Trends in the treatment of fibromyalgia in South Korea between 2011 and 2018: a retrospective analysis of cross-sectional health insurance data.

OBJECTIVES: Fibromyalgia treatment trends vary globally; however, the trend in South Korea has not been investigated yet. This study aimed to analyse the fibromyalgia treatment trends in South Korea. DESIGN: Retrospective, observational study using serial cross-sectional data. SETTING: The National Patient Samples of the Korean Health Insurance Review & Assessment Service from 2011 to 2018 were used. PARTICIPANTS: A total of 31 059 patients with fibromyalgia were included in this study. The basic characteristics of the patients were stratified by sex, age and comorbidity. A patient was considered to have a condition if it was recorded as a principal diagnosis at least once in a year. PRIMARY AND SECONDARY OUTCOME MEASURES: Trends in the types of medical visits and prescribed treatments were investigated and the values are presented as rates per 100 patients. The types of pharmacological treatment were presented according to the existing clinical guidelines. Additionally, combination prescription trends and associated characteristics were investigated. RESULTS: Of the patients, 66.2% were female. Visits to internal medicine departments showed the most significant increase (2011: 11.34; 2018: 21.99; p<0.001). Non-pharmacological treatment rates declined (physical therapy 2011: 18.11; 2018: 13.69; p<0.001, acupuncture 2011: 52.03; 2018: 30.83; p<0.001). Prescription rates increased for analgesics, relaxants, antiepileptics and antidepressants. Non-steroidal anti-inflammatory drug prescriptions had the highest increase (2011: 27.65; 2018: 40.02; p<0.001). Serotonin-norepinephrine reuptake inhibitor prescriptions showed significant growth (2011: 2.4; 2018: 8.05; p<0.001). Prescription durations were generally longer for women (p<0.001), with higher rate increases in this group. Combinations of ≥3 medication classes increased (2011: 8.2; 2018: 9.64; p=0.041). Women were more likely to receive combination prescriptions (crude OR 1.47 (95% CI 1.29 to 1.68), adjusted 1.18 (95% CI 1.03 to 1.36)). CONCLUSIONS: Our findings provide basic reference data for the development and application of national guidelines for fibromyalgia.

Cost-utility of a multicomponent intervention for fibromyalgia versus usual care: a pragmatic randomised controlled trial.

OBJECTIVE: To perform an economic evaluation on a multicomponent intervention programme for patients with fibromyalgia syndrome compared with usual clinical practice in primary care. DESIGN: A cost-utility analysis was conducted alongside a pragmatic randomised controlled trial (ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/record/NCT04049006) from a societal perspective, a human capital approach, and a 1-year time horizon. PATIENTS: Patients diagnosed with fibromyalgia  syndrome from the public health system in south Catalonia, Spain. METHODS: Crude and adjusted incremental cost- utility ratios were estimated to compare the treatment strategies based on cost estimations (direct medical costs and productivity losses) and quality-adjusted life years. One-way and 2-way deterministic sensitivity analyses were performed. RESULTS: The final analysed sample comprised 297 individuals, 161 in the intervention group and 136 in the control group. A crude incremental cost-utility ratio of € 1,780.75 and an adjusted ratio of € 851.67 were obtained, indicating that the programme  significantly improved patients' quality of life with a cost-increasing outcome that fell below the cost-effectiveness threshold. The sensitivity analysis  confirmed these findings when  varying large cost components, and showed dominance when increasing session attendance. CONCLUSION: The proposed multicomponent intervention programme was cost-effective compared with usual care for fibromyalgia, which supports its addition to standard practice in the regional  primary care service.

[Chinese recommendations for the management of fibromyalgia syndrome].

