Diarrhea-predominant irritable bowel syndrome (IBS-d) significantly diminishes the health-related quality of life (HRQOL) of patients. Psychological and social impacts are common with many IBS-d patients reporting comorbid depression, anxiety, decreased intimacy, and lost working days. The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire is a 34-item instrument developed and validated for measurement of HRQOL in non-subtyped IBS patients. The current paper assesses this previously-validated instrument employing data collected from 754 patients who participated in a randomized clinical trial of a novel treatment, eluxadoline, for IBS-d.
Psychometric methods common to HRQOL research were employed to evaluate the IBS-QOL. Many of the historical analyses of the IBS-QOL validations were used. Other techniques that extended the original methods were applied where more appropriate for the current dataset. In IBS-d patients, we analyzed the items and substructure of the IBS-QOL via item reduction, factor structure, internal consistency, reproducibility, construct validity, and ability to detect change.
This study supports the IBS-QOL as a psychometrically valid measure. Factor analyses suggested that IBS-specific QOL as measured by the IBS-QOL is a unidimensional construct. Construct validity was further buttressed by significant correlations between IBS-QOL total scores and related measures of IBS-d severity including the historically-relevant Irritable Bowel Syndrome Adequate Relief (IBS-AR) item and the FDA’s Clinical Responder definition. The IBS-QOL also showed a significant ability to detect change as evidenced by analysis of treatment effects. A minority of the items, unrelated to the IBS-d, performed less well by the standards set by the original authors.
We established that the IBS-QOL total score is a psychometrically valid measure of HRQOL in IBS-d patients enrolled in this study. Our analyses suggest that the IBS-QOL items demonstrate very good construct validity and ability to detect changes due to treatment effects. Furthermore, our analyses suggest that the IBS-QOL items measure a univariate construct and we believe further modeling of the IBS-QOL from an item response theory (IRT) approach under both non-treatment and treatment conditions would greatly further our understanding as item-based methods could be used to develop a short form.
IBS-QOL; Patient-reported Outcomes; Psychometrics; HRQOL; Irritable Bowel Syndrome; Diarrhea; Eluxadoline
Obesity is associated with impaired health-related quality of life (QoL) and reduced productivity; less is known about the effect of dietary factors. This study investigated how dietary behaviors, physical activity, and Body Mass Index (BMI) relate to weight-specific QoL and work productivity. The study was conducted in 31 small blue-collar and service industry worksites in Seattle. Participants were 747 employees (33.5% non-White). Measures included self-reported servings of fruits and vegetables, dietary behaviors such as fast food consumption, Godin free-time physical activity scores, measured height and weight, Obesity and Weight Loss Quality of Life (OWLQOL) scores, and Work Limitations Questionnaire (WLQ) scores. Baseline data were analyzed using linear mixed models separately for men (n=348) and women (n=399), since gender modified the effects. BMI was negatively associated with OWLQOL in both women (p<0.001) and men (p<0.001). The linear effect estimate for OWLQOL score associated with one-category increase in BMI was 30% (95% CI: 25%, 44%) for women and 14% (95% CI: 10%, 17%) for men. BMI was positively associated with productivity loss only in women (exp(slope)=1.46, 95% CI: 1.02, 2.11, p=0.04). Eating while doing another activity was negatively associated with OWLQOL scores in men (p=0.0006, independent of BMI) and with productivity in women (p=0.04, effect diminished when adjusting for BMI). Fast food meals were associated with decreased productivity for men (p=0.038, independent of BMI). Results suggest the obesogenic dietary behaviors and higher BMI are associated with decreased QoL and productivity variously in women and men.
Dietary behaviors; Obesity; Quality of Life; Work productivity
The Prostate Cancer Prevention Trial (PCPT)—a randomized placebo-controlled study of the efficacy of finasteride in preventing prostate cancer—offered the opportunity to prospectively study effects of finasteride and other covariates on the health-related quality of life of participants in a multiyear trial.
