Assessing the impact of grief on quality of life, work productivity, and health outcomes for parents bereaved from SMA: A study protocol.

BACKGROUND: U.S. cost-effectiveness recommendations suggest that analyses should include all costs and effects relevant to the decision problem [1]. However, in many diseases, including spinal muscular atrophy (SMA), few studies have evaluated bereaved family outcomes after a child has died, neglecting potential impacts on their health-related quality of life (HRQoL), work productivity, and mental health. Additionally, grief-related outcomes are rarely included in economic evaluations. This manuscript outlines the protocol of a study that will estimate the HRQoL, work functioning, and mental health of bereaved parents of children with SMA type 1 to determine how outcomes vary based on parent's sex and the time since a child's death. METHODS: This study will involve two phases. In Phase 1, we will conduct a literature review to identify prior research that has measured how parental grief impacts HRQoL, work productivity, and mental health. We will also interview four bereaved parents of children with SMA type 1, stratified by parent sex and time since their child's death, and analyze findings using a thematic analysis. In Phase 2, we will develop a survey draft based on Phase 1 findings. Parents bereaved from SMA type 1 will review our survey draft and we will revise the survey based on their feedback. We will send a cross-sectional survey to approximately 880 parents bereaved from SMA type 1. We will analyze findings from the survey to investigate whether the severity of grief symptoms is correlated with HRQoL, productivity, depression and anxiety symptom severity. We will also evaluate whether the mean scores of grief and each of the outcomes vary significantly when stratified by parent sex and the time since the child's death. DISCUSSION: Our results will provide preliminary information on how parental grief can impact HRQoL, productivity, and mental health outcomes over time. Increasing the availability of family outcomes data will potentially assist organizations performing health economic evaluations, such as the Institute of Clinical and Economic Review (ICER) in the U.S. This research will also help to inform the development of future economic guidelines on this topic.

Cardiovascular Health Research in the Workplace: A Workshop Report.

Heart disease and stroke are the first and fifth leading causes of death in the United States, respectively. Employers have a unique opportunity to promote cardiovascular health, because >60% of US adults are employed, and most spend half of their waking hours at work. Despite the scope of the opportunity, <1 in 5 businesses implement evidence-based, comprehensive workplace health programs, policies, and practices. Integrated, systems-based workplace health approaches that harness data science and technology may have the potential to reach more employees and be cost-effective for employers. To evaluate the role of the workplace in promoting cardiovascular health across the lifespan, the National Heart, Lung, and Blood Institute, the National Institute for Occupational Safety and Health, and the American Heart Association convened a workshop on March 7, 2019, to share best practices, and to discuss current evidence and knowledge gaps, practical application, and dissemination of the evidence, and the need for innovation in workplace health research and practice. This report presents the broad themes discussed at the workshop and considerations for promoting worker cardiovascular health, including opportunities for future research.

Research on the Tufts Be Well at Work Program for Employees With Depression: 2005-2020.

OBJECTIVE: Although depression is a prevalent and costly health problem exacting a large toll on work productivity, interventions targeting occupational functioning are rare. This article describes the development of the Tufts Be Well at Work intervention, a brief telephonic program designed to improve occupational functioning among employees with depression and reduce depression symptom severity. Results from 15 years of research are summarized evaluating the occupational, clinical, and economic impact of Be Well at Work. METHODS: The design, methods, and results of all six Tufts Be Well at Work studies are reported. Studies included an initial workplace pilot study, two workplace randomized clinical trials (RCTs), one RCT in a health care system, and two pilot implementation studies conducted in a workplace and in an academic medical center. RCTs compared Tufts Be Well at Work to usual care. RESULTS: Tufts Be Well at Work consistently and significantly improved occupational functioning, work productivity, and depression symptom severity. Employees randomly assigned to usual care experienced smaller gains. The program also delivered a positive return on investment. CONCLUSIONS: Evidence suggests that Tufts Be Well at Work is an effective intervention for improving occupational and clinical functioning. Its relatively low cost and its impact on work productivity contribute to its positive economic impact.

A Population-Based Survey of the Workplace Costs for Caregivers of Persons With Treatment-Resistant Depression Compared With Other Health Conditions.

