Abstract Priority setting in health care has been long recognized as an intrinsically complex and value-laden process. Yet, health technology assessment agencies (HTAs) presently employ value ...assessment frameworks that are ill fitted to capture the range and diversity of stakeholder values and thereby risk compromising the legitimacy of their recommendations. We propose “evidence-informed deliberative processes” as an alternative framework with the aim to enhance this legitimacy. This framework integrates two increasingly popular and complementary frameworks for priority setting: multicriteria decision analysis and accountability for reasonableness. Evidence-informed deliberative processes are, on one hand, based on early, continued stakeholder deliberation to learn about the importance of relevant social values. On the other hand, they are based on rational decision-making through evidence-informed evaluation of the identified values. The framework has important implications for how HTA agencies should ideally organize their processes. First, HTA agencies should take the responsibility of organizing stakeholder involvement. Second, agencies are advised to integrate their assessment and appraisal phases, allowing for the timely collection of evidence on values that are considered relevant. Third, HTA agencies should subject their decision-making criteria to public scrutiny. Fourth, agencies are advised to use a checklist of potentially relevant criteria and to provide argumentation for how each criterion affected the recommendation. Fifth, HTA agencies must publish their argumentation and install options for appeal. The framework should not be considered a blueprint for HTA agencies but rather an aspirational goal—agencies can take incremental steps toward achieving this goal.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
There is a wide variety of participatory approaches to involve stakeholders in the development of medical devices, but there is no comprehensive overview of these approaches. We therefore studied ...what participatory approaches are used in the development of medical devices as well as the most important characteristics and challenges of these approaches.
We conducted a scoping review and searched PubMed, Embase and Web of Science for articles published between July 2014 and July 2019. Papers were included if they presented original research featuring any form of stakeholder participation in the development of medical devices. We used The Spectrum of Public Participation to categorise the approach of each paper. Subsequently, we described the characteristics of each approach: the stakeholders involved, data collection methods, and topics addressed. We also identified challenges of the approaches as reported by researchers.
277 papers were included, which could be categorised into three levels of participation: collaboration, involvement, and consultation. Patients and healthcare professionals are frequently engaged in all approaches. The most often used methods are workshops in the collaboration approach papers, and interviews in the involvement and consultation approach papers. Topics addressed in all approaches are: the problem, device requirements, design choices, testing, and procedural aspects of involvement. Reported challenges entail issues related to sampling, analysis, social dynamics, feasibility, and the limited number of topics that can be addressed.
Participatory approaches reported in literature can be categorised in three overarching approaches that have comparable methodological characteristics. This suggests that if researchers want to apply a participatory approach it is not necessary to adopt a pre-determined approach, such as 'participatory action research' (PAR). Instead, they can independently determine the degree of participation, stakeholders, methods, topics, and strategies to account for challenges, making sure the participatory approach fits their research question and context.
A deliberative Citizen Forum 'Choices in healthcare' was held in the Netherlands to obtain insight into the criteria informed citizens would propose for the public reimbursement of healthcare. During ...3 weekends, 24 citizens participated in evidence-informed deliberation on the basis of 8 case studies. The aim of this study was to assess how the opinions of 8 participants in the deliberative Citizens Forum changed and if so, why participants themselves believe their opinions have changed, whether participation influenced their perceived reasonableness of other participants in the forum and whether it influenced their opinions about involvement of citizens in decision-making.
Semi-structured interviews were held with 8 participants before and after their participation in the Citizen Forum. Using the method of reconstructing interpretive frames opinions about the public reimbursement of healthcare were reconstructed.
Participants' opinions changed over time; they became more aware of the complexity of decision-making and came to accept that there are limits to the available resources and accept cost as a criterion for reimbursement decisionmaking. Participants report that exchanging arguments and personal experiences with other participants made them change their initial opinions. Participants ascribed increases in the perceived reasonableness of other participants' opinions to feelings of group-bonding and becoming more familiar with each other's personal circumstances. Participants further believe that citizens represent an additional opinion to that of other stakeholders and believe their opinions should be considered in relation to those of other stakeholders, given they are provided with opportunities for critical discussion.
Organized deliberation should allow for the exchange of arguments and the sharing of personal experiences which is linked to learning. On the one hand this is reflected in the uptake of new arguments and on the other hand in the revision, specification or expansion of personal argumentation. Providing opportunities for critical deliberation is key to prevent citizens from adhering to initial emotional reactions that remain unchallenged and which may no longer be supported after deliberation.
