Implementation of a cross-border health service: physician and pharmacists' opinions from the epSOS project.

OBJECTIVES: To explore the opinions of health professionals with experience of the European Patient Smart Open Services (epSOS) system regarding the epSOS services perceived utility, potential impact and main barriers and facilitators to its use. METHODS: Qualitative study design involving focus groups with health care professionals with experience of epSOS system. A semi-structured topic guide was developed to guide the discussion. RESULTS: epSOS services were seen as interesting intuitive services and easy to operate. The greatest impact was in terms of positive impact on communication, clinical safety and patient management. Data reliability, difficulties in accessing the service and aspects related to information technology architecture were considered the most relevant barriers. CONCLUSION: This study has provided insights into the strengths and limitations of two new eHealth services for use across countries within the European Union, and has provided indications of how those services could be improved.

Views of Multiple Sclerosis Patients About Key Elements for a Decision Aid: A Qualitative Study.

ABSTRACT: BACKGROUND: Patients with multiple sclerosis (MS) may experience decisional conflict during treatment choice. Shared decision making (SDM), whereby patients and health professionals, primarily nurses, collaborate in making decisions, reduces this decisional conflict. It requires understanding large amounts of information and may be complex, especially when decisions affect patients' autonomy and quality and prolongation of life. Patient decision aids are tools in facilitating SDM. This study aimed to identify the key elements from the perspective of patients with relapsing-remitting MS to create a patient decision aid in the Spanish sociocultural context. METHODS: This is a qualitative study using focus groups led by a clinical nurse specialist. Semistructured interviews included healthcare needs and demands, the SDM process, and general characteristics of a peer support program. After the transcription of interview recordings, data were analyzed by thematic analysis and a constructivist naturalistic approach. RESULTS: Patients with MS (27) from Spain participated in 4 focus groups of 90 to 120 minutes each. Three overarching themes were identified: information access to sufficient high-quality data; knowledge of available treatment options, including efficacy, adverse effects, frequency, administration route, and the impact on daily life; decision-making role, engaged versus nonengaged patients. The former require support in facilitating their active involvement in decisions, whereas the latter prefer more passive health models. CONCLUSION: The needs identified by patients with relapsing-remitting MS regarding treatment choice in the Spanish setting align with those reported by other studies. The identified themes provide valuable information to design and develop a virtual patient decision aid jointly by clinical MS nurses and patients according to the International Patient Decision Aid Standards Collaboration criteria. This aid will help improve understanding between nurses and patients during SDM and facilitate the process.

Correction: Evaluation Criteria for Weight Management Apps: Validation Using a Modified Delphi Process.

[This corrects the article DOI: 10.2196/16899.].

Correction: Assessment of the Efficacy, Safety, and Effectiveness of Weight Control and Obesity Management Mobile Health Interventions: Systematic Review.

[This corrects the article DOI: 10.2196/12612.].

Catalan experience of deadoption of low-value practices in primary care.

Reducing ineffective practices is one way to ensure high-quality and efficient healthcare for the population. For this reason, several initiatives have been implemented worldwide to reduce low-value care. This article describes the experience of the Essencial project, a multifaceted deadoption strategy implemented in the Catalan primary care system. Lessons learnt from this project include the importance of considering the local context in deadoption strategies, providing adequate training and communication material to patients and clinicians and supporting the key role of clinical champions. Given the knowledge gaps regarding the conditions for successful deadoption strategies, the Catalan experience could provide enlightenment on how to implement, evaluate and sustain a large-scale collaborative deadoption strategy in primary healthcare.

Addressing issues in health technology assessment promotion: Motives, enablers, and barriers.

