Development and psychometric validation of a new patient satisfaction instrument: the osteoARthritis Treatment Satisfaction (ARTS) questionnaire.

Given the increasing interest in treatment satisfaction research and the lack of a specific questionnaire in osteoarthritis (OA), we developed and explored the psychometric properties of the osteoARthritis Treatment Satisfaction (ARTS) questionnaire. The ARTS questionnaire which consists of 18 items was developed in French following the analysis of semi-structured interviews performed among 20 OA participants, five rheumatologists and five general practitioners. Psychometric properties were assessed in France on a cross-sectional sample of 797 OA participants and test-retest reliability was evaluated in an independent sample of 111 clinically stable OA participants who filled-in the questionnaire within a 7.7 (+/- 3.1) day interval. Using principal component analysis, four scales were identified: Treatment advantages (seven items), Treatment convenience (three items), Treatment confidence (two items) and Satisfaction with physician (six items). Item convergent and item discriminant validity were satisfactory. Internal consistency provided evidence of reliability and lack of redundancy (Cronbach's alphas ranged from 0.66 to 0.86). Test-retest reliability was acceptable for two out of four scales (intraclass correlations coefficients (ICC) ranged from 0.61 to 0.75). Significant between groups differences were found on the ARTS scales, demonstrating the known groups validity of the ARTS questionnaire. The responsiveness of the ARTS is still to be documented.

Early conceptual and linguistic development of a patient and partner treatment satisfaction scale (TSS) for erectile dysfunction.

OBJECTIVE: To describe the early development of a pluri-language self-report questionnaire to assess male patients and their female partners' satisfaction with drug treatment for erectile dysfunction (ED). METHODS: This first development phase proceeded in several parts. Item generation followed literature review, hypothesized characteristics of the drug and in-depth interviews with patients and their partners. Perceptions and feelings related to ED and patients' expectations of treatment were explored. Items were generated simultaneously in 5 languages (American English, Canadian French, English, French and German). Content and face validity were empirically assessed by interviews with a few patients and partners in each country. Conceptual equivalence between languages was ascertained. RESULTS: The final content domains included satisfaction with: sexual spontaneity, quality of erection, quality of ejaculation, sexual pleasure, orgasm, confidence, reliability of treatment, side effects, convenience, overall satisfaction, conformity to treatment expectations and intent to continue use of drug. Cognitive debriefing with patients and partners found few issues with comprehension, however some words were considered problematic. The simultaneous development for the different languages allowed adaptation of the content at this stage and ensured consistency of all language versions. The final questionnaire consisted of 4 modules: unmedicated patient, medicated patient, unmedicated partner, and medicated partner modules. The questionnaire was then linguistically validated into 15 additional languages for further psychometric validation. CONCLUSIONS: The Treatment Satisfaction Scale (TSS) is a multi-facetted measure of patients' and partners' satisfaction with their sexual life relating to erectile dysfunction and intended for prospective use. Its simultaneous development for a variety of countries and languages has fostered true item equivalence across language versions. However, further work is needed to validate the TSS psychometrically, including identification of domains, test responsiveness and determination of appropriate scoring prior to its clinical use.

Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders.

OBJECTIVE: Describe the development and evaluation of a new self-report instrument, the patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) in subjects with gastroesophageal reflux disease (GERD), dyspepsia, or gastroparesis. METHODS: Recruited subjects with GERD (n=810), dyspepsia (n = 767), or gastroparesis (n = 169) from the US, France, Germany, Italy, the Netherlands, and Poland. Subjects completed the PAGI-SYM, SF-36, a disease-specific HRQL measure (PAGI-QOL), and disability day questions. Two-week reproducibility was evaluated in 277 stable subjects. We evaluated construct validity by correlating subscale scores with SF-36, PAGI-QOL, disability days, and global symptom severity scores. RESULTS: The final 20-item PAGI-SYM has six subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Internal consistency reliability was good (alpha = 0.79-0.91); test-retest reliability was acceptable (Intraclass correlation coefficients alpha=0.60-0.82). PAGI-SYM subscale scores correlated significantly with SF-36 scores (all p < 0.0001), PAGI-QOL scores (all p < 0.0001), disability days (p < 0.0001), and global symptom severity (p < 0.0001). Mean PAGI-SYM scores varied significantly in groups defined by disability days (all p < 0.0001), where greater symptom severity was associated with more disability days. CONCLUSIONS: Results suggest the PAGI-SYM, a brief symptom severity instrument, has good reliability and evidence supporting construct validity in subjects with GERD, dyspepsia, or gastroparesis.

Quality of life and patient satisfaction: two important aspects in asthma therapy.