Stakeholder engagement in evaluation of medical devices is crucial for aligning devices with stakeholders' views, needs, and values. Methods for these engagements have however not been compared to ...analyse their relative merits for medical device evaluation. Therefore, we systematically compared these three methods in terms of themes, interaction, and time-investment.
We compared focus groups, interviews, and an online survey in a case-study on minimally invasive endoscopy-guided surgery for patients with intracerebral haemorrhage. The focus groups and interviews featured two rounds, one explorative focussing on individual perspectives, and one interactive focussing on the exchange of perspectives between participants. The comparison between methods was made in terms of number and content of themes, how participants interact, and hours invested by all researchers.
The focus groups generated 34 themes, the interviews 58, and the survey 42. Various improvements for the assessment of the surgical procedure were only discussed in the interviews. In focus groups, participants were inclined to emphasise agreement and support, whereas the interviews consisted of questions and answers. The total time investment for researchers of focus groups was 95 h, of interviews 315 h, and survey 81 h.
Within the context of medical device evaluation, interviews appeared to be the most appropriate method for understanding stakeholder views since they provide a scope and depth of information that is not generated by other methods. Focus groups were useful to rapidly bring views together. Surveys enabled a quick exploration. Researchers should account for these methodological differences and select the method that is suitable for their research aim.
Full text
Available for:
CEKLJ, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
ObjectivesInvolving end-users and patients in the development of surgical devices, even when patients are not end-users, is deemed important in policy and in academia since it could improve strategic ...choices in research and development (R&D). Nonetheless, research into innovators’ views on end-user and patient involvement is rare. This study explores what end-users and patients are being involved by innovators during development, what methods for involvement are being used and what topics are being discussed with these end-users and patients.DesignA qualitative study featuring semi-structured interviews with innovators of surgical devices. Interviews were recorded and a thematic analysis was performed on verbatim transcripts.Participants15 interviews were conducted with 19 innovators of 14 surgical devices.SettingInnovation practices of surgical devices in the Netherlands and Belgium.ResultsEnd-users were engaged in R&D with formal methods and in unsystematic ways. These users all work in the clinical domain, for example, as surgeons or nurses. The innovators engaged users to analyse problems for which a device could be a solution, define functionalities, make design choices, analyse usability, ensure safety and improve aesthetics. Patients were rarely involved. Innovators stated that patients are not considered to be end-users, that physicians can represent patient interests and that involving patients is unethical as false expectations could be raised.ConclusionInnovators involve end-users with methods and unsystematic ways in the development of surgical devices. Despite governmental calls for patient involvement in the development of medical devices and surgical devices, innovators do not generally involve patients.
Background
Prophylactic removal of asymptomatic disease‐free impacted wisdom teeth is surgical removal of wisdom teeth in the absence of symptoms and with no evidence of local disease. Impacted ...wisdom teeth may be associated with pathological changes, such as pericoronitis, root resorption, gum and alveolar bone disease (periodontitis), caries and the development of cysts and tumours. When surgical removal is carried out in older people, the risk of postoperative complications, pain and discomfort is increased. Other reasons to justify prophylactic removal of asymptomatic disease‐free impacted third molars have included preventing late lower incisor crowding, preventing damage to adjacent structures such as the second molar or the inferior alveolar nerve, in preparation for orthognathic surgery, in preparation for radiotherapy or during procedures to treat people with trauma to the affected area. Removal of asymptomatic disease‐free wisdom teeth is a common procedure, and researchers must determine whether evidence supports this practice. This review is an update of an existing review published in 2012.
Objectives
To evaluate the effects of removal compared with retention (conservative management) of asymptomatic disease‐free impacted wisdom teeth in adolescents and adults.
Search methods
We searched the following electronic databases: Cochrane Oral Health's Trials Register (to 24 May 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (2016, Issue 4), MEDLINE Ovid (1946 to 24 May 2016) and Embase Ovid (1980 to 24 May 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing and unpublished studies to 24 May 2016. We imposed no restrictions on language or date of publication in our search of electronic databases.
