Participatory methods used in the evaluation of medical devices: a comparison of focus groups, interviews, and a survey.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Impact of time-to-treatment on survival for early-stage non-small cell lung cancer in The Netherlands-a nationwide observational cohort study.

Background: Varied outcomes on the relation between time-to-treatment and survival in early-stage non-small cell lung cancer (NSCLC) patients are reported. We examined this relation in a large multicentric retrospective cohort study and identified factors associated with extended time-to-treatment. Methods: We included 9,536 patients with clinical stage I-II NSCLC, diagnosed and treated in 2014-2019, from the Netherlands Cancer Registry that includes nation-wide data. Time-to-treatment was defined as the number of days between first outpatient visit for suspected lung cancer and start of treatment. The effect of extended time-to-treatment beyond the first quartile and survival was studied with Cox proportional hazard regression. Analyses were stratified for stage and type of therapy. Time-to-treatment was adjusted for multiple covariates including performance status and socioeconomic status. Factors associated with treatment delay were identified by multilevel logistic regression. Results: Median time-to-treatment was 47 days [interquartile range (IQR): 34-65] for stage I and 46 days (IQR: 34-62) for stage II. The first quartile extended to 33 days for both stages. Risk of death increased significantly with extended time-to-treatment for surgical treatment of clinical stage II patients [adjusted hazard ratio (aHR) >33 days: 1.36, 95% confidence intervals (CI): 1.09-1.70], but not in stage II patients treated with radiotherapy or in stage I patients. Causes of prolonged time-to-treatment were multifactorial including diagnostic tests, such as endoscopic ultrasound (EUS) or endobronchial ultrasound (EBUS). Conclusions: Clinical stage II patients benefit from fast initiation of surgical treatment. Surprisingly this appears to be accounted for by patients who are clinically stage II but pathologically stage I. Further study is needed on characterizing these patients and the significance of lymph node- or distant micrometastasis in guiding time-to-treatment and treatment strategy.

An Overview of Stakeholders, Methods, Topics, and Challenges in Participatory Approaches Used in the Development of Medical Devices: A Scoping Review.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Patient-preferred outcomes in patients with vestibular schwannoma: a qualitative content analysis of symptoms, side effects and their impact on health-related quality of life.

PURPOSE: During counseling and management of patients with vestibular schwannoma (VS), the emphasis is shifting from tumour control and nerve preservation towards maintaining or improving health-related quality of life (HRQoL). Understanding the patients' perspective and impact of VS is, therefore, of utmost importance. The current study aimed to identify treatment outcomes preferred by patients and to explore the patient-reported VS symptoms and management-related side effects and their impact on HRQoL. METHODS: Patients with VS were contacted through the Dutch VS association Stichting Hoormij and questioned using a semi-structured, cross-sectional online survey. Patients were asked to report and rank symptoms and side effects, with their impact on HRQoL and frequency of occurrence. Results were structured through qualitative content analysis. Coded symptoms, side effects, impacts, frequencies, and patient-preferred outcomes were analysed and summarized with descriptive statistics. RESULTS: Of the 231 respondents, 71% were actively treated. Hearing (symptoms vs. side effects: 78.8% vs. 63.6%), balance (62.3%; 48.8%), and energy issues (33.8%; 32.6%) were the most frequently mentioned symptoms and management-related side effects. Fatigue, deafness, headaches, and hearing loss had the highest impact on HRQoL. The majority of patients identified hearing preservation (61%), balance preservation (38.5%), and reduced tinnitus (34.6%) to be the patient-preferred outcomes. CONCLUSION: This qualitative study demonstrates that in this population many patients with VS encounter participation difficulties in their daily physical and social activities and value hearing and balance preservation, reduced tinnitus, and restored energy as preferred outcomes as they are hampered by symptoms and side effects related to hearing, balance, and energy. Healthcare professionals should consider these key points and use these and the patient-preferred outcomes in consultation, shared decision making, treatment, and follow-up to optimize patient-centred care.

Impact of time-to-treatment on survival for advanced non-small cell lung cancer patients in the Netherlands: a nationwide observational cohort study.