Health-related quality of life and satisfaction with treatment are important and complementary measures of the patient's health care experience. Whereas health-related quality of life provides information on the implications and consequences of the disease or its treatment for the patient's functional ability and well-being, satisfaction with received medical care has an important influence on compliance with therapy. Studies in patients with asthma have shown that health-related quality of life is correlated with symptom control and is a predictor of physician visits. Although few studies of treatment satisfaction using validated questionnaires have been performed, there is evidence that ease of use is an important determinant of patient satisfaction with inhalational devices. Prospective, long-term, naturalistic assessments of patient satisfaction with such devices, performed alongside studies of their efficacy, could help to improve the overall management of patients with asthma.

Symptom and health-related quality-of-life measures for use in selected gastrointestinal disease studies: a review and synthesis of the literature.

Patient-rated symptom and health-related quality-of-life (HR-QOL) outcomes are important end-points for clinical trials of medical treatments for gastrointestinal (GI) disorders. Based on this review, patient outcomes research is focused on gastroesophageal reflux disease and dyspepsia, with a growing interest in irritable bowel syndrome but little research in gastroparesis. State-of-the-art for patient-rated symptom scales is rudimentary with an abundance of scales and little attention to systematic instrument development or comprehensive psychometric evaluation. Generally, disease-specific HR-QOL measures have been more systematically developed and evaluated psychometrically, but few have been incorporated into clinical trials. More comprehensive outcome assessments are needed to determine the effectiveness of new medical treatments for functional GI disorders. Future clinical trials of GI disorders should combine clinician assessments of outcomes and symptoms with patient-rated symptom and HR-QOL end-points.

Motivations for healthful dietary change.

OBJECTIVE: To describe scales that measure motivations for changing dietary behaviour, and to examine associations of these scales with current diet and dietary change. DESIGN: A secondary analysis of a randomised trial of a self-help intervention to promote lower fat and higher fruit and vegetable consumption. PARTICIPANTS AND SETTING: Participants were 1205 adults selected at random from enrolees of a large Health Maintenance Organization. At baseline, data were collected on motives for changing diet, fruit and vegetable intake, fat-related dietary habits, and demographic characteristics. Participants were then randomised to receive the intervention or to receive no materials. A follow-up survey was administered at 12 months. RESULTS: A majority of participants reported that it was very important to make dietary changes to feel better (72%) and to control an existing medical problem (57%), but very few (4%) were motivated by pressure from others. Factor analysis of the diet motivation items yielded two intrinsic ('self-image' and 'personal health') and one extrinsic ('social pressure') scales with fair internal consistency reliabilities (Cronbach's alpha = 0.59 to 0.68). Motivation scales were statistically significantly associated with demographic characteristics and baseline diet. For example, desire for a better self-image was a stronger motivator for changing diet among females, while personal health was more important to older persons and men (P < 0.001). Social pressure to change diet was statistically significantly associated with higher fat intake (r = 0.11) and self-image was associated with lower fat intake (r = -0.14, both P < 0.001). Motivation by social pressure and self-image were both significantly associated with greater fat reduction at 12 months post-intervention (P < 0.05). CONCLUSIONS: The intrinsic and extrinsic motivation scales were weakly associated with current diet and predicted response to dietary intervention. More research is needed to better characterise and measure motives for dietary change, and to test whether tailoring interventions based on individuals' motives for dietary change would improve intervention effectiveness.

Demographic and psychosocial predictors of fruit and vegetable intakes differ: implications for dietary interventions.

OBJECTIVE: The National Cancer Institute (Rockville, Md) has launched a nationwide initiative--5 A Day for Better Health--to encourage consumption of fruits and vegetables. Because the tastes and culinary uses of fruits and vegetables differ, however, it is not known whether a general 5-A-Day message is an effective intervention strategy. This study examined whether there are differences between the demographic and psychosocial correlates of fruit and vegetable intakes. DESIGN: Data are from the Washington State Cancer Risk Behavior Survey (1995-1996), a cross-sectional, random-digit-dial telephone survey representative of the adult population of Washington State. SUBJECTS/SETTING: Interviews were completed with 1,450 adults. Data were collected about demographic characteristics, health status, health-related behavior, fruit and vegetable intakes, and the following diet-related psychosocial factors: beliefs, motives, barriers, attitudes, and stages of dietary change. STATISTICAL ANALYSES: Multivariate linear regression analysis was used to test whether the associations of demographic characteristics and psychosocial factors with fruit intake differed from associations with vegetable intake. RESULTS: In general, health status, health-related behavior, and psychosocial factors were more strongly associated with fruit intakes than vegetable intakes. For example, regular exercisers consumed 0.44 more daily servings of fruits and 0.36 more servings of vegetables than nonexercisers. Compared with those in the preaction stage of dietary change, adults in the maintenance stage consumed 0.99 more daily servings of fruits and 0.68 more servings of vegetables. Intrinsic motivations for eating a healthful diet (eg, to feel better) were strongly associated with both fruit and vegetable intakes, and these associations were stronger for fruit. Extrinsic motivations were not associated with either fruit or vegetable intakes. APPLICATIONS: Dietary interventions based on a general 5-A-Day message may be more effective in increasing fruit intakes than vegetable intakes. Targeted interventions that focus specifically on vegetables are probably necessary. Intrinsic motives for eating a healthful diet should be key components of interventions to increase fruit and vegetable intakes.