We assessed three health-related quality-of-life domains (measured with the Health Survey Short Form–36: Physical Functioning, Mental Health, and Vitality scales) via questionnaires completed by PCPT participants at enrollment (3 months before randomization), at 6 months after randomization, and annually for 7 years. Covariate data obtained at enrollment from patient-completed questionnaires were included in our model. Mixed-effects model analyses and a cross-sectional presentation at three time points began at 6 months after randomization. All statistical tests were two-sided.
For the physical function outcome (n = 16 077), neither the finasteride main effect nor the finasteride interaction with time were statistically significant. The effects of finasteride on physical function were minor and accounted for less than a 1-point difference over time in Physical Functioning scores (mixed-effect estimate = 0.07, 95% confidence interval [CI] = −0.28 to 0.42, P = .71). Comorbidities such as congestive heart failure (estimate = −5.64, 95% CI = −7.96 to −3.32, P < .001), leg pain (estimate = −2.57, 95% CI = −3.04 to −2.10, P < .001), and diabetes (estimate = −1.31, 95% CI = −2.04 to −0.57, P < .001) had statistically significant negative effects on physical function, as did current smoking (estimate = −2.34, 95% CI = −2.97 to −1.71, P < .001) and time on study (estimate = −1.20, 95% CI = −1.36 to −1.03, P < .001). Finasteride did not have a statistically significant effect on the other two dependent variables, mental health and vitality, either in the mixed-effects analyses or in the cross-sectional analysis at any of the three time points.
Finasteride did not negatively affect SF–36 Physical Functioning, Mental Health, or Vitality scores.
Systematic reviews and meta-analyses of randomized trials that include patient-reported outcomes (PROs) often provide crucial information for patients and clinicians facing challenging health care decisions. Based on emerging methods, guidance on combining PROs in meta-analysis is likely to enhance their usefulness.
The objectives of this paper are: i) to describe PROs and why they are important for health care decision-making, ii) illustrate the key risk of bias issues that systematic reviewers should consider and, iii) address outcome characteristics of PROs and provide guidance for combining outcomes.
We suggest a step-by-step approach to addressing issues of PROs in meta-analyses. Systematic reviewers should begin by asking themselves if trials have addressed all the important effects of treatment on patients’ quality of life. If the trials have addressed PROs, have investigators chosen the appropriate instruments? In particular, does evidence suggest the PROs used are valid and responsive, and is the review free of outcome reporting bias? Systematic reviewers must then decide how to categorize PROs and when to pool results.
Patient-reported outcomes; Health-related quality of life; Meta-analysis; Systematic review; Health care decision-making
This study evaluated the measurement properties of a newly developed instrument – the Self-Management Profile for Type 2 Diabetes (SMP-T2D).
The 18-item SMP-T2D assesses 12 constructs: level and perceived ease of performance in five self-care domains (blood glucose monitoring, medication-taking, healthy eating, being physically active, and coping), and two global constructs (ease of weight management, confidence with ability to manage diabetes). Validation analyses were based on two studies involving 240 patients with T2D, Study 1 (Clinicaltrials.gov #NCT00637273) with SMP-T2D administration supplemented by SMP-T2D retest one week later, and Study 2 (Clinical trials.gov #NCT00877890) with SMP-T2D administration supplemented by 24-week SMP-T2D follow-up after medication change. Validation included clinical indicators and measures of patient reported quality of life, psychological well-being and treatment outcomes.
All multi-item SMP-T2D measures showed acceptable internal consistency (alphas = 0.71 to 0.87); ten measures had test-retest reliability >0.75. Correlations among SMP-T2D measures and between SMP-T2D measures and validation measures, which were as hypothesized, provided evidence of convergent and discriminant validity. Scores for six SMP-T2D measures improved significantly during Study 2. Multiple regression analysis showed independent associations between change in SMP-T2D measures and change in trial outcomes from baseline to end-of-study.