BACKGROUND: The assumption that more rapid treatment improves survival of advanced non-small cell lung cancer (NSCLC) has not yet been proven. We studied the relation between time-to-treatment and survival in advanced stage NSCLC patients in a large multicentric nationwide retrospective cohort. Additionally, we identified factors associated with delay. METHOD: We selected 10 306 patients, diagnosed and treated between 2014 and 2019 for clinical stage III and IV NSCLC, from the Netherlands Cancer Registry that includes nationwide data from 109 Dutch hospitals. Associations between survival and time-to-treatment were tested with Cox proportional hazard regression analyses. Time-to-treatment was adjusted for multiple covariates including diagnostic procedures and type of therapy. Factors associated with delay were identified by multilevel logistic regression. RESULTS: Risk of death significantly decreased with longer time-to-treatment for stage III patients receiving only radiotherapy (adjusted HR, aHR >21 days: 0.59 (95% CI 0.48 to 0.73)) or any type of systemic therapy (aHR >49 days: 0.72 (95% CI 0.56 to 0.91)) and stage IV patients receiving chemotherapy and/or immunotherapy (aHR >21 days: 0.81 (95% CI 0.73 to 0.88)). No significant association was found for stage III patients treated with chemoradiotherapy and stage IV patients treated with targeted therapy. More complex diagnostic procedures often delay treatment. CONCLUSION: Although in general it is important to start treatment as early as possible, our study finds no evidence that a more rapid start of treatment improves outcomes in advanced stage NSCLC patients. The benefit of urgent treatment is probably confounded by unmeasured patient and tumour characteristics and, clinical urgency dictating timelines of treatment. Time-to-treatment and its impact should be continuously evaluated as therapeutic strategies continue to evolve and improve.

Age-based treatment differences in and reluctance to treating older adults with systemic antipsoriatic therapy - a mixed-method pilot study.

BACKGROUND: Evidence-based guidance in older adults (≥65 years) with psoriasis is sparse and undertreatment might be present. OBJECTIVES: To assess prescribing patterns, comfort levels, barriers and needs of dermatologists when treating older adults with systemic antipsoriatic therapy. METHODS: A mixed-methods design was used including a survey among all Dutch dermatologists and residents, followed by semi-structured interviews. RESULTS: Most of the survey respondents applied systemic treatment to the same extent in older versus younger patients (n = 49; 67.1%) and weren't reluctant prescribing systemic therapy (n = 50; 68.5%) in older adults. However, 26% (n = 19) of the respondents treated older adults less often with systemic therapy compared to younger patients and 68.1% (n = 49) performed additional actions in older adults, e.g. intensified monitoring or dose reduction. Based on the survey and interviews (n = 10), the main reasons for these age-based treatment differences were comorbidity, comedication, and fear of adverse events. More evidence-based guidance, education, and time to assess older adults were identified as most important needs, especially regarding frailty screening. CONCLUSIONS: Age-based treatment differences in and reluctance to treating older adults with systemic antipsoriatic therapy were common. There is a need for more evidence-based guidance, education, and consultation time, to improve treatment in this growing population.

Methods for Early Assessment of the Societal Value of Health Technologies: A Scoping Review and Proposal for Classification.

OBJECTIVES: Early assessments of health technologies help to better align and integrate their development and assessment. Such assessments can take many forms and serve different purposes, hampering users in their selection of the most appropriate method for a specific goal. The aim of this scoping review was to structure the large set of methods according to their specific goal. METHODS: A scoping review was conducted using PubMed and reference lists of retrieved articles, to identify review studies with a methodological focus. From the included reviews, all individual methods were listed. Based on additional literature and examples, we extracted the specific goal of each method. All goals were clustered to derive a set of subclasses and methods were grouped into these subclasses. RESULTS: Of the 404 screened, 5 reviews were included, and 1 was added when searching reference lists. The reviews described 56 methods, of which 43 (77%) were included and classified as methods to (1) explore the nature and magnitude of the problem, (2) estimate the nature and magnitude of the expected (societal) value, (3) identify conditions for the potential value to materialize, and (4) help develop and design the type of research that is needed. CONCLUSIONS: The wide range of methods for exploring the societal value of health technologies at an early stage of development can be subdivided into a limited number of classes, distinguishing methods according to their specific objective. This facilitates selection of appropriate methods, depending on the specific needs and aims.