Fibromyalgia syndrome (FMS) is a common clinical syndrome. At present, the lack of epidemiological data from large-sample studies in our country persists, and there are many difficulties in diagnosis and treatment. It is imperative to formulate diagnosis and treatment guidelines for FMS in our country. As such, a project was jointly initiated by the China Association of Chinese Medicine Rheumatology Society, the Fibromyalgia Research Group of Traditional Chinese and Western Medicine in Rheumatology and Immunology, and the Capital Institute of Rheumatology and Immunology of Integrated Chinese and Western Medicine, which adopted the Grading of Recommendations Assessment, Development, and Evaluation grading system and the Reporting Items for Practice Guidelines in Health Care for guideline development. Detailed evidence-based recommendations on 11 clinical problems of FMS that concern Chinese first-line physicians are given in the guideline, aiming to encourage the departments of rheumatology, psychology, pain, and other related departments to attach great importance to the comprehensive management, early identification and intervention, and assessment of FMS to improve the quality of life of patients with FMS.

Assessment of complementary and alternative medicine methods in the management of ankylosing spondylitis, rheumatoid arthritis, and fibromyalgia syndrome.

A wide variety of musculoskeletal, arthritic, connective tissue, and vasculitic diseases fall under the umbrella of "rheumatic diseases". Ankylosing spondylitis, rheumatoid arthritis, and fibromyalgia syndrome are the three members of this disease group with relatively high prevalence. Pharmacological options are at the center of therapeutic algorithms in treating rheumatic diseases, particularly in reducing inflammation. Despite significant advances in pharmacological treatment in recent years, achieving complete treatment success in a group of patients is impossible. Therefore, patients with rheumatic diseases frequently utilize alternative treatment options, such as complementary and alternative medicine. Complementary and alternative medicine is a broad category of health practices not part of the leading health system. Patients with rheumatic diseases turn to complementary and alternative medicine for various reasons, including restricted access to some treatments due to high prices and rigorous regulations, worries about drug side effects, and symptoms that continue despite pharmacological treatment. In addition, because complementary and alternative medicine options are considered natural, they are frequently accepted as well tolerated and have few harmful effects. Ankylosing spondylitis, rheumatoid arthritis, and fibromyalgia syndrome are the primary foci of this comprehensive review. First, we attempted to summarize the non-traditional physical medicine and complementary and alternative medicine options that can be utilized to manage these diseases. Second, we addressed the link between exercise and inflammation in rheumatic diseases. We briefly discussed the possible benefits of exercise-based approaches. In addition, we highlighted the benefits of cooperation between rheumatology and physical medicine-rehabilitation clinics.

Is Pilates more effective and cost-effective than aerobic exercise in the treatment of patients with fibromyalgia syndrome? A randomized controlled trial with economic evaluation.

BACKGROUND: The aim of this study was to assess the effectiveness and cost-effectiveness of Pilates versus aerobic exercises in the treatment of patients with fibromyalgia syndrome from a societal perspective. METHODS: This two-arm randomized controlled trial with blinded assessor and economic evaluation included 98 patients diagnosed with fibromyalgia syndrome using the American College of Rheumatology 2010 criteria, aged between 20 and 75 years, and pain intensity ≥3 points in the Pain Numerical Rating Scale. Patients were randomly allocated into the aerobic or Pilates group. Treatment was performed twice a week for 8 weeks. The primary outcome was the impact of fibromyalgia measured 8 weeks after randomization. Cost-effectiveness and cost-utility analyses were conducted for the impact of fibromyalgia and quality-adjusted life-years (QALYs), respectively, with a 12-month time horizon. RESULTS: There was no difference between the groups for the impact of fibromyalgia (MD: 6.5 points; 95% CI: -1.8 to 14.9). The incremental cost-effectiveness ratio showed that 1-point increase in the impact of fibromyalgia was on average associated with a societal cost of £56 for the Pilates group compared to the aerobic group. The cost-utility analysis showed that the Pilates group had a 0.71 probability of being cost-effective at a willingness-to-pay of £30,000 per QALY gained. CONCLUSION: There was no significant difference between groups for the impact of fibromyalgia. Pilates was not cost-effective compared to aerobic exercises for the impact of fibromyalgia. However, Pilates seemed to be the preferred option of treatment considering QALYs, although it depends on the willingness-to-pay threshold. SIGNIFICANCE: Pilates showed to be a safe and effective alternative for the treatment of patients with fibromyalgia syndrome. Pilates presented similar results for the impact of fibromyalgia and superior results for pain relief compared to aerobic exercises, a highly recommended intervention for the treatment of fibromyalgia syndrome. Pilates was not cost-effective compared to aerobic exercises for the impact of fibromyalgia. However, Pilates seemed to be a cost-effective intervention for QALYs, depending on the decision-maker's willingness-to-pay threshold.

