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Development of a reliable and valid nutritional knowledge questionnaire for urban South African adolescents.

OBJECTIVES: We wanted to develop a valid and reliable nutritional knowledge test for urban South African adolescents who were participating in the Birth-to-Twenty cohort study. The questionnaire was intended for use every second year, from ages 13 to 14 y until age 20 y. METHODS: The initial steps involved the development of a conceptual framework and identification of nutritional concepts in collaboration with nutritional experts, and this defined the construct of the questionnaire. The South African national teaching curriculum objectives for nutritional education and other relevant issues were selected as the desired concepts, and most items were phrased in accordance with the recently developed South African Food-Based Dietary Guidelines. Thereafter, 140 items (questions) were developed and in turn assessed by an expert panel, and the result was that only 88 items remained. This was done to ensure content and face validity of the items. The 88 items were constructed into a questionnaire and piloted for appropriateness and understanding by adolescents, ages 13 to 14 y, as a means of assessing face validity by non-experts. The edited preliminary questionnaire (still with 88 items) was administered to a nutrition expert group (n = 71) versus a non-expert group (n = 82), referred to as sample 1, for the purposes of performing item analysis and assessing construct validity of the questionnaire. The result of the analysis, a 63-item questionnaire, was administered to adolescents at three school grade levels, 8 (n = 128), 10 (n = 143), and 12 (n = 98), referred to as sample 2, which was representative of the grades in which the Birth-to-Twenty group will be in when the questionnaire is administered. The questionnaire was administered to the sample to assess its content validity and internal consistency reliability. The final questionnaire had 60 items, and its construct, content, and internal consistency reliability were reassessed. RESULTS: The final 60-item questionnaire displayed a significant difference (P < 0.0001) in the mean scores of the expert and non-expert groups tested. It had internal consistencies (Cronbach's alpha) of 0.71, 0.79, and 0.82 for grades 8, 10, and 12 respectively, and an overall value of 0.77 for all groups combined. However, it was less than 0.7 for most grade 8 pupils and for all grades at a historically disadvantaged school. CONCLUSION: A nutritional knowledge questionnaire with construct, face, and content validities and internal consistency was developed for use in South African adolescents to evaluate their nutritional knowledge. Internal consistency was low in children at a disadvantaged school and those in grade 8 compared with multiracial groups at a multiracial school. It is recommended that pupils at disadvantaged schools be assisted by trained interviewers when taking the test.

Adolescent↗

Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale.

OBJECTIVE: The study goal was to validate a disease-specific health status instrument for use in patients with nasal obstruction.Design, settings, and patients The study consisted of a prospective instrument validation conducted at 4 academic medical centers with 32 adults with nasal septal deformity. METHODS: Prospective instrument validation occurred in 2 stages. Stage 1 was the development of a preliminary (alpha-version) instrument of potential items. Stage 2 was a test of the alpha-version for item performance, internal consistency, and test-retest reliability; construct, discriminant, criterion validity, and responsiveness; and creation of the final instrument. RESULTS: Items with poor performance were eliminated from the alpha-version instrument. In testing the final instrument, test-retest reliability was adequate at 0.702; internal consistency reliability was also adequate at 0.785. Validity was confirmed using correlation and comparison analysis, and response sensitivity was excellent. CONCLUSIONS: The Nasal Obstruction Symptom Evaluation Scale is a valid, reliable, and responsive instrument that is brief and easy to complete and has potential use for outcomes studies in adults with nasal obstruction.

Adult↗

Validity and reliability of the Italian version of the Quality-of-Life in Epilepsy Inventory (QOLIE-31).