OBJECTIVES: The aim of this study was to analyze the motives, enablers, and barriers to promote or initiate health technology assessment (HTA) in different contexts. METHODS: An observational study design was used to address the above question that included a survey questionnaire and a two-phase study. The respondents for the questionnaire and first round of the study were from HTA agencies of high income countries and those low and middle income countries that have managed to establish HTA agencies (n = 50), that are members of International Network of Agencies for Health Technology Assessment (INAHTA), EuroScan, or European network for Health Technology Assessment (EUnetHTA). The second round of the study was exclusively with respondents from low and middle income countries that were manly affiliated to Health Technology Assessment International (HTAi) interest subgroup for low and middle income countries and aimed to initiate HTA activities (n = 34). RESULTS: Forty-one of fifty HTA agencies answered the survey questionnaire. Thirty-three of fifty individuals belonging to HTA agencies from high income countries and sixteen of thirty-four individuals from low and middle income countries answered in the first and second phases of the study, respectively. In the promotion and/or initiation of HTA, the top three motives were the same for both high income and low and middle income countries. The top three enablers were also similar but the prioritization varies. The top three barriers were more context specific. CONCLUSIONS: HTA promotion or initiation is influenced by the following: (i) key players that affect the time taken to establish HTA agencies; (ii) three models for HTA promotion and initiation: top-down (political interest), bottom-up (academic/research interest), and converging (political and academic/research interests); and (iii) motives, enablers, and barriers at the local context.

Evaluation Criteria for Weight Management Apps: Validation Using a Modified Delphi Process.

BACKGROUND: The use of apps for weight management has increased over recent years; however, there is a lack of evidence regarding the efficacy and safety of these apps. The EVALAPPS project will develop and validate an assessment instrument to specifically assess the safety and efficacy of weight management apps. OBJECTIVE: The aim of this study was to reach a consensus among stakeholders on a comprehensive set of criteria to guide development of the EVALAPPS assessment instrument. A modified Delphi process was used in order to verify the robustness of the criteria that had been identified through a literature review and to prioritize a set of the identified criteria. METHODS: Stakeholders (n=31) were invited to participate in a 2-round Delphi process with 114 initial criteria that had been identified from the literature. In round 1, participants rated criteria according to relevance on a scale from 0 ("I suggest this criterion is excluded") to 5 ("This criterion is extremely relevant"). A criterion was accepted if the median rating was 4 or higher and if the relative intraquartile range was equal to 0.67 or lower. In round 2, participants were asked about criteria that had been discarded in round 1. A prioritization strategy was used to identify crucial criteria according to (1) the importance attributed by participants (criteria with a mean rating of 4.00 or higher), (2) the level of consensus (criteria with a score of 4 or 5 by at least 80% of the participants). RESULTS: The response rate was 83.9% (26/31) in round 1 and 90.3% (28/31) in round 2. A total of 107 out of 114 criteria (93.9%) were accepted by consensus-105 criteria in round 1 and 2 criteria in round 2. After prioritization, 53 criteria were deemed crucial. These related mainly to the dimensions of security and privacy (13/53, 24.5%) and usability (9/53, 17.0%), followed by activity data (5/53, 9.4%), clinical effectiveness (5/53, 9.4%), and reliability (5/53, 9.4%). CONCLUSIONS: Results confirmed the robustness of the criteria that were identified, with those relating to security and privacy being deemed most relevant by stakeholders. Additionally, a specific set of criteria based on health indicators (activity data, physical state data, and personal data) was also prioritized.

Practical tools and methods for health technology assessment in Europe: structures, methodologies, and tools developed by the European Network for Health Technology Assessment, EUnetHTA.

OBJECTIVES: This article presents an overview of the practical methods and tools to support transnational Health Technology Assessment (HTA) that were developed and pilot tested by the European network for HTA (EUnetHTA), which involved a total of sixty-four Partner organizations. METHODS: The methods differ according to scope and purpose of each of the tools developed. They included, for example, literature reviews, surveys, Delphi and consensus methods, workshops, pilot tests, and internal/public consultation. RESULTS: Practical results include an HTA Core Model and a Handbook on the use of the model, two pilot examples of HTA core information, an HTA Adaptation Toolkit for taking existing reports into new settings, a book about HTA and health policy making in Europe, a newsletter providing structured information about emerging/new technologies, an interactive Web-based tool to share information about monitoring activities for emerging/new technologies, and a Handbook on HTA capacity building for Member States with limited institutionalization of HTA. CONCLUSIONS: The tools provide high-quality information and methodological frameworks for HTA that facilitate preparation of HTA documentation, and sharing of information in and across national or regional systems. The tools will be used and further tested by partners in the EUnetHTA Collaboration aiming to (i) help reduce unnecessary duplication of HTA activities, (ii) develop and promote good practice in HTA methods and processes, (iii) share what can be shared, (iv) facilitate local adaptation of HTA information, (v) improve the links between health policy and HTA.