OBJECTIVE: To describe caregiving work outcomes and related indirect (ie, productivity) and direct (ie, caregiving hours and expenses) costs. METHODS: A national, population-based survey to identify employed caregivers assisting a person with treatment-resistant depression (TRD) and a comparison group of employed caregivers assisting others (No TRD). RESULTS: Screening identified 169 TRD caregivers and 1070 No TRD caregivers providing 23.3 and 14.6 mean weekly caregiving hours, respectively. Adjusted annual indirect cost estimates were $11,121 for caregivers of TRD and $7761 for caregivers in the No TRD group (P ≤ 0.0001). At-work productivity loss (presenteeism) was the largest component. Adjusted annual direct cost estimates were $29,805 for caregivers of TRD and $20,642 for caregivers in the No TRD group (P ≤ 0.0001). CONCLUSIONS: TRD exacts a toll on caregivers and their employers exceeding that for other caregivers.

Effect of Adding a Work-Focused Intervention to Integrated Care for Depression in the Veterans Health Administration: A Randomized Clinical Trial.

Importance: Thousands of working-age veterans with depression experience impaired occupational functioning. Objectives: To test whether the Veterans Health Administration (VHA) integrated care (IC) program combined with telephonic work-focused counseling, known as Be Well at Work (BWAW), is superior to IC alone for improving occupational functioning and depression, to determine whether these effects persist 4 months later, and to determine whether the return on investment is positive. Design, Setting, and Participants: In this randomized clinical trial conducted from October 21, 2014, to December 6, 2019, patients undergoing IC at VHA facilities were screened for eligibility and randomized to IC alone or IC plus BWAW. Blinded interviewers administered questionnaires before the intervention, immediately after completion of the intervention at month 4, and at month 8. Eligibility criteria were individuals 18 years or older who were working at least 15 hours per week in a job they had occupied for at least 6 months, were experiencing work limitations, and had current major depressive disorder or persistent depressive disorder. Exclusion criteria were individuals who could not read or speak English, had planned maternity leave, or had a history of bipolar disorder or psychosis. Data analyses were conducted from January 1, 2018, to December 6, 2019. Interventions: Integrated care is multidisciplinary depression care involving screening, clinical informatics, measurement-based care, brief behavioral interventions, and referral as needed to specialty mental health care. Be Well at Work counseling involves 8 biweekly telephone sessions and 1 telephone booster visit after 4 months. Doctoral-level psychologists helped patients to identify barriers to functioning and to adopt new work-focused cognitive-behavioral and work-modification strategies. Main Outcomes and Measures: The primary outcome was the adjusted mean group difference in changes from before to after intervention (hereafter, adjusted effect) in the percentage of at-work productivity loss, measured with the Work Limitations Questionnaire (range, 0%-25%). The secondary outcome was adjusted effect in the Patient Health Questionnaire 9-item symptom severity score (range, 0-27, with 0 indicating no symptoms and 27, severe symptoms). Results: Of 670 veterans referred for participation, 287 veterans (42.8%) consented and completed eligibility screening, and 253 veterans (37.8%) were randomized. Among these 253 patients (mean [SD] age, 45.7 [11.6] years; 218 [86.2%] men; 135 [53.4%] white), 114 (45.1%) were randomized to IC and 139 (54.9%) were randomized to IC plus BWAW. At the 4-month follow-up, patients who received IC plus BWAW had greater reductions in at-work productivity loss (adjusted effect, -1.7; 95% CI, -3.1 to -0.4; P = .01) and depression symptom severity (adjusted effect, -2.1; 95% CI, -3.5 to -0.7; P = .003). The improvements from IC plus BWAW persisted 4 months after intervention (at-work productivity loss mean difference, -0.5; 95% CI, -1.9 to 0.9; P = .46; depression symptom severity mean difference, 0.6; 95% CI -0.9 to 2.1; P = .44). The cost per patient participating in BWAW was $690.98, and the return on investment was 160%. Conclusions and Relevance: These findings suggest that adding this work-focused intervention to IC improves veterans' occupational and psychiatric outcomes, reducing obstacles to having a productive civilian life. Trial Registration: ClinicalTrials.gov Identifier: NCT02111811.

Analysis of the Full Economic Cost for Japanese Encephalitis Under Different Risk Scenarios for Business Travelers to Asia.

