Biomedical subjects

A M Rentz

Publications and source records attributed to A M Rentz.

13 recordsLinked to original sources

PubMed2004

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.

Analysis of Variance↗

PubMed2003

Development and validation of a patient-assessed gastroparesis symptom severity measure: the Gastroparesis Cardinal Symptom Index.

BACKGROUND: Patient-based symptom assessments are necessary to evaluate the effectiveness of medical treatments for gastroparesis. AIM: To summarize the development and measurement qualities of the Gastroparesis Cardinal Symptom Index (GCSI), a new measure of gastroparesis-related symptoms. METHODS: The GCSI was based on reviews of the medical literature, clinician interviews and patient focus groups. The measurement qualities (i.e. reliability, validity) of the GCSI were examined in 169 gastroparesis patients. Patients were recruited from seven clinical centres in the USA to participate in this observational study. Patients completed the GCSI, SF-36 Health Survey and disability day questions at a baseline visit and again after 8 weeks. Clinicians independently rated the severity of the patients' symptoms, and both clinicians and patients rated the change in gastroparesis-related symptoms over the 8-week study. RESULTS: The GCSI consists of three sub-scales: post-prandial fullness/early satiety, nausea/vomiting and bloating. The internal consistency reliability was 0.84 and the test-re-test reliability was 0.76 for the GCSI total score. Significant relationships were observed between the clinician-assessed symptom severity and the GCSI total score, and significant associations were found between the GCSI scores and SF-36 physical and mental component summary scores and restricted activity and bed disability days. Patients with greater symptom severity, as rated by clinicians, reported greater symptom severity on the GCSI. The GCSI total scores were responsive to changes in overall gastroparesis symptoms as assessed by clinicians (P = 0.0002) and patients (P = 0.002). CONCLUSION: The findings of this study indicate that the GCSI is a reliable and valid instrument for measuring the symptom severity in patients with gastroparesis.

Adolescent↗

PubMed2003

Health-related quality of life assessment in adult haemophilia patients: a systematic review and evaluation of instruments.

The objective of this study was to review and evaluate the performance of health-related quality of life (HRQL) and other health status measures used in studies of adult haemophilia and provide recommendations for future research. A systematic literature review was performed to identify HRQL and health status measures used in haemophilia. Literature was identified using medical databases, Internet and manual searches. The search was restricted to articles published in English since 1986. Ninety-six abstracts were located; 19 relevant articles were selected for detailed review. Three main types of HRQL measures were identified: generic psychometric-based HRQL (SF-36 and SF-12), utility-based HRQL [EQ-5D and Health Utilities Index (HUI)], and musculoskeletal-specific HRQL (Arthritis Impact Measurement Scale 2, AIMS 2) instruments. No patient-rated haemophilia-specific HRQL instrument was found. The SF-36, the EQ-5D, and the HUI were able to discriminate haemophilia patient subgroups with respect to disease severity and HIV comorbidity status. Sixteen additional scales were identified that were used to measure the different aspects of physical, psychological, and social functioning of patients. There were no clinical studies of haemophilia carried out that employed HRQL instruments, thus responsiveness of these instruments could not be evaluated. The variety of instruments used in haemophilia studies highlights the need for a tool that can capture the full impact of haemophilia and its treatment on patients' HRQL. Developing such a tool poses the unique challenge of accounting for common comorbidities, such as HIV and chronic hepatitis that may have a greater HRQL impact than the underlying disease.

Health Status↗

PubMed2001

Impact of smoking status on workplace absenteeism and productivity.