Systems to support health technology assessment (HTA) in member states of the European union with limited institutionalization of HTA.

OBJECTIVES: The aim of this study was to support health technology assessment (HTA) capacity building in Member States of the European Union with limited experience or without institutionalized HTA. The main output is a Handbook on HTA Capacity Building. METHODS: The methods used were worldwide surveys of (i) HTA organizations, (ii) information management units, and (iii) HTA educational programs. The results of two surveys (i & ii) were combined with expert opinion to produce the Handbook on HTA Capacity Building. RESULTS: Survey of HTA organizations (n = 41, response rate 35 percent). Most of the organizations were established by the government (61 percent), and all were not-for-profit. Working on HTA (80.5 percent) and doing research (63.4 percent) were the main lines of activity. Survey on information management units (n = 23, response rate 23 percent). Most (74.2 percent) of the responding HTA agencies reported having personnel dedicated to HTA information services. Survey on HTA educational programs (n = 48, response rate 60 percent). In total, nine Master of Science (MSc) programs were identified (three MSc in HTA and six MSc in HTA-related areas). Handbook on HTA Capacity Building. A group of twenty experts from thirteen countries developed the handbook. It consists of nine chapters focusing on HTA institutional development (structural setup, work processes, and visibility). CONCLUSIONS: Setting up organizational structures and establishing effective HTA programs that guide key policy decisions is a challenging task. There are no standard models or pathways. "One size fits all" is not a useful principle because of the wide systemic and cultural differences between countries. The Handbook on HTA Capacity Building includes approaches for overall institutional development, especially in formulating objectives, setting up structures, and defining work processes.

Assessment of the Efficacy, Safety, and Effectiveness of Weight Control and Obesity Management Mobile Health Interventions: Systematic Review.

BACKGROUND: The use of apps to tackle overweight and obesity by tracking physical and dietary patterns and providing recommendations and motivation strategies to achieve personalized goals has increased over recent years. However, evidence of the efficacy, effectiveness, and safety of these apps is severely lacking. OBJECTIVE: The aim of this study was to identify efficacy, safety, and effectiveness criteria used to assess weight control, overweight, and obesity management in mobile health (mHealth) interventions through a systematic review. METHODS: PubMed, PsycINFO, Scopus, UK Trial Database, ClinicalTrials.gov, and the Cochrane Library were surveyed up to May 2018. All types of clinical studies were considered. A total of 2 independent reviewers assessed quality using Scottish Intercollegiate Guidelines Network (SIGN) criteria. Ratings were used to provide an overall score for each study (low, moderate, or high). Data were synthesized in evidence tables. RESULTS: From 233 potentially relevant publications, only 28 studies were included. Of these, 13 (46%) were randomized control trials, 11 were single-arm studies (39%), 3 were nonrandomized controlled trials (11%), and 1 study was a cluster randomized trial (4%). The studies were classified as low (15), high (7), and moderate (6) quality according to SIGN criteria. All studies focused on efficacy, with only 1 trial mentioning safety and another 1 effectiveness. In 11 studies, the apps were used as stand-alone interventions, the others were multicomponent studies that included other tools for support such as sensors or websites. The main management tool included in the apps was feedback messaging (24), followed by goal-setting mechanisms (20) and self-monitoring (19). The majority of studies took weight or body mass index loss as the main outcome (22) followed by changes in physical activity (14) and diet (12). Regarding outputs, usability, adherence, and engagement (17) were the most reported, followed by satisfaction (7) and acceptability (4). CONCLUSIONS: There is a remarkable heterogeneity among these studies and the majority have methodological limitations that leave considerable room for improvement. Further research is required to identify all relevant criteria for assessing the efficacy of mHealth interventions in the management of overweight and obesity. TRIAL REGISTRATION: PROSPERO CRD42017056761; https://tinyurl.com/y2zhxtjx.

Prioritisation of patients on waiting lists for hip and knee arthroplasties and cataract surgery: Instruments validation.