The economic burden of fibromyalgia: A systematic literature review.

INTRODUCTION: Fibromyalgia (FM) is a common disorder characterised by heterogeneous symptoms often leading to decreased functioning, work productivity and quality of life. Although a multimodal approach is used to treat FM, a significant proportion of patients show low satisfaction with perceived care, potentially resulting in an inefficient use of health care resources. The aim of the present review is to summarize the available evidence about the economic impact of FM and the specific cost drivers of health care expenditure for the syndrome. METHODS: MedLine and Web of Science databases were searched to identify eligible articles. Studies reporting direct medical and non-medical costs and/or indirect costs of FM were included. Annual costs per person were extrapolated from each study and converted to United States Dollars ($) after adjusting the local currency for inflation in year 2019. RESULTS: The 36 studies included in the final synthesis differed considerably in their design and in the cost categories analysed. Overall risk of bias was high. Estimates for the total annual direct costs per patient ranged from $ 1750 to $ 35,920 in the USA and from $ 1250 to $ 8504 in Europe. In most included studies, medications were the major contributor to overall expenditures. CONCLUSION: Fibromyalgia represents a substantial economic burden to health care systems and society. A better understanding of this complex disorder may not only improve quality of life of FM patients, but also have a significant impact on direct and indirect costs associated with the syndrome.

Amigos de Fibro (Fibro Friends): Validation of an Educational Program to Promote Health in Fibromyalgia.

Health education is one of the main items to enable the promotion of health for individuals with fibromyalgia (FM) in Primary Health Care (PHC) in Brazil. The purpose of this study was to validate a multidisciplinary educational health promotion program called Amigos de Fibro (Fibro Friends) for individuals with FM. Methodological research involving 23 health professionals (expert judges) and 45 individuals with FM (target audience) used an instrument to assess the objectives, proposed themes and initiatives, relevance, writing style, and structure of the program through the Delphi technique. The content validity index (CVI) ≥ 0.78 and coefficient kappa ≥ 0.61 were used for data analysis. All 25 items evaluated in both groups presented considerable minimum CVI by CVI and the kappa coefficient. In the global evaluation of Amigos de Fibro, the CVI of the specialist judges was 0.90, while the values of the target audience judges were 0.95. The kappa coefficient of the expert judges was 0.90 and that of the target audience judges was 0.85. Amigos de Fibro, a light technology in health, was considered with adequate content validity and internal consistency and is, therefore, valid in the use by health professionals with the target audience in PHC, making it possible for them to act as health-promoting agents.

Telemedicine in the Management of Patients with Rheumatic Disease during COVID-19 Pandemic: Incidence of Psychiatric Disorders and Fibromyalgia in Patients with Rheumatoid Arthritis and Psoriatic Arthritis.

The management of patients with immuno-rheumatological diseases has profoundly changed during the COVID-19 pandemic and telemedicine has played an important role in the disease follow-up. In addition to monitoring disease activity and any adverse events, especially infectious events, assessing the psychological situation of the patient can be fundamental. Furthermore, COVID-19 has a serious impact on mental health and, since the beginning of the pandemic, a significantly higher incidence of anxiety disorders and depressive symptoms especially in younger people was observed. In this study, we evaluated the incidence of depressive disorders, anxiety, and fibromyalgia (FM) in our patients with rheumatoid arthritis and psoriatic arthritis during the lockdown period due to the COVID-19 pandemic and we validate the use of telemedicine in the clinical management of these patients. Mental and physical stress during the COVID-19 pandemic can greatly worsen FM symptoms and intensify patients' suffering without a clinical flare of the inflammatory disease for patients affected by rheumatoid arthritis. Telemedicine has allowed us to identify patients who needed a face-to-face approach for therapeutic reevaluation even if not related to a flare of the inflammatory disease. Even if our data does not allow us to draw definitive conclusions regarding the effectiveness of telemedicine as greater than or equal to the standard face-to-face approach, we continue to work by modifying our approach to try to ensure the necessary care in compliance with safety and, optimistically, this tool will become an important part of rheumatic disease management.

