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.

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.

Cost-effectiveness of direct oral anticoagulants versus vitamin K antagonist in atrial fibrillation: A study protocol using Real-World Data from Catalonia (FantasTIC Study).

BACKGROUND: Anticoagulant therapy is used for stroke prevention and proved to be effective and safe in the long term. The study aims to analyse the cost-effectiveness relationship of using of direct-acting oral anticoagulants vs vitamin K antagonists to prevent ischaemic stroke in patients with nonvalvular atrial fibrillation, including all the active ingredients marketed in Spain, prescribed for 2 years in the Primary Care service of the Institut Català de la Salut. METHODS: Population-based cohort study, in which the cost of the 2 treatment groups will be evaluated. Direct costs (pharmacy, primary care, emergency and hospitalization) and indirect costs (lost productivity) will be included from a social perspective. Effectiveness (assessed as the occurrence of a health event, the 1 of primary interest being stroke) will be determined, with a 2-year time horizon and a 3% discount rate. The average cost of the 2 groups of drugs will be compared using a regression model to determine the factors with the greatest influence on determining costs. We will carry out a univariate ('one-way') deterministic sensitivity analysis. DISCUSSION: We hope to provide relevant information about direct and indirect costs of oral anticoagulants, which, together with aspects of effectiveness and safety, could help shape the consensual decision-making of evaluating bodies.

Efectividad, seguridad y costes de la prevención tromboembólica en fibrilación auricular. Estudio de cohortes apareado por Propensity score / Effectiveness, safety and costs of stroke prevention in non-valvular auricular fibrillation. Study of cohorts matched by Propensity score

OBJETIVO: El objetivo de este estudio es analizar el uso, la efectividad, la seguridad y los costes de la prevención de ictus en fibrilación auricular (FA) no valvular en pacientes que inician tratamiento con dabigatrán o antagonistas de la vitamina K (AVK). EMPLAZAMIENTO: Atención Primaria (AP) del Instituto Catalán de la Salud (ICS), en Cataluña, durante el período 2011-2013. PARTICIPANTES: Todos los pacientes atendidos en los centros de AP del ICS con diagnóstico de FA que inician dabigatrán o AVK. INTERVENCIONES: No aplica (estudio observacional). Mediciones principales: Número de prescripciones y facturaciones de dabigatrán y AVK, incidencia de ictus y eventos tromboembólicos, incidencia de hemorragias mayores, incidencia de muertes durante el seguimiento, número de bajas laborales y medida de los costes asociados a estas variables. RESULTADOS: Se incluyó a 14.930 pacientes en el estudio; el 94,6% inició AVK y el 5,4%, dabigatrán. Estos últimos eran pacientes más jóvenes y con menos comorbilidades asociadas. No hubo diferencias estadísticamente significativas entre AVK y dabigatrán en el riesgo de ictus, hemorragias y mortalidad. Los costes asociados al manejo de la FA eran mayores para visitas de AP en el grupo de AVK y mayores para laboratorio, y farmacia en el grupo de dabigatrán, aunque los costes totales no fueron estadísticamente diferentes. CONCLUSIONES: La mayoría de los pacientes iniciaron AVK. No hubo diferencias entre AVK y dabigatrán en el riesgo de ictus, hemorragias y mortalidad

OBJECTIVE: To analyze the use, effectiveness, safety and costs of stroke prevention in non-valvular atrial fibrillation (AF) in patients initiating treatment with dabigatran or vitamin K antagonists (VKA). SETTING: Primary Care (PC) at the Catalan Health Institute (ICS) in Catalonia, during 2011-2013. PARTICIPANTS: Patients attended in ICS PC centres with a registered diagnosis of AF who initiate dabigatran or VKA. INTERVENTIONS: Not aplicable. MAIN MEASUREMENTS: Number of prescriptions and reimbursements of dabigatran and VKA, incidence of stroke and haemorrhages, incidence of mortatlity, number of sickness leave, and costs associated to all the previous variables. RESULTS: 14,930 patients were included; 94.6% initiated VKA and 5.4%, dabigatran. Dabigatran patients were younger and with less comorbidity. There were no statistically significant differences between VKA and dabigatran in the risk of stroke, haemorrhages or death. The costs associated to AF management were higher for PC visits in the VKA group, and higher for laboratory and pharmacy in the dabigatran group, although overall costs were not statistically different. CONCLUSIONS: Most patients initiated VKA. We found no differences between VKA and dabigatran in the risk of stroke, haemorrhages or mortality

