The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature.

OBJECTIVE: The purpose of this paper is to summarize the best evidence regarding the impact of providing patient-reported outcomes (PRO) information to health care professionals in daily clinical practice. METHODS: Systematic review of randomized clinical trials (Medline, Cochrane Library; reference lists of previous systematic reviews; and requests to authors and experts in the field). RESULTS: Out of 1,861 identified references published between 1978 and 2007, 34 articles corresponding to 28 original studies proved eligible. Most trials (19) were conducted in primary care settings performed in the USA (21) and assessed adult patients (25). Information provided to professionals included generic health status (10), mental health (14), and other (6). Most studies suffered from methodologic limitations, including analysis that did not correspond with the unit of allocation. In most trials, the impact of PRO was limited. Fifteen of 23 studies (65%) measuring process of care observed at least one significant result favoring the intervention, as did eight of 17 (47%) that measured outcomes of care. CONCLUSIONS: Methodological concerns limit the strength of inference regarding the impact of providing PRO information to clinicians. Results suggest great heterogeneity of impact; contexts and interventions that will yield important benefits remain to be clearly defined.

Measuring stigma in people with HIV: psychometric assessment of the HIV stigma scale.

An instrument to measure the stigma perceived by people with HIV was developed based on the literature on stigma and psychosocial aspects of having HIV. Items surviving two rounds of content review were assembled in a booklet and distributed through HIV-related organizations across the United States. Psychometric analysis was performed on 318 questionnaires returned by people with HIV (19% women, 21% African American, 8% Hispanic). Four factors emerged from exploratory factor analysis: personalized stigma, disclosure concerns, negative self-image, and concern with public attitudes toward people with HIV. Extraction of one higher-order factor provided evidence of a single overall construct. Construct validity also was supported by relationships with related constructs: self-esteem, depression, social support, and social conflict. Coefficient alphas between .90 and .93 for the subscales and .96 for the 40-item instrument provided evidence of internal consistency reliability. The HIV Stigma Scale was reliable and valid with a large, diverse sample of people with HIV.

Topical capsaicin in the management of HIV-associated peripheral neuropathy.

Distal symmetrical peripheral neuropathy (DSPN) is a particularly distressing pain syndrome associated with human immunodeficiency virus (HIV) disease. Capsaicin has been found to be effective in relieving pain associated with other neuropathic pain syndromes, and is mentioned as a possible topical adjuvant analgesic for the relief of DSPN. This multicenter, controlled, randomized, double-masked clinical trial studied patients with HIV-associated DSPN and compared measures of pain intensity, pain relief, sensory perception, quality of life, mood, and function for patients who received topical capsaicin to the corresponding measures for patients who received the vehicle only. Twenty-six subjects were enrolled in the study. At the end of 1 week, subjects receiving capsaicin tended to report higher current pain scores than did subjects receiving the vehicle (Mann-Whitney test; P = 0.042). The dropout rate was higher for the capsaicin group (67%) than for the vehicle group (18%) (chi 2 test of association; P = 0.014). There were no other statistically significant differences between the capsaicin and vehicle groups with respect to current pain, worst pain, pain relief, sensory perception, quality of life, mood, or function at study entry or at any time during the 4-week trial. These results suggest capsaicin is ineffective in relieving pain associated with HIV-associated DSPN.

Factors influencing intensive care unit survival for critically ill elderly patients.

OBJECTIVE: To examine factors influencing intensive care unit (ICU) survival for critically ill elderly patients and to compare survivors and nonsurvivors of ICU on demographic and illness-related variables. DESIGN: Retrospective, ex post facto research design. SETTING: Adult medical and surgical ICUs. PATIENTS: The records of 164 survivors and 111 nonsurvivors from 2 medical-surgical ICUs were examined. Patients were placed into 3 age groups (middle-aged, young-old, and old-old) to compare outcomes for elderly ICU patients. OUTCOME MEASURES: ICU survival, ICU treatments received, severity of illness. INTERVENTION: The Acute Physiology Age and Chronic Health Evaluation II (APACHE II) was used to assess illness severity. Additional illness-related information was collected by chart review. RESULTS: Predictors of ICU nonsurvival were severity of illness (measured by APACHE II scores) and intubation. Comparison of survivors and nonsurvivors revealed no statistically significant differences in sex or age. For all age groups, nonsurvivors had significantly higher mean days of ICU hospitalization (F (1,239) = 7.20 P < .0078) and higher APACHE II scores (F (1,239) = 106.5 P < .0001). Analysis of ICU treatments received by the 3 age groups of survivors revealed a significant difference only on oxygen therapy, (chi-square = 10.2, df = 2, P = .006), with more young-old (aged 65 to 79) and old-old (aged 80 and older) ICU patients receiving oxygen therapy than middle-aged patients (aged 45 to 64). CONCLUSIONS: The findings of this study demonstrated that severity of illness was a predictor of ICU outcome; age was not. Additionally, age was not related to ICU treatments received.

Quality of life of patients with prostate cancer treated with surgery or radiation therapy.