Diagnostic difficulty, delayed diagnosis, and increased tendencies of surgical treatment in fibromyalgia syndrome.

PURPOSE: Aimed to evaluate the time elapsed between the onset of early symptoms and the diagnosis of fibromyalgia syndrome (FMS), the delays in diagnosis and frequent physician visits, increased tendencies of surgical treatment, and the effects of FMS symptoms on the post-surgical result. PATIENTS AND METHODS: While there were 101 patients diagnosed with FMS in the 1st group, there were 100 patients in the 2nd group who presented with musculoskeletal complaints but were not diagnosed with FMS. In both groups, information on duration of complaints, time until diagnosis, and number of evaluating physicians were included. They were questioned in terms of whether they had undergone elective surgery before and after FMS diagnosis, and in terms of operation sites. Among these operations, the ones regarding the musculoskeletal system were evaluated, and the preoperative and postoperative, before and after FMS diagnosis. RESULTS: It was determined that the diagnosis of FMS was made late; the number of doctor visits increased in the period until the diagnosis, and the rate of surgical treatment was higher than in patients without FMS. It was determined that the patients who were operated on after being diagnosed with FMS gained from the operation while the rate of gaining from surgery was lower in patients with FMS symptoms who were operated on before the diagnosis was made. CONCLUSION: The diagnosis of FMS reduces healthcare use, including referrals and examinations. Educating clinicians in the recognition and diagnosis of FMS will provide both patients and healthcare providers with benefits. Key Points • Early detection of FMS reduces healthcare utilization and expenditure, including referrals and examinations. • Educating clinicians in the recognition and diagnosis of FMS will provide both patients and healthcare providers with benefits. Therefore, it is important to understand why the diagnosis of FMS is made in a delayed manner. • Providing pragmatic tools to improve the methodology of primary care providers may help with diagnosing FMS accurately. • Early diagnosis and treatment of FMS may lead to a decrease in the number of operations and an improvement in the results of the operation.

High cost of illness in fibromyalgia patients in Iran, irrespective of disease severity: A prospective cost study.

AIMS: This study aimed to estimate the economic burden of fibromyalgia (FM) in 6 months, using a cost-diary, and to evaluate its relationship with the disease severity. METHODS: This is a prospective cost-of-illness study on 62 participants with an FM diagnosis within a 6 month period. Patients completed the questionnaires, including FIQR (Revised Fibromyalgia Impact Questionnaire) and SF-12 (12-item short-form survey). The cost-diary method was used to track the cost of the disease. The participants received six cost-diary booklets during the study period to report their FM-related costs, hours, and days of productivity loss. The final costs are reported in US dollars. RESULTS: Most of the participants were women (90.3%) with a mean (±SD) age of 40.80 (±5.50) years and a mean (±SD) FIQR score of 54.38 (±14.13). Moreover, 45.2% of patients fulfilled all six booklets, whereas 24.2% returned only one booklet. The participants showed a mean (±SD) direct healthcare, non-healthcare, and indirect cost of $ 2817.08 (±$ 1860.04), $ 1497.98(±$ 1358.21), and $ 1449.05(±$ 3637.41) per patient for 6 months, respectively. CONCLUSION: Fibromyalgia is associated with high health-related and non-health-related costs in our country, irrespective of its severity. This study warrants urgent consideration in managing the disease burden on both patients and society.

Cost-utility analysis of a multicomponent intervention for fibromyalgia syndrome in primary care versus usual clinical practice: study protocol for an economic evaluation of a randomised control trial.