Moderators and determinants of satisfaction with diet counseling for patients consuming a therapeutic diet.

OBJECTIVE: To identify moderators and key determinants of patient satisfaction with diet counseling. DESIGN: Survey questionnaire. SETTING: A French-Canadian acute-care urban hospital. SUBJECTS: Population of eligible patients hospitalized for a minimum stay of 5 days. Patients excluded from the study were those with notable physical, cognitive, or emotional limitations; those receiving enteral and parenteral nutrition; and those from long-term-care units. Analyses were performed on 49 patients who consumed a therapeutic diet and who received diet counseling during their current hospital stay. MAIN OUTCOME MEASURES: Overall satisfaction with diet counseling, compliance intentions, and satisfaction with four components of diet counseling. Measures were taken on seven-point graphic scales and five-point semantic scales. STATISTICAL ANALYSIS: Reliability estimates with Cronbach's alpha correlation coefficient, stepwise multiple regression analyses, t tests, and one-way analyses of variance. RESULTS: Facilitation skills and knowledge components of diet counseling were the key determinants of patient satisfaction. Among the moderators of patient satisfaction with diet counseling, women and patients with a good appetite were more satisfied with the knowledge components and had stronger compliance intentions. Patients who spent more than 50% of the time at rest were less satisfied than more active patients. APPLICATIONS: Enhancing patient satisfaction implies having a good understanding of a patient's social and cultural context, developing problem-solving skills, and demonstrating greater flexibility and creativity about the means of providing diet counseling.

Determining the complexity of patient satisfaction with foodservices.

OBJECTIVES: (a) To identify the psychological dimensions representing how patients perceive the quality of foodservice; (b) to identify which dimensions best explain variation in the satisfaction ratings of patients; and (c) to identify subgroups based on individual characteristics of patients and contextual factors. DESIGN: Survey questionnaire. SETTING: Patients of a specialized acute-care urban hospital in Canada. SUBJECTS: One hundred thirty-two hospitalized patients (minimum stay of 5 days) who had not received nutrition counseling. Subjects excluded from the study were patients with notable physical, cognitive, or emotional limitations; patients receiving enteral or parenteral nutrition; and patients from long-term-care units. MAIN OUTCOME MEASURE: Overall satisfaction with meals and with foodservices, and satisfaction with 26 specific foodservice attributes. STATISTICAL ANALYSIS: Factor analysis followed by orthogonal rotation (varimax), stepwise multiple regression analysis, and one-way analysis of variance. RESULTS: Seven dimensions represented patients' perceptions of foodservice: food quality, service timeliness, service reliability, food temperature, attitude of the staff who deliver menus, attitude of the staff who serve meals, and customization. Food quality was the best predictor of patient satisfaction with meals and foodservice, followed by customization and attitude of the staff who deliver menus. Individual characteristics (gender, age, education, perception of degree of control over health, and belief that food influences one's health status) and contextual factors (normal or therapeutic diet, time spent at rest, and appetite) influenced patient satisfaction. IMPLICATIONS: The results emphasize the need for a comprehensive and differentiated approach in measuring and monitoring patient satisfaction with foodservices.

Serum ceruloplasmin concentrations in rats with primary and transplanted sarcomas induced by nickel subsulfide.

Ceruloplasmin (CPN) concentrations were measured by p-phenylenediamine oxidase assay in serums from (a) 30 control Fischer rats; (b) 5 rats with primary sarcomas induced by i.m. injection of nickel subsulfide (alpha Ni3S2), and (c) 12 rats at intervals up to six weeks after s.c. transplantation of four alpha Ni3S2-induced sarcomas. Serum CPN concentrations were not significantly increased in rats with primary sarcomas (mean = 0.38 g per liter) (S.D. +/- 0.05), versus 0.35 g per liter (S.D. +/- 0.04) in controls. In contrast, serum CPN concentrations were increased within 11 to 21 days in all rats with transplanted sarcomas. Maximum concentrations of serum CPN occurred at 31 to 34 days after tumor transplantation, (mean = 0.56 +/- 0.05 g per liter), equivalent to 1.6 +/- 0.2 times the initial CPN concentrations in serums obtained prior to treatment (P less than 0.001). The development of hyperceruloplasminemia in rats with transplanted sarcomas and not in rats with primary sarcomas is attributed to greatly enhanced growth-rates of the transplanted neoplasms.