Paul C Langley

The prevalence, correlates and treatment of pain in the European Union

Abstract Objectives: To report on the results of a recent large-scale, internet-based survey of the population, prevalence and attributes of pain experience in the United Kingdom (UK), France, Spain, Germany and Italy. Methods: The results reported here are taken from the internet-based, 2008 National Health and Wellness Survey (NHWS). In addition to detailing the prevalence of pain, the survey reports on the correlates of pain – socio-demographic characteristics of respondents, health status and health related quality of life, pain associated comorbidities, satisfaction with care, employment and productivity and utilization of health care resources. In addition, the survey also captures treatment patterns, satisfaction with medications (both prescription and over the counter [OTC]) and adherence experience. Results: An estimated 49.7 million persons in these five countries reported pain by both its severity and frequency in the previous month. Of these, 11.2 million reported severe pain, 29.4 million reported moderate pain and 9.0 million reported mild pain. The population prevalence of daily pain is 8.85% with 3.47% reporting severe daily pain and 4.70% moderate daily pain. The cumulative burden of pain is demonstrated in terms of HRQoL, employment status and workforce activities as well as in healthcare resource utilization. The most striking impacts are seen in the impact of severe and frequent pain on HRQoL. Of the measures employed, the impact on the physical component score (PCS) of the SF-12 and the SF-6D absolute utility scores are substantial. The presence of severe and daily pain not only reduces the PCS score against that reported for the no pain population by over 20 points (or approximately 40%) but the impact on the absolute utility score is to reduce it from a no pain average of 0.74 to a score of 0.54. As far as productivity losses to the community are concerned the impact of severe pain is equally dramatic. Conclusions: The reported prevalence of pain in these five countries represents a substantial burden to individuals, employers, healthcare systems and society in general. The fact that one in five of the adult population has experienced pain presents a major policy challenge. This would involve not only reducing the prevalence of pain – where chronic pain may be considered a disease in its own right – but to co-ordinate pain management programs across a range of disease states and socio-economic groups.

The impact of pain on labor force participation, absenteeism and presenteeism in the European Union

Abstract Objectives: The aims of this paper are to generate estimates of the association between the experience and burden of pain, by severity and frequency, with (1) labor force participation and workforce status in five EU countries (the UK, France, Spain, Germany and Italy) and (2) patterns of absenteeism and presenteeism for the employed workforce. Methods: Data are from the internet-based 2008 National Health and Wellness Survey (NHWS). This survey covers both those who report experiencing pain in the last month as well as the no pain population. A series of regression models are developed with the no pain group as the reference category. The impact of pain, categorized by severity and frequency reported, is assessed within a labor supply framework for (1) labor force participation and (2) absenteeism and presenteeism. In the former case both binomial and multinomial logistic models are estimated; in the latter case ordered logit models are estimated. Results: The results demonstrate that, in the context of health status, the experience of frequent severe and moderate pain has a dominant, independent and negative association with labor force participation and employment status as well as absenteeism and presenteeism. The presence of severe daily pain is associated with a 20-point reduction in the probability of being employed full-time; with moderate daily pain associated with a 10-point reduction. The impact of pain is far greater than the potential impact of other health status measures (e.g., chronic comorbidities and BMI). The experience of pain, notably severe and frequent pain, also outstrips the impact of other health status factors in absenteeism and presenteeism. Conclusions: The experience of pain, in particular severe daily pain, has a substantial negative association with labor force participation in these five European countries as well as reported absenteeism and presenteeism. As a measure of health status, it clearly outweighs other health status measures. Whether or not pain is considered as a disease in its own right, the experience of chronic pain, as defined here, presents policy makers with a major challenge. Programs to relieve the burden of pain in the community clearly have the potential for substantial benefits from societal, individual and employer perspectives.

The societal impact of pain in the European Union: health-related quality of life and healthcare resource utilization