INTRODUCTION: Fibromyalgia syndrome (FMS) imposes a high cost on society. The significant economic burden from the use of healthcare and, especially, social resources is a spur to revising the usual clinical care (UCC) and to improving treatment strategies. FMS has a deleterious effect on the quality of life (QOL) and productivity, which considerably increase the indirect costs to society. This study reports an economic evaluation comparing the cost and health benefits in a multicomponent intervention programme and UCC of patients with FMS who attend primary healthcare centres of the Gerència Territorial Terres de L'Ebre region of Catalonia, Spain. This article is linked to the pre-results of a randomised control trial study on the implementation of this intervention programme (ClinicalTrials.gov: NCT04049006). METHOD AND ANALYSIS: A cost-utility analysis will be conducted from a societal perspective. Quality-adjusted life years will be calculated from the results of the SF-36 questionnaire, a QOL measurement instrument. Direct and indirect healthcare costs will be obtained from official prices and reports published by the Spanish Public Health Administration and the National Statistics Institute. The incremental cost-utility ratio will be estimated to compare the two healthcare practices. Deterministic sensitivity analysis will also be used to compare different cost scenarios, modifying the items with the highest weight in the cost composition. ETHICS AND DISSEMINATION: The Clinical Research Ethics Committee of the IDIAPJGol Institute approved this study on 25 April 2018 (code P18/068) in accordance with the Helsinki/Tokyo Declaration. Information will be provided orally and in writing to participants, and their informed consent will be required. Participant anonymity will be guaranteed. The dissemination strategy includes publications in scientific journals and presentations in local and national media and at academic conferences. Trial registration number: NCT04049006; Pre-results.

Economic evaluations of educational, physical, and psychological treatments for fibromyalgia: a systematic review with meta-analysis.

ABSTRACT: Nonpharmacological interventions are recommended for the treatment of fibromyalgia, but there is a lack of knowledge about the cost-effectiveness of these interventions. The aim of this study was to systematically review economic evaluations of educational, physical, and psychological interventions for the treatment of fibromyalgia. The search was performed in PUBMED, EMBASE, CINAHL, Cochrane Library, Physiotherapy Evidence Database, PsycINFO, EconLit, National Health Service Economic Evaluation Database, and Health Technology Assessment. Economic evaluations of educational, physical, and psychological interventions for adult patients with fibromyalgia were included. Primary outcomes were healthcare and societal costs, and quality-adjusted life-years, and secondary outcomes were any disease-specific clinical outcome. Costs and effects were pooled in a meta-analysis, when possible. Eleven studies were included, of which 7 compared a psychological intervention with another intervention or usual care/control. Over a 6-month time horizon, healthcare and societal costs of the psychological intervention were significantly lower than usual care (mean difference: $-2087, 95% confidence interval [CI]: -3061 to -1112; mean difference: $-2411, 95% CI: -3582 to -1240, respectively), and healthcare costs were significantly lower for the psychological intervention compared with a pharmacological intervention (mean difference: $-1443, 95% CI: -2165 to -721). Over a 12-month time horizon, healthcare costs for the psychological intervention were significantly lower than for usual care (mean difference: $-538, 95% CI: -917 to -158). Incremental cost-effectiveness ratios for quality-adjusted life-years and impact of fibromyalgia showed that the psychological intervention was cost-effective compared with other interventions and control conditions. There is a need of more economic evaluations conducted alongside randomized controlled trials with interventions recommended for the treatment of fibromyalgia, such as physical exercise.

Syrian female war refugees: preliminary fibromyalgia and insomnia screening and treatment trends.

BACKGROUND: Fibromyalgia (FM) is a chronic disorder characterised by chronic widespread pain, fatigue and sleep disturbances with higher prevalence in females. Psychological factors contribute largely to FM. Although women war refugees represent a fragile population that is prone to psychological distress, FM was not studied in this population. OBJECTIVE: The current study had three objectives: (1) to screen FM and insomnia prevalence and severity, (2) to study the correlation between FM severity and insomnia and (3) to study FM treatment trends and their concordance with the guidelines among female Syrian refugees residing in Jordan. METHODS: A cross-sectional study design was performed. Data from 384 Syrian female were analysed from four medical centres in Jordan. The Fibromyalgia Impact Questionnaire (FIQ) was used to study FM prevalence. Structured questions were designed to explore FM pharmacotherapeutic trend, and the Insomnia Severity Index (ISI) was used to screen insomnia. RESULTS: The prevalence of severe FM was about (30%), with a significant correlation with insomnia. Acetaminophen was used for FM relief in 60% of the study sample. CONCLUSIONS: Fibromyalgia prevalence is high among female refugees and is associated with insomnia. The treatment is suboptimal. The early screening and raising awareness of FM diagnosis and treatments are highly recommended. Key Points Fibromyalgia is an overlooked disorder especially among female war refugees The prevalence of severe fibromyalgia was about (30%), with a significant correlation with insomnia Fibromyalgia among the Syrian female refugees is mistreated perhaps due to lack of the proper diagnosis.

