Health System Stakeholders' Perspective on the Role of Mobile Health and Its Adoption in the Swiss Health System: Qualitative Study.

BACKGROUND: Digital health solutions have great potential to change the way health care is delivered, including better clinical outcomes and improved processes and access to health services. However, the adoption of mobile health (mHealth) solutions for patient monitoring has been rather slow in Switzerland. The reasons are complex, and a better understanding is needed to leverage the full potential of mHealth. OBJECTIVE: This study aimed to deepen the understanding of the potential relevance and influence of mHealth for the health system and health care provision, and factors influencing its adoption. The findings will be used to provide an outlook on feasible recommendations for action. METHODS: We conducted a qualitative survey using a maximum variation sample of a heterogeneous group of stakeholders (N=50) in the Swiss health care system with a profound knowledge of digital health and medical devices. A semistructured interview guide including open- and closed-ended questions was used to address questions around mHealth relevance and its influence on the health system, the relevance of selected determinants for mHealth adoption, and important influencing factors. A content analysis method was applied. RESULTS: Overall, respondents thought that mHealth would have a beneficial impact on the Swiss health system but that its adoption would evolve slowly. We derived 23 key opportunities regarding patient and patient pathway, treatment of disease, and diseases and health conditions. High consistency in answers among respondents was observed for treatment of disease. Stakeholders' attitudes toward mHealth adoption along the relevance of 23 preselected determinants were relatively consistent. However, we obtained diverging attitudes regarding the influence of trends, enablers, and restraints in Switzerland and translated them into 26 key themes influencing mHealth adoption. Relevant trends comprise changing needs and expectations of patients, a rising need for efficient health care delivery, growing interest in improved outpatient care, and emerging technologies and progressing digitization. Important enablers include growing demand for new financing schemes and incentive concepts, rising demand for comprehensive information on and stronger body of evidence for mHealth use cases, and increasing need for easy to use alternate care approaches. Challenging restraints are rigidness of thinking and siloed actions of health system actors, complexity of changing the existing regulations and structures, little understanding of mHealth use and the role of clinicians, and risk of further polarization of the population. CONCLUSIONS: This study provides a comprehensive look at mHealth in the Swiss health system. It becomes apparent that strong governance is inevitable to foster a sustainable data strategy and to reconcile the different interests of stakeholders. The use of mHealth will add value but will not necessarily reduce the burden on the system caused by emerging societal needs and changing disease prevalence.

Economic evaluation of a novel genetic screening test for risk of venous thromboembolism compared with standard of care in women considering combined hormonal contraception in Switzerland.

AIM: The aim of this study was to assess the cost effectiveness of the Pill Protect (PP) genetic screening test for venous thromboembolism (VTE) risk compared with standard of care (SoC), for women considering combined hormonal contraceptives (CHCs) in Switzerland. METHODS: A two-part microsimulation model was developed to estimate VTE events, costs and quality-adjusted life years (QALYs) associated with the PP and SoC strategies. In the first portion of the model, a cohort of 1 million Swiss first-time seekers of a CHC were simulated. It was determined whether each women would receive a CHC or non-CHC by using prescribing patterns elicited from a modified Delphi study. These results formed the basis of the SoC strategy. For the PP strategy, a PP test was included and the results considered in addition to SoC practice. Each woman then entered a Markov model that captured morbidity and mortality over a lifetime. The risk of having a VTE was derived from the risk algorithm that underpins the PP test. The remaining model inputs relating to population characteristics, costs, health resource use, mortality and utilities were derived from published studies or national sources. The model was validated and calibrated to align with population-based studies. Extensive uncertainty analyses were conducted. RESULTS: From a Swiss health system perspective, the PP strategy in comparison with the SoC strategy generated an additional CHF 231, and gained 0.003 QALYs per woman, leading to an incremental cost-effectiveness ratio of CHF 76 610 per QALY gained. Assuming a threshold of CHF 100 000 per QALY gained, the PP strategy is likely to be cost effective. Our results were generally robust to variations in the parameter values. CONCLUSIONS: The PP test may be cost effective in Switzerland for screening women seeking CHCs for their risk of VTE based on the current evidence.