Selection criteria
Studies comparing removal (or absence) with retention (or presence) of asymptomatic disease‐free impacted wisdom teeth in adolescents or adults. We included randomised controlled trials (RCTs) with no restriction on length of follow‐up, if available. We considered quasi‐RCTs and prospective cohort studies for inclusion if investigators measured outcomes with follow‐up of five years or longer.
Data collection and analysis
Eight review authors screened search results and assessed the eligibility of studies for inclusion according to the review inclusion criteria. Eight review authors independently conducted risk of bias assessments in duplicate. When information was unclear, we contacted study authors for additional information.
Main results
This review includes two studies. The previous review included one RCT with a parallel‐group design, which was conducted in a dental hospital setting in the United Kingdom; our new search for this update identified one prospective cohort study conducted in the private sector in the USA.
Primary outcome
No eligible studies in this review reported the effects of removal compared with retention of asymptomatic disease‐free impacted wisdom teeth on health‐related quality of life
Secondary outcomes
We found only low to very low quality evidence of the effects of removal compared with retention of asymptomatic disease‐free impacted wisdom teeth for a limited number of secondary outcome measures.
One prospective cohort study, reporting data from a subgroup of 416 healthy male participants, aged 24 to 84 years, compared the effect of the absence (previous removal or agenesis) against the presence of asymptomatic disease‐free impacted wisdom teeth on periodontitis and caries associated with the distal of the adjacent second molar during a follow‐up period of three to over 25 years. Very low quality evidence suggests that the presence of asymptomatic disease‐free impacted wisdom teeth may be associated with increased risk of periodontitis affecting the adjacent second molar in the long term. In the same study, which is at serious risk of bias, there is insufficient evidence to demonstrate a difference in caries risk associated with the presence or absence of impacted wisdom teeth.
One RCT with 164 randomised and 77 analysed adolescent participants compared the effect of extraction with retention of asymptomatic disease‐free impacted wisdom teeth on dimensional changes in the dental arch after five years. Participants (55% female) had previously undergone orthodontic treatment and had 'crowded' wisdom teeth. No evidence from this study, which was at high risk of bias, was found to suggest that removal of asymptomatic disease‐free impacted wisdom teeth has a clinically significant effect on dimensional changes in the dental arch.
The included studies did not measure our other secondary outcomes: costs, other adverse events associated with retention of asymptomatic disease‐free impacted wisdom teeth (pericoronitis, root resorption, cyst formation, tumour formation, inflammation/infection) and adverse effects associated with their removal (alveolar osteitis/postoperative infection, nerve injury, damage to adjacent teeth during surgery, bleeding, osteonecrosis related to medication/radiotherapy, inflammation/infection).
Authors' conclusions
Insufficient evidence is available to determine whether or not asymptomatic disease‐free impacted wisdom teeth should be removed. Although asymptomatic disease‐free impacted wisdom teeth may be associated with increased risk of periodontitis affecting adjacent second molars in the long term, the evidence is of very low quality. Well‐designed RCTs investigating long‐term and rare effects of retention and removal of asymptomatic disease‐free impacted wisdom teeth, in a representative group of individuals, are unlikely to be feasible. In their continuing absence, high quality, long‐term prospective cohort studies may provide valuable evidence in the future. Given the lack of available evidence, patient values should be considered and clinical expertise used to guide shared decision making with patients who have asymptomatic disease‐free impacted wisdom teeth. If the decision is made to retain asymptomatic disease‐free impacted wisdom teeth, clinical assessment at regular intervals to prevent undesirable outcomes is advisable.
To assess whether early health economic modeling helps to distinguish those healthcare innovations that are potentially cost-effective from those that are not potentially cost-effective. We will also ...study what information is retrieved from the health economic models to inform further development, research and implementation decisions.
We performed secondary analyses on an existing database of 32 health economic modeling assessments of 30 innovations, performed by our group. First, we explored whether the assessments could distinguish innovations with potential cost-effectiveness from innovations without potential cost-effectiveness. Second, we explored which recommendations were made regarding development, implementation and further research of the innovation.
Of the 30 innovations, 1 (3%) was an idea that was not yet being developed and 14 (47%) were under development. Eight (27%) innovations had finished development, and another 7 (23%) innovations were on the market. Although all assessments showed that the innovation had the potential to become cost-effective, due to improved patient outcomes, cost savings or both, differences were found in the magnitude of the potential benefits, and the likelihood of reaching this potential. The assessments informed how the innovation could be further developed or positioned to maximize its cost-effectiveness, and informed further research.