BACKGROUND: Prioritisation instruments were developed for patients on waiting list for hip and knee arthroplasties (AI) and cataract surgery (CI). The aim of the study was to assess their convergent and discriminant validity and inter-observer reliability. METHODS: Multicentre validation study which included orthopaedic surgeons and ophthalmologists from 10 hospitals. Participating doctors were asked to include all eligible patients placed in the waiting list for the procedures under study during the medical visit. Doctors assessed patients' priority through a visual analogue scale (VAS) and administered the prioritisation instrument. Information on socio-demographic data and health-related quality of life (HRQOL) (HUI3, EQ-5D, WOMAC and VF-14) was obtained through a telephone interview with patients. The correlation coefficients between the prioritisation instrument score and VAS and HRQOL were calculated. For the reliability study a self-administered questionnaire, which included hypothetic patients' scenarios, was sent via postal mail to the doctors. The priority of these scenarios was assessed through the prioritisation instrument. The intraclass correlation coefficient (ICC) between doctors was calculated. RESULTS: Correlations with VAS were strong for the AI (0.64, CI95%: 0.59-0.68) and for the CI (0.65, CI95%: 0.62-0.69), and moderate between the WOMAC and the AI (0.39, CI95%: 0.33-0.45) and the VF-14 and the CI (0.38, IC95%: 0.33-0.43). The results of the discriminant analysis were in general as expected. Inter-observer reliability was 0.79 (CI95%: 0.64-0.94) for the AI, and 0.79 (CI95%: 0.63-0.95) for the CI. CONCLUSION: The results show acceptable validity and reliability of the prioritisation instruments in establishing priority for surgery.

[Development of a Conceptual Framework for the Assessment of Chronic Care in the Spanish National Health System]. / Desarrollo de un marco conceptual para la evaluación de la atención a la cronicidad en el sistema nacional de salud.

The aim was to develop a conceptual framework for the assessment of new healthcare initiatives on chronic diseases within the Spanish National Health System. A comprehensive literature review between 2002 and 2013, including systematic reviews, meta-analysis, and reports with evaluation frameworks and/or assessment of initiatives was carried out; integrated care initiatives established in Catalonia were studied and described; and semistructured interviews with key stakeholders were performed. The scope and conceptual framework were defined by using the brainstorming approach.Of 910 abstracts identified, a total of 116 studies were included. They referred to several conceptual frameworks and/or assessment indicators at a national and international level. An overall of 24 established chronic care initiatives were identified (9 integrated care initiatives); 10 in-depth interviews were carried out. The proposed conceptual framework envisages: 1)the target population according to complexity levels; 2)an evaluation approach of the structure, processes, and outcomes considering the health status achieved, the recovery process and the maintenance of health; and 3)the dimensions or attributes to be assessed. The proposed conceptual framework will be helpful has been useful to develop indicators and implement them with a community-based and result-oriented approach and a territorial or population-based perspective within the Spanish Health System. This will be essential to know which are the most effective strategies, what are the key elements that determine greater success and what are the groups of patients who can most benefit.

El objetivo del trabajo fue desarrollar un marco conceptual para la evaluación de nuevos programas de gestión clínica y asistencial de carácter integrado en el Sistema Nacional de Salud para la atención a las personas con enfermedades crónicas. Se realizó una revisión exhaustiva de la literatura entre 2002-2013 incluyendo revisiones sistemáticas, metaanálisis e informes con modelos de evaluación y/o evaluaciones de programas. Se estudiaron y describieron programas locales de atención a la cronicidad implementados en Cataluña y se realizaron entrevistas semiestructuradas con expertos clave en el ámbito catalán. El alcance y el marco conceptual se definieron mediante la técnica del brainstorming. De 910 resúmenes identificados, se incluyeron 116 documentos que se referían a marcos conceptuales e indicadores de evaluación a nivel español e internacional. Se identificaron 24 programas de atención a la cronicidad (9 de carácter integrado). El marco conceptual propuesto contempló: 1) la población diana según niveles de complejidad; 2) un enfoque de evaluación de la estructura, procesos y resultados teniendo en cuenta el estado de salud conseguido, el proceso de recuperación y mantenimiento de la salud; y 3) las dimensiones o atributos que se deben evaluar. El marco conceptual propuesto permite desarrollar indicadores e implementarlos con un enfoque comunitario, orientados a los resultados y tener una visión territorial o poblacional, que será imprescindible para saber cuál es la estrategia más efectiva, cuáles son los elementos que determinan un mayor éxito y cuáles son los grupos de pacientes que más se pueden beneficiar.

