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This paper aims to describe the development of a flowchart to guide the decisions of researchers in the Spanish Network for Health Technology Assessment of the National Health System (RedETS) regarding patient involvement (PI) in Health Technology Assessment (HTA). By doing so, it reflects on current methodological challenges in PI in the HTA field: how best to combine PI methods and what is the role of patient-based evidence.
A decisional flowchart for PI in HTA was developed between March and April 2019 following an iterative process, reviewed by the members of the PI Interest Group and other RedETS members and validated during an online deliberative meeting. The development of the flowchart was based on a previous methodological framework assessed in a pilot study.
The guidelines on how to involve patients in HTA in the RedETS were graphically represented in a flowchart. PI must be included in all HTA reports, except those that assess technologies with no relevant impact on patients’ experiences, values, and preferences. Patient organizations or expert patients related to the topic of the HTA report must be identified and invited. These patients can participate in protocol development, outcomes' identification, assessment process, and report review. When the technology assessed affects in a relevant way patient experiences, values, and preferences, patient-based evidence should be included through a systematic literature review or a primary study.
The decisional flowchart for PI in HTA contributes to the current methodological challenges by proposing a combination of direct involvement and patient-based evidence.
The Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) defined a patient involvement (PI) framework for health technology assessment (HTA) activities in 2016. The aim of this study is to evaluate the process and impact of those PI initiatives that were implemented in the first year following the publication of this new framework.
A survey was sent to those HTA researchers who implemented PI in RedETS projects. Responses were reviewed by two authors. An adapted thematic analysis was performed and the results were later discussed by all authors.
Six responses from six agencies/units were analyzed. The objectives of PI initiatives were the following: inclusion of patient perspectives, preferences and values; elicitation of important health outcomes measures; and barriers, facilitators, or suggestions for implementation. Different methods were used for PI: surveys, focus groups, in depth interviews, and participation in an expert panel. Five main themes emerged: (i) challenges with the recruitment process, (ii) needs identified, (iii) impact of PI, (iv) lessons learned, and (v) suggestions for the future.
PI initiatives within the RedETS framework were tailored to each HTA project, its specific goals and the individual needs and resources of each HTA agency. The results also pointed out how PI has a relevant impact that has enriched RedETS products providing key information on experiences, values, and preferences of patients, contributions that benefit the HTA and the process of drawing up recommendations. The main challenges were related to recruitment processes and capacity building.
Malnutrition, specifically protein-energy wasting (PEW), is common in patients with chronic kidney disease (CKD), and its prevalence increases as CKD progresses. Oral nutritional supplementation (ONS) with complete formulas specific to this pathology, is a strategy aimed at meeting energy and protein requirements that are not possible with dietary recommendations and advice alone. This study systematically reviewed the available scientific literature on the safety and effectiveness of nutritional therapy with complete formulas specially designed for adults with CKD who have PEW that is not reversible through ordinary food consumption.
We systematically searched for articles published up to May 2018 in several electronic databases. We included comparative studies that evaluated the safety and effectiveness of complete nutritional formulas for malnourished adults with CKD. Relevant outcomes included rates of death, hospitalization, and adverse effects, and changes in nutritional status, anthropometrics, and health-related quality of life (HRQoL).
Three systematic reviews and 22 primary studies were identified. The primary studies comprised nine randomized controlled trials, nine non-randomized comparative studies, and four before-after studies (the latter were only included in the safety review). The majority of studies were conducted in patients on hemodialysis. The studies exhibited methodological heterogeneity in terms of the methods used to measure nutritional status and the interventions and comparators evaluated. There was also inconsistency among the results. Adherence to ONS, especially in the long term, can be affected by taste fatigue produced by repeatedly taking the same formula. Some studies recommend supplementation during hemodialysis sessions.
The studies with less risk of bias indicated a trend toward improvements in rates of death and hospitalization, HRQoL and, to a lesser extent, some anthropometric variables and serum markers, such as albumin, when ONS was given to patients with CKD. High quality comparative studies are needed to make conclusive statements about the effectiveness of this intervention.
The aim of this study was to develop a feasible and effective strategy to involve patients in the Spanish Network of Agencies of Health Technology Assessment (RedETS).