[Effectiveness, safety and costs of stroke prevention in non-valvular auricular fibrillation. Study of cohorts matched by Propensity score]. / Efectividad, seguridad y costes de la prevención tromboembólica en fibrilación auricular. Estudio de cohortes apareado por Propensity score.

OBJECTIVE: To analyze the use, effectiveness, safety and costs of stroke prevention in non-valvular atrial fibrillation (AF) in patients initiating treatment with dabigatran or vitamin K antagonists (VKA). SETTING: Primary Care (PC) at the Catalan Health Institute (ICS) in Catalonia, during 2011-2013. PARTICIPANTS: Patients attended in ICS PC centres with a registered diagnosis of AF who initiate dabigatran or VKA. INTERVENTIONS: Not applicable MAIN MEASUREMENTS: Number of prescriptions and reimbursements of dabigatran and VKA, incidence of stroke and haemorrhages, incidence of mortatlity, number of sickness leave, and costs associated to all the previous variables. RESULTS: 14,930 patients were included; 94.6% initiated VKA and 5.4%, dabigatran. Dabigatran patients were younger and with less comorbidity. There were no statistically significant differences between VKA and dabigatran in the risk of stroke, haemorrhages or death. The costs associated to AF management were higher for PC visits in the VKA group, and higher for laboratory and pharmacy in the dabigatran group, although overall costs were not statistically different. CONCLUSIONS: Most patients initiated VKA. We found no differences between VKA and dabigatran in the risk of stroke, haemorrhages or mortality.

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.

Annual costs attributed to atrial fibrillation management: cross-sectional study of primary healthcare electronic records.

Atrial fibrillation (AF) is the most common chronic arrhythmia, with increasing healthcare and economic burden and a prevalence which increases with progressive ageing. This study aims to describe overall annual costs per patient for management of non-valvular AF in a primary healthcare (PHC) setting and compare these costs between the groups of patients treated with vitamin K antagonists, antiplatelets or non-treated through a population-based study conducted with electronic health records. We analysed annual costs per person of 19,787 patients in 2012; PHC visits, hospital admissions, AF-related events requiring hospital admission, referrals to secondary specialists, sick leave, diagnostic tests and laboratory tests at PHC level, including INR determinations performed in PHC, and drug therapy. Higher costs of AF management were associated with increasing age, male sex, stroke and bleeding risks, comorbidities and occurrence of events associated to AF. The sensitivity analyses conducted showed that PHC visits and hospitalizations represented the most important part of overall costs for all patients.

Effectiveness and safety of drugs used for stroke prevention in a cohort of non-valvular atrial fibrillation patients from a primary care electronic database.