Strategies to improve the medical device life cycle in Mexico.

OBJECTIVE: To analyze the role of stakeholders to three alternative strategies to improve processes and practices regarding the regulation, assessment, and management of orthopaedic medical devices in Mexico. MATERIALS AND METHODS: The study was based on document analysis and 17 structured interviews with multiple key actors within the Mexican health system to inform a stakeholder analysis aiming at assessing the political feasibility of these strategies. RESULTS: Central level government agencies, those with a relation to quality of care, were identified as most relevant stakeholders to influence the adaption and application of the strategies. Major barriers identified are financial and human resources, and organisational culture towards reform. CONCLUSIONS: Discussed strategies are political feasible. However, solving identified barriers is crucial to achieve changes directed to improve outputs and outcomes of medical device life cycle and positively influence the quality of health care and the health system's performance.

Strategies to improve the medical device life cycle in Mexico / Estrategias para mejorar el ciclo de vida de dispositivos médicos en México

Abstract Objective To analyze the role of stakeholders to three alternative strategies to improve processes and practices regarding the regulation, assessment, and management of orthopaedic medical devices in Mexico. Materials and methods The study was based on document analysis and 17 structured interviews with multiple key actors within the Mexican health system to inform a stakeholder analysis aiming at assessing the political feasibility of these strategies. Results Central level government agencies, those with a relation to quality of care, were identified as most relevant stakeholders to influence the adaption and application of the strategies. Major barriers identified are financial and human resources, and organisational culture towards reform. Conclusion Discussed strategies are political feasible. However, solving identified barriers is crucial to achieve changes directed to improve outputs and outcomes of medical device life cycle and positively influence the quality of health care and the health system's performance.

Resumen Objetivo Analizar el papel de actores clave ante tres estrategias para mejorar los procesos y prácticas relacionados con la regulación, evaluación y gestión de dispositivos médicos ortopédicos en México. Material y métodos Análisis de grupos de interés (stakeholder analysis) basado en un análisis documental y 17 entrevistas estructuradas con actores clave, dirigido a evaluar la viabilidad política de las estrategias. Resultados El papel de las agencias federales de gobierno, principalmente las relacionadas con calidad de atención, fue identificado como central y con mayor poder para influenciar la adaptación y aplicación de las estrategias. Como barreras se identificaron los recursos financieros y humanos, y reorientar la cultura organizacional hacia la reforma. Conclusión Las estrategias discutidas son políticamente viables. Resolver las barreras es importante para lograr cambios que optimicen el ciclo de vida de los dispositivos médicos e influyan positivamente en la calidad de atención y el desempeño del sistema de salud.

ATTITUDES OF ORTHOPEDIC SPECIALISTS TOWARD EFFECTS OF MEDICAL DEVICE PURCHASING.

OBJECTIVES: The aim of this study was to assess viewpoints of end-users concerning the purchasing process of high-risk medical devices and to discuss the relevance of health technology assessments (HTAs) at the hospital level and other potential areas for improvement of purchasing processes. METHODS: We used a cross-sectional study and assessed the attitudes and thoughts of orthopedic specialists. The study took place between June and October 2015 in Mexico. RESULTS: We collected data from 187 orthopedic surgeons. Involvement of orthopedic specialists in purchasing was reported by 86 percent. However, clinical practice was perceived as negatively influenced by purchasing outcomes by 92 percent. The problems were described as: material failure; effectiveness of medical devices; obsolete medical device technology; incomplete provision of implant / instrument sets; delayed provision of implants and instruments. CONCLUSIONS: To prevent sub-standard outcomes of purchasing decisions, this study and the current literature suggest that technologies should be assessed during the purchasing process, end-users should be adequately involved, and decisions should be based on multiple criteria including clinical impact in the short-term (e.g., primary stability of implant) and long-term (e.g., survival of implant). The focus on Mexico is particularly novel and provides insights into a health system where HTA is mainly present at the macro level and can be used for the listing of medical device technologies in the standard list. This study concludes that Mexican stakeholders of the purchasing process underestimate the contribution of HTAs at the level of purchasing decisions. HTA in Mexico has improved over the past years but still requires more advancement.