Hospitalization in fibromyalgia: a cohort-level observational study of in-patient procedures, costs and geographical variation in England.

OBJECTIVES: Fibromyalgia is a complex, debilitating, multifactorial condition that can be difficult to manage. Recommended treatments are usually delivered in outpatient settings; evidence suggests that significant inpatient care occurs. We describe the scale and cost of inpatient care with a primary diagnostic code of fibromyalgia within the English National Health Service. METHODS: We conducted a cohort-level observational study of all patients admitted to hospital due to a diagnosis of fibromyalgia, between 1 April 2014 and 31 March 2018 inclusive, in the National Health Service in England. We used data from Hospital Episode Statistics Admitted Patient Care to study: the age and sex of patients admitted, number and costs of admissions, length of stay, procedures undertaken, class and type of admission, and distribution of admissions across clinical commissioning groups. RESULTS: A total of 24 295 inpatient admissions, costing £20 220 576, occurred during the 4-year study period. Most patients were women (89%) with peak age of admission of between 45 and 55 years. Most admissions were elective (92%). A number of invasive therapeutic procedures took place, including a continuous i.v. infusion (35%). There was marked geographical variation in the prevalence and cost of inpatient fibromyalgia care delivered across the country, even after accounting for clinical commissioning group size. CONCLUSIONS: Many patients are admitted for treatment of their fibromyalgia and given invasive procedures for which there is weak evidence, with significant variation in practice and cost across the country. This highlights the need to identify areas of resource use that can be rationalized and diverted to provide more effective, evidence-based treatment.

Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care: A mixed methods study protocol.

INTRODUCTION: Fibromyalgia (FM) is a chronic condition characterized by chronic pain, fatigue and loss of function which significantly impairs quality of life. Although treatment of FM remains disputed, some studies point at the efficacy of interdisciplinary therapy. This study aims to analyze the effectiveness, cost-utility and benefits of a multicomponent therapy on quality of life (main variable), functional impact, mood and pain in people suffering from FM that attend primary care centers (PCCs) of the Catalan Institute of Health (ICS). METHODS AND ANALYSIS: A 2-phase, mixed methods study has been designed following Medical Research Council guidance. Phase 1: Pragmatic randomized clinical trial with patients diagnosed with FM that attend one of the 11 PCCs of the ICS Gerència Territorial Terres de l'Ebre. We estimate a total sample of 336 patients. The control group will receive usual clinical care, while the multicomponent therapy group (MT group) will receive usual clinical care plus group therapy (consisting of health education, exercise and cognitive-behavioural therapy) during 12 weeks in 2-hourly weekly sessions. ANALYSIS: the standardized mean response and the standardized effect size will be assessed at 3, 9, and 15 months after the beginning of the study using multiple linear regression models. Utility measurements will be used for the economic analysis. Phase 2: Qualitative socio constructivist study to evaluate the intervention according to the results obtained and the opinions and experiences of participants (patients and professionals). We will use theoretical sampling, with 2 discussion groups of participants in the multicomponent therapy and 2 discussion groups of professionals of different PCCs. A thematic content analysis will be carried out. ETHICS AND DISSEMINATION: This study protocol has been approved by the Clinical Research Ethics Committee of the Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (code P18/068). Articles will be published in international, peer-reviewed scientific journals. TRIAL REGISTRATION: Clinical-Trials.gov: NCT04049006.

Maintained physical activity and physiotherapy in the management of distal arm pain: a randomised controlled trial.