OBJECTIVE: Methods for assessing the costs and benefits of administering vaccines to international business/occupational travelers, assignees, and expatriates have neglected the impact of health and treatment on work productivity. The research objective is to evaluate the benefit to cost ratio of the Japanese encephalitis (JE) vaccine for international business/occupational travelers to Asia and other endemic areas incorporating a health and productivity approach. METHODS: Costs and benefits were estimated using actuarial methods with data obtained from secondary sources describing prevalence of infection risk and health outcomes, and business traveler demographic and travel characteristics. Results assumed 2018 salaries and prices, with employee time valued according to total compensation. RESULTS: Risks contracting JE vary widely on the basis of length of trip, season, and destination. The productivity benefits of vaccinating a traveler outweigh the vaccination costs for those staying 30 days or longer in endemic areas during one or more transmission seasons ($2009 vs $750 per traveler), and for business travelers to endemic areas during the transmission season with outdoor activities for the average 2-week/15.4-day international business trip ($502 to $815 vs $500). Vaccination costs outweigh the productivity benefits for short-term travelers who remain in urban areas or travel outside of the transmission season ($10 vs $500). CONCLUSION: JE Vaccination for business travelers in the active transmission season has a net benefit under certain conditions that are not commonly considered risky, such as average-length trips to peri-urban areas, in situations where contracting disease would result in significant business disruption, or when multiple trips are anticipated over several years.

Psychological Distress Among Caregivers of Individuals With a Diagnosis of Schizophrenia or Schizoaffective Disorder.

OBJECTIVE: The aim was to quantify caregiver distress among informal caregivers of individuals with schizophrenia or schizoaffective disorder and identify its correlates. METHODS: From December 2014 through April 2015, ads posted with mental health advocates and the media recruited informal caregivers, age ≥21 years, to complete an online questionnaire. It included the ten-item Perceived Stress Scale (PSS) (0, no distress; 39, highest) and hypothesized distress correlates in four groups: caregiver and care recipient characteristics; caregiver role demands; caregiver social supports; and caregiver cognitive appraisals of caregiving. Three hypotheses were tested: first, distress is significantly related to variables from each group; second, social supports moderate the effects of role demands on distress; and third, cognitive appraisals mediate the effects of role demands on distress. Hypotheses were tested with multiple linear regression equations and structural equation models (SEMs). RESULTS: Of 2,338 Web site "hits," 1,708 individuals consented, 1,398 were eligible, and 1,142 had complete data. Most caregivers were women (83%), white (89%), and college educated (59%), with a mean±SD age of 55.6±13.0. Compared with U.S. norms on the PSS (13.4±6.5), mean caregiver distress was high (18.9±7.1). According to SEMs, variables from each group were associated with distress. Contributing most to greater distress were caregiver health problems, providing frequent caregiving assistance, monitoring medication, having limited social support, and appraising caregiving negatively. Cognitive appraisals mediated the effects of demands on distress. Social support had a significant direct effect only. CONCLUSIONS: Caregiver distress was relatively high and related to multiple variables, some of which are potentially modifiable.

Reliability and validity of severity dimensions of psychopathology assessed using the Structured Clinical Interview for DSM-5 (SCID).

This study examined whether the Structured Clinical Interview for DSM (SCID), a widely used semistructured interview designed to assess psychopathology categorically, can be adapted to identify reliable and valid severity dimensions of psychopathology. The present study also examined whether these severity dimensions have better psychometric properties (internal consistency, test-retest reliability, and concurrent and predictive validity) than categorical diagnoses. Participants (N = 234) were recruited from the community and clinics. Retest reliability and prospective predictive validity (symptoms and functioning 1 year later) were examined in subsamples of participants. Dimensional severity scales were created from an adapted version of the SCID for both current and lifetime major depression, alcohol, substance, post-traumatic stress disorder, panic, agoraphobia, social anxiety, specific phobia, obsessive-compulsive disorder, and generalized anxiety disorder. The SCID's severity scales demonstrated substantial internal consistency (all Cronbach's αs >.80), test-retest reliability, and concurrent and predictive validity. Symptom severity scales demonstrated significant incremental validity over and above categorical diagnoses for both current and prospective outcomes. The psychometric properties of SCID-identified symptom scales were far superior to the psychometrics of categorical diagnoses for both current and lifetime psychopathology. These results highlight the feasibility and utility of the SCID to assess reliable and valid symptom severity dimensions of both current and lifetime psychopathology.

Measuring the Work Impact of Caregiving for Individuals With Schizophrenia and/or Schizoaffective Disorder With the Caregiver Work Limitations Questionnaire (WLQ).