Effects of procurement practices on quality of medical device or service received: a qualitative study comparing countries.

BACKGROUND: We know little about how procurement of a high-risk medical device (HRMD) affects clinical practice and outcomes. In health systems in high-income countries, and specifically those that maintain a national arthroplasty registry, procurement decisions are frequently guided by long-term clinical results, with the goal of ensuring at least standard quality of HRMDs. But in countries like Mexico, decision-making is often dominated by lowest acquisition price. We set out to study the impact of procurement for orthopaedic HRMDs on clinical procedures and outcomes. METHODS: We based our qualitative study on 59 in-depth interviews with stakeholders from Mexico, Switzerland, Germany, and UK: orthopaedic specialists, government officials, other experts, and social security system managers or administrators. We took a healthcare delivery approach to capturing and comparing factors that affected the regulations of HRMDs and procurement processes, and to understanding connections between procurement and clinical practice. RESULTS: Our findings demonstrate for procurement processes that the three European countries compared to Mexico don't have similar concerns with regards to their procurement processes. Deficiencies of procurement regulations and practices identified from representatives in Mexico were almost absent in European countries. We identified three areas of deficiency: 1) HRMD regulations based on insufficiently robust clinical evidence (mainly noted by European countries); 2) Follow-up on Health Technology Assessments is inadequate (noted by Mexico) and methodology not always good enough (noted by European countries); and, 3) Lowest-acquisition price often guides procurement decisions and thus may not align with needs of clinical procedures (noted by Mexico and some European countries). CONCLUSIONS: Procurement processes for orthopaedic HRMDs may have an impact on clinical procedures and outcomes. A favourable approach is one where orthopaedic specialists are parties to the procurement process, and post-market surveillance data informs decision-making. Actors in the procurement process can improve their impact on clinical procedures and outcomes by developing specific strategies that better align the needs of both, procurement and clinical procedures.

How does the knowledge environment shape procurement practices for orthopaedic medical devices in Mexico?

BACKGROUND: In organisational theory there is an assumption that knowledge is used effectively in healthcare systems that perform well. Actors in healthcare systems focus on managing knowledge of clinical processes like, for example, clinical decision-making to improve patient care. We know little about connecting that knowledge to administrative processes like high-risk medical device procurement. We analysed knowledge-related factors that influence procurement and clinical procedures for orthopaedic medical devices in Mexico. METHODS: We based our qualitative study on 48 semi-structured interviews with various stakeholders in Mexico: orthopaedic specialists, government officials, and social security system managers or administrators. We took a knowledge-management related perspective (i) to analyse factors of managing knowledge of clinical procedures, (ii) to assess the role of this knowledge and in relation to procurement of orthopaedic medical devices, and (iii) to determine how to improve the situation. RESULTS: The results of this study are primarily relevant for Mexico but may also give impulsion to other health systems with highly standardized procurement practices. We found that knowledge of clinical procedures in orthopaedics is generated inconsistently and not always efficiently managed. Its support for procuring orthopaedic medical devices is insufficient. Identified deficiencies: leaders who lack guidance and direction and thus use knowledge poorly; failure to share knowledge; insufficiently defined formal structures and processes for collecting information and making it available to actors of health system; lack of strategies to benefit from synergies created by information and knowledge exchange. Many factors are related directly or indirectly to technological aspects, which are insufficiently developed. CONCLUSIONS: The content of this manuscript is novel as it analyses knowledge-related factors that influence procurement of orthopaedic medical devices in Mexico. Based on our results we recommend that the procurement mechanism should integrate knowledge from clinical procedures adequately in their decision-making. Without strong guidance, organisational changes, and support by technological solutions to improve the generation and management of knowledge, procurement processes for orthopaedic high-risk medical devices will remain sub-optimal.