OBJECTIVES: To: evaluate the impact of smoking status on objective productivity and absenteeism measures; evaluate the impact of smoking status on subjective measures of productivity; and assess the correlation between subjective and objective productivity measures. DESIGN: Prospective cohort study in a workplace environment. SUBJECTS: Approximately 300 employees (100 each of former, current, and never smokers) at a reservation office of a large US airline. MAIN OUTCOME MEASURES: Objective productivity and absenteeism data were supplied by the employer. Subjective assessments of productivity were collected using a self report instrument, the Health and Work Questionnaire (HWQ). RESULTS: Current smokers had significantly greater absenteeism than did never smokers, with former smokers having intermediate values; among former smokers, absenteeism showed a significant decline with years following cessation. Former smokers showed an increase in seven of 10 objective productivity measures as compared to current smokers, with a mean increase of 4.5%. While objective productivity measures for former smokers decreased compared to measures for current smokers during the first year following cessation, values for former smokers were greater than those for current smokers by 1-4 years following cessation. Subjective assessments of "productivity evaluation by others" and "personal life satisfaction" showed significant trends with highest values for never smokers, lowest for current smokers, and intermediate for former smokers. CONCLUSIONS: Workplace productivity is increased and absenteeism is decreased among former smokers as compared to current smokers. Productivity among former smokers increases over time toward values seen among never smokers. Subjective measures of productivity provide indications of novel ways of productivity assessment that are sensitive to smoking status.

Absenteeism↗

PubMed2001

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.

Clinical Trials as Topic↗

PubMed2000

Patient-based assessment in dyspepsia: development and validation of Dyspepsia Symptom Severity Index (DSSI).

This paper describes the development and testing of a new self-report measure, the Dyspepsia Symptom Severity Index (DSSI), for assessing the severity of symptoms commonly associated with dyspepsia. The instrument was based on the literature, focus groups, and feedback from gastroenterologists; 48 patients and 24 controls participated in testing. Patients completed the DSSI and a symptom diary to test concurrent validity; one-week reproducibility was evaluated in 21 stable patients. Three subscales comprise the 20-item DSSI, representing reflux-, ulcer-, and dysmotility-like symptoms. Subscale internal consistency levels (alpha) were high (0.84-0.89), total score alpha levels were very good (0.76, 0.80), and scores were reproducible (ICC = 0.90-0.92). Correlations between the DSSI and diary were moderate to strong (r = 0.33-0.77; P < 0.05). Patients reported significantly more severe symptoms than controls (P < 0.001). Results indicate the DSSI is a reliable and valid tool for evaluating symptom severity in patients with functional dyspepsia.

Adult↗

PubMed1999

Telephone validation of the Quality of Life in Epilepsy Inventory-89 (QOLIE-89).

PURPOSE: To assess the psychometric properties of the Quality of Life in Epilepsy Inventory-89 (QOLIE-89) administered via telephone and to compare these properties with data gathered through self-administration. METHODS: A study of 139 patients with epilepsy was undertaken at three clinical sites in the United States. Patients participated in both telephone interview (T) and self-administration (S). Order effect was controlled through randomization (T-S and S-T). Twenty-eight S-T subjects participated in an assessment of the 2-week reproducibility of telephone interviews. RESULTS: Internal consistency and test-retest reliability levels of the QOLIE-89 overall score were very high across method of administration (T = 0.98; S = 0.98; ICC of T = 0.96). Scores were significantly related to mood (Profile of Mood States, r = -0.76, for both methods, p<0.001) and two indicators of epilepsy severity (seizure frequency in the past month, T: r = 0.52, p<0.0001; S: r = 0.54, p<0.0001; days since last seizure, T: r = 0.28, p<0.001; S: r = 0.25, p<0.01), with no significant differences in coefficients by method of administration. Performance of the measure was consistent for patients with unimpaired and impaired memory, using the Rivermead Behavioural Memory Test, and across level of education. CONCLUSIONS: Results of this study indicate telephone interview is a viable option for evaluating HRQL in persons with epilepsy and support the reliability and validity of the QOLIE-89 regardless of method of administration.

Adult↗

PubMed1999

The cost-effectiveness of a new chlorhexidine delivery system in the treatment of adult periodontitis.