PURPOSE: To develop an Italian adaptation of the shortened version of the Quality-of-Life in Epilepsy Inventory (QOLIE-31). METHODS: The study population comprised 503 consecutive ambulatory patients with epilepsy from 44 centers. Internal validity was tested by factor analysis, to detect similarities to and differences from the original version, and by multitrait/multi-item analysis, to assess item convergent and discriminant validity. External validity testing included correlation to the SF-36 Inventory, to check the properties of the epilepsy-specific dimensions. Validity testing was completed by analysis of variance (ANOVA) of QOLIE-31 dimension scores against demographic and clinical variables, including age, sex, seizure frequency and number of drugs. RESULTS: The domains showing the highest internal consistency and the best discriminant validity were Medication effect, and Seizure worry. Social functioning had the lower discriminant validity. With reference to the SF-36 scores, the study patients were slightly but constantly below the population values, mostly for General health and Role physical domains. All QOLIE-31 dimensions were sensitive to almost any demographic and clinical variable, except for Medication effects (sensitive to number of drugs) and Energy-fatigue (sensitive to age). CONCLUSIONS: Except for Social functioning, the psychometric properties of the Italian adaptation of the QOLIE-31 Inventory are fairly good and similar to the American version and the Spanish translation. Social functioning scale suffers shortcomings because of life constraints caused by epilepsy (with missing values for regular job and driving license).

Adolescent↗

The reliability, validity and responsiveness of the International Restless Legs Syndrome Study Group rating scale and subscales in a clinical-trial setting.

PATIENTS AND METHODS: To assess the reliability, validity, and responsiveness of the International Restless Legs Syndrome Study Group's rating scale (the International Restless Legs Scale (IRLS)) (V2.0), using pooled data from two matching, placebo-controlled studies of ropinirole for treating Restless Legs Syndrome (RLS). RESULTS: Pooled patient samples comprised 550 patients in the baseline (validation) sample and 439 patients in the week 12 longitudinal (responsiveness) sample. Factor analysis revealed acceptability of the IRLS total score (accounting for 40% of the variance) and that nine of the 10 IRLS items could also be assigned to two distinct subscales, the symptoms or symptoms impact subscales. The IRLS total score, symptoms and symptoms impact subscales had acceptable construct validity, internal consistency reliability (alpha=0.81, 0.80, and 0.76, respectively), and concurrent validity (r=-0.68, -0.52, -0.70, respectively, with the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) overall life impact score). IRLS scores differed significantly between different levels of sleep problems and Clinical Global Impression (CGI) of health status (P<0.0001), indicating known groups and clinical validity, respectively. Changes in scores differed significantly among CGI 'global improvement' levels (P<0.0001), providing evidence of responsiveness. CONCLUSIONS: The IRLS total score, symptoms, and symptoms impact subscales are reliable, valid, and responsive in a clinical trial setting.

Adult↗

Driving simulator validation for speed research.

The behavioral validation of an advanced driving simulator for its use in evaluating speeding countermeasures was performed for mean speed. Using mature drivers, 24 participants drove an instrumented car and 20 participants drove the simulator in two separate experiments. Participants drove on roads which contained transverse rumble strips at three sites, as well as three equivalent control sites. The three pairs of sites involved deceleration, and were the approaches to stop sign intersections, right curves, and left curves. Numerical correspondence (absolute validity), relative correspondence (or validity), and interactive (or dynamic) relative validity were analyzed, the latter using correlations developed from canonical correlation. Participants reacted to the rumble strips, in relation to their deceleration pattern on the control road, in very similar ways in both the instrumented car and simulator experiments, establishing the relative validities. However, participants generally drove faster in the instrumented car than the simulator, resulting in absolute validity not being established.

Adult↗

Validity and reliability of the Cataract TyPE Spec: an instrument for measuring outcomes of cataract extraction.

