Management, development and methodology of the Clinical Practice Guidelines and Recommendations of the Spanish Society of Rheumatology.

The Spanish Society of Rheumatology (SER) brings together the majority of Spain's rheumatologists and, among the many services it offers its members, has a Research Unit (RU). This unit provides methodological support to SER members in clinical and epidemiological research, coordinates and carries out research projects, designs and maintains large patient databases, develops qualitative research projects and produces evidence-based medicine (EBM) documents. Through this last activity, the RU of the SER produces clinical practice guidelines and recommendation documents on topics relevant to rheumatology that meet the most demanding methodological standards. The aim of this article is to describe the management process and methodology followed by the UI of the SER to identify the topics of its EBM documents and how it executes and develops its guidelines and recommendations.

SER recommendations on treatment of refractory Behçet's syndrome.

OBJECTIVE: To develop multidisciplinary recommendations based on available evidence and expert consensus for the therapeutic management of patients with refractory Behçet's syndrome (BS) (difficult to treat, severe resistant, severe relapse) to conventional treatment. METHODS: A group of experts identified clinical research questions relevant to the objective of the document. These questions were reformulated in PICO format (patient, intervention, comparison and outcome). Systematic reviews of the evidence were conducted, the quality of the evidence was evaluated following the methodology of the international working group Grading of Recommendations Assessment, Development, and Evaluation (GRADE). After that, the multidisciplinary panel formulated the specific recommendations. RESULTS: 4 PICO questions were selected regarding the efficacy and safety of systemic pharmacological treatments in patients with BS with clinical manifestations refractory to conventional therapy related to mucocutaneous and/or articular, vascular, neurological parenchymal and gastrointestinal phenotypes. A total of 7 recommendations were made, structured by question, based on the identified evidence and expert consensus. CONCLUSIONS: The treatment of most severe clinical manifestations of BS lacks solid scientific evidence and, besides, there are no specific recommendation documents for patients with refractory disease. With the aim of providing a response to this need, here we present the first official Recommendations of the Spanish Society of Rheumatology for the management of these patients. They are devised as a tool for assistance in clinical decision making, therapeutic homogenisation and to reduce variability in the care of these patients.

SER recommendations for the treatment of uveitis.

OBJECTIVE: To develop evidence-based expert-consensus recommendations for the management of non-infectious, non-neoplastic, non-demyelinating disease associated uveitis. METHODS: Clinical research questions relevant to the objective of the document were identified, and reformulated into PICO format (patient, intervention, comparison, outcome) by a panel of experts selected based on their experience in the field. A systematic review of the available evidence was conducted, and evidence was graded according to GRADE (Grading of Recommendations Assessment, Development, and Evaluation) criteria. Subsequently, recommendations were developed. RESULTS: Three PICO questions were constructed referring to uveitis anterior, non-anterior and complicated with macular edema. A total of 19 recommendations were formulated, based on the evidence found and/or expert consensus. CONCLUSIONS: Here we present the first official recommendations of the Spanish Society of Rheumatology for the treatment of non-infectious and non-demyelinating disease associated uveitis. They can be directly applied to the Spanish healthcare system as a tool for assistance and therapeutic homogenisation.

Information needs and research priorities in long-term survivorship of breast cancer: Patients and health professionals' perspectives.

OBJECTIVE: The objective of this work is to identify unmet information needs of long-term-survivors of breast cancer (BC) and future research needs from the perspectives of patients and health care professionals. METHODS: Two online Delphi surveys were conducted. Participants in Survey 1 were patients. Participants in Survey 2 were health care professionals from both primary and secondary care involved in BC care. Both surveys included three successive rounds. The first round aimed to identify research and information needs; the second round aimed to rank the relative importance of those needs; the third round aimed to find consensus. RESULTS: The most important information needs were self-management recommendations of common health problems after treatment and complications of breast reconstruction after 5 years. The most important research priorities were related to interventions and tools to increase information provision by professionals about certain tests, diet, and coordinated action between primary and specialised care during follow-up, and indications and safety issues of pregnancy in survivors. CONCLUSIONS: Two fundamental ideas were identified: (1) Patients request information about self-management common health problems after treatment and breast reconstruction complications. (2) Health care professionals emphasise the need for a standardised approach based on protocols, recommendations, and coordinated actions in the provision of information. IMPLICATIONS FOR CANCER SURVIVORS: Given the increasing number of BC survivors, it is essential to identify information and research needs to improve their care and health outcomes.