BACKGROUND: Periodontal treatment is costly. The authors assessed the potential economic impact of a new periodontal chemotherapeutic, testing the hypothesis that its adjunctive use would result in reduced periodontal surgical needs. METHODS: An economic model estimated treatment needs following two clinical trials of the adjunctive use of a chlorhexidine, or CHX, -containing chip compared with scaling and root planing, or SRP, alone. Needs were based on periodontal status at nine months and a probabilistic algorithm; costs were assigned on the basis of a national dental survey and an average wholesale price of the CHX chip. RESULTS: The base case model projected significantly more maintenance procedures and significantly fewer periodontal surgical procedures for patients treated with SRP and the CHX chip compared with patients who were treated with SRP alone (54.4 percent vs. 46.4 percent, P = .014; 29.2 percent vs. 35.5 percent, P = .015, respectively). Average total costs of care for patients treated with SRP and CHX chip were $737 +/- $244 compared with $734 +/- $239 for patients treated with SRP alone. Sensitivity analyses to account for variations in practice patterns did not appreciably alter the results. When data were analyzed after only three or six months of treatment, the significant differences in treatment needs disappeared. CONCLUSIONS: The CHX chip is a new, apparently cost-effective treatment option for non-surgical periodontal therapy. Adjunctive use of the CHX chip could reduce periodontal surgical needs significantly at little or no additional cost. CLINICAL IMPLICATIONS: Results suggest that incorporating the CHX chip into routine practice requires a new algorithm for management of periodontal disease. To obtain full clinical benefit, treatment needs to be continued for nine months.

Adult↗

PubMed1999

Evaluating Health-related quality-of-life outcomes in patients with congestive heart failure. A review of recent randomised controlled trials.

Congestive heart failure (CHF) is a chronic disorder characterised by fatigue, shortness of breath and congestion. Treatment is designed to relieve symptoms, halt or delay progression of the disease, prolong life and, ultimately, improve quality of life. The purpose of this paper is to identify recent trends in the assessment of health-related quality-of-life (HR-QOL) outcomes in randomised, controlled trials evaluating treatment effectiveness in patients with CHF. 41 studies using HR-QOL as an explicit outcome and published in English between 1990 and September 1998 were reviewed. Trends in the measurement of HR-QOL and evidence of treatment effectiveness are presented followed by a discussion of the implications for future research. Results suggest that pharmacological and nonpharmacological treatment regimens can have a positive impact on HR-QOL. However, treatment-related improvement in exercise capacity in patients with CHF was not consistently associated with improvement in all domains of HR-QOL. The primary HR-QOL domain affected by treatment appears to be the performance of daily activities, which may or may not be accompanied by enhanced well-being. This suggests that functional status should be considered a primary HR-QOL end-point in clinical intervention trials. Preference-based or utility assessment, ethnic group differences in treatment effectiveness, caregiver burden and cost effectiveness are understudied outcomes in CHF research.

Heart Failure↗

PubMed1998

The impact of candidemia on length of hospital stay, outcome, and overall cost of illness.

Although numerous studies have examined trends in nosocomial fungal infections, few have specifically addressed the cost of care associated with candidemia. This study analyzes the direct medical costs associated with treating candidemia in the United States. The study design was a cost-of-illness analysis estimating the average cost of candidemia for a single episode of care. Data were obtained from three sources: the 1993 Healthcare Cost and Utilization Project of the Agency for Health Care Policy and Research, the relevant literature, and a clinical expert in systemic fungal infections. The estimated cost (1997 U.S.$) of an episode of care for candidemia is $34,123 per Medicare patient and $44,536 per private insurance patient. The major cost associated with candidemia is that of an increased hospital stay. The estimated cost of care for candidemia may change in the future because of the use of more expensive antifungal treatments with improved safety and efficacy profiles.

Adolescent↗

PubMed1998

Evaluating health-related quality of life outcomes in clinical trials of antiepileptic drug therapy.