PURPOSE: To design and validate a survey instrument that measures vision-related functional status, which is appropriate for self-administration in a clinical practice and mail survey setting. DESIGN: Observational, validation study in sequential patients. METHODS: A prototype visual function instrument (the Cataract TyPE Spec) was developed based on focus group input and then validated in an outcomes study conducted among 1,823 patients who underwent cataract extraction performed by 22 surgeons at six centers in the United States. Reliability was determined by calculating Cronbach alpha for different types of administration (self-administration at the site of care and mailed survey) and across race and gender. Criterion validity was determined by correlating scores on the TyPE Spec with baseline measures and changes in visual acuity, overall rating of vision, and general quality of life. RESULTS: The instrument was internally valid (Chronbach alpha = 0.94), both on self-administration in the patient care setting and upon mailed survey administration and across patient race and gender. The TyPE Spec score was highly correlated with overall rating of vision (r =.54, P <.0001) and moderately correlated with Snellen acuity (r =.32, P <.0001), rating of vision in the better eye (r =.42, P <.0001), and quality of life, as measured by the physical component summary score of the SF-36 (r =.27, P <.001). Change in TyPE Spec similarly correlated with change in rating of vision overall, change in best-corrected Snellen acuity, and change in rating of vision in the operated eye. CONCLUSIONS: The cataract TyPE Spec instrument was found to be equally valid and internally consistent when administered in the patient care setting and by mail survey.

Adult↗

American translation, modification, and validation of the St. George's Respiratory Questionnaire.

BACKGROUND: The St. George's Respiratory Questionnaire (SGRQ) is a 50-item health status survey specific for chronic obstructive pulmonary disease (COPD) and other respiratory diseases that is available in British English but not American English. The SGRQ's symptom-reporting component requires a 1-year reporting period, which may be too long for reliable and accurate patient recall. OBJECTIVES: The objectives of the present study were to translate the SGRQ from British to American English, modify the reporting period of the symptom-reporting component from 1 year to 1 month, and assess the reliability, validity, and sensitivity to change of this translated modified version in a sample of patients with COPD. METHODS: Based on input from American patients with COPD and health professionals, the SGRQ was translated into American English (SGRQ-A) and then translated back to British English. For SGRQ-A reliability and validity studies, patients were asked to report symptoms experienced over 1 year (reporting period in the original SGRQ) and 1 month (modification made to SGRQ-A). We evaluated 102 patients with COPD (50% female; mean age, 68 years; mean forced expiratory volume in 1 second [FEV1], 1.01 L) at an administrative session before and after completion of a pulmonary rehabilitation program. The SGRQ-A, Chronic Respiratory Disease Questionnaire (CRQ), 36-Item Short Form Health Survey (SF-36), 6-minute walk (6MW), Medical Research Council (MRC) Dyspnea scale, and pulmonary function tests (FEV1 and % predicted FEV1) were used in the assessment battery. RESULTS: The SGRQ-A showed good agreement with the original SGRQ when translated back to British English. Internal reliability (Cronbach alpha) was > 0.70 for all SGRQ-A components except the 1-year symptom-reporting component. Test-retest intraclass correlations were 0.795 to 0.900. Construct validity was strengthened when all SGRQ-A components (except 1-year symptoms and most 1-month symptoms) correlated (P < or = 0.01) with the MRC Dyspnea scale, 6MW, all SF-36 concept scores, and 80% of CRQ domains (r = 0.30-0.72). Discriminate validity was demonstrated when all components of the SGRQ-A with the modified 1-month symptom-reporting period were shown to discriminate better between disease-severity groups (based on patient self-reports of disease severity) than did pulmonary function tests and the 6MW. Responsiveness of the SGRQ-A to change in health status was demonstrated when scores on the Symptoms-1 month and Total-1 month components detected significant improvements in patients' health status (P = 0.02 and P = 0.04, respectively). CONCLUSION: The SGRQ-A with a modified 1-month symptom-reporting period demonstrated reliability and validity in this sample of patients with COPD. Key words: chronic obstructive pulmonary disease, St. George's Respiratory Questionnaire, American translation, reliability, validity, symptom recall.

Adult↗

Validation of a questionnaire for self-rating of urological and gynaecological morbidity after treatment of gynaecological cancer.