SER-SEPAR recommendations for the management of rheumatoid arthritis-related interstitial lung disease. Part 1: Epidemiology, risk factors and prognosis.

OBJECTIVE: To develop multidisciplinary recommendations to improve the management of rheumatoid arthritis-related interstitial lung disease (RA-ILD). METHODS: Clinical research questions relevant to the objective of the document were identified by a panel of rheumatologists and pneumologists selected based on their experience in the field. Systematic reviews of the available evidence were conducted, and evidence was graded according to the Scottish Intercollegiate Guidelines Network (SIGN) criteria. Specific recommendations were made. RESULTS: Six PICO questions were selected, three of which analysed the incidence and prevalence of RA-ILD, associated risk factors, and predictors of progression and mortality. A total of 6 specific recommendations on these topics, structured by question, were formulated based on the evidence found and/or expert consensus. CONCLUSIONS: We present the first official SER-SEPAR document with specific recommendations for RA-ILD management developed to resolve some common clinical questions and facilitate decision-making for patients.

SER-SEPAR recommendations for the management of rheumatoid arthritis-related interstitial lung disease. Part 2: Treatment.

OBJECTIVE: To develop multidisciplinary recommendations to improve the management of rheumatoid arthritis-related interstitial lung disease (RA-ILD). METHODS: Clinical research questions relevant to the objective of the document were identified by a panel of rheumatologists and pneumologists selected based on their experience in the field. Systematic reviews of the available evidence were conducted, and evidence was graded according to the Scottish Intercollegiate Guidelines Network (SIGN) criteria. Specific recommendations were made. RESULTS: Six PICO questions were selected, three of which analysed the safety and effectiveness of glucocorticoids, classical synthetic disease-modifying anti-rheumatic drugs (DMARDs) and other immunosuppressants, biological agents, targeted synthetic DMARDs, and antifibrotic therapies in the treatment of this complication. A total of 12 recommendations were formulated based on the evidence found and/or expert consensus. CONCLUSIONS: We present the first official SER-SEPAR document with specific recommendations for RA-ILD management developed to resolve some common clinical questions, reduce clinical healthcare variability, and facilitate decision-making for patients.

Recommendations for prevention of infection in systemic autoimmune rheumatic diseases.

OBJECTIVES: To develop recommendations for the prevention of infection in adult patients with systemic autoimmune rheumatic diseases (SARD). METHODS: Clinical research questions relevant to the objective of the document were identified by a panel of experts selected based on their experience in the field. Systematic reviews of the available evidence were conducted, and evidence was graded according to the Scottish Intercollegiate Guidelines Network criteria. Specific recommendations were made. RESULTS: Five questions were selected, referring to prevention of infection by Pneumocystis jirovecii with trimethoprim/sulfamethoxazole, primary and secondary prophylactic measures against hepatitis B virus, vaccination against human papillomavirus, vaccination against Streptococcus pneumoniae and vaccination against influenza virus, making a total of 18 recommendations, structured by question, based on the evidence found for the different SARD and/or expert consensus. CONCLUSIONS: There is enough evidence on the safety and efficacy of vaccinations and other prophylactic measures against the microorganisms reviewed in this document to specifically recommend them for patients with SARD.

Recommendations by the Spanish Society of Rheumatology on Fibromyalgia. Part 1: Diagnosis and treatment.

