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Patient-reported outcomes are recognized as essential for the evaluation of medical and public health interventions. Over the last 50 years, health-related quality of life (HRQoL) research has grown exponentially from 0 to more than 17,000 papers published annually. We provide an overview of generic HRQoL measures used widely in epidemiological studies, health services research, population studies, and randomized clinical trials [e.g., Medical Outcomes Study SF-36 and the Patient-Reported Outcomes Measurement Information System (PROMIS®)-29]. In addition, we review methods used for economic analysis and calculation of the quality-adjusted life year (QALY). These include the EQ-5D, the Health Utilities Index (HUI), the self-administered Quality of Well-being Scale (QWB-SA), and the Health and Activities Limitation Index (HALex). Furthermore, we consider hybrid measures such as the SF-6D and the PROMIS-Preference (PROPr). The plethora of HRQoL measures has impeded cumulative science because incomparable measures have been used in different studies. Linking among different measures and consensus on standard HRQoL measurement should now be prioritized. In addition, enabling widespread access to common measures is necessary to accelerate future progress.

INTRODUCTION:Older adults are a rapidly growing segment of the U.S. POPULATION:Mobility problems that lead to further disability can be addressed through physical activity interventions. Quality of life outcome results are reported from a large trial of physical activity for sedentary older adults at risk for mobility disability. METHODS:Data were from the Lifestyle Interventions and Independence for Elders study. This multisite RCT compared physical activity to health education among 1,635 randomly assigned sedentary older adults at risk for mobility disability in 2010-2011. Measures included demographics; comorbidity; a timed 400-meter walk; the Short Physical Performance Battery; and the Quality of Well-Being Scale (0-1.0 scale). Baseline and long-term follow-up (2.6 years) health-related quality of life data were collected as a secondary outcome. Multivariate linear regression modeling was used to examine covariates of health-related quality of life over time in 2017. RESULTS:The sample had an overall mean Quality of Well-Being score of 0.613. Both groups declined in quality of life over time, but assignment to the physical activity intervention resulted in a slower decline in health-related quality of life scores (p=0.03). Intervention attendance was associated with higher health-related quality of life for both groups. Baseline characteristics including younger age, fewer comorbid conditions, non-white ethnicity, and faster 400-meter walk times were also associated with higher health-related quality of life over time. CONCLUSIONS:Declining mobility measured by physical performance is associated with lower quality of life in sedentary older adults. Physical activity interventions can slow the decline in quality of life, and targeting specific subgroups may enhance the effects of such interventions.

BackgroundThe most recent reports of nationally representative health-related quality-of-life (HRQOL) values for the United States used data that were collected over a decade ago.ObjectivesTo update these values using data from 2011, stratified by age and sex.MethodsThis study used data from two sources-the 2011 Medical Expenditures Panel Survey (MEPS) and the 2011 National Health Interview Survey (NHIS). Both are nationally representative surveys of the US noninstitutionalized civilian population. The MEPS was used to calculate four HRQOL scores: categorical self-rated health, mental and physical component summaries from the short form-12 items (SF-12) health survey, and the health state short form-6 dimensions (SF-6D). We also estimated Quality of Well-Being Scale scores from the NHIS. We reported means and quartiles for all continuous scores, stratified by decade of age and sex.ResultsThere were 23,906 eligible subjects in the 2011 MEPS and 32,242 eligible subjects in the 2011 NHIS. All age and sex categories had instrument completion rates above 84%. Females reported lower mean scores than did males across all ages and instruments. In general, those in older age groups reported lower scores than did those in younger age groups, with the exception of the mental component summary scores from the SF-12 health survey. When compared with previous reports, these new values were generally lower than those in previous reports but rarely reached minimally important difference criteria.ConclusionsThis report updates US nationally representative age- and sex-stratified estimates for five HRQOL scores using data from 2011. These values are important for use in both generalized comparisons of health status and in cost-effectiveness analyses.