BACKGROUND AND PURPOSE: Patient self-assessment of symptom severity provides clinicians and researchers with important information. It is crucial to evaluate the validity of a self-assessment questionnaire in the context of its intended use. The objective of this study was to evaluate the validity of the uro-gynaecological questionnaire (UGQ), a new instrument for patient self-assessment of urological-, genital-, menopausal-, and pain symptomatology in gynaecological cancer patients. MATERIAL AND METHODS: The UGQ was developed after literature review, patient- and expert interviews and pilot testing. From February 1992 to October 1992, 88 gynaecological cancer patients were invited to participate in a validation study after the initiation of their primary radiotherapy or chemotherapy. The method of validation investigated whether patients and researchers interpreted the items of the questionnaire in the same way. The patient's written response before interview was compared with an observer rating of the patient's open-ended audio-taped responses to the same questionnaire, administered as an interview. Qualitative recordings by the observer were made to describe potential misinterpretations. RESULTS: The agreement between the patient's and the observer's ratings was high: the median overall agreement was 0.91 (range 0.71-1.00) and the median kappa was 0.88 (range 0.45-1.00). The quantitative and the qualitative results identified a few minor validity problems; especially, the issue of selective reporting, i.e. some patients only reporting those symptoms they considered relevant for the study, which may lead to systematic errors. CONCLUSIONS: The results strongly suggest that patients interpret the UGQ items as intended, i.e. they are valid. The UGQ is recommended for patient self-assessment of uro-gynaecological morbidity in gynaecological cancer patients.

Adult↗

[Inventory of experiences in grief (IEG): adaptation to Spanish, reliability and validity].

OBJECTIVE: To adapt to Castilian the Inventory of Experiences of Grief (IEG) of Catherine Sanders et al. (1977) and study its reliability and validity. DESIGN: In two stages: cross-cultural adaptation of a questionnaire and cross-sectional study with control group. SETTING: Primary care teams in Vizcaya. PARTICIPANTS: 147 people bereaved in the period between 3 months and 3 years before the study, and 36 who had lost no direct family member in the previous 5 years. MEASUREMENTS AND MAIN RESULTS: The IEG in American English was translated, back-translated and finally reviewed by Sanders and her colleagues, whose valuation was that the Castilian version was the same as the original. Reliability: the internal consistency of each of the scales of grief on the IEG (Cronbach's alpha) ran from 0.43 to 0.85. Factor validity: the first IEG factor adapted was similar to the original one (despair, somatization, anger, blame, depersonalisation and social isolation). Discriminating validity: all the grief scales on the IEG, except anxiety in face of death, discriminated (p < 0.05) between grieving and not grieving. Validity by hypothesis: the IEG scales showed differences (p < 0.05) between the bereaved according to sex, age, place of death of the spouse and time elapsed since death. Convergent validity: all the IEG grief scales correlated positively (p < 0.05) with the scales in the Texas Revised Inventory of Grief. CONCLUSIONS: The IEG adapted to Castilian is equivalent to the original and has similar reliability and validity.

Attitude to Death↗

[Validity and reliability of an instrument to assess the clinical interviews of residents in family and community medicine: the GATHA-RES questionnaire].

OBJECTIVE: To check the validity of content, the internal consistency and the intra-observer reliability of a questionnaire to evaluate the doctor-patient communication of family medicine residents. DESIGN: Observation study, to validate a measurement instrument. SETTING: Primary care. Family and community medicine teaching units. STUDY POPULATION: For the validity analysis: 25 family and community medicine residents. For the reliability analysis: 48 doctors in the same speciality. MEASUREMENTS AND INTERVENTIONS: The questionnaire was constructed on the basis of a version (GATHA-BASE) composed of 42 items selected by a panel of 60 general practitioners. For content validity, 68 clinical encounters with simulated patients, video-recorded and evaluated, were used. The questionnaire's validity content was studied through a factorial analysis. To measure its internal consistency, Cronbach's alpha coefficients were calculated. Intra-observer reliability of the GATHA-RES version was evaluated through the kappa indexes and the intra-class correlation coefficients. RESULTS: We obtained a version of the GATHA-RES with 27 items. The factorial analysis revealed that there were 9 factors (< >, < >, < >, < >, < >, < >, < > and < >) which showed close correlation with the theoretical and formal contents of the original questionnaire (originally grouped in three sections: attitudes, communication tasks and skills). All the intraclass correlation coefficients had figures > or = 0.90. CONCLUSIONS: The GATHA-RES questionnaire is a valid and reliable instrument that can be used for evaluating the communication skills of general practitioners in training.