Abstract Objectives: This paper reports on the results of a series of quantitative assessments of the association of severe and frequent pain with health-related quality of life and healthcare resource utilization in five European countries. Methods: The analysis contrasts the contribution of the increasing severity and frequency of pain reported against respondents reporting no pain in the previous month. The data are taken from the 2008 National Health and Wellness Survey. Single-equation generalized linear regression models are used to evaluate the association of pain with the physical and mental component scores of the SF-12 questionnaire as well as health utilities generated from the SF-6D. In addition, the role of pain is assessed in its association with healthcare provider visits, emergency room visits and hospitalizations. Results: The results indicate that the experience of pain, notably severe and frequent pain, is substantial and is significantly associated with the SF-12 physical component scores, health utilities and all aspects of healthcare resource utilization, which far outweighs the role of demographic and socioeconomic variables, health risk factors (in particular body mass index) and the presence of comorbidities. In the case of severe daily pain, the marginal contribution of the SF-12 physical component score is a deficit of −17.86 compared to those reporting no pain (population average score 46.49), while persons who are morbidly obese report a deficit of only −6.63 compared to those who are normal weight. The corresponding association with health utilities is equally dramatic with a severe daily pain deficit of −0.19 compared to those reporting no pain (average population utility 0.71). Conclusions: For the five largest EU countries, the societal burden of pain is considerable. The experience of pain far outweighs the contribution of more traditional explanations of HRQoL deficits as well as being the primary factor associated with increased provider visits, emergency room visits and hospitalizations.

Humanistic and economic impacts of hepatitis C infection in the United States

Abstract Objective: Prior research examining the effect of hepatitis C virus (HCV) on health-related quality of life (HRQoL) and healthcare costs is flawed because non-patient controls were not adequately comparable to HCV patients. The current study uses a propensity score matching methodology to address the following research question: is the presence of diagnosed hepatitis C (HCV) associated with poorer health-related quality of life (HRQoL) and greater healthcare resource use? Methods: Using data from the 2009 US National Health and Wellness Survey, patients who reported a HCV diagnosis (n = 695) were compared to propensity-matched controls (n = 695) on measures of HRQoL and healthcare resource use. All analyses applied sampling weights to project to the US population. Results: HCV patients reported significantly lower levels of HRQoL relative to the matched-control group, including the physical component score (39.6 vs. 42.7, p < 0.0001) and health utilities (0.63 vs. 0.66, p < 0.0001). The number of emergency room visits (0.59 vs. 0.44, p < 0.05) and physician visits (7.7 vs. 5.9, p < 0.05) in the past 6 months were significantly higher for the HCV group relative to matched controls. Conclusion: The results of this study suggest that HCV represents a substantial burden on patients by having a significant and clinically-relevant impact on key dimensions of HRQoL as well as on utilization of healthcare resources, the latter of which would result in increased direct medical costs. Limitations: Due to limitations of the internet survey approach (e.g., inability to confirm HCV diagnosis), future research is needed to confirm these findings.

The burden associated with neuropathic pain in Western Europe

Abstract Background: The purpose of this study is to assess the burden of neuropathic pain (NeP) on health-related quality-of-life (HRQoL), health status, employment status, absenteeism and presenteeism, and direct medical costs in Western Europe. Methods: Data are from the 2010 National Health and Wellness Survey (NHWS) for five countries in western Europe: the UK, France, Spain, Germany, and Italy. Among subjects who reported experiencing pain in the past month, those who attributed their pain to NeP were compared with those who attributed their pain to another chronic pain condition other than NeP (the latter was the reference group). These two groups were compared on demographic and both pain and non-pain related comorbidities. Generalized linear models were used to estimate the independent contribution of the presence of NeP on: (a) HRQoL (using the SF-12v2); (b) self-reported health status (the first item of the SF-12v2); (c) employment status; (d) absenteeism and presenteeism (using the WPAI questionnaire); and (e) direct medical costs (estimated from self-reported healthcare resource use and unit costs from the literature). Results: Relative to the chronic pain reference group, subjects with NeP reported a higher prevalence of severe daily pain (38.12% vs 12.67%, p < 0.05), lower labor force participation (39.68% vs 55.56%; p < 0.05), higher prevalence of sleep difficulties (59.14% vs 46.73%; p < 0.05), insomnia (45.61% vs 29.78%; p < 0.05) anxiety (42.42% vs 31.99%; p < 0.05), and depression (35.25% vs 24.03%; p < 0.05). NeP subjects reported higher rates of absenteeism (39.78% vs 21.47%; p < 0.05) and presenteeism (86.48% vs. 66.70%; p < 0.050). Direct medical costs were approximately twice as high compared to non-NeP controls. In addition, >80% of NeP patients reported having other pain conditions. Regression results amplified these findings by indicating the independent contribution of confounding factors on the presence of NeP. Limitations: The NHWS is an Internet-based survey and may not be representative of the respective country populations if Internet access is limited. Second, respondents are asked to report their experience of pain. Although respondents are asked if their pain condition has been diagnosed by a physician there is no separate clinical confirmation of the presence of pain, pain conditions reported, and the presence of comorbidities. Conclusions: The presence of NeP is associated with an increased disease burden in the chronic pain population. This is seen in terms of HRQoL, health status, employment experience, and direct medical costs.