OBJECTIVE: The aim of this study was to test the reliability, validity, and responsiveness of the Caregiver Work Limitations Questionnaire (WLQ) for employed caregivers of individuals with schizophrenia and/or schizoaffective disorder. METHODS: A cross-sectional web-based survey with test/retest and responsiveness test components was administered to informal caregivers. Using data from employed caregivers, psychometric tests were performed of the questionnaire's four at-work limitation scales and work absence score. RESULTS: Of 1142 eligible caregivers, 710 (62.2%) were employed. On the basis of the 4-week recall period, caregivers were limited in performing work tasks approximately between 20% and 30% of the time on average and absent a mean of 2 to 3 days. With few exceptions, the Caregiver WLQ demonstrated scale homogeneity, test/retest reliability, construct validity, and responsiveness to change. CONCLUSION: The Caregiver WLQ provides new information about the impact of caregiving on employment.

Rationale and study design of MOTION: A phase 4, prospective, single-arm, open-label study to measure outcomes in patients with pulmonary arterial hypertension not on active treatment.

In clinical trials of treatments for pulmonary arterial hypertension (PAH), objective measures, such as 6-min walk distance (6MWD) are limited in their ability to characterize the impact of PAH therapy from a patient's perspective. Few clinical studies have evaluated the primary effects of pharmacologic treatment on patient-reported outcomes, such as symptoms, health-related quality of life (HRQoL), and productivity. MOTION (NCT02191137) is a prospective, multicenter, single-arm, open-label, phase 4 trial designed to assess whether riociguat monotherapy will improve patient-reported outcomes in patients with PAH in the United States who are not currently on treatment. Following a screening period of up to 14 days, eligible subjects will receive riociguat (0.5-2.5 mg TID) during a 10-week titration phase and a 14-week maintenance phase. The primary endpoint is change from baseline in the Living with Pulmonary Hypertension (LPH) questionnaire, a disease-specific HRQoL measure, after 24 weeks of riociguat treatment. The Short Form-12 Health Survey (SF-12) and the Work Limitations Questionnaire 8 (WLQ-8) will also be utilized to assess patient-reported outcomes. Other variables include change from baseline in World Health Organization functional class, 6MWD, and modified Borg Dyspnea Index. In addition, accelerator band activity will be validated against the 6MWD test. Safety will also be assessed. The MOTION trial will provide information on the effect of riociguat on patient-reported outcomes in PAH patients in the United States who are not currently on active treatment through the use of disease-specific and generic HRQoL measures (LPH and SF-12) and a measure of worker productivity (WLQ-8).

Consumer Information and Treatment Resources for Posttraumatic Stress Disorder: Within Reach but Not Grasp.

In the context of multiple treatment options for posttraumatic stress disorder (PTSD) and a large, growing need for consumer information regarding accessible and effective treatments, this article identifies and reviews available information and treatment resources. Multiple search strategies identified a suite of information sources, including meta-analyses and systematic reviews of PTSD treatments, the program evaluation and implementation literature, the economics literature, Internet sites, and other resources for veteran and civilian consumers. Resources were evaluated with regard to their target audiences, depth and breadth of treatment options covered, nature of the information provided, and accessibility to consumers. A large body of research covers the various treatments and sets of treatment guidelines for PTSD. Despite the extensive scientific information targeted at providers and researchers, the quality, accessibility, and usability of the published research varies widely. The Veterans Health Administration provides the most extensive information on various treatment options and where to obtain treatment within that system. Publicly available websites provide information on multiple treatment options, but information to help nonveterans navigate treatment choices is limited. Published reports of PTSD program-evaluation and implementation studies are sparse. Information on PTSD treatment options available to consumers can be overwhelming and confusing, which places an unnecessary burden on an already vulnerable group of patients and their families. Exacerbating the situation is the shortage of program-evaluation and implementation research. The dearth of centralized and accessible information related to nonveteran PTSD patient groups needs to be addressed.

Improving work outcomes of dysthymia (persistent depressive disorder) in an employed population.

OBJECTIVE: To test the effectiveness of a work-focused intervention (WFI) on the work outcomes of employed adults with dysthymia. METHOD: This subgroup analysis from a randomized controlled trial compares an initial sample of 167 employees (age: ≥45 years), screened for dysthymia using the PC-SAD without current major depressive disorder randomized to WFI (n=85) or usual care (UC) (n=82). Study sites included 19 employers and five additional organizations. Telephone-based WFI counseling (eight, twice monthly 50-min sessions) provided work coaching and modification, care coordination and cognitive behavioral therapy. Adjusted mixed effects models compared the WFI vs. UC group preintervention to 4-month postintervention change in at-work limitations measured by the Work Limitations Questionnaire. Secondary outcome analysis compared the change in self-reported absences and depression symptom severity (Patient Health Questionnaire PHQ-9 scores). RESULTS: Work productivity loss scores improved 43.0% in the WFI group vs. 4.8% in UC (difference in change: P<.001). Absence days declined by 58.3% in WFI vs. 0.0% in UC (difference in change: P=.09). Mean PHQ-9 depression symptom severity declined 44.2% in WFI vs. 5.3% in UC (difference in change: P<.001). CONCLUSION: At 4 months, the WFI was more effective than UC on two of the three outcomes. It could be an important mental and functional health improvement resource for the employed dysthymic population.