Communication↗

[Validation of the OMRON BF 300 monitor for measuring body fat by bioelectric impedance].

OBJECTIVES: To assess the accuracy of the OMRON BF 300 body fat monitor using bioelectric impedance and to validate its measurement of body fat percentage (BF%) against the Siri equation. DESIGN: Cross-sectional descriptive study. SETTING: Primary care. Coronel de Palma and San Fernando Health Centres, Móstoles. PARTICIPANTS: 88 people took part in the assessment of the accuracy of the monitor, and 91 in the validation. MEASUREMENTS AND MAIN RESULTS: The BF% were recorded in triplicate, with the mean being the figure noted. Precision was evaluated through the intra-class correlation coefficient (ICC) and the coefficient of variation (CV); validity, through technical error, the ICC and the Bland-Altman method. In the Siri equation, body density was calculated through the Durnin-Womersley equation. Precision: ICC was 0.999 and CV 0.4 +/- 0.03. VALIDATION: the difference between the BF% monitor (26.6 +/- 9.1%) and the Siri equation (27.8 +/- 8.2%) was -1.27% (p < 0.01; 95% CI -1.97 to -0.57); the technical error of the monitor was 2.2% and of the ICC 0.956 (95% CI, 0.9335-0.9710). Thus, 80.2% of the monitor-equation differences were below 5%, with a concordance interval under the Bland-Altman method of +5.45 to -7.99%. CONCLUSIONS: The OMRON BF 300 monitor satisfies the precision criteria (ICC > 0.95 and low CV) and validation (excellent technical error, ICC > 0.75 and clinically acceptable differences) and is a valid alternative to cutaneous folds as a method of assessing nutrition of the patient.

Adipose Tissue↗

[Validity of clinical records and information systems in studies of health-care delivery in primary care].

OBJECTIVES: To examine how well the clinical process was recorded in the clinical history (CH), and care delivery on the activity sheet (AS). To assemble a series of recommendations on the validity of these documents for recording health care delivery. DESIGN: Multi-centred, observational, and cross-sectonal study. SETTING: Four medical clinics at 12 health centres in the Community of Valencia, Spain. PARTICIPANTS: There were 2051 attendances, with 284 CH and 407 AS involved. Main measurements and results. The information recorded by doctors in the CH and on the AS was validated by external observers who collected directly at the consultation the working day's entire care activity. The following was analysed: 1) in the CH, filling out of the "SOAP" form (basic info.); 2) on the AS, mean per professional per day of scheduled and on-demand patients, home visits and length of consultations; 3) information in the documents validated on the organisation of consultations; 4) analysis of care delivery according to how predictable it is and its clinical content; 5) clinical practice guidelines with validity and clinical usefulness indicators and reliability index (kappa). CONCLUSIONS: The documents validated do not properly reflect the reality of health care demand. There was an under-recording bias and validity problems that may limit their usefulness as sources of information for health care planning and management.

Cross-Sectional Studies↗

Validation in pharmaceutical analysis. Part I: an integrated approach.