PURPOSE/OBJECTIVES: To compare the quality-of-life (QOL) perceptions of men treated for prostate cancer with surgery to those of men treated for prostate cancer with radiation therapy. DESIGN: A two-group descriptive study. SETTING: Midwestern community cancer center and teaching hospital. SAMPLE: The study group consisted of 121 men: 68 treated by radical prostatectomy and 53 treated with radiation therapy. METHODS: Mailed survey using the Quality of Life Index (QLI) Cancer Version and the University of California at Los Angeles Prostate Cancer Index. MAIN RESEARCH VARIABLES: QOL; level of urinary, bowel, and sexual function; impact of dysfunction on patients' lives. FINDINGS: No significant differences were found between the groups in QLI scores, but significant differences were found in urinary, bowel, and sexual function. Urinary function was superior in the radiation therapy group (p = 0.0002). Patients who had undergone surgery were more likely to leak urine every day (p < 0.001). Only 6% of patients who had undergone radiation therapy needed to use pads or diapers as compared to 32% of patients who had undergone surgery. Bowel function was better in the surgery group (p = 0.05). Both groups reported poor sexual function, although it was worse in the surgery group (p = 0.009). CONCLUSIONS: The patients who were treated with surgery had significantly worse urinary and sexual function and better bowel function than those treated with radiation therapy. QOL scores were consistent with these findings, although they did not differ significantly between groups. IMPLICATIONS FOR NURSING PRACTICE: This information on the problems of survivors of prostate cancer after surgery and radiation therapy and the effects of therapy on QOL will assist nurses in providing patient education, emotional support, and rehabilitative interventions.

Teaching program effects on high phosphorus levels in patients receiving hemodialysis.

OBJECTIVE: The objective was to determine the effect of a patient education intervention on decreasing serum phosphorus levels, increasing calcium levels, and increasing knowledge in hemodialysis patients with abnormally high phosphorus levels (n = 29). SAMPLE/SETTING: Study subjects were (a) on hemodialysis at least 3 months, (b) English speaking, (c) mentally alert, (d) not under constant nursing care, and (e) hyperphosphatemic. The study was conducted at two suburban dialysis units in the Chicago Metropolitan area. DESIGN: This study had a one group, pretest-posttest design, using subjects as their own controls. METHODS: The intervention was a one-on-one education session performed by a nephrology nurse using a teaching booklet, an Osteodystrophy Tool, and a medication diary. RESULTS: The mean change score for phosphorus did not reach significance (t [28] = .68, p = .50). The change in mean phosphorus levels was not related to gender, education, or dialysis unit. There was a weak relationship between a decrease in phosphorus and an increase in knowledge about phosphorus (r = 0.21). However, calcium levels improved significantly after the teaching intervention (t [28] = 3.23, p = 0.003). Mean overall scores for knowledge about phosphorus control increased significantly also (t [28] = 2.60, p = < 0.01). CONCLUSION: The findings of this study demonstrated that an education session can have an effect on patients' knowledge and compliance.

Effectiveness of a structured communication program for family members of patients in an ICU.

BACKGROUND: In ICUs, an essential component of caring for patients' families is providing information about the patient's status. Nevertheless, interruptions by family members requesting information create an additional burden for nursing staff. OBJECTIVES: To test a structured communications program for family members to determine whether the program would increase family members' satisfaction with care, meet their needs for information better, and decrease disruption for the ICU nursing staff caused by incoming telephone calls from patients' family members. METHODS: The study used a two-group, pretest-posttest quasi-experimental design. The sample consisted of 30 family members of patients in a medical ICU (experimental group, n = 15; control group, n = 15). The intervention consisted of a structured communication program consisting of three components: (1) a discussion with a nurse approximately 24 hours after admission of the patient, (2) an informational pamphlet given at the time of the discussion, and (3) a daily telephone call from the nurse who was caring for the patient that day. RESULTS: The number of incoming calls from family members was significantly lower in the experimental group than in the control group. In the experimental group, satisfaction with care increased significantly from pretest to posttest, as did the members' perception of how well their information needs were being met. CONCLUSIONS: The intervention reduced the number of incoming calls from family members, without compromising family members' satisfaction with care or how well their information needs were met.

The quality of life of persons with chronic fatigue syndrome.

This descriptive study used a between-methods triangulation design to analyze the multiple dimensions of quality of life in persons with chronic fatigue syndrome (CFS). This method, which refers to the combination of both quantitative and qualitative methods in the same study, allowed the authors to obtain more comprehensive and robust data than could be obtained by either method alone. A convenience sample of 110 persons with CFS completed the quality of life index and CFS questionnaire, and a subset of 22 persons were interviewed regarding their lived experience with CFS. Overall scores on the quality of life index were significantly lower in CFS than for other chronic illness groups. Subjects reported the lowest quality of life scores in health and functioning domain. Indepth interviews provided a more complete understanding of the quality of life in CFS and further explained the low ratings that were found on the quality of life index. The findings suggest that quality of life is particularly and uniquely disrupted in CFS.

Sleep in men and women infected with human immunodeficiency virus.