Two studies provide preliminary evidence regarding the reliability, validity and responsiveness of the SMP-T2D. Further research on the utility of the instrument is needed.
When treating metastatic bone disease, relief of bone pain is often a key outcome. Because pain cannot be quantified with objective clinical measures, patient-reported outcome (PRO) measures are required to assess patients' subjective experience. The goal of the current review was to examine measures used to assess pain, as well as the impact of pain on functional status and health-related quality of life (HRQL), in trials of bisphosphonates for the treatment of bone metastases.
A literature search focused on articles published from January 1999 to April 2009.
A total of 49 articles were located that used PROs to assess pain-related outcomes of bisphosphonate treatment for bone metastases. The Brief Pain Inventory was the most commonly used multi-item instrument. However, the most common approach for assessing pain was to administer a single-item scale such as a visual analog scale, numerical rating scale, or verbal rating scale. Of the 49 studies, 19 included a PRO assessing functional status or HRQL.
Although pain is an important outcome of trials examining treatment for bone metastases, the current review suggests that there is little consistency in PRO measurement across studies. Furthermore, presentation of measures often lacked clear description, information on measurement properties, citations, clarity regarding method of administration, and consistent instrument names. Recommendations are provided for instrument validation within the target population, assessment of content validity, use of PRO instruments recently developed for patients with bone metastases, clear description of instruments, and implementation of measures consistent with recommendations from instrument developers.
Bisphosphonate; Bone metastases; Bone pain; Patient-reported outcomes; Pain assessment
The COSMIN checklist is a tool for evaluating the methodological quality of studies on measurement properties of health-related patient-reported outcomes. The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist (n = 114).
75 articles evaluating measurement properties were randomly selected from the bibliographic database compiled by the Patient-Reported Outcome Measurement Group, Oxford, UK. Raters were asked to assess the methodological quality of three articles, using the COSMIN checklist. In a one-way design, percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item.
88 raters participated. Of the 75 selected articles, 26 articles were rated by four to six participants, and 49 by two or three participants. Overall, percentage agreement was appropriate (68% was above 80% agreement), and the kappa coefficients for the COSMIN items were low (61% was below 0.40, 6% was above 0.75). Reasons for low inter-rater agreement were need for subjective judgement, and accustom to different standards, terminology and definitions.
Results indicated that raters often choose the same response option, but that it is difficult on item level to distinguish between articles. When using the COSMIN checklist in a systematic review, we recommend getting some training and experience, completing it by two independent raters, and reaching consensus on one final rating. Instructions for using the checklist are improved.
To evaluate the psychometric properties of a new multicultural weight-specific quality-of-life (QOL) measure for children and adolescents–Youth Quality-of-Life Instrument–Weight module (YQOL-W).
Twenty-five candidate items were administered to 443 children and adolescents between 11 and 18 years of age, of whom 53% were female, 33% were white, 30% were African American and 37% were Mexican American. Thirty-four percent had a healthy body mass index (BMI), 20% were overweight and 46% were obese.
Twenty-one of the original 25 candidate items were retained in the final instrument. Exploratory and confirmatory factor analyses (CFA) resulted in a one-factor (21 items, alpha = 0.97) and a three-factor model including a Self factor (4 items, alpha = 0.90), a Social factor (11 items, alpha = 0.95) and an Environment factor (5 items, alpha = 0.90). CFA found the three-factor model had better model fit (P < 0.05). Both the one-factor and three-factor scores were negatively correlated with BMI and the Children’s Depression Inventory and positively correlated with generic quality of life, all at the P < 0.05 level. The 1-week test–retest intra-class correlation coefficients were 0.73 for Social, 0.71 for Self, 0.73 Environment and 0.77 for the one-factor model.
The YQOL-W shows good reliability and validity for assessing weight-specific QOL in children and adolescents.