PURPOSE: The aim of this study was to assess effectiveness and safety of antithrombotics for stroke prevention in non-valvular atrial fibrillation in real-use conditions. METHODS: We used a population-based retrospective cohort study. Information emerges from SIDIAP, a database containing anonymized information from electronic health records from 274 primary healthcare centres of the Catalan Health Institute, Catalonia (Spain), with a reference population of 5 835 000 people. Population includes all adults with a new diagnosis of non-valvular atrial fibrillation registered in SIDIAP from 2007 to 2012. The main outcome of antithrombotics' effectiveness was stroke. The main outcomes of safety were cerebral and gastrointestinal haemorrhages. We also estimated all-cause mortality. We used multivariable Cox proportional hazard models to examine association between antithrombotic treatment and main outcomes. RESULTS: We included 22 205 subjects with non-valvular atrial fibrillation; 40.8% initiated on vitamin K antagonists (VKA), 33.4% on antiplatelets and 25.8% untreated. We found stroke-risk reduction with VKA, hazard ratio (HR) 0.72 (95% confidence interval (CI), 0.58-0.91), also seen in patients with CHADS2 ≥ 2, HR 0.65 (95%CI, 0.49-0.86), and CHA2 DS2 -VASc ≥ 2, HR 0.66 (95%CI, 0.52-0.84). We observed a higher risk of digestive bleeding with antiplatelets, HR 1.32 (95%CI, 1.01-1.73). Both VKA and antiplatelets were associated with reduction of all-cause mortality risk; HR 0.55 (95%CI, 0.49-0.62) and HR 0.89 (95%CI, 0.80-0.97), respectively. CONCLUSIONS: This study found a stroke-risk reduction associated with VKA and an increased risk of gastrointestinal bleeding associated with platelet-aggregation inhibitors in comparison with untreated patients. Both antithrombotic groups showed a reduction in all-cause mortality. Copyright © 2016 John Wiley & Sons, Ltd.

Effectiveness, safety and costs of thromboembolic prevention in patients with non-valvular atrial fibrillation: phase I ESC-FA protocol study and baseline characteristics of a cohort from a primary care electronic database.

PURPOSE: Atrial fibrillation is the most common arrhythmia. Its management aims to reduce symptoms and to prevent complications through rate and rhythm control, management of concomitant cardiac diseases and prevention of related complications, mainly stroke. The main objective of Effectiveness, Safety and Costs in Atrial Fibrillation (ESC-FA) study is to analyse the drugs used for the management of the disease in real-use conditions, particularly the antithrombotic agents for stroke prevention. The aim of this work is to present the study protocol of phase I of the ESC-FA study and the baseline characteristics of newly diagnosed patients with atrial fibrillation in Catalonia, Spain. PARTICIPANTS: The data source is System for the Improvement of Research in Primary Care (SIDIAP) database. The population included are all patients with non-valvular atrial fibrillation diagnosis registered in the electronic health records during 2007-2012. FINDINGS TO DATE: A total of 22,585 patients with non-valvular atrial fibrillation were included in the baseline description. Their mean age was 72.8 years and 51.6% were men. The most commonly prescribed antithrombotics were vitamin K antagonists (40.1% of patients) and platelet aggregation inhibitors (32.9%); 25.3% had not been prescribed antithrombotic treatment. Age, gender, comorbidities and co-medication at baseline were similar to those reported for previous studies. FUTURE PLANS: The next phase in the ESC-FA study will involve assessing the effectiveness and safety of antithrombotic treatments, analysing stroke events and bleeding episodes' rates in our patients (rest of phase I), describing the current management of the disease and its costs in our setting, and assessing how the introduction of new oral anticoagulants changes the stroke prevention in non-valvular atrial fibrillation.

Direct medical costs attributable to type 2 diabetes mellitus: a population-based study in Catalonia, Spain.

We estimated healthcare costs associated with patients with type 2 diabetes compared with non-diabetic subjects in a population-based primary care database through a retrospective analysis of economic impact during 2011, including 126,811 patients with type 2 diabetes in Catalonia, Spain. Total annual costs included primary care visits, hospitalizations, referrals, diagnostic tests, self-monitoring test strips, medication, and dialysis. For each patient, one control matched for age, gender and managing physician was randomly selected from a population database. The annual average cost per patient was €3110.1 and €1803.6 for diabetic and non-diabetic subjects, respectively (difference €1306.6; i.e., 72.4 % increased cost). The costs of hospitalizations were €1303.1 and €801.6 (62.0 % increase), and medication costs were €925.0 and €489.2 (89.1 % increase) in diabetic and non-diabetic subjects, respectively. In type 2 diabetic patients, hospitalizations and medications had the greatest impact on the overall cost (41.9 and 29.7 %, respectively), generating approximately 70 % of the difference between diabetic and non-diabetic subjects. Patients with poor glycaemic control (glycated haemoglobin >7 %; >53 mmol/mol) had average costs of €3296.5 versus €2848.5 for patients with good control. In the absence of macrovascular complications, average costs were €3008.1 for diabetic and €1612.4 for non-diabetic subjects, while its presence increased costs to €4814.6 and €3306.8, respectively. In conclusion, the estimated higher costs for type 2 diabetes patients compared with non-diabetic subjects are due mainly to hospitalizations and medications, and are higher among diabetic patients with poor glycaemic control and macrovascular complications.