BackgroundLosing the ability to walk safely and independently is a major concern for many older adults. The Lifestyle Interventions and Independence for Elders study recently demonstrated that a physical activity (PA) intervention can delay the onset of major mobility disability. Our objective is to examine the resources required to deliver the PA intervention and calculate the incremental cost-effectiveness compared with a health education intervention.MethodsThe Lifestyle Interventions and Independence for Elders study enrolled 1,635 older adults at risk for mobility disability. They were recruited at eight field centers and randomly assigned to either PA or health education. The PA program consisted of 50-minute center-based exercise 2× weekly, augmented with home-based activity to achieve a goal of 150 min/wk of PA. Health education consisted of weekly workshops for 26 weeks, and monthly sessions thereafter. Analyses were conducted from a health system perspective, with a 2.6-year time horizon.ResultsThe average cost per participant over 2.6 years was US$3,302 and US$1,001 for the PA and health education interventions, respectively. PA participants accrued 0.047 per person more Quality-Adjusted Life-Years (QALYs) than health education participants. PA interventions costs were slightly higher than other recent PA interventions. The incremental cost-effectiveness ratios were US$42,376/major mobility disability prevented and US$49,167/QALY. Sensitivity analyses indicated that results were relatively robust to varied assumptions.ConclusionsThe PA intervention costs and QALYs gained are comparable to those found in other studies. The ICERS are less than many commonly recommended medical treatments. Implementing the intervention in non-research settings may reduce costs further.

South Asians are disproportionately impacted by cardiovascular disease (CVD). Our objective was to examine the association between duration of residence in the US and CVD risk factors among South Asian adult immigrants. Multivariate logistic regression analyses using pooled data from the 2005, 2007, 2009 California Health Interview Surveys. Duration of residence in the US < 15 years was significantly associated with overweight/obese BMI (OR 0.59; 95% CI 0.35, 0.98 for 5 to < 10 years), daily consumption of 5+ servings of fruits/vegetables (OR 0.37; 95% CI 0.15, 0.94 for 10 to < 15 years), and sedentary lifestyle (OR 2.11; 95% CI 1.17, 3.81 for 10 to < 15 years) compared with duration of residence ≥ 15 years after adjusting for illness burden, healthcare access, and socio-demographic characteristics. Duration of residence was not significantly associated with other CVD risk factors. Duration of residence is an important correlate of overweight/obesity and other risk factors among South Asian immigrants.

PurposeA collaborative pharmacist-primary care provider (PharmD-PCP) team approach to medication-therapy management (MTM), with pharmacists initiating and changing medications at separate office visits, holds promise for the cost-effective management of hypertension, but has not been evaluated in many systematic trials. The primary objective of this study was to examine blood pressure (BP) control in hypertensive patients managed by a newly formed PharmD-PCP MTM team versus usual care in a university-based primary care clinic.MethodsThis randomized, pragmatic clinical trial was conducted in hypertensive patients randomly selected for PharmD-PCP MTM or usual care. In the PharmD-PCP MTM group, pharmacists managed drug-therapy initiation and monitoring, medication adjustments, biometric assessments, laboratory tests, and patient education. In the usual-care group, patients continued to see their PCPs. Participants were aged ≥ 18 years, were diagnosed with hypertension, had a most recent BP measurement of ≥ 140/≥ 90 mm Hg (≥ 130/≥ 80 mm Hg if codiagnosed with diabetes mellitus), were on at least 1 antihypertensive medication, and were English speaking. The primary outcome was the difference in the mean change from baseline in systolic BP at 6 months. Secondary outcomes included the percentage achieving therapeutic BP goal and the mean changes from baseline in diastolic BP and low- and high-density lipoprotein cholesterol.FindingsA total of 166 patients were enrolled (69 men; mean age, 67.7 years; PharmD-PCP MTM group, n = 75; usual-care group, n = 91). Mean reduction in SBP was significantly greater in the PharmD-PCP MTM group at 6 months (-7.1 [19.4] vs +1.6 [21.0] mm Hg; P = 0.008), but the difference was no longer statistically significant at 9 months (-5.2 [16.9] vs -1.7 [17.7] mm Hg; P = 0.22), based on an intent-to-treat analysis. In the intervention group, greater percentages of patients who continued to see the MTM pharmacist versus those who returned to their PCP were at goal at 6 months (81% vs 44%) and at 9 months (70% vs 52%). No significant between-group differences in changes in cholesterol were detected at 6 and 9 months; however, the mean baseline values were near recommended levels. The PharmD-PCP MTM group had significantly fewer PCP visits compared with the usual-care group (1.8 [1.5] vs 4.2 [1.0]; P < 0.001).ImplicationsA PharmD-PCP collaborative MTM service was more effective in lowering BP than was usual care at 6 months in all patients and at 9 months in patients who continued to see the pharmacist. Incorporating pharmacists into the primary care team may be a successful strategy for managing medication therapy, improving patient outcomes and possibly extending the capacity of primary care. ClinicalTrials.gov identifier: NCT01973556.