The early health economic assessments provided insight in the potential cost-effectiveness of an innovation in its intended context, and the associated uncertainty. None of the assessments resulted in a firm 'no-go' recommendation, but recommendations could be provided on further research and development in order to maximize value for money.
The complexity associated with how interventions result—or fail to result—in outcomes and how context matters is increasingly recognised. Logic models provide an important tool for handling ...complexity, with contrasting uses in programme evaluation and evidence synthesis. To reconcile these, we developed an approach that combines the strengths of both traditions, propose a taxonomy of logic models, and provide guidance on how to choose between approaches and types of logic models in systematic reviews and health technology assessments (HTA).
The taxonomy distinguishes 3 approaches (a priori, staged, and iterative) and 2 types (systems‐based and process‐orientated) of logic models. An a priori logic model is specified at the start of the systematic review/HTA and remains unchanged. With a staged logic model, the reviewer prespecifies several points, at which major data inputs require a subsequent version. An iterative logic model is continuously modified throughout the systematic review/HTA process. System‐based logic models describe the system, in which the interaction between participants, intervention, and context takes place; process‐orientated models display the causal pathways leading from the intervention to multiple outcomes.
The proposed taxonomy of logic models offers an improved understanding of the advantages and limitations of logic models across the spectrum from a priori to fully iterative approaches. Choice of logic model should be informed by scope of evidence synthesis, presence/absence of clearly defined population, intervention, comparison, outcome (PICO) elements, and feasibility considerations. Applications across distinct interventions and methodological approaches will deliver good practice case studies and offer further insights on the choice and implementation of logic modelling approaches.
Full text
Available for:
FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
To deal with complexity in cancer care, computerized clinical decision support systems (CDSSs) are developed to support quality of care and improve decision-making. We performed a systematic review ...to explore the value of CDSSs using automated clinical guidelines, Artificial Intelligence, datamining or statistical methods (higher level CDSSs) on the quality of care in oncology.
The search strategy combined synonyms for 'CDSS' and 'cancer.' Pubmed, Embase, The Cochrane Library, Institute of Electrical and Electronics Engineers, Association of Computing Machinery digital library and Web of Science were systematically searched from January 2000 to December 2019. Included studies evaluated the impact of higher level CDSSs on process outcomes, guideline adherence and clinical outcomes.
11,397 studies were selected for screening, after which 61 full-text articles were assessed for eligibility. Finally, nine studies were included in the final analysis with a total population size of 7985 patients. Types of cancer included breast cancer (63.1%), lung cancer (27.8%), prostate cancer (4.1%), colorectal cancer (3.1%) and other cancer types (1.9%). The included studies demonstrated significant improvements of higher level CDSSs on process outcomes and guideline adherence across diverse settings in oncology. No significant differences were reported for clinical outcomes.
Higher level CDSSs seem to improve process outcomes and guidelines adherence but not clinical outcomes. It should be noticed that the included studies primarily focused on breast and lung cancer. To further explore the impact of higher level CDSSs on quality of care, high-quality research is required.
Full text
Available for:
IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Oncological computerized clinical decision support systems (CCDSSs) to facilitate workflows of multidisciplinary team meetings (MDTMs) are currently being developed. To successfully implement these ...CCDSSs in MDTMs, this study aims to: (a) identify barriers and facilitators for implementation for the use case of lung cancer; and (b) provide actionable findings for an implementation strategy.
The Consolidated Framework for Implementation Science was used to create an interview protocol and to analyze the results. Semi-structured interviews were conducted among various health care professionals involved in MDTMs. The transcripts were analyzed using a thematic analysis following a deductive approach.
Twenty-six professionals participated in the interviews. The main facilitators for implementation of the CCDSS were considered to be easy access to well-structured patient data, and the resulting reduction of MDTM preparation time and of duration of MDTMs. Main barriers for adoption were seen in incomplete or non-trustworthy output generated by the system and insufficient adaptability of the system to local and contextual needs.
Using a CCDSS in lung cancer MDTMs was expected to increase efficiency of workflows. Successful implementation was seen as dependent on the reliability and adaptability of the CCDSS and involvement of key users in the implementation process.
PDF