Quality of life; Obesity; Children; Adolescents; Minority health; Hispanic American; African American
Investigators of clinical trials in which the list of outcomes include patient-reported outcomes (PROs) - usually labeled quality of life (QoL) - have a large number of instruments from which to choose. The extent and manner in which PRO instruments are used in clinical trials can be assessed using data from clinical trial registries. Most medical journals now require a clinical trial be registered before its results are considered for publication. This requirement is intended to discourage publication bias, such as the reporting of tests of hypotheses different from those stipulated at the start of the trial and selective reporting of partial results.
To assess the usage of PRO instruments in registered trials by various trial characteristics and to determine if the instruments are adequately identified in the registry.
A local copy of the ClinicalTrials.gov database was made in September 2007. The outcomes of all interventional trials registered since September 2004 were assessed for usage of a PRO instrument. Odds ratios of PRO usage were estimated by a logistic regression model.
Of 17,704 interventional trials, 2,481 (14.0%) used at least one PRO instrument. However, less than half of those trials (41.0%) identified the instrument to be used. PRO usage is positively associated with phase (III), randomization type (randomized), intervention type (behavior) and sponsorship type (university/research organization).
PRO instruments are used in a significant percentage but minority of clinical trials. Trial registries should require that all PRO instruments be identified, including the concepts or outcomes they are intended to measure.
patient-reported outcomes; quality of life; clinical trial registration; publication bias
This article reports findings from a randomized controlled trial of massage and guided meditation with patients at the end of life. Using data from 167 randomized patients, the authors consider patient outcomes through 10 weeks post-enrollment, as well as next-of-kin ratings of the quality of the final week of life for 106 patients who died during study participation. Multiple regression models demonstrated no significant treatment effects of either massage or guided meditation, delivered up to twice a week, when compared with outcomes of an active control group that received visits from hospice-trained volunteers on a schedule similar to that of the active treatment arms. The authors discuss the implications of their findings for integration of these complementary and alternative medicine therapies into standard hospice care.
The COSMIN checklist (COnsensus-based Standards for the selection of health status Measurement INstruments) was developed in an international Delphi study to evaluate the methodological quality of studies on measurement properties of health-related patient reported outcomes (HR-PROs). In this paper, we explain our choices for the design requirements and preferred statistical methods for which no evidence is available in the literature or on which the Delphi panel members had substantial discussion.
The issues described in this paper are a reflection of the Delphi process in which 43 panel members participated.
The topics discussed are internal consistency (relevance for reflective and formative models, and distinction with unidimensionality), content validity (judging relevance and comprehensiveness), hypotheses testing as an aspect of construct validity (specificity of hypotheses), criterion validity (relevance for PROs), and responsiveness (concept and relation to validity, and (in) appropriate measures).
We expect that this paper will contribute to a better understanding of the rationale behind the items, thereby enhancing the acceptance and use of the COSMIN checklist.
Aim of the COSMIN study (COnsensus-based Standards for the selection of health status Measurement INstruments) was to develop a consensus-based checklist to evaluate the methodological quality of studies on measurement properties. We present the COSMIN checklist and the agreement of the panel on the items of the checklist.
A four-round Delphi study was performed with international experts (psychologists, epidemiologists, statisticians and clinicians). Of the 91 invited experts, 57 agreed to participate (63%). Panel members were asked to rate their (dis)agreement with each proposal on a five-point scale. Consensus was considered to be reached when at least 67% of the panel members indicated ‘agree’ or ‘strongly agree’.
Consensus was reached on the inclusion of the following measurement properties: internal consistency, reliability, measurement error, content validity (including face validity), construct validity (including structural validity, hypotheses testing and cross-cultural validity), criterion validity, responsiveness, and interpretability. The latter was not considered a measurement property. The panel also reached consensus on how these properties should be assessed.