A randomized clinical trial of a telephone depression intervention to reduce employee presenteeism and absenteeism.

OBJECTIVES: The study tested an intervention aimed at improving work functioning among middle-aged and older adults with depression and work limitations. METHODS: A randomized clinical trial allocated an initial sample of 431 eligible employed adults (age ≥45) to a work-focused intervention (WFI) or usual care. Inclusion criteria were depression as measured by the Patient Health Questionnaire-9 (PHQ-9) and at-work limitations indicated by a productivity loss score ≥5% on the Work Limitations Questionnaire (WLQ). Study sites included 19 employers and five related organizations. Telephone-based counseling provided three integrated modalities: care coordination, cognitive-behavioral therapy strategy development, and work coaching and modification. Effectiveness (change in productivity loss scores from preintervention to four months postintervention) was tested with mixed models adjusted for confounders. Secondary outcomes included change in WLQ work performance scales, self-reported absences, and depression. RESULTS: Of 1,227 eligible employees (7% of screened), 431 (35%) enrolled and 380 completed the study (12% attrition). At-work productivity loss improved 44% in the WFI group versus 13% in usual care (difference in change, p<.001). WFI group scores on the four WLQ scales improved 44% to 47%, significantly better than in usual care (p<.001 for each scale). Absence days declined by 53% in the WFI group versus 13% in usual care (difference in change, p<.001). Mean PHQ-9 depression symptom severity scores declined 51% for WFI versus 26% for usual care (difference in change, p<.001). CONCLUSIONS: The WFI was more effective than usual care at four-month follow-up. Given increasing efforts to provide more patient-centered, value-based care, the WFI could be an important resource.

The health care and productivity costs of back and neck pain in a multi-employer sample of utility industry employees.

OBJECTIVE: To determine the cost of back and/or neck (B/N) pain among predominantly rural employees insured through an employee benefits trust. METHODS: Eligible employees had 1 year or more of medical coverage and completed a survey subsequently linked to their claims data. B/N pain costs consisted of medical and pharmacy claims, over-the-counter expenses, and presenteeism and absenteeism costs valued according to median occupational earnings. RESULTS: Of 1342 eligible employees, 52.7% currently had B/N pain of which 87.9% was chronic. The average annualized cost of B/N pain per employee was $1727; 56.1% was due to lost productivity. Covered medical care was utilized by 35.6% of employees, 55.7% used pharmacy care, and 71.6% purchased uncovered over-the-counter pain medication. CONCLUSIONS: Many covered employees did not use formal care. The effect of care choices on productivity costs requires closer scrutiny.

The reliability and validity of the Caregiver Work Limitations Questionnaire.

OBJECTIVE: To test a new Caregiver Work Limitations Questionnaire (WLQ). On the basis of the original WLQ, this new survey instrument assesses the effect of caregiving for ill and/or disabled persons on the caregiver's work performance. METHOD: A questionnaire was administered anonymously to employees of a large business services company. Scale reliability and validity were tested with psychometric methods. RESULTS: Of 4128 survey participants, 18.3% currently were caregivers, 10.2% were past caregivers, and 71.5% were not caregivers. Current caregivers were limited in their ability to perform basic job tasks between mean 10.3% and 16.8% of the time. Confirmatory factor analysis yielded a scale structure similar to the WLQ's. Scales reliabilities (the Cronbach's α) ranged from 0.91 to 0.95. CONCLUSIONS: The Caregiver WLQ is a new tool for understanding the workplace effect of caregiving.

Cross-cultural adaptation of the Individual Work Performance Questionnaire.