OBJECTIVE: To prevent the impairment of fibromyalgia patients due to harmful actions in daily clinical practice that are potentially avoidable. METHODS: A multidisciplinary team identified the main areas of interest and carried out an analysis of scientific evidence and established recommendations based on the evidence and "formal evaluation" or "reasoned judgment" qualitative analysis techniques. RESULTS: A total of 39 recommendations address diagnosis, unsafe or ineffective treatment interventions and patient and healthcare workers' education. This part I shows the first 27 recommendations on the first 2 areas. CONCLUSIONS: Establishing a diagnosis improves the patient's coping with the disease and reduces healthcare costs. NSAIDs, strong opioids and benzodiazepines should be avoided due to side effects. There is no good evidence to justify the association of several drugs. There is also no good evidence to recommend any complementary medicine. Surgeries show a greater number of complications and a lower degree of patient satisfaction and therefore should be avoided if the surgical indication is not clearly established.

Recommendations by the Spanish Society of Rheumatology on the management of patients with fibromyalgia. Part II.

OBJECTIVE: To prevent the deterioration of patients with fibromyalgia due to potentially avoidable harmful actions in clinical practice. METHODS: A multidisciplinary panel of experts identified key areas, analysed the scientific evidence and formulated recommendations based on this evidence and qualitative techniques of "formal assessment" or "reasoned judgement". RESULTS: Thirty-nine recommendations were made on diagnosis, ineffective and unsafe treatments, patient education and practitioner training. This part II shows the 12 recommendations, referring to the latter two areas. CONCLUSIONS: Good knowledge of fibromyalgia on the part of patients improves their coping and acceptance of the disease and reduces the severity of some clinical manifestations. Healthcare professionals treating patients with fibromyalgia should be well trained in this disease to improve treatment outcomes and patient relationships.

Recommendations for prevention of infection in systemic autoimmune rheumatic diseases. / Recomendaciones SER sobre prevención de infección en enfermedades reumáticas autoinmunes sistémicas.

OBJECTIVES: To develop recommendations for the prevention of infection in adult patients with systemic autoimmune rheumatic diseases (SARD). METHODS: Clinical research questions relevant to the objective of the document were identified by a panel of experts selected based on their experience in the field. Systematic reviews of the available evidence were conducted, and evidence was graded according to the Scottish Intercollegiate Guidelines Network criteria. Specific recommendations were made. RESULTS: Five questions were selected, referring to prevention of infection by Pneumocystis jirovecii with trimethoprim/sulfamethoxazole, primary and secondary prophylactic measures against hepatitis B virus, vaccination against human papillomavirus, vaccination against Streptococcus pneumoniae and vaccination against influenza virus, making a total of 18 recommendations, structured by question, based on the evidence found for the different SARD and/or expert consensus. CONCLUSIONS: There is enough evidence on the safety and efficacy of vaccinations and other prophylactic measures against the microorganisms reviewed in this document to specifically recommend them for patients with SARD.

Recommendations by the Spanish Society of Rheumatology on the Management of Patients with Fibromyalgia. Part II. / Recomendaciones SER sobre el manejo de los pacientes con fibromialgia. Parte II.

OBJECTIVE: To prevent the deterioration of patients with fibromyalgia due to potentially avoidable harmful actions in clinical practice. METHODS: A multidisciplinary panel of experts identified key areas, analysed the scientific evidence and formulated recommendations based on this evidence and qualitative techniques of «formal assessment¼ or «reasoned judgement¼. RESULTS: Thirty-nine recommendations were made on diagnosis, ineffective and unsafe treatments, patient education and practitioner training. This partII shows the 12 recommendations, referring to the latter two areas. CONCLUSIONS: Good knowledge of fibromyalgia on the part of patients improves their coping and acceptance of the disease and reduces the severity of some clinical manifestations. Healthcare professionals treating patients with fibromyalgia should be well trained in this disease to improve treatment outcomes and patient relationships.