The resulting COSMIN checklist could be useful when selecting a measurement instrument, peer-reviewing a manuscript, designing or reporting a study on measurement properties, or for educational purposes.
Delphi technique; Outcome assessment; Psychometrics; Quality of life; Questionnaire
This study investigated end-of-life priorities of terminally ill patients and their intimate associates. A primary goal was to reduce the number of items in an existing instrument measuring survivors’ evaluations of the quality of dying and death. Three Seattle-area patient samples (chronic obstructive pulmonary disease patients, hospice patients, and participants in an efficacy trial of complementary comfort care) and their significant others provided priority rankings of 26 experiences at end of life. Two items represented top priorities for all subgroups: time with family/friends and pain control. Clustered multivariate probit regression models suggested only a few significant differences between participant groups in priority rankings: higher education increased the priority placed on having available means to hasten death; cancer patients and persons in the hospice sample (likely those experiencing disproportionate pain) assigned pain control higher priority than other groups; persons in the clinical trial (which included massage as an intervention) assigned higher priority to human touch; racial/ethnic minorities emphasized the importance of having funeral arrangements made. In the clinical trial sample (the most recently interviewed), the importance attributed to taking care of health care costs increased over time. If researchers were to use a reduced set of the 17 items mentioned among the top five priorities by at least 10% of the sample, none of the items that varied significantly between subgroups or over time would be eliminated. This change would reduce respondent burden in future investigations, simplify analyses aimed at identifying domains underlying the dying and death experience, and exclude the top-priority item of fewer than 4% of respondents.
End of life; patient preferences; palliative care; quality of life; quality of dying and death; priority ratings; pain control; psychosocial needs
People with schizophrenia frequently have significant problems in community functioning. Progress in developing effective interventions to ameliorate these problems has been slowed by the absence of reliable and valid measures that are suitable for use in clinical trials. The National Institute of Mental Health convened a workgroup in September 2005 to examine this issue and make recommendations to the field that would foster research in this area. This article reports on issues raised at the meeting. Many instruments have been developed to assess community functioning, but overall insufficient attention has been paid to psychometric issues and many instruments are not suitable for use in clinical trials. Consumer self-report, informant report, ratings by clinicians and trained raters, and behavioral assessment all can provide useful and valid information in some circumstances and may be practical for use in clinical trials. However, insufficient attention has been paid to when and how different forms of assessment and sources of information are useful or how to understand inconsistencies. A major limiting factor in development of reliable and valid instruments is failure to develop a suitable model of functioning and its primary mediators and moderators. Several examples that can guide thinking are presented. Finally, the field is limited by the absence of an objective gold standard of community functioning. Hence, outcomes must be evaluated in part by “clinical significance.” This criterion is problematic because different observers and constituencies often have different opinions about what types of change are clinically important and how much change is significant.
schizophrenia; assessment; outcomes
We analyzed internal tobacco industry documents that describe the industry's response to the Community Intervention Trial for Smoking Cessation (COMMIT), a multi-center community-based tobacco intervention project funded by the National Cancer Institute from 1988 to 1992. Our analysis of documents from the Legacy Tobacco Documents Library (www.legacy.library.ucsf.edu) suggests that the tobacco industry reacted to COMMIT by (1) closely monitoring trial activities, (2) confronting COMMIT in communities where it was most active, (3) distorting COMMIT findings on underage smoking data reported in the media, and (4) using COMMIT activities as practice to strengthen their attack against the subsequent ASSIST trial, falsely accusing both studies of illegal political lobbying with taxpayers' money.
The tobacco industry closely monitored COMMIT activities and organized local responses to findings and activities perceived as threatening to the industry's public image or interests. Although we could not document a concerted attack by the tobacco industry that impacted the results of the COMMIT trial, data suggest that the industry used COMMIT as a learning opportunity to mount a well orchestrated and potentially damaging response to the larger American Stop Smoking Intervention Study for Cancer Prevention Trial.