Participación ciudadana en los comités éticos institucionales de investigación clínica y asistenciales de Cataluña / Participation of civilians in Catalonian clinical research and health care institutional ethical review committees / Participação dos cidadãos na pesquisa clínica institucional das comissões éticas e cuidado na Catalunha

Resumen: Objetivo: Conocer el nivel de participación de pacientes, usuarios y ciudadanos en los comités de ética de la investigación (CEI) y los comités de ética asistencial (CEA) acreditados en Cataluña. Material y métodos: Estudio descriptivo transversal en una muestra oportunista de 30 CEI y CEA. Se administró un cuestionario dirigido a los presidentes y al representante de los usuarios o ciudadanos (miembro lego). Para la interpretación de los resultados se analizó medias y desviación estándar. Las respuestas a las preguntas de texto abierto se analizaron mediante un análisis cualitativo del contenido. Resultados: Del total de los 30 comités de ética (CEI y CEA) contactados, 12 (40%) aceptaron participar. En total se realizaron 15 entrevistas (9 miembros de CEI y 6 miembros de CEA): 8 presenciales, 4 telefónicamente y 3 contestadas por correo electrónico. Resultados de los CEI: del total de 7 CEI entrevistados, 2 tenían representación ciudadana en su comité. El perfil correspondía a una mujer, de profesión administrativa y a un hombre de profesión auditor contable, ambos de más de 50 años. Resultados de los CEA: de los 5 CEA que participaron, 2 declararon tener representación de la ciudanía. El perfil correspondía a una mujer, de profesión administrativa y a un hombre de profesión profesor, ambos de más de 50 años. Discusión: Actualmente hay poca representación de la ciudadanía/pacientes en los comités éticos institucionales. Constituye un tema actual de debate la necesidad de incorporar el punto de vista del ciudadano/paciente, habiendo, sin embargo, un desconocimiento sobre el perfil más idóneo y en discusión su representatividad.

Abstract: Aim: To know the level of participation of patients, users and civilians in scientific ethical review committees (SERC) and health care ethical review committees (HCERC) accredited in Catalonian. Materials and methods: Descriptive transversal study using an opportunistic sample of 30 SERC and HCERC. A questionnaire was filled out addressed to presidents and consumer or civilian (lay member) representatives. For the interpretation of results means and standard deviations were analyzed. Answers to open texts questions were analyzed using qualitative content analysis. Results: 12 committees (40%) accepted to participate; 15 interviews were carried out (9 SERC members and 6 HCERC members): 8 person to person, 4 by phone and 3 by email. SERC Results: Of 7 SERC interviewed, 2 have a civilian representative in the committee. The profile was a woman of administrative profession and an auditor accountant man, both older than 50 years. HCERC Results: Of 5 HCERC participating, 2 declared having a civilian representative. The profile was a woman of administrative profession and a man teacher, both older than 50 years. Discussion: Currently, there is low civilian/patient representation in institutional ethical review committees. Today, the need to incorporate the point of view of the civilian/patient is a debatable issue, being unknown the suitable profile and their representativeness is under discussion.