Recommendations by the Spanish Society of Rheumatology on Fibromyalgia. Part 1: Diagnosis and Treatment. / Recomendaciones SER sobre el manejo de los pacientes con fibromialgia. Parte I: diagnóstico y tratamiento.

OBJECTIVE: To prevent the impairment of fibromyalgia patients due to harmful actions in daily clinical practice that are potentially avoidable. METHODS: A multidisciplinary team identified the main areas of interest and carried out an analysis of scientific evidence and established recommendations based on the evidence and "formal evaluation" or "reasoned judgment" qualitative analysis techniques. RESULTS: A total of 39 recommendations address diagnosis, unsafe or ineffective treatment interventions and patient and healthcare workers' education. This part I shows the first 27 recommendations on the first 2 areas. CONCLUSIONS: Establishing a diagnosis improves the patient's coping with the disease and reduces healthcare costs. NSAIDs, strong opioids and benzodiazepines should be avoided due to side effects. There is no good evidence to justify the association of several drugs. There is also no good evidence to recommend any complementary medicine. Surgeries show a greater number of complications and a lower degree of patient satisfaction and therefore should be avoided if the surgical indication is not clearly established.

Efficacy, Effectiveness, Safety, and Cost-effectiveness of Epidural Adhesiolysis for Treating Failed Back Surgery Syndrome. A Systematic Review.

BACKGROUND: Failed back surgery syndrome (FBSS) has a profound impact on patients' quality of life and represents a major clinical challenge and a significant economic burden for society. Adhesiolysis is used as a treatment to eliminate perineural/epidural adhesions in patients with chronic pain attributed to FBSS. OBJECTIVE: To evaluate the efficacy, effectiveness, safety, and cost-effectiveness of epidural adhesiolysis compared with other procedures for treating FBSS. METHOD: A systematic review was conducted. The electronic databases Medline/PreMedline, EMBASE, Cochrane Library Plus, Centre for Reviews and Dissemination databases, SCOPUS, Science Citation Index, and PEDRO were consulted through April 2017. Predefined criteria were used to determine inclusion of the studies and to assess their methodological quality. RESULTS: Ten reports were included. No randomized controlled trials (RCTs) on efficacy or cost-effectiveness were found. Three reports (corresponding to two RCTs, N = 212) suggested that adhesiolysis was effective, especially for pain and disability. However, both studies presented serious methodological flaws. In addition to RCTs, seven observational studies with high risk of bias reported data on effectiveness and safety. Fifty-eight adverse events were reported among 130 patients undergoing endoscopic adhesiolysis, and 19 among the 110 undergoing percutaneous adhesiolysis. CONCLUSIONS: The evidence on the efficacy and cost-effectiveness of adhesiolysis for treating FBSS is nonexistent, whereas evidence on its effectiveness and safety is insufficient. Incorporating data from observational studies did not improve the quality of the evidence on effectiveness.

Cost-effectiveness of vaccines for the prevention of seasonal influenza in different age groups: a systematic review / Coste-efectividad de la vacunación contra la gripe estacional para diferentes grupos de edad: Una revisión sistemática

BACKGROUND: Given the economic burden of seasonal influenza for the healthcare system, we performed a systematic review aiming to update available evidence on the cost-effectiveness of vaccination of seasonal influenza in different age groups, including children. METHODS: A systematic review of the literature on economic evaluations of seasonal influenza vaccination programs in children and adults was carried out. The following databases were searched (January 2013 - April 2018): Medline and PREMEDLINE, EMBASE, EconLit and databases of the Centre for Reviews and Dissemination (DARE, HTA, NHS EED). RESULTS: A total of 11 economic evaluations were included. Methodological quality of included studies was acceptable. Scientific evidence shows that seasonal influenza vaccination programs in school-age children can be a cost-effective alternative from national health system perspective and can be cost-saving from societal perspective in European countries. However, available evidence does not allow us to conclude that influenza vaccination programs in healthy adults under 65 years of age were a cost-effective alternative in our context, due to the high uncertainty and the lack of studies carried out in Spanish context. CONCLUSIONS: Vaccination programs for the prevention of seasonal influenza in school-age children (3-16 years) can be a cost-effective strategy.