Little is known about self-perceived quality of life (QOL) near the end of life, because such information is difficult to collect and to interpret. Here, we describe QOL in the weeks near death and determine correlates of QOL over time, with emphasis on accounting for death and missing data.
Data on QOL were collected approximately every week in an ongoing randomized trial involving persons at the end of life. We used these data to describe QOL in the 52 weeks after enrollment in the trial (prospective analysis, N = 115), and also in the 10 weeks just prior to death (retrospective analysis, N = 83). The analysis consisted of graphs and regressions that accounted explicitly for death and imputed missing data.
QOL was better than expected until the final 3 weeks of life, when a terminal drop was observed. Gender, race, education, cancer, and baseline health status were not significantly related to the number of “weeks of good-quality life” (WQL) during the study period. Persons younger than 60 had significantly higher WQL than older persons in the prospective analysis, but significantly lower WQL in the retrospective analysis. The retrospective results were somewhat sensitive to the imputation model.
In this exploratory study, QOL was better than expected in persons at the end of life, but special interventions may be needed for persons approaching a premature death, and also for the last 3 weeks of life. Our descriptions of the trajectory of QOL at the end of life may help other investigators to plan and analyze future studies of QOL. Methodology for dealing with death and the high amount of missing data in longitudinal studies at the end of life needs further investigation.
Managed care efforts to regulate access to specialists and reduce costs may lower quality of care. Few studies have examined whether managed care is associated with patient perceptions of the quality of care provided by physician and non-physician specialists. Aim is to determine whether associations exist between managed care controls and patient ratings of the quality of specialty care among primary care patients with pain and depressive symptoms who received specialty care for those conditions.
A prospective cohort study design was conducted in the offices of 261 primary physicians in private practice in Seattle in 1997. Patients (N = 17,187) were screened in waiting rooms, yielding a sample of 1,514 patients with pain only, 575 patients with depressive symptoms only, and 761 patients with pain and depressive symptoms. Patients (n = 1,995) completed a 6-month follow-up survey. Of these, 691 patients received specialty care for pain, and 356 patients saw mental health specialists. For each patient, managed care was measured by the intensity of managed care controls in the patient's health plan and primary care office. Quality of specialty care at follow-up was measured by patient rating of care provided by the specialists. Outcomes were pain interference and bothersomeness, Symptom Checklist for Depression, and restricted activity days.
The intensity of managed care controls in health plans and primary care offices was generally not associated with patient ratings of the quality of specialty care. However, pain patients in more-managed primary care offices had lower ratings of the quality of specialty care from physician specialists and ancillary providers.
For primary care patients with pain or depressive symptoms and who see specialists, managed care controls may influence ratings of specialty care for patients with pain but not patients with depressive symptoms.
The Rapid Assessment of Physical Activity (RAPA) was developed to provide an easily administered and interpreted means of assessing levels of physical activity among adults older than 50 years.
A systematic review of the literature, a survey of geriatricians, focus groups, and cognitive debriefings with older adults were conducted, and an expert panel was convened. From these procedures, a nine-item questionnaire assessing strength, flexibility, and level and intensity of physical activity was developed. Among a cohort of 115 older adults (mean age, 73.3 years; age range, 51–92 years), half of whom were regular exercisers (55%), the screening performance of three short self-report physical activity questionnaires — the RAPA, the Behavioral Risk Factor Surveillance System (BRFSS) physical activity questions, and the Patient-centered Assessment and Counseling for Exercise (PACE) — was compared with the Community Healthy Activities Model Program for Seniors (CHAMPS) as the criterion.