PURPOSE: To provide an overview of condition-specific health-related quality of life (HRQL) assessment in clinical trials of antiepileptic drug (AED) therapy in adults. We describe the key measurement issues in HRQL evaluation, identify the instruments that have been used in this population, summarize the psychometric characteristics of these instruments, propose areas of HRQL most likely to change with treatment, and offer recommendations for further research. METHODS: We conducted a comprehensive review of the literature using repeated searches of the MEDLINE database together with a review of reference lists from published papers. Psychometric information on the instruments was gathered from published literature. RESULTS: Three epilepsy-specific HRQL measures were identified: the Epilepsy-Surgery Inventory (ESI-55), the Liverpool Assessment Battery, and the Quality of Life in Epilepsy Inventory (QOLIE, the 89-, 31-, and 10-item versions). One new measure, the Epilepsy Foundation of America (EFA) Concerns Index was also found. The psychometric characteristics of these instruments are discussed in relationship to performance or expected performance in a clinical trial setting. A review of descriptive studies and trials to date suggests that subscales reflecting the psychological and social domains of HRQL may be most sensitive to treatment designed to increase seizure-free periods, reduce seizure severity, and minimize undesirable side effects. CONCLUSIONS: Although evaluation of HRQL outcomes in clinical trials of epilepsy is still in its infancy, several reliable and valid condition-specific measures are available for understanding the impact of disease and treatment on HRQL. Further research is needed to determine minimal clinically important change scores and to assess the psychometric stability of measures across cultures and mode of administration (self, interview, telephone). Studies of patient preferences for health outcomes in the form of utilities will provide needed data for evaluating the cost-effectiveness of new treatments.

Adult↗

PubMed1997

Managed care pharmacy, socioeconomic assessments and drug adoption decisions.

A telephone survey of a representative national sample of 51 large managed care organizations in the U.S. (> 50,000 enrollees) was undertaken (1) to understand the role of socioeconomic assessments on drug adoption decisions; (2) to determine the sources of these assessments and the reliance of managed care pharmacy on each; and (3) to determine the resources for internally versus externally performed drug assessments. Socioeconomic assessments (clinical effectiveness, safety, cost of treatment, cost-effectiveness, and quality of life) are often tied to formulary decisions. Plans differ in their use of externally available socioeconomic assessments and in their ratings of the importance to decision making of drug assessments from the various sources. Those using a specific source of drug assessment information rated them in the following order of importance: PBM assessments, other HMOs, peer reviewed literature, evaluations performed by industry, articles in non-peer reviewed publications and, lastly, government reports. Timeliness and comprehensiveness are important components of the overall utility of information. A high percentage of plans reported using some of the various types of assessments, with clinical effectiveness most common, and cost-effectiveness second. The percentage of new drugs that undergo assessments in each of the plans covers a broad range, with 57% of the plans evaluating at least half of all new drugs. All but one surveyed managed care plan reported having either implemented or plans to implement a disease management program. Eighty percent of those surveyed are more concerned about drug assessments than in the past and 88% anticipate greater future use. Although 38 plans (75%) have a person in the organization responsible for drug assessments, this is the primary job in only 14 plans (37%). With greater reliance on drug assessments in the future, there are substantial opportunities for integrating drug assessments, formularies and disease management programs.

Cost Control↗

PubMed1996

The view from managed care pharmacy.

This stratified, national telephone survey of fifty-one managed care organizations concerns the perspectives of managed care pharmacy directors on pharmacoeconomics, disease management, and the roles of the pharmaceutical industry and the Food and Drug Administration (FDA). Respondents rated clinical effectiveness assessments as most useful, cost-effectiveness assessments second, and quality-of-life assessments as least useful. Peer-reviewed and industry literature were rated as equally important for decision making. Most plans would consider establishing a partnership with a drug company for disease management, if they have not already done so. Most plans (76 percent) support some form of FDA regulation of pharmacoeconomic claims. Conversely, 69 percent favor either no regulation (24 percent) or less stringent regulation (45 percent) than exists today.

Cost-Benefit Analysis↗