Little is known about sleep problems in persons with human immunodeficiency virus (HIV) infection. The article reports a study that assessed quantitative and qualitative aspects of sleep in a group of men and women with HIV infection and examined sleep parameters in regard to the degree of immune function. The convenience sample of 50 persons was drawn from an HIV clinic in a large midwestern metropolitan area. Subjects identified a variety of problems with their sleep that were not significantly related to their immune status. The findings of this study indicate that nurses should perform a sleep history and assessment on all persons with HIV infection to identify those in need of intervention.

Development of a conceptual model of quality of life.

Quality of life is a critically important concept for health care that has been developed predominantly in the past three decades. Conceptual clarity is extremely important, because differences in meaning can lead to profound differences in outcomes for research, clinical practice, and allocation of health care resources. This paper describes the development of the Ferrans conceptual model of quality of life. The model was developed based on the adoption of an individualistic ideology, which recognizes that quality of life depends on the unique experience of life for each person. Individuals are the only proper judge of their quality of life, because people differ in what they value. Consistent with this ideology, quality of life was defined in terms of satisfaction with the aspects of life that are important to the individual. The model was developed using qualitative methodology. Factor analysis of patient data was used to cluster related elements into domains of quality of life. The resulting model identifies four domains of quality of life: health and functioning, psychological/spiritual, social and economic, and family. Subsequent cross-cultural work with African Americans and Mexican Americans has provided evidence that the elements of the model appropriately reflect quality of life for segments of the population not sampled in the original work. The Ferrans and Powers Quality of Life Index was developed based on this model.

Quality of life of hemodialysis patients.

The purpose of this study was to assess the quality of life of hemodialysis patients. The sample (n = 349) was selected randomly from the adult, inunit hemodialysis patient population of 90% of the counties of Illinois, with the exception of those dialyzed by the Veterans Administration. The findings indicate that the patients in this study were satisfied with their lives in general. Nevertheless, the results also indicated that continued efforts are needed to improve the health and financial independence of hemodialysis patients.

Quality of life after coronary angioplasty.

OBJECTIVE: To explore the impact of percutaneous transluminal coronary angioplasty (PTCA) on perceived quality of life and health-related quality of life. DESIGN: One-group, pretest-posttest design. Pretest data were collected the evening before PTCA and posttest data were collected 4 to 6 weeks after PTCA. Data were collected from medical records, structured interview, and mailed questionnaire. SETTING: University-affiliated, Midwestern medical center. PATIENTS: Forty patients undergoing PTCA. OUTCOME MEASURES: Perceived quality of life was assessed by use of the Ferrans and Powers Quality of Life Index. Health-related quality of life was assessed in terms of cardiac symptoms, tolerance of physical activity, exercise capacity, perceived general health, return to work, and lifestyle changes. INTERVENTION: PTCA. RESULTS: Perceived quality of life increased significantly due to increased satisfaction with health and functioning rather than changes in other areas of life. Significant improvements were found in cardiac symptoms (decreased incidence of chest pain and frequency of cardiac symptoms), tolerance of physical activity (decrease in symptoms with activity, increase in number of blocks able to walk, and decrease in interference with recreational activities because of symptoms), treadmill tests, and perceived general health. Regarding lifestyle changes, significant numbers of subjects quit smoking and increased their frequency of exercise, but the majority reported cheating on their prescribed diets. CONCLUSIONS: PTCA was found to result in significant improvements in perceived quality of life and health-related quality of life.

Quality of life after liver transplant.

The purpose of this study was to compare the quality of life and health related variables in two groups of liver transplant patients, one at 2 years or less after transplant and the other at more than 2 years after transplant. Both groups reported a high overall quality of life and an above average health status. Long-term transplant patients reported significantly more health-related functional impairment and a tendency toward higher levels of depressed and anxious moods. The high quality of life suggested that patients were coping effectively with the realities of life, despite health-related functional impairment.

Psychometric assessment of the Quality of Life Index.

The purpose of this study was to examine the psychometric properties of the Quality of Life Index (QLI) (Ferrans & Powers, 1985a). The sample consisted of 349 patients selected randomly from the adult, in-unit hemodialysis patient population of Illinois. Factor analysis was used to examine the underlying factor structure. A four-factors solution best fit the data, indicating that there were four dimensions underlying the QLI: health and functioning, socioeconomic, psychological/spiritual, and family. Factor analysis of the four primary factors revealed one higher order factor, representing quality of life. Construct validity also was supported by the contrasted groups approach. As predicted, it was found that those who had higher incomes had significantly higher quality of life scores on the social and economic subscale. Support for convergent validity was provided by a strong correlation (r = .77) between scores from the QLI and an assessment of life satisfaction. Findings supported the internal consistency reliability of the entire QLI (alpha = .93) and the four subscales (alphas = .87, .82, .90, .77).

Conceptualizations of quality of life in cardiovascular research.

The purpose of this article is to examine how quality of life has been conceptualized in studies of patients with cardiovascular disorders. To accomplish this purpose the instruments that were used as measures of quality of life in 22 published studies were examined. The majority of conceptualizations could be grouped into five broad categories: social utility, happiness/affect, satisfaction, achievement of personal goals, and normal life. Most of the studies used more than one category to measure quality of life.