Compared with the BRFSS and the PACE, the RAPA was more positively correlated with the CHAMPS moderate caloric expenditure (r = 0.54 for RAPA, r = 0.40 for BRFSS, and r = 0.44 for PACE) and showed as good or better sensitivity (81%), positive predictive value (77%), and negative predictive value (75%) as the other tools. Specificity, sensitivity, and positive predictive value of the questions on flexibility and strength training were in the 80% range, except for specificity of flexibility questions (62%). Mean caloric expenditure per week calculated from the CHAMPS was compared between those who did and those who did not meet minimum recommendations for moderate or vigorous physical activity based on these self-report questionnaires. The RAPA outperformed the PACE and the BRFSS.
The RAPA is an easy-to-use, valid measure of physical activity for use in clinical practice with older adults.
Oral health is essential to the general health and well-being of individuals and the population. Yet significant oral health disparities persist in the U.S. population because of a web of influences that include complex cultural and social processes that affect both oral health and access to effective dental health care.
This paper introduces an organizing framework for addressing oral health disparities. We present and discuss how the multiple influences on oral health and oral health disparities operate using this framework. Interventions targeted at different causal pathways bring new directions and implications for research and policy in reducing oral health disparities.
Little is known about longitudinal associations among measures of depression, mental and physical health, and quality of life (QOL). We followed 982 clinically depressed persons to determine which measures changed and whether the change was synchronous with change in depressive symptoms.
Data were from the Longitudinal Investigation of Depression Outcomes (LIDO). Depressive symptoms, physical and mental health, and quality of life were measured at baseline, 6 weeks, 3 months, and 9 months. Change in the measures was examined over time and for persons with different levels of change in depressive symptoms.
On average, all of the measures improved significantly over time, and most were synchronous with change in depressive symptoms. Measures of mental health changed the most, and physical health the least. The measures of change in QOL were intermediate. The 6-week change in QOL could be explained completely by change in depressive symptoms. The instruments varied in sensitivity to changes in depressive symptoms.
In clinically depressed persons, measures of physical health, mental health, and quality of life showed consistent longitudinal associations with measures of depressive symptoms.
To determine the associations between managed care, physician job satisfaction, and the quality of primary care, and to determine whether physician job satisfaction is associated with health outcomes among primary care patients with pain and depressive symptoms.
Prospective cohort study.
Offices of 261 primary physicians in private practice in Seattle.
We screened 17,187 patients in waiting rooms, yielding a sample of 1,514 patients with pain only, 575 patients with depressive symptoms only, and 761 patients with pain and depressive symptoms; 2,004 patients completed a 6-month follow-up survey.
MEASUREMENTS AND RESULTS
For each patient, managed care was measured by the intensity of managed care controls in the patient's primary care office, physician financial incentives, and whether the physician read or used back pain and depression guidelines. Physician job satisfaction at baseline was measured through a 6-item scale. Quality of primary care at follow-up was measured by patient rating of care provided by the primary physician, patient trust and confidence in primary physician, quality-of-care index, and continuity of primary physician. Outcomes were pain interference and bothersomeness, Symptom Checklist for Depression, and restricted activity days. Pain and depression patients of physicians with greater job satisfaction had greater trust and confidence in their primary physicians. Pain patients of more satisfied physicians also were less likely to change physicians in the follow-up period. Depression patients of more satisfied physicians had higher ratings of the care provided by their physicians. These associations remained after controlling statistically for managed care. Physician job satisfaction was not associated with health outcomes.
For primary care patients with pain or depressive symptoms, primary physician job satisfaction is associated with some measures of patient-rated quality of care but not health outcomes.
managed care programs; pain; depression; quality; physician job satisfaction
To determine whether managed care controls were associated with reduced access to specialists and worse outcomes among primary care patients with pain.
Data Sources/Study Setting
Patient, physician, and office manager questionnaires collected in the Seattle area in 1996–1997, plus data abstracted from patient records and health plans.
A prospective cohort study of 2,275 adult patients with common pain problems recruited in the offices of 261 primary care physicians in Seattle.