Intervention for Smokers through New Communication Technologies: What Perceptions Do Patients and Healthcare Professionals Have? A Qualitative Study.

BACKGROUND: The use of information and communication technologies (ICTs) in the health service is increasing. In spite of limitations, such as lack of time and experience, the deployment of ICTs in the healthcare system has advantages which include patient satisfaction with secure messaging, and time saving benefits and utility for patients and health professionals. ICTs may be helpful as either interventions on their own or as complementary tools to help patients stop smoking. OBJECTIVES: To gather opinions from both medical professionals and smokers about an email-based application that had been designed by our research group to help smoking cessation, and identify the advantages and disadvantages associated with interventions based on the utilization of ICTs for this purpose. METHODS: A qualitative, descriptive-interpretative study with a phenomenological perspective was performed to identify and interpret the discourses of the participating smokers and primary healthcare professionals. Data were obtained through two techniques: semi-structured individual interviews and discussion groups, which were recorded and later systematically and literally transcribed together with the interviewer's notes. Data were analyzed with the ATLAS TI 6.0 programme. RESULTS: Seven individual interviews and four focal groups were conducted. The advantages of the application based on the email intervention designed by our research group were said to be the saving of time in consultations and ease of access for patients who found work timetables and following a programme for smoking cessation incompatible. The disadvantages were thought to be a lack of personal contact with the healthcare professional, and the possibility of cheating/ self-deception, and a greater probability of relapse on the part of the smokers. CONCLUSIONS: Both patients and healthcare professionals viewed the email-based application to help patients stop smoking as a complementary aid to face-to-face consultations. Nevertheless, ICTs could not substitute personal contact in the smoking cessation programme.

Effectiveness of an intensive E-mail based intervention in smoking cessation (TABATIC study): study protocol for a randomized controlled trial.

BACKGROUND: Intensive interventions on smoking cessation increase abstinence rates. However, few electronic mail (E-mail) based intensive interventions have been tested in smokers and none in primary care (PC) setting. The aim of the present study is to evaluate the effectiveness of an intensive E-mail based intervention in smokers attending PC services. METHODS/DESIGN: Randomized Controlled Multicentric Trial. STUDY POPULATION: 1060 smokers aged between 18-70 years from Catalonia, Salamanca and Aragón (Spain) who have and check regularly an E-mail account. Patients will be randomly assigned to control or intervention group. INTERVENTION: Six phase intensive intervention with two face to face interviews and four automatically created and personal E-mail patients tracking, if needed other E-mail contacts will be made. Control group will receive a brief advice on smoking cessation. OUTCOME MEASURES: Will be measured at 6 and 12 months after intervention: self reported continuous abstinence (confirmed by cooximetry), point prevalence abstinence, tobacco consumption, evolution of stage according to Prochaska and DiClemente's Stages of Change Model, length of visit, costs for the patient to access Primary Care Center. STATISTICAL ANALYSIS: Descriptive and logistic and Poisson regression analysis under the intention to treat basis using SPSS v.17. DISCUSSION: The proposed intervention is an E-mail based intensive intervention in smokers attending primary care. Positive results could be useful to demonstrate a higher percentage of short and long-term abstinence among smokers attended in PC in Spain who regularly use E-mail. Furthermore, this intervention could be helpful in all health services to help smokers to quit. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT01494246.

Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial.

BACKGROUND: Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. METHODS/DESIGN: The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP.Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term).Assessment of outcomes will be blinded and will follow the intention-to-treat principle. DISCUSSION: We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. TRIAL REGISTRATION: ISRCTN: ISRCTN58719694.