A Review of Duloxetine 60 mg Once‐Daily Dosing for the Management of Diabetic Peripheral Neuropathic Pain, Fibromyalgia, and Chronic Musculoskeletal Pain Due to Chronic Osteoarthritis Pain and Low Back Pain

Background:  Duloxetine is a selective dual neuronal serotonin (5‐Hydroxytryptamine, 5‐HT) and norepinephrine reuptake inhibitor (SSNRI). It is indicated in the United States for treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), and several chronic pain conditions, including management of diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain due to chronic osteoarthritis (OA) pain and chronic low back pain (LBP). Its use for antidepressant and anxiolytic actions has been extensively reviewed previously. We here review the evidence for the efficacy of 60 mg once‐daily dosing of duloxetine for chronic pain conditions.

The prevalence, correlates and treatment of pain in Spain.

Abstract Objectives: The aims of this paper are to report on the prevalence, correlates and treatment of pain in the adult Spanish population. The analysis also explores the association between the experience of pain and health-related quality of life (HRQoL), employment and productivity, and healthcare resource utilization. Methods: Data are from the internet-based, 2010 National Health and Wellness Survey (NHWS) Spain. The sample was weighted by age and sex to correspond to the 2010 adult Spanish population. All respondents to the NHWS reported on socio-demographic and economic characteristics, medication adherence and major health conditions. They also reported on their HRQoL (the SF-12), their employment status and workplace productivity experience (WPAI instrument) and their healthcare resource utilization. Persons reporting experiencing pain gave details on conditions causing pain, prescription and over the counter (OTC) medication utilization, duration of utilization and satisfaction with medications. A supplementary analysis evaluated the population prevalence of pain for the five most populous Spanish autonomous communities (regions). Results: An estimated 6.10 million (17.25%) of the adult population of Spain reported experiencing pain in the last month. Of these11.69% experienced severe pain, 64.17% moderate pain and 24.14% mild pain. Daily pain was experienced by 6.95% of the population The major conditions causing pain are back pain (60.53%) followed by joint pain (40.21%). Sleep difficulties (42.24%) and anxiety (40.62%) were most commonly cited as comorbidities. Prescription medication utilization was most important in the severe and moderate pain categories, with 71.62% reporting they were satisfied with their prescription pain medications. Adherence to pain medications was high with an overall Morisky score of 0.99 (range 0–4). Pain had a major negative effect on labor force participation for those reporting moderate and severe pain with a participation rate of only 42.62% for those with severe pain. Pain was associated with substantial health-related quality of life deficits as measured by the physical and mental score components of the SF-12. In the case of SF-6D utilities, the utility score for the pain population was markedly below that for the no-pain population (0.65 vs. 0.75; p < 0.05).The experience of pain also negatively impacted rates of absenteeism and presenteeism, as well as being associated with greater healthcare resource utilization. Finally, for the five most populous autonomous communities of Spain estimated pain prevalence ranged from 14.80% for Madrid to 18.79% for Comunidad Valenciana. The are a number of limitations which should be noted. First, this is an internet-based sample study and the respondent population may not be representative of the Spanish adult population. Second, respondents are asked to report their experience of pain with no independent clinical conformation. Finally, while a number of obvious acute pain categories are exclude, there is no attempt to arbitrarily define a chronic pain population or to identify pain categories such as neuropathic pain. Conclusions: The experience of pain represents a substantial burden on both individuals and the Spanish economy. The experience of pain is associated with a substantial reduction in both the PCS component of the SF-12 and SF-6D absolute utilities – most notably in respect of severe pain. The experience of pain is also associated, not only with reduced labor force participation and increased absenteeism and presenteeism, but with substantially higher patterns of healthcare resource utilization.