ObjectivesBecause gastrointestinal (GI) illnesses can cause physical, emotional, and social distress, patient-reported outcomes (PROs) are used to guide clinical decision making, conduct research, and seek drug approval. It is important to develop a mechanism for identifying, categorizing, and evaluating the over 100 GI PROs that exist. Here we describe a new, National Institutes of Health (NIH)-supported, online PRO clearinghouse-the GI-PRO database.MethodsUsing a protocol developed by the NIH Patient-Reported Outcome Measurement Information System (PROMIS(®)), we performed a systematic review to identify English-language GI PROs. We abstracted PRO items and developed an online searchable item database. We categorized symptoms into content "bins" to evaluate a framework for GI symptom reporting. Finally, we assigned a score for the methodological quality of each PRO represented in the published literature (0-20 range; higher indicates better).ResultsWe reviewed 15,697 titles (κ>0.6 for title and abstract selection), from which we identified 126 PROs. Review of the PROs revealed eight GI symptom "bins": (i) abdominal pain, (ii) bloat/gas, (iii) diarrhea, (iv) constipation, (v) bowel incontinence/soilage, (vi) heartburn/reflux, (vii) swallowing, and (viii) nausea/vomiting. In addition to these symptoms, the PROs covered four psychosocial domains: (i) behaviors, (ii) cognitions, (iii) emotions, and (iv) psychosocial impact. The quality scores were generally low (mean 8.88 ± 4.19; 0 (min)-20 (max). In addition, 51% did not include patient input in developing the PRO, and 41% provided no information on score interpretation.ConclusionsGI PROs cover a wide range of biopsychosocial symptoms. Although plentiful, GI PROs are limited by low methodological quality. Our online PRO library (www.researchcore.org/gipro/) can help in selecting PROs for clinical and research purposes.

After 150 years of careful progress, despite setbacks along the way, psychiatry is in a state of crisis. This can be attributed to huge acceptance of the Diagnostic & Statistical Manual (DSM), which has changed the practice of psychiatry. Its iterations have added large numbers of new conditions that are being used to medicalise normal life, notably in poorly defined and now over-treated conditions like PTSD, autism, and ADHD. The DSM produces new conditions by committee decisions, ignoring the careful observation of cases over long periods that characterised psychiatry in the past. This has been a bonanza for pharmaceutical companies producing drugs of dubious benefit. It is difficult to see a solution to the situation until someone emerges to change the existing paradigm. [ABSTRACT FROM AUTHOR]

Those trained in psychiatry should be familiar with the M'Naghten (pronounced McNaughton) Rule, which states that: (1) an individual suffers from a 'defect of reason,' which is (2) caused by [...]

PURPOSE Health care expenditures and biomedical research funding are often justified by the belief that modern health care powerfully improves life expectancy in wealthy countries. We examined 4 different methods of estimating the effect of health care on health outcomes. METHODS We reviewed the contributions of medical care to health outcomes using 4 methods: (1) analyses by McGinnis and Schroeder, (2) Wennberg and colleagues' studies of small area variation, (3) Park and colleagues' analysis of County Health Rankings and Roadmaps, and (4) the RAND Health Insurance Experiment. RESULTS The 4 methods, using different data sets, produced estimates ranging from 0% to 17% of premature mortality attributable to deficiencies in health care access or delivery. Estimates of the effect of behavioral factors ranged from 16% to 65%. CONCLUSIONS The results converge to suggest that restricted access to medical care accounts for about 10% of premature death or other undesirable health outcomes. Health care has modest effects on the extension of US life expectancy, while behavioral and social determinants may have larger effects., INTRODUCTION It is often argued that improvements in population health, (1,2) and life expectancy in particular, (3) are best pursued via investments in medical services. Over the last few decades [...]

ObjectiveThe aim of this study was to examine the association between religiosity and overweight or obese body mass index among a multi-religious group of Asian Indian immigrants residing in California.MethodsWe examined cross-sectional survey data obtained from in-language telephone interviews with 3228 mostly immigrant Asian Indians in the 2004 California Asian Indian Tobacco Survey using multivariate logistic regression.ResultsHigh self-identified religiosity was significantly associated with higher BMI after adjusting for socio-demographic and acculturation measures. Highly religious Asian Indians had 1.53 greater odds (95% CI: 1.18, 2.00) of being overweight or obese than low religiosity immigrants, though this varied by religious affiliation. Religiosity was associated with greater odds of being overweight/obese for Hindus (OR 1.54; 95% CI: 1.08, 2.22) and Sikhs (OR 1.88; 95% CI: 1.07, 3.30), but not for Muslims (OR 0.69; 95% CI: 0.28, 1.70).ConclusionsReligiosity in Hindus and Sikhs, but not immigrant Muslims, appears to be independently associated with greater body mass index among Asian Indians. If this finding is confirmed, future research should identify potentially mutable mechanisms by which religion-specific religiosity affects overweight/obesity risk.