BACKGROUND: The Individual Work Performance Questionnaire (IWPQ), measuring task performance, contextual performance, and counterproductive work behavior, was developed in The Netherlands. OBJECTIVES: To cross-culturally adapt the IWPQ from the Dutch to the American-English language, and assess the questionnaire's internal consistency and content validity in the American-English context. METHODS: A five stage translation and adaptation process was used: forward translation, synthesis, back-translation, expert committee review, and pilot-testing. During the pilot-testing, cognitive interviews with 40 American workers were performed, to examine the comprehensibility, applicability, and completeness of the American-English IWPQ. RESULTS: Questionnaire instructions were slightly modified to aid interpretation in the American-English language. Inconsistencies with verb tense were identified, and it was decided to consistently use simple past tense. The wording of five items was modified to better suit the American-English language. In general, participants were positive on the comprehensibility, applicability and completeness of the questionnaire during the pilot-testing phase. Furthermore, the study showed positive results concerning the internal consistency (Cronbach's alphas for the scales between 0.79-0.89) and content validity of the American-English IWPQ. CONCLUSION: The results indicate that the cross-cultural adaptation of the American-English IWPQ was successful and that the measurement properties of the translated version are promising.

Effect of glycemic load on eating behavior self-efficacy during weight loss.

High eating behavior self-efficacy may contribute to successful weight loss. Diet interventions that maximize eating behavior self-efficacy may therefore improve weight loss outcomes. However, data on the effect of diet composition on eating behavior self-efficacy are sparse. To determine the effects of dietary glycemic load (GL) on eating behavior self-efficacy during weight loss, body weight and eating behavior self-efficacy were measured every six months in overweight adults participating in a 12-mo randomized trial testing energy-restricted diets differing in GL. All food was provided during the first six months and self-selected thereafter. Total mean weight loss did not differ between groups, and GL-level had no significant effect on eating behavior self-efficacy. In the combined cohort, individuals losing the most weight reported improvements in eating behavior self-efficacy, whereas those achieving less weight loss reported decrements in eating behavior self-efficacy. Decrements in eating behavior self-efficacy were associated with subsequent weight regain when diets were self-selected. While GL does not appear to influence eating behavior self-efficacy, lesser amounts of weight loss on provided-food energy restricted diets may deter successful maintenance of weight loss by attenuating improvements in eating behavior self-efficacy.

A systematic review of the evidence concerning the economic impact of employee-focused health promotion and wellness programs.

OBJECTIVE: To assess the evidence regarding the economic impact of worker health promotion programs. OBJECTIVE: Peer-reviewed research articles were identified from a database search. Included articles were published between January 2000 and May 2010, described a study conducted in the United States that used an experimental or quasi-experimental study design and analyzed medical, pharmacy (direct), and/or work productivity (indirect) costs. A multidisciplinary review team, following specific criteria, assessed research quality. RESULTS: Of 2030 retrieved articles, 44 met study inclusion criteria. Of these, 10 were of sufficient quality to be considered evidentiary. Only three analyzed direct and indirect costs. CONCLUSIONS: Evidence regarding economic impact is limited and inconsistent. Higher-quality research is needed to demonstrate the value of specific programs.

Imputing at-work productivity loss using results of a randomized controlled trial comparing tapentadol extended release and oxycodone controlled release for osteoarthritis pain.

OBJECTIVE: : To determine the impact of tapentadol extended release (ER) versus placebo or oxycodone controlled release (CR) on the work productivity of adults with chronic moderate to severe knee osteoarthritis pain. METHODS: : Using clinical trial data on pain outcomes, a validated methodology imputed treatment group differences in at-work productivity and associated differences in productivity costs (assuming a $100,000 annual salary per participant). RESULTS: : Imputed improvements in at-work productivity were significantly greater for tapentadol ER compared with either placebo (mean, 1.96% vs 1.51%; P = 0.001) or oxycodone CR (mean, 1.96% vs 1.40%; P < 0.001). Mean net savings per participant were $450 (P < 0.01) for tapentadol ER versus placebo and $560 (P = 0.001) for tapentadol ER versus oxycodone CR. CONCLUSION: : Effective osteoarthritis pain treatment also may help employees to function better at work and reduce their employers' productivity costs.

Imputing productivity gains from clinical trials.

OBJECTIVE: To respond to employer and payer interest in the extent to which productivity gains offset therapy costs by identifying clinical trials that did not include such measures and using their clinical data to impute productivity impact. METHODS: A PubMed search identified the sample of 25 clinical trials of musculoskeletal pain medications and antidepressants. Next, we applied regression coefficients, quantifying the empirical relationship between clinical measures to each trial's clinical outcomes data. This validated methodology provides estimates of Work Limitations Questionnaire Productivity Loss scores. RESULTS: Based on imputation, musculoskeletal medications and antidepressants achieved median productivity gains of approximately 0.5% and 1.0%, respectively. CONCLUSION: Accounting for productivity gains based on the Work Limitations Questionnaire could substantially influence cost-effectiveness results reported in the health economics literature.