The framework for patient involvement (PI) in the assessment activities and processes of RedETS were developed through a research project that included: (i) a systematic search of the international literature describing a strategy and/or a methodology linking health technology assessment (HTA) and PI; (ii) a qualitative study through interviews with RedETS members to analyze the perceptions of PI among HTA managers in the Spanish context; (iii) a Delphi consultation with three large platforms of patients, carers and consumer organizations in Spain about their perspectives of PI; (iv) a consensus process with the members of the RedETS Governing Council to define the final strategy.
Three main themes were identified in the literature and Web site review: (i) PI methods for the different HTA phases; (ii) Participant definition and selection; (iii) Resources needed. A three-step implementation strategy was proposed: (i) short-term actions: piloting and testing patient participation in HTA and building patients' capacity; (ii) medium-term actions: broadening the participation of patients, and building internal capacity; (iii) long-term actions: consolidating and mainstreaming patient involvement
Patient participation can be incorporated into almost all the HTA phases and products with greater or lesser degrees of difficulty. However, a progressive implementation strategy is suggested for a feasible PI process.
Conclusions and recommendations of health technology assessment (HTA) reports have an impact on all relevant actors involved in the health system (health authorities, administrators, health professionals, patients, citizens and industry). The involvement of all those relevant stakeholders in the HTA process facilitates making valid and informed decisions and an efficient allocation of resources. Improving communication, participation and transparency among all agents will lead to more efficient evaluation and decision-making processes.
To review key aspects of the relations between HTA agencies and health industries, two process were carried out: a narrative review of literature searched in Medline, PubMed, Embase, CINAHL and WOS (2007-2017) and a review of websites of international HTA agencies. References and webs with information on the framework, objectives, methodologies, impact or results of the relationships were included.
A total of 1961 references were located and forty-five were selected. From the synthesis of the selected references the following key aspects of the relationships between HTA and industry were identified: (i) the importance of early dialogues with industry to align HTA objectives with the generation of evidence; (ii) challenges of the bias in the evidence produced by industry; (iii) difficulties in industry engagement in HTA processes; and (iv) industry interest in HTA. The review of six agency websites provided information on industry involvement in strategic activities, early dialogues, provision of documentation, management of industry clarifications, review of the report/allegations and other forms of relationship.
Both the review of the literature and the contents of the web pages of international agencies with experience in relations with industry show that the interest is in the creation of collaborative frameworks between regulatory authorities that decide on authorization and price and reimbursement and HTA agencies, while both try to maintain an early, transparent and systematic interaction with the healthcare industry.
In December 2017, a patient involvement (PI) Interest Group was created in the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) Annual conference. It started as a voluntary group of health technology assessment (HTA) methodologists interested in PI. The objective of the Group is to promote and facilitate PI in HTA. With the support of the Spanish Ministry of Health and the RedETS Council the Interest Group grew to at least one member for each of the eight RedETS regional agencies and units. It currently has 22 members. The PI Interest Group works in periodic online meetings and an annual offline meeting to establish a space for experiences exchange and reach consensus on main issues regarding PI.
RedETS published a strategy to facilitate effective and efficient PI in HTA processes in 2017. The long-term objective is to mainstream PI in all RedETS products. This strategy was built on a literature review and a qualitative study with semi-structured interviews. The interviews detected capacity building needs for technicians and methodologist in the network to be able to actively engage patients in HTA reports.
Since the kick-off meeting the PI Interest Group has worked in a number of activities. The main lines of action since its creation were: (i) evaluation of PI process in RedETS HTA reports in 2017 and in current reports, (ii) discussion on main methodological and procedural aspects, and feasibility of different patient participation approaches, (iii) development of technical protocols and templates to facilitate PI, (iv) the creation/adaptation of educational materials for patients and (v) translation of the HTAi Glossary for patients to Spanish.
Peer-to-peer learning processes can foster technical capacity of HTA methodologist in the Spanish HTA Network and may favor the implementation of the PI strategy.
Stereo-electroencephalography (SEEG) has been shown to be a valuable tool for the anatomo-electroclinic definition of the epileptogenic zone (EZ) in some patients with medically refractory epilepsy considered for surgery. In Spain, many of those patients are not offered this diagnostic procedure. The objective of our health technology assessment (HTA) report was to evaluate the effectiveness, safety and cost-effectiveness of SEEG to define the EZ in patients with refractory epilepsy considered for surgery compared to no SEEG intervention (i.e. remaining with further antiepileptic drugs).