Abstract Background Official descriptive data from France showed a strong increase in breast-cancer incidence between 1980 to 2005 without a corresponding change in breast-cancer mortality. This study quantifies the part of incidence increase due to secular changes in risk factor exposure and in overdiagnosis due to organised or opportunistic screening. Overdiagnosis was defined as non progressive tumours diagnosed as cancer at histology or progressive cancer that would remain asymptomatic until time of death for another cause. Methods Comparison between age-matched cohorts from 1980 to 2005. All women residing in France and born 1911-1915, 1926-1930 and 1941-1945 are included. Sources are official data sets and published French reports on screening by mammography, age and time specific breast-cancer incidence and mortality, hormone replacement therapy, alcohol and obesity. Outcome measures include breast-cancer incidence differences adjusted for changes in risk factor distributions between pairs of age-matched cohorts who had experienced different levels of screening intensity. Results There was an 8-fold increase in the number of mammography machines operating in France between 1980 and 2000. Opportunistic and organised screening increased over time. In comparison to age-matched cohorts born 15 years earlier, recent cohorts had adjusted incidence proportion over 11 years that were 76% higher [95% confidence limits (CL) 67%, 85%] for women aged 50 to 64 years and 23% higher [95% CL 15%, 31%] for women aged 65 to 79 years. Given that mortality did not change correspondingly, this increase in adjusted 11 year incidence proportion was considered as an estimate of overdiagnosis. Conclusions Breast cancer may be overdiagnosed because screening increases diagnosis of slowly progressing non-life threatening cancer and increases misdiagnosis among women without progressive cancer. We suggest that these effects could largely explain the reported "epidemic" of breast cancer in France. Better predictive classification of tumours is needed in order to avoid unnecessary cancer diagnoses and subsequent procedures.

BackgroundArthritis is the leading cause of disability in the United States. We assess the generic health-related quality-of-life (HRQOL) among a nationally representative sample of U.S. adults with and without self-reported arthritis.MethodsThe NHMS, a cross-sectional survey of 3,844 adults (35-89 years) administered EuroQol-5D (EQ-5D), Health Utilities Index Mark 2 (HUI2) and 3 (HUI3), SF-36v2™, Quality of Well-being Scale self-administered form (QWB-SA), and the Health and Activities Limitations index (HALex) to each respondent via a telephone interview. Weighted multiple linear regression was used to generate age-gender-arthritis-stratified unadjusted HRQOL means and means adjusted for sociodemographic, socioeconomic covariates and comorbidities by arthritis-age category.ResultsThe estimated population prevalence of self-reported arthritis was 31%. People with arthritis were more likely to be woman, older, of lower socioeconomic status, and had more self-reported comorbidities than were those not reporting arthritis. Adults with arthritis had lower HRQOL on six different indexes compared with adults without arthritis, with overall differences ranging from 0.03 (QWB-SA, age-group 65-74) to 0.17 (HUI3, age-group 35-44; all P-value < .05).ConclusionArthritis in adults is associated with poorer HRQOL. We provide age-related reference values for six generic HRQOL measures in people with arthritis.

