questionnaire for use in head and neck oncology outpatient clinics

A new short questionnaire to assess the quality of life of head and neck patients has been designed at the University of Liverpool Head and Neck Oncology Department. The questionnaire is short, simple and can be easily completed by a patient whilst in the waiting room before consultation. It is filled in 6 months after completion of treatment and shows very good correlation with the standard long exhaustive questionnaires that are difficult to complete on every patient in a busy National Health Service clinic. The University of Liverpool questionnaire provides a simple score from 0%-100% which should prove valuable in the assessment of quality of care and help with decisions regarding treatment options in head and neck cancer patients.     

Evaluation of the short-form 36-item questionnaire to measure health-related quality of life in patients with COPD

STUDY OBJECTIVE: To evaluate the short-form 36-item questionnaire (SF-36) as an instrument for measuring health-related quality of life (HRQL) in patients with symptomatic COPD. DESIGN: Observational data at a single point in time. SETTING: Outpatient pulmonary clinic. PATIENTS: Fifty male patients with COPD and no significant comorbidity. MEASUREMENTS AND RESULTS: HRQL was assessed with the SF-36, which consists of 36 questions that cover nine health domains. Clinical ratings of dyspnea were measured by the multidimensional baseline dyspnea index (BDI). Pulmonary function tests included forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), and maximal inspiratory mouth pressure (PImax). The mean (+/- SD) age of the patients was 72 +/- 8 years. The BDI focal score was 5.6 +/- 2.3, FEV1 was 1.32 +/- 0.60 L (48 +/- 22% pred), and PImax was 62 +/- 23 cm H2O. The BDI focal score was significantly correlated with seven of nine components of the SF-36 (range of r, 0.42 to 0.91; p < 0.05). The FEV1 percent of predicted and PImax were significantly correlated with five of nine health components (range of r, 0.30 to 0.65 and 0.31 to 0.61, respectively). Using linear regression model analysis with the different SF-36 components as the dependent variable and BDI, FVC, FEV1, and PImax as independent variables, the BDI score was the only significant predictor of social and physical functioning, role-physical, vitality, pain, health perceptions, and health transition (p < 0.05). CONCLUSIONS: The SF-36 is a valid instrument to measure HRQL in patients with COPD. The severity of dyspnea but not respiratory function was a significant predictor of various components of HRQL.     

Validation of a French version of an informant-based questionnaire as a screening test for Alzheimer's disease

BACKGROUND: Development of informant-based screening tests for dementia is an emerging field. The reliability and validity of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), an instrument that screens for dementia in general, have been established. We conducted a study to validate a French version of the IQCODE as a screening test for Alzheimer's dementia in the elderly living in the community. METHOD: In the Canadian Study of Health and Aging, subjects were screened in their own homes using the modified Mini-Mental State Exam (3-MS). Those who screened positive, along with a sample of subjects who screened negative, were referred for a complete clinical examination. In Quebec, an informant was asked to complete the French version, IQCODE(F), at that time. Based on the final clinical diagnoses, performances of the IQCODE(F) and Mini-Mental State Examination (MMSE, converted from 3-MS) in screening for Alzheimer's disease were evaluated. RESULTS: Of the 237 subjects, the mean IQCODE (F) score was 3.4 (s.d. = 0.6), on a 5-point scale (1 = improvement in condition over the past 10 years, 5 = marked deterioration, 3 = no change). The mean MMSE score was 23.1 (s.d. = 4.5). The scores on the two scales were correlated (r = -0.44, P < 0.001). The IQCODE(F) scores were unrelated to education (r = -0.07, P > 0.3) in contrast to the MMSE scores (r = 0.28, P < 0.001). With respect to a diagnosis of probable Alzheimer's disease, the IQCODE(F) (cut-off point 3.6) had a sensitivity of 75% and a specificity of 95.6%. The sensitivity and specificity of the MMSE (cut-off point 23) were 70% and 82.3% respectively. CONCLUSION: The findings of the IQCODE(F) are consistent with those of the English version in correlation with the MMSE and apparent freedom from educational bias. The IQCODE is superior to the MMSE as a screening test for probable Alzheimer's disease in the elderly living in the community. It may be a useful addition to the screening tests already available, especially for the less well educated.     

Some methodological issues in the development of quality of life measures for the evaluation of medical interventions

This paper discusses a series of important methodological issues in developing targeted health-related quality of life measures in studies of the effects of medical interventions. Such measures cannot be developed unless the evaluator understands the life domains that medical interventions affect. Qualitative discovery methods are needed to obtain this understanding. Once domains are targeted for measurement, careful and systematic laboratory pilot work should be used to select initial scale items. Psychometric evaluation of response patterns in subsequent field tests is needed to assess the measures. Less concern should be directed to internal consistency reliability of scales in the psychometric evaluation and more to the ability of short scales to reproduce total scale variance and to provide precise measurement within the range of the outcome where effects are expected. The paper closes with a discussion of modern methods of item response scaling that can be used to address these issues.     