Patients completed a waiting room questionnaire and follow-up surveys at the end of the first and sixth months to measure access to specialists and outcomes. Intensity of managed care controls measured by plan managed care index and benefit/cost-sharing indexes, office managed care index, physician compensation, financial incentives, and use of clinical guidelines.
A financial withhold for referral was associated with a lower likelihood of referral to a physician specialist, a greater likelihood of seeing a specialist without referral, and a lower patient rating of care from the primary physician. Otherwise, patients in more managed offices and with greater out-of-network plan benefits had greater access to specialists. Patients with more versus less managed care had similar health outcomes, but patients in more managed offices had lower ratings of care provided by their primary physicians.
Increased managed care controls were generally not associated with reduced access to specialists and worse health outcomes for primary care patients with pain, but patients in more managed offices had lower ratings of care provided by their primary physicians.
Managed care programs; pain, primary care; specialties (medical); referral; consultation; outcome assessment
To determine whether managed care is associated with reduced access to mental health specialists and worse outcomes among primary care patients with depressive symptoms.
Prospective cohort study.
Offices of 261 primary physicians in private practice in Seattle.
Patients (N = 17,187) were screened in waiting rooms, enrolling 1,336 adults with depressive symptoms. Patients (n = 942) completed follow-up surveys at 1, 3, and 6 months.
MEASUREMENTS AND RESULTS
For each patient, the intensity of managed care was measured by the managedness of the patient's health plan, plan benefit indexes, presence or absence of a mental health carve-out, intensity of managed care in the patient's primary care office, physician financial incentives, and whether the physician read or used depression guidelines. Access measures were referral and actually seeing a mental health specialist. Outcomes were the Symptom Checklist for Depression, restricted activity days, and patient rating of care from primary physician. Approximately 23% of patients were referred to mental health specialists, and 38% saw a mental health specialist with or without referral. Managed care generally was not associated with a reduced likelihood of referral or seeing a mental health specialist. Patients in more-managed plans were less likely to be referred to a psychiatrist. Among low-income patients, a physician financial withhold for referral was associated with fewer mental health referrals. A physician productivity bonus was associated with greater access to mental health specialists. Depressive symptom and restricted activity day outcomes in more-managed health plans and offices were similar to or better than less-managed settings. Patients in more-managed offices had lower ratings of care from their primary physicians.
The intensity of managed care was generally not associated with access to mental health specialists. The small number of managed care strategies associated with reduced access were offset by other strategies associated with increased access. Consequently, no adverse health outcomes were detected, but lower patient ratings of care provided by their primary physicians were found.
managed care programs; access; insurance; behavioral medicine; depression; primary care; mental health services; physician referral; outcome assessment; quality of care; internal medicine; family medicine; psychiatry; psychology
Patients and physicians do not adequately discuss patients' preferences for medical care at the end of life. Our objective was to perform a qualitative study using focus groups to identify barriers and facilitators to communication about end-of-life medical care for patients with AIDS and their physicians.
Patients with AIDS and physicians with moderate or extensive HIV experience were recruited from clinics and community-based settings using network sampling. A total of 47 patients participated in six focus groups and 19 physicians participated in three groups.
MEASUREMENTS AND MAIN RESULTS
Patients or physicians identified 29 barriers and facilitators to communication about end-of-life care. Many patients and physicians expressed discomfort talking about death and dying, and some felt that discussing end-of-life care could cause harm or even hasten death. Several patients expressed the view that a living will obviated the need for discussion with their physician. Previous experience of discrimination from the health care system was a strong barrier to end-of-life communication for some patients with AIDS. Some patients hesitate to bring up end-of-life issues because they want to protect their physicians from uncomfortable discussions. Many patients identified the quality of communication as an important facilitator to these difficult discussions.
Improving the quality of patient-physician communication about end-of-life care will require that physicians identify and overcome the barriers to this communication. To improve the quality of medical care at the end of life, we must address the quality of communication about end-of-life care.
end of life; death; AIDS; HIV infection; communication