Objectives: The epidemiology of distal arm pain and back pain are similar. However, management differs considerably: for back pain, rest is discouraged, whereas patients with distal arm pain are commonly advised to rest and referred to physiotherapy. We hypothesised that remaining active would reduce long-term disability and that fast-track physiotherapy would be superior to physiotherapy after time on a waiting list. Methods: Adults referred to community-based physiotherapy with distal arm pain were randomised to: advice to remain active while awaiting physiotherapy (typically delivered after 6-8 weeks); advice to rest while awaiting physiotherapy, or immediate treatment. Intention-to-treat analysis determined whether the probability of recovery at 26 weeks was greater among the active advice group, compared with those advised to rest and/or among those receiving immediate versus usually timed physiotherapy. Results: 538 of 1663 patients invited between February 2012 and February 2014 were randomised (active=178; rest=182; immediate physiotherapy=178). 81% provided primary outcome data, and complete recovery was reported by 60 (44%), 46 (32%) and 53 (35%). Those advised to rest experienced a lower probability of recovery (OR: 0.54; 95% CI 0.32 to 0.90) versus advice to remain active. However, there was no benefit of immediate physiotherapy (0.64; 95% CI 0.39 to 1.07). Conclusions: Among patients awaiting physiotherapy for distal arm pain, advice to remain active results in better 26-week functional outcome, compared with advice to rest. Also, immediate physiotherapy confers no additional benefit in terms of disability, compared with physiotherapy delivered after 6-8 weeks waiting time. These findings question current guidance for the management of distal arm pain.

Cost-Effectiveness and Cost-Utility of Internet-Delivered Exposure Therapy for Fibromyalgia: Results From a Randomized, Controlled Trial.

Fibromyalgia (FM) is a prevalent and debilitating chronic pain disorder associated with a substantial economic burden. Although there are several studies investigating the effectiveness of psychological treatments such as cognitive-behavioral therapy for FM, studies on cost-effectiveness are scarce. The aim of the present study was to investigate the cost-effectiveness of Internet-delivered exposure therapy (iExp) for FM. We used health economic data from a recently conducted randomized, controlled trial, where 140 participants were randomized to either iExp or a waitlist control (WLC) condition. Economic data were collected at pre-treatment, post-treatment, and at the 1-year follow-up. Treatment effectiveness in relation to costs were analyzed using both a societal perspective (including all direct and indirect costs) and a health care unit perspective (including only the direct treatment costs). Bootstrapped net benefit regression analyses were also conducted, comparing the difference in costs and effects between iExp and WLC, within different willingness-to-pay scenarios. Results showed that the incremental cost-effectiveness ratio was -$15,295, indicating that iExp was highly cost-effective as each successfully treated case (treatment responder) was associated with a substantial net reduction in costs. The robustness of the results was tested in 2 different sensitivity analyses, where iExp remained cost-effective, even in a willingness-to-pay-scenario of $0. We conclude that iExp is a cost-effective treatment that generates large societal cost savings. PERSPECTIVE: Health-economic evaluations of psychological interventions for FM are scarce. This study is a cost-effectiveness analysis of Internet-delivered exposure therapy for patients with FM. Results showed that iExp was highly cost-effective compared with no treatment, where each successfully treated case generated a substantial societal cost saving.

Categorisation of disease severity states in fibromyalgia: a first step to support decision-making in health care policy.

OBJECTIVES: To establish the cut-off points for disease severity states of two self-administered questionnaires (the revised version of the Fibromyalgia-Impact Questionnaire [FIQR] and the Fibromyalgia Assessment Status [FAS]) designed for the evaluation of multidimensional aspects of fibromyalgia (FM). METHODS: In this cross-sectional study, consecutive FM patients completed both FIQR and FAS. The external criterion for grading disease severity was the item one of the Short Form-36 Health Survey (SF-36). The reconciliation approach of the 75th-25th percentiles of adjacent ranks was applied to establish cut-off points distinguishing between disease activity states. RESULTS: 521 FM patients (80.0% women, mean age 49 years) completed the assessment. The overall mean (standard deviation [SD]) FIQR and FAS were 47.87 (SD 20.69) and 5.57 (SD 2.09), respectively. The highest FIQR scored items were those related to sleep quality, fatigue/energy, pain, stiffness, tenderness, and environmental sensitivity. With the reconciliation of 75th-25th percentiles of adjacent ranks, the FIQR cut-off points obtained were: remission ≤30, mild severity >30 and ≤45, moderate severity >46 and ≤65, high severity >65. The same approach for FAS leaded to: remission ≤4, mild severity >4 and ≤5.5, moderate severity >5.6 and ≤7.0, high severity >7.0. The majority of the subjects was classified as suffering from a moderate (FIQR 28.4%; FAS 23.2%) or severe (FIQR 24.4%; FAS 30.7%) FM. CONCLUSIONS: The FIQR and FAS cut-off points for remission, mild, moderate and high disease severity are valid measures which can be easily applied in daily clinical practice.