OBJETIVO: Dada la carga económica que supone para el sistema sanitario la gripe estacional, se plantea esta revisión sistemática cuyo objetivo fue actualizar la evidencia disponible sobre el coste-efectividad de vacunación contra la gripe estacional en diferentes grupos de edad, incluyendo población infantil. METODOS: Se llevó a cabo una revisión sistemática de la literatura de evaluaciones económicas de los programas de vacunación contra la gripe estacional en niños y adultos. Se realizaron búsquedas en las bases de datos (enero 2013 ­ abril 2018): Medline y PREMEDLINE, EMBASE, EconLit y en las bases de datos del Centre for Reviews and Dissemination (DARE, HTA, NHS EED). RESULTADOS: Se incluyeron 11 evaluaciones económicas. La calidad metodológica de los estudios incluidos fue buena. La evidencia científica muestra que los programas de vacunación contra la gripe estacional en niños en edad escolar pueden ser una estrategia coste-efectiva desde la perspectiva sanitaria en países europeos. La evidencia científica disponible hasta el momento no nos permite concluir que los programas de vacunación antigripal en adultos sanos de menos de 65 años de edad sean una alternativa costeefectiva en nuestro contexto, debido a la elevada incertidumbre existente y a la escasez de estudios realizados en el contexto español. CONCLUSIONES: Los programas de vacunación contra la gripe estacional en niños en edad escolar (3-16 años) pueden ser una estrategia coste-efectiva desde la perspectiva del SNS.

Communication of scientific uncertainty: international case studies on the development of folate and vitamin D Dietary Reference Values.

OBJECTIVE: Transparent evidence-based decision making has been promoted worldwide to engender trust in science and policy making. Yet, little attention has been given to transparency implementation. The degree of transparency (focused on how uncertain evidence was handled) during the development of folate and vitamin D Dietary Reference Values was explored in three a priori defined areas: (i) value request; (ii) evidence evaluation; and (iii) final values. DESIGN: Qualitative case studies (semi-structured interviews and desk research). A common protocol was used for data collection, interview thematic analysis and reporting. Results were coordinated via cross-case synthesis. SETTING: Australia and New Zealand, Netherlands, Nordic countries, Poland, Spain and UK. SUBJECTS: Twenty-one interviews were conducted in six case studies. RESULTS: Transparency of process was not universally observed across countries or areas of the recommendation setting process. Transparency practices were most commonly seen surrounding the request to develop reference values (e.g. access to risk manager/assessor problem formulation discussions) and evidence evaluation (e.g. disclosure of risk assessor data sourcing/evaluation protocols). Fewer transparency practices were observed to assist with handling uncertainty in the evidence base during the development of quantitative reference values. CONCLUSIONS: Implementation of transparency policies may be limited by a lack of dedicated resources and best practice procedures, particularly to assist with the latter stages of reference value development. Challenges remain regarding the best practice for transparently communicating the influence of uncertain evidence on the final reference values. Resolving this issue may assist the evolution of nutrition risk assessment and better inform the recommendation setting process.

EURRECA-A framework for considering evidence in public health nutrition policy development.

A key step toward developing appropriate evidence-based public health nutrition policies is determining exactly how that evidence should be collected and assessed. Despite this the extent to which different evidence bases influence policy selection is rarely explored. This article presents an epistemological framework which offers a range of considerations affecting this process generally and with particular implications for both micronutrient requirements and the role of behavior in the policy-making process. Qualitative case study data covering 6 European countries/regions (Czech Republic, Italy, the Netherlands, Nordic countries, Poland, and Spain), and three micronutrients (folate, iodine, and vitamin D), have been presented to illustrate the relevance of the Framework.