Abstract Background Healthcare costs in most developed countries are not clearly linked to better patient and public health outcomes, but are rather associated with service delivery orientation. In the U.S. this has resulted in large variation in healthcare availability and use, increased cost, reduced employer participation in health insurance programs, and reduced overall population health outcomes. Recent U.S. healthcare reform legislation addresses only some of these issues. Other countries face similar healthcare issues. Discussion A major goal of healthcare is to enhance patient health outcomes. This objective is not realized in many countries because incentives and structures are currently not aligned for maximizing population health. The misalignment occurs because of the competing interests between "actors" in healthcare. In a simplified model these are individuals motivated to enhance their own health; enterprises (including a mix of nonprofit, for profit and government providers, payers, and suppliers, etc.) motivated by profit, political, organizational and other forces; and government which often acts in the conflicting roles of a healthcare payer and provider in addition to its role as the representative and protector of the people. An imbalance exists between the actors, due to the resources and information control of the enterprise and government actors relative to the individual and the public. Failure to use effective preventive interventions is perhaps the best example of the misalignment of incentives. We consider the current Pareto efficient balance between the actors in relation to the Pareto frontier, and show that a significant change in the healthcare market requires major changes in the utilities of the enterprise and government actors. Summary A variety of actions are necessary for maximizing population health within the constraints of available resources and the current balance between the actors. These actions include improved transparency of all aspects of medical decision making, greater involvement of patients in shared medical decision making, greater oversight of guideline development and coverage decisions, limitations on direct to consumer advertising, and the need for an enhanced role of the government as the public advocate.

ObjectivePsoriatic arthritis (PsA) and scleroderma (SSc) are chronic rheumatic disorders with detrimental effects on health-related quality of life. Our objective was to assess health values (utilities) from the general public for health states common to people with PsA and SSc for economic evaluations.MethodsAdult subjects from the general population in a Midwestern city (N = 218) completed the SF-12 Health Survey and computer-assisted 0-100 rating scale (RS), time trade-off (TTO, range: 0.0-1.0) and standard gamble (SG, range: 0.0-1.0) utility assessments for several hypothetical PsA and SSc health states.ResultsSubjects included 135 (62%) females, 143 (66%) Caucasians, and 62 (28%) African-Americans. The mean (SD) scores for the SF-12 Physical Component Summary scale were 52.9 (8.3) and for the SF-12 Mental Component Summary scale were 49.0 (9.1), close to population norms. The mean RS, TTO, and SG scores for PsA health states varied with severity, ranging from 20.2 to 63.7 (14.4-20.3) for the RS 0.29 to 0.78 (0.24-0.31) for the TTO, and 0.48 to 0.82 (0.24-0.34) for the SG. The mean RS, TTO, and SG scores for SSc health states were 25.3-69.7 (15.2-16.3) for the RS, 0.36-0.80 (0.25-0.31) for the TTO, and 0.50-0.81 (0.26-0.32) for the SG, depending on disease severity.ConclusionHealth utilities for PsA and SSc health states as assessed from the general public reflect the severity of the diseases. These descriptive findings could have implications regarding comparative effectiveness research for tests and treatments for PsA and SSc.

To derive preference weights in Trinidad and Tobago for Quality of Well-being Scale (QWB) health states in order to calculate QWB scores that can be compared to scores calculated from US-derived preference weights. The comparison was to determine whether the QWB scores from these different preference weights would lead to similar conclusions.We conducted in-person household interviews to elicit preferences for 65 health states using a probability sample of 235 adults from Port of Spain, Chaguanas and San Fernando, Trinidad and Tobago. A regression model with correction for within-person clustering of observations was used to obtain preference weights based on case judgments on a 0 (dead) to 10 (“perfect health”) scale. The independent variables were the components of the QWB entered as indicator (0, 1) variables.One hundred and nineteen (51%) respondents provided ratings. The respondents that provided ratings were demographically no different from those that did not. The QWB response patterns were very similar using Trinidad and US weights. The mean (SD) QWB score was 0.750 (0.130) for female respondents and 0.784 (0.125) for male respondents using Trinidad coefficients (t 2, 233 = −2.05, P = 0.04) and 0.747 (0.131) for female respondents and 0.783 (0.126) for male respondents using US weights (t 2, 233 = −2.17, P = 0.03).Overall, we found the US and Trinidad and Tobago weights were highly similar and that the choice of either set of weights would lead to similar conclusions.

To compare HRQoL differences with CHD in generic indexes and a proxy CVD-specific score in a nationally representative sample of U.S. adults.The National Health Measurement Study, a cross-sectional random-digit-dialed telephone survey of adults aged 35–89, administered the EQ-5D, QWB-SA, HUI2, HUI3, SF-36v2™ (yielding PCS, MCS, and SF-6D), and HALex. Analyses compared 3,350 without CHD (group 1), 265 with CHD not taking chest pain medication (group 2), and 218 with CHD currently taking chest pain medication (group 3), with and without adjustment for demographic variables and comorbidities. Data on 154 patients from heart failure clinics were used to construct a proxy score utilizing generic items probing CVD symptoms.Mean scores differed between CHD groups for all indexes with and without adjustment (P