We undertook a systematic review with meta-analyses on the effectiveness and safety of SEEG. A cost-effectiveness analysis was conducted using a Markov model which simulates the costs and health outcomes of individuals for a lifetime horizon from the perspective of the Spanish National Health Service (NHS). The effectiveness measure was quality-adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis.
The EZ was found in 92 percent of patients who underwent SEEG, 72 percent were eligible for epilepsy surgery and 33 percent were free of seizures after surgery (47 percent of those who received surgery). Any complications related to insertion and monitoring of SEEG and the subsequent intervention occurred in 1.3 percent of patients. In the base case analysis, SEEG led to higher QALYs and healthcare costs with an estimated incremental cost-effectiveness ratio of EUR 10,368 (USD 12,217) per QALY. The sensitivity analyses showed that the results of the study were robust.
SEEG is a cost-effective technology in patients with refractory epilepsy considered for surgery when compared to no SEEG intervention.
New therapeutic strategies have been established in chronic wound healing procedures, such as the use of platelet-rich plasma (PRP). There is currently still uncertainty about the effectiveness, cost-effectiveness and real safety of PRP in promoting chronic wound healing and what specific types of chronic wounds can benefit most from its use.
We conducted a systematic review of available scientific literature on the effectiveness, safety and cost-effectiveness of PRP compared to placebo, standard care or alternative topical therapies for the treatment of chronic wounds in adults. Overall effect size was estimated through a meta-analysis. A cost-effectiveness analysis was conducted using a Markov model which simulates the costs and health outcomes of individuals for a 5-year horizon, from the perspective of the Spanish National Health Service (NHS) for the PRP versus standard treatment in patients with diabetic foot ulcers. The effectiveness measure was quality-adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis.
Sixteen RCTs and four observational studies were included for the effectiveness and safety meta-analysis. The primary outcome was the proportion of chronic wounds completely healed: 143 patients out of 334 (42.8 percent) were cured in the standard treatment arm and 251 patients out of 375 (66.9 percent) in the PRP arm, relative risk (RR) 1.68 (95% CI: 1.22–2.31). It was unclear whether there was a difference in the risk of infection (RR 0.53, 95% CI: 0.10–2.71) or adverse events (RR 1.05, 95% CI: 0.29–3.88) between PRP and standard care. Three studies were considered for the cost-effectiveness analysis. In the base case analysis, PRP led to higher QALYs and healthcare costs with an estimated incremental cost-effectiveness ratio (ICER) of EUR 41,767 (USD 48,323)/QALY.
PRP treatment is more expensive and more effective than standard treatment. The estimated ICER is above the acceptability threshold in Spain.
With heightened awareness of the value of patient and provider perspectives to decision making, Qualitative Evidence Synthesis (QES) is increasingly used within a health technology assessment (HTA) context. Acceptability, feasibility and implementation can all be addressed by synthesis of qualitative research. Concerns have been raised about the quality of the synthesis product, especially when conducted within a constrained time window. How can we test the validity of qualitative studies and assess confidence in synthesized qualitative findings, particularly when time is tight?
A brief examination of issues relating to production and use of QES identified from within the Canary Islands HTA agency will identify practical and methodological challenges. How can existing approaches address wider patient, social, organizational and ethical considerations that inform HTA? The potential for use of Evidence To Decision frameworks and approaches such as GRADE CERQual (a transparent method for assessing the confidence of evidence from reviews of qualitative research) will be briefly examined.
This presentation will identify potential gaps between the needs of a small HTA agency and the methodological support and tools required to address these gaps, based on experience of conducting QES to date. Issues identified are particularly relevant to other small HTA agencies but are also generalizable to larger agencies and guideline producers worldwide. Pragmatic solutions are suggested. A future research agenda for potential methodological and applied research is outlined and current GRADE-CERQual development initiatives briefly shared.
Despite significant progress in developing methodologies for integrating QES within HTA decision making, substantive challenges remain. Observations derived from this small HTA agency can inform further developments across all HTA organizations. Research is required to examine the impact of potential dissemination bias, application of tools across a wider HTA decision making framework and use of rigorous approaches within a time-limited evaluation window.
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