The ICH guidelines achieved a great deal in harmonising the definitions of the required validation characteristics and their basic requirements. However, they provide only a basis for a general discussion of the validation parameters, their calculation and interpretation. It is the responsibility of the analyst to identify parameters which are relevant to the performance of the given analytical procedure as well as to design proper validation protocols including acceptance criteria and to perform an appropriate evaluation. In order to fulfil this responsibility properly, the background of the validation parameters and their consequences must be understood. In this part, the general concept of an integrated validation is discussed. The interdependencies to other ICH guidelines and topics during drug development (e.g. impurities and degradants, stability and specification design) must be taken into account to define the required acceptance criteria. Evaluation of the results in order to prove the suitability of the analytical procedure must be based on the specification limits. Important parameters and aspects are discussed for the individual validation characteristics. In the following parts, these parameters will be discussed in detail. Examples will be given for their interpretation in order to facilitate the selection of parameters which are relevant to the performance and suitability of the given analytical procedure.

Chemistry, Pharmaceutical↗

[Validation of the French version of the Princess Margaret Hospital Patient Satisfaction with their Doctor Questionnaire].

BACKGROUND: The evaluation of patient satisfaction receives increasing attention partly due to pressure from state agencies involved in the administration of health care. Outpatients' satisfaction with their doctor is a major component of total patient satisfaction. However, a validated instrument for assessing this has not previously been available in French. PATIENTS AND METHODS: The Princess Margaret Hospital Patient Satisfaction with Doctor Questionnaire (PMH/PSQ-MD) is a recently validated tool available in English for this purpose. A three-step procedure was conducted to obtain a validated French translation of the PMH/PSQ-MD. Subsequently, outpatients receiving chemotherapy, symptomatic treatment or attending a follow-up clinic were approached to participate in the study and complete the questionnaire. Acceptability and reliability (Cronbach's alpha score), as well as internal and external (Pearson correlation coefficient with the Patient Satisfaction Questionnaire IV) validities were studied. RESULTS: 137 patients were approached and 116 fully completed the study. The PMH/PSQ-MD's acceptability was high (<10% of non-responders). Internal validity was also high (Cronbach's alpha score > 0.7 for each dimension). External validity in comparison with the PSQ IV was high as well. Women demonstrated higher satisfaction scores, while age had no influence on patient satisfaction. CONCLUSIONS: The F-PMH/PSQ-MD is a questionnaire which addresses outpatients' satisfaction with their doctor, and is now available for research purpose as well as for daily practice.

Aged↗

Validation of the rhinitis outcomes questionnaire (ROQ).

BACKGROUND: Currently, there is no easy-to-use and comprehensive questionnaire that measures the effectiveness of treatment of rhinitis-related symptoms in a private practice setting. OBJECTIVE: To validate a brief, effective, self-administered rhinitis symptoms questionnaire that can easily be used in a private practice setting for tracking treatment outcomes. METHODS: One hundred seventy-five patients were randomly chosen from three private practices nationwide and were surveyed regarding systemic problems, nasal, eye, and chest symptoms, as well as medical treatment obtained. This survey was administered twice in one sitting with the first administration a recall of symptoms before immunotherapy, and the second administration an evaluation of current symptoms. Appropriate statistical methods were used to evaluate the validity, reliability, and responsiveness of the questionnaire presented. The validation of this instrument included content, statistical, construct, and predictive validity. RESULTS: Both the content and statistical validity were very good in that the questionnaire was easily understood and covered required domains. Construct validity revealed that the items were sensibly related to the domains that contained them and had less association with items from different domains. The reliability of the scales was very good (Cronbach's alpha = 0.80) to outstanding (Cronbach's alpha = 0.92). CONCLUSIONS: Functionality was established for the rhinitis outcomes questionnaire (ROQ) for use in a private practice setting. This allows private practice allergists to collect reliable data with the ROQ.

Adult↗

Validation of array-based gene expression profiles by real-time (kinetic) RT-PCR.