'Exercise to me is a scary word': perceptions of fatigue, sleep dysfunction, and exercise in people with fibromyalgia syndrome-a focus group study.

Fibromyalgia syndrome (FMS) is a common and complex chronic pain condition. Exercise is recommended in the management of the FMS; however, people with FMS often find exercise exacerbates their condition and causes overwhelming fatigue. The objective of this study was to explore the perceptions of fatigue and sleep dysfunction, and exercise in people with FMS. Three, 60-90 min focus groups were conducted with people with FMS (n = 14). Participants were recruited from patient support groups who had experienced therapeutic exercise in the management of their condition. Focus groups were video and audio recorded and transcriptions analysed for thematic content by three independent evaluators. Fatigue, sleep dysfunction, and pain were universally reported by participants. The over-arching theme to emerge was a lack of understanding of the condition by others. A huge sense of loss was a major sub-theme and participants felt that they had fundamentally changed since the onset of FMS. Participants reported that they were unable to carry out their normal activities, including physical activity and exercise. The invisibility of FMS was associated with the lack of understanding by others, the sense of loss, and the impact of FMS. People with FMS perceive that there is a lack of understanding of the condition among health care professionals and the wider society. Those with FMS expressed a profound sense of loss of their former 'self'; part of this loss was the ability to engage in normal physical activity and exercise.

An overview of systematic reviews of complementary and alternative therapies for fibromyalgia using both AMSTAR and ROBIS as quality assessment tools.

BACKGROUND: Fibromyalgia (FM) is a chronic, debilitating pain disorder. Dissatisfaction with conventional medicine can lead people with FM to turn to complementary and alternative medicine (CAM). Two previous overviews of systematic reviews of CAM for FM have been published, but they did not assessed for risk of bias in the review process. METHODS: Five databases Medline, Embase, AMED (via OVID), Web of Science and Central were searched from their inception to December 2015. Reference lists were hand-searched. We had two aims: the first was to provide an up-to-date and rigorously conducted synthesis of systematic reviews of CAM literature on FM; the second was to evaluate the quality of the available systematic review evidence using two different tools: AMSTAR (Shea et al. BMC Med Res Methodol 15; 7:10, 2007) and a more recently developed tool ROBIS (Whiting et al. J Clin Epidemiol 69:225-34, 2016) specifically designed to assess risk of bias in systematic reviews. Any review that assessed one of eight CAM therapies for participants diagnosed with FM was considered. The individual studies had to be randomised controlled trials where the intervention was compared to placebo, treatment as usual or waitlist controls to be included. The primary outcome measure was pain, and the secondary outcome measure was adverse events. RESULTS: We identified 15 reviews that met inclusion criteria. There was low-quality evidence that acupuncture improves pain compared to no treatment or standard treatment, but good evidence that it is no better than sham acupuncture. The evidence for homoeopathy, spinal manipulation and herbal medicine was limited. CONCLUSIONS: Overall, five reviews scored 6 or above using the AMSTAR scale and the inter-rater agreement was good (83.6%), whereas seven reviews achieved a low risk of bias rating using ROBIS and the inter-rater agreement was fair (60.0%). No firm conclusions were drawn for efficacy of either spinal manipulation or homoeopathy for FM. There is limited evidence for topical Capsicum, but further research is required. There is some evidence to support the effectiveness of acupuncture for FM, but further high-quality trials are needed to investigate its benefits, harms and mechanisms of action, compared with no or standard treatment. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016035846 .