Validation of a personality questionnaire designed for defining sub-groups at risk for ischemic cardiopathy or cancer in the Gazel cohort

Within the context of a prospective survey project among 20,000 volunteers working for "Electricité de France--Gaz de France" Company (GAZEL cohort), we performed a feasibility study using four self-assessment questionnaires: the Jenkins Activity Survey (measuring type A behaviour pattern), the Buss and Durkee Hostility Inventory, the Center for Epidemiologic Studies--Depression Scale and a personality questionnaire developed by Grossarth-Maticek and Eysenck (GME). Questionnaires were sent twice by mail, at an interval of three months, to a random sample of 408 males: 71% returned the filled forms the first time, 66% the second time, and 80% at least once. The test-retest correlation coefficients ranged from 0.62 to 0.87. The validity of the six personality type scores, calculated from GME, was tested by correlations with the scores of the three other instruments. These correlations appeared consistent with the proposed typology, especially for the "Healthy" type, the "Cancer prone" type and the "Coronary Heart Disease prone" type. The labelling of these types was justified by their association with different disease events, suggested from previous studies.     

Health-related quality of life measurement for evaluation research and policy analysis.

Describes a unit of health status, the "Well-Year," which expresses the output of health programs in terms of the number of years and the health-related quality of life produced by a treatment or program. Dividing the cost of the program by the number of Well-Years that it produces gives the cost–utility of the program. This cost–utility ratio can be used in a general health policy model to compare the efficiency of different programs or to assess the relative contribution of different programs and providers in the health-care system. Different components of the model are useful (1) for the effectiveness of medical interventions, (2) to assess the quality of care, (3) to improve clinical decision making, (4) to assess needs of different populations, and (5) to understand causes of variations in health. A comprehensive standardized measure of health status has many advantages for health planning, decision analysis, and program evaluation. An example demonstrates how the relative production of Well-Years by psychologists might be compared to the contribution of other health-care services. (66 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Grandmothering, menopause, and the evolution of human life histories

Long postmenopausal lifespans distinguish humans from all other primates. This pattern may have evolved with mother-child food sharing, a practice that allowed aging females to enhance their daughters' fertility, thereby increasing selection against senescence. Combined with Charnov's dimensionless assembly rules for mammalian life histories, this hypothesis also accounts for our late maturity, small size at weaning, and high fertility. It has implications for past human habitat choice and social organization and for ideas about the importance of extended learning and paternal provisioning in human evolution.     

Measuring quality of life for patients with terminal illness: the Missoula-VITAS quality of life index

OBJECTIVE: To investigate whether fibronectin fragments (Fn-fs), shown to damage cultured cartilage, can be found in cartilage from patients with osteoarthritis (OA) or rheumatoid arthritis, or can be generated from fibronectin (Fn) within synovial fluids or from Fn in the matrix of cultured cartilage. To also determine whether cartilage or synovial fluid Fn-fs are active and, thus, could contribute to cartilage damage in vivo. METHODS: Fn-fs were immunochemically identified in cartilage extracts from patients with OA or rheumatoid arthritis or in bovine cartilage cultured with IL-1 alpha or in bovine synovial fluids treated with stromelysin-1 (MMP-3). The effect of removal of Fn-fs from OA synovial fluids was tested by passing fluids over an anti-Fn column and adding the resultant fluids to bovine cartilage cultures to measure proteoglycan (PG) degradation. Gelatin-Sepharose purified Fns from bovine plasma, synovial fluid or cartilage were digested with MMP-3 and the Fn-fs tested for degradation of PG in cultured cartilage. RESULTS: Extracts of cartilage from patients with rheumatoid arthritis or with OA contained a range of Fn-fs. Removal of Fn-fs from OA synovial fluids significantly reduced the resultant damage when the fluids were added to cultured cartilage. Addition of IL-1 alpha to cultured cartilage or of MMP-3 to synovial fluids enhanced generation of Fn-fs. Fn-fs, whether derived from bovine plasma or synovial fluid or cartilage Fns, damaged cartilage. CONCLUSIONS: These data demonstrate that although Fn-fs could be generated in vivo within synovial fluids and Fn-fs found in OA synovial fluid may contribute to cartilage damage in vivo, Fn-fs could also be generated within cartilage and amplify cartilage damage. Thus, Fn-fs may be both autocrine and paracrine regulators of cartilage metabolism.     

Development of the multidimensional index of life quality. A quality of life measure for cardiovascular disease

OBJECTIVES: The purpose of this study was to design a multidimensional measure of health-related quality of life appropriate for patients with cardiovascular disease that was psychometrically sound, brief, and easy to administer. METHODS: Qualitative interviews conducted with healthy subjects and patients with cardiovascular diseases identified nine major quality of life domains. Based on the responses of 129 cardiovascular disease patients recruited from hospitals and clinics, a criterion-based approach was used to select 35 questionnaire items that best tapped these domains. Psychometric properties of the Multidimensional Index of Life Quality (MILQ) were tested with a sample of 348 patients with various cardiovascular diseases. RESULTS: Cronbach's alpha was 0.76 or higher for eight of the nine MILQ domains. Test-retest reliability coefficients were 0.73 or greater in all but two domains. Individual domain scores as well as a weighted overall quality of life index were correlated highly with self-assessed health and the number of heart-related symptoms. CONCLUSIONS: The Multidimensional Index of Life Quality is a psychometrically reliable and valid instrument for measuring quality of life in patients with cardiovascular diseases. The MILQ also may be a suitable measure for other types of chronic diseases.