We evaluated real-time (kinetic) reverse transcription-polymerase chain reaction (RT-PCR) to validate differentially expressed genes identified by DNA arrays. Gene expression of two keratinocyte subclones differing in the physical state of human papillomavirus (episomal or integrated) was used as a model system. High-density filter arrays identified 444 of 588 genes as either negative or expressed with less than twofold difference, and the other 144 genes as expressed uniquely or with more than twofold difference between the two subclones. Real-time RT-PCR used LightCycler-based SYBR Green I dye detection and melting curve analysis to validate the relative change in gene expression. Real-time RT-PCR confirmed the change in expression of 17 of 24 (71%) genes identified by high-density filter arrays. Genes with strong hybridization signals and at least twofold difference were likely to be validated by real-time RT-PCR. This data suggests that (i) both hybridization intensity and the level of differential expression determine the likelihood of validating high-density filter array results and (ii) genes identified by DNA arrays with a two- to fourfold difference in expression cannot be eliminated as false nor be accepted as true without validation. Real-time RT-PCR based on LightCycler technology is well-suited to validate DNA array results because it is quantitative, rapid, and requires 1000-fold less RNA than conventional assays.

Computer Systems↗

Validation of a quality-of-life questionnaire for patients with pituitary adenoma.

BACKGROUND: The purpose of this study was to develop and validate a self-administered questionnaire to measure the health-related quality of life of patients with pituitary adenoma. METHODS: A patient-centred iterative process, involving a literature review and focus group interviews with 84 patients, was used to develop a preliminary 106-item questionnaire and to validate it. The final questionnaire comprised the 30 most important items chosen by 20 patients and 17 items considered important by health care professionals. For assessment of its validity and reliability, 55 patients were asked to complete the final questionnaire, RAND-36, FACT- G/FACT-Br, and Karnofsky Performance Scale (KPS). Concurrent validity of the results of our questionnaire with those of the other instruments was assessed with Pearson correlation coefficients. Known-group validity for the scores of extreme groups was assessed with a Student's t test. Test-retest reliability was determined with Pearson correlation coefficients and a Student's t test for two sets of scores obtained one month apart. RESULTS: Forty-seven (85.5%) of the 55 questionnaires were completed. Our questionnaire was well correlated with the RAND-36, the FACT-Br, the FACT-G, and the KPS in the general health domain, but not with the KPS overall. Extreme groups (n = 20) were significantly different. Test-retest reliability (n = 24) was 0.88, and scores one month apart were not significantly different. CONCLUSION: Our patient-centred health-related quality of life questionnaire developed for patients with pituitary adenoma had good validity and reliability. This questionnaire could be used as a patient-centred outcome measure in clinical trials and for assessment of disease progression.

Adenoma↗

Cross-cultural validation of an international questionnaire, the General Measure of the Functional Assessment of Cancer Therapy scale (FACT-G), for Japanese.

The General Measure of the Functional Assessment of Cancer Therapy scale (FACT-G) was developed in an English-speaking culture (USA). To determine if FACT-G could be used in Japan, a cross-cultural validation was performed. The Japanese version was created through an iterative forward-backward translation sequence used throughout the FACT multi-lingual translation project. In evaluating psychometric testing, its construct validity was investigated by factor analysis and multi-trait scaling analysis. Clinical validity was estimated by known-groups comparison using stage, performance score (PS) and patient location, and validated longitudinally by PS. The FACT-G (version 3) was given to 180 patients with lung cancer. Analyses showed that the scales of Physical, Functional, Emotional Well-Being, and Relationship with Doctors were constructively valid in Japan. Japanese patients felt that familial relationships were different than those with friends and neighbors, indicating that the Social/Family Well-Being scale needed cultural adaptation. Two items concerning coping with illness and acceptance of illness did not load predictably onto their respective scales and were considered to be cross-culturally problematic. However, clinical validity demonstrated its sensitivity. Japanese version 4 has been improved to address the weakness in an attempt to become an instrument that is applicable across cultures.

Adult↗