The impact of hepatitis C on labor force participation, absenteeism, presenteeism and non-work activities

Abstract Objective: Between 2.7 and 3.9 million people are currently infected with the hepatitis C virus (HCV) in the United States. Although many studies have investigated the impact of HCV on direct healthcare costs, few studies have estimated the indirect costs associated with the virus using a nationally-representative dataset. Methods: Using data from the 2009 United States (US) National Health and Wellness Survey, patients who reported a hepatitis C diagnosis (n = 695) were compared to controls on labor force participation, productivity loss, and activity impairment after adjusting for demographics, health risk behaviors, and comorbidities. All analyses applied sampling weights to project to the population. Results: Patients with HCV were significantly less likely to be in the labor force than controls and reported significantly higher levels of absenteeism (4.88 vs. 3.03%), presenteeism (16.69 vs. 13.50%), overall work impairment (19.40 vs.15.35%), and activity impairment (25.01 vs. 21.78%). A propensity score matching methodology replicated many of these findings. Conclusions: While much of the work on HCV has focused on direct costs, our results suggest indirect costs should not be ignored when quantifying the societal burden of HCV. To our knowledge, this is the first study which has utilized a large, nationally-representative data source for identifying the impact of HCV on labor force participation and work and activity impairment using both a propensity-score matching and a regression modeling framework. Limitations: All data were patient-reported (including HCV diagnosis and work productivity), which could have introduced some subjective biases.

The Burden of Illness for Patients with Viral Hepatitis C: Evidence from a National Survey in Japan

OBJECTIVE Viral hepatitis C (HCV) affects 170 million patients worldwide and 2 million patients in Japan. The objective of the current study was to examine the burden of HCV in Japan from a patients perspective. METHODS Using data from the 2008 and 2009 Japan National Health and Wellness Surveys, patients who reported an HCV diagnosis (n = 306) were compared with a propensity-score-matched control group (n = 306) on measures of quality of life (using the Medical Outcomes Study 12-Item Short Form Survey Instrument version 2), work productivity (using the Work Productivity and Activity Impairment questionnaire), and health-care resource use. All analyses applied sampling weights to project to the population. RESULTS Prior to matching, patients with HCV had higher rates of hepatocellular carcinoma (4.88% vs. 0.02%) and cirrhosis (12.20% vs. 0.11%) than did subjects without HCV. The propensity-matching process eliminated differences between the two groups on demographics and patient characteristics. The postmatching analysis found significantly lower levels of quality of life for patients with HCV as measured by bodily pain (72.07 vs. 76.28), general health (44.64 vs. 48.61), and mental health (66.50 vs. 70.32) (all Ps < 0.05). Furthermore, compared with the matched group, the HCV group had significantly higher workplace absenteeism (8.59% vs. 4.12%), overall work impairment (26.08% vs. 17.32%), and health-care provider visits in the past 6 months (14.80 vs. 9.74). CONCLUSIONS The results of this study suggest that HCV can be a substantial burden on patients in terms of quality of life in both physical and mental health measures. In addition, HCV can be a significant cost driver in terms of health-care use and lost productivity.

The societal burden of pain in Germany: Health-related quality-of-life, health status and direct medical costs

Abstract Objectives: The purpose of this paper is to estimate the impact of the severity and frequency of pain on health-related quality-of-life (HRQoL), self-reported health status, and direct medical costs in Germany. Methods: Data are from the internet-based 2010 National Health and Wellness Survey (NHWS). Estimates of the impact of pain experience are generated by a series of regression models. In the case of HRQoL the physical and mental summary scores from the SF-12, together with SF-6D utilities, are evaluated within an ordinary least squares framework. Health status is assessed through an ordered logit model. Direct medical costs are estimated through a semi-logarithmic healthcare cost function. Socioeconomic characteristics, health risk behaviors, and the Charlson Comorbidity Index (CCI) are introduced as control variables in all regressions. Results: An estimated 23.96% of the adult German population (16.39 million) reported experiencing pain in the last 30 days. Of these 13.16% reported severe pain. The experience of frequent severe and moderate pain has a significant deficit impact on HRQoL. For those experiencing severe daily pain, the deficit in the SF-12 physical component score (PCS) is −17.930 (95% CI: −18.720 to −17.140), the SF-12 mental component score (MCS) is −8.787 (05% CI: −9.857 to −7.716), and SF-6D absolute utilities −0.201 (95% CI: −0.214 to −0.188); with self-reported health status the deficit impact of severe daily pain is also substantial (OR = 29.000; 95% CI: 23.000–36.580). In the case of direct medical costs severe daily pain increases healthcare provider costs by 101.6% and total direct costs by 123.9%. Limitations: The NHWS is an internet survey. The principal limitation is that as a self-report there is no separate validation of pain severity or chronicity. Conclusions: The experience of pain has a substantial negative impact on HRQoL, health status, and resource utilization in Germany. If pain is considered as a disease in its own right, the experience of chronic pain presents policy-makers with a major challenge.