Resumo: Objetivo: Conhecer o nível de participação de pacientes, usuários e cidadãos em comitês de ética de pesquisa (CEI) e as comissões de ética de cuidados de saúde (CEA) acreditados na Catalunha. Material e métodos: Estudo descritivo, transversal em uma amostra oportunista de 30 CEI e CEA. Um questionário dirigido aos presidentes e representante dos usuários ou cidadãos (membro de leigo) foi administrado. Para a interpretação dos resultados foi feita uma análise que incluiu as médias e o desvio-padrão. Analisaram-se as respostas às perguntas do texto aberto com uma análise qualitativa do conteúdo. Resultados: Do total dos 30 comitês de ética (CEI e CEA) contatados, 12 (40%) concordaram em participar. No total foram realizadas 15 entrevistas (9 membros do CEI e 6 membros da CEA). De todas as entrevistas realizadas, 8 foram presenciais, 4 foram realizadas por telefone e 3 foram respondidas por e-mail. Resultados da CEI: do total de 7 entrevistados da CEI, 2 tinham representação cidadã na sua Comissão. O perfil correspondia a uma mulher, de carreira administrativa e a um home de profissão auditor contábil, ambos com mais de 50 anos. Resultados da CEA: dos 5 CEA que participaram, 2 declararam ter representação cidadã. O perfil correspondente era de uma mulher, de carreira administrativa e a um homem professor, ambos com mais de 50 anos. Discussão: Atualmente há pouca representação dos cidadãos/pacientes em comitês de ética institucionais. A necessidade de incorporar o ponto de vista do cidadão/paciente constitui um tema atual de discussão, no entanto, falta conhecimento sobre o perfil mais adequado e discussão sua representatividade.

Relationship between total hip replacement appropriateness and surgical priority instruments.

RATIONALE: Variability in indications for total hip replacement (THR) and unequal waiting times may limit health care access. OBJECTIVE: To analyse the relationship between appropriateness and previously developed surgical priority instruments. METHOD: Multicentre cross-validation study of patients placed on the waiting list for THR. Information on surgical priority, surgeons' evaluation of priority through a visual analogue scale (VAS) and health-related quality of life (HRQOL) (Health Utilities Index mark 3, EQ-5D, Western Ontario McMaster Osteoarthritic Index) was collected. THR indications were considered appropriate, uncertain or inappropriate according to appropriateness criteria. Statistical differences and clinically important differences in surgical priority, VAS and HRQOL between appropriateness categories were analysed with the Mann-Whitney U-test and effect size (ES), respectively. Surgical priority score's ability to discriminate appropriate and inappropriate indications was evaluated through the area under the receiver-operating characteristic curve (AUC) and its 95% confidence interval (95% CI). RESULTS: 49.4% (87) of the THR indications were deemed appropriate, 39.8% (70) uncertain and 10.8% (19) inappropriate. Differences in surgical priority score, VAS and HRQOL between appropriateness categories were statistically significant. Clinically important differences were generally small (ES, 0.2-0.5) between inappropriate and uncertain, moderate (ES, 0.5-0.8) between uncertain and appropriate, and large (ES > 0.8) between inappropriate and appropriate categories. The AUC to discriminate appropriate and inappropriate indications was 0.97 (95% CI: 0.96-0.99) and 0.90 (95% CI: 0.83-0.97), respectively. CONCLUSIONS: The relationship between the surgical priority and appropriateness instruments reinforces their validity and could improve waiting list management by establishing maximum waiting periods based on patients' characteristics.

Potential for 2 priority systems to be used as appropriateness of indication tools for cataract surgery.

OBJECTIVE: To test 2 systems developed to prioritize patients on waiting lists for cataract surgery, the Western Canadian Waiting List (WCWL), and the Catalan Agency for Health Technology Assessment and Research Cataract Priority System (CCPS), as tools for judging the appropriateness of the intervention. DESIGN: Cross-sectional study with follow-up. PARTICIPANTS: A total of 1723 prospective patients awaiting cataract extraction in 5 hospitals were included in the study. METHODS: Priority scores using the WCWL and the CCPS systems were calculated and compared with visual acuity (VA) and visual function, measured by the Visual Function-14 index, before and after surgery. The sensitivity of each priority system to different groups was evaluated using a validated appropriateness of indications tool for cataract extraction. One-way analysis of variance and the Jonckheere-Terpstra test were used to detect differences in group scores. Spearman correlation coefficients were also examined. RESULTS: The WCWL and CCPS systems produced different mean values according to the preoperative levels of VA and visual function (p < 0.0001). Neither system showed a significant difference in mean scores based on gains in VA and visual function. Both systems produced different mean scores according to the different groups of appropriateness set by the appropriateness of indications tool for cataract (p < 0.0001). CONCLUSIONS: Given that appropriateness tools should correlate with outcomes, we recommend using neither the WCWL nor the CCPS for appropriateness purposes. Incorporating new criteria into these systems may improve the correlation with important outcomes and their adequacy for use as appropriateness tools.