The Dutch Citizen Forum on Public Reimbursement of Healthcare: A Qualitative Analysis of Opinion Change.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Innovators' views on involving users and patients in surgical device development: a qualitative interview study.

OBJECTIVES: Involving 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. DESIGN: A qualitative study featuring semi-structured interviews with innovators of surgical devices. Interviews were recorded and a thematic analysis was performed on verbatim transcripts. PARTICIPANTS: 15 interviews were conducted with 19 innovators of 14 surgical devices. SETTING: Innovation practices of surgical devices in the Netherlands and Belgium. RESULTS: End-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. CONCLUSION: Innovators 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.

Barriers and Facilitators for Implementation of a Computerized Clinical Decision Support System in Lung Cancer Multidisciplinary Team Meetings-A Qualitative Assessment.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

On the integration of early health technology assessment in the innovation process: reflections from five stakeholders.

Early health technology assessment (HTA), which includes all methods used to inform industry and other stakeholders about the potential value of new medical products in development, including methods to quantify and manage uncertainty, has seen many applications in recent years. However, it is still unclear how such early value assessments can be integrated into the technology innovation process. This commentary contributes to the discussion on the purposes early HTA can serve. Similarities and differences in the perspectives of five stakeholders (i.e., the hospital, the patient, the assessor, the medical device industry, and the policy maker) on the purpose, value, and potential challenges of early HTA are described. All five stakeholders agreed that integrating early HTA in the innovation process has the possibility to shape and refine an innovation, and inform research and development decisions. The early assessment, using a variety of methodologies, can provide insights that are relevant for all stakeholders but several challenges, for example, feasibility and responsibility, need to be addressed before early HTA can become standard practice. For early evaluations to be successful, all relevant stakeholders including patients need to be involved. Also, nimble, flexible assessment methods are needed that fit the dynamics of medical technology. Best practices should be shared to optimize both the innovation process and the methods to perform an early value assessment.

ESUR/ESUI consensus statements on multi-parametric MRI for the detection of clinically significant prostate cancer: quality requirements for image acquisition, interpretation and radiologists' training.

OBJECTIVES: This study aims to define consensus-based criteria for acquiring and reporting prostate MRI and establishing prerequisites for image quality. METHODS: A total of 44 leading urologists and urogenital radiologists who are experts in prostate cancer imaging from the European Society of Urogenital Radiology (ESUR) and EAU Section of Urologic Imaging (ESUI) participated in a Delphi consensus process. Panellists completed two rounds of questionnaires with 55 items under three headings: image quality assessment, interpretation and reporting, and radiologists' experience plus training centres. Of 55 questions, 31 were rated for agreement on a 9-point scale, and 24 were multiple-choice or open. For agreement items, there was consensus agreement with an agreement ≥ 70% (score 7-9) and disagreement of ≤ 15% of the panellists. For the other questions, a consensus was considered with ≥ 50% of votes. RESULTS: Twenty-four out of 31 of agreement items and 11/16 of other questions reached consensus. Agreement statements were (1) reporting of image quality should be performed and implemented into clinical practice; (2) for interpretation performance, radiologists should use self-performance tests with histopathology feedback, compare their interpretation with expert-reading and use external performance assessments; and (3) radiologists must attend theoretical and hands-on courses before interpreting prostate MRI. Limitations are that the results are expert opinions and not based on systematic reviews or meta-analyses. There was no consensus on outcomes statements of prostate MRI assessment as quality marker. CONCLUSIONS: An ESUR and ESUI expert panel showed high agreement (74%) on issues improving prostate MRI quality. Checking and reporting of image quality are mandatory. Prostate radiologists should attend theoretical and hands-on courses, followed by supervised education, and must perform regular performance assessments. KEY POINTS: • Multi-parametric MRI in the diagnostic pathway of prostate cancer has a well-established upfront role in the recently updated European Association of Urology guideline and American Urological Association recommendations. • Suboptimal image acquisition and reporting at an individual level will result in clinicians losing confidence in the technique and returning to the (non-MRI) systematic biopsy pathway. Therefore, it is crucial to establish quality criteria for the acquisition and reporting of mpMRI. • To ensure high-quality prostate MRI, experts consider checking and reporting of image quality mandatory. Prostate radiologists must attend theoretical and hands-on courses, followed by supervised education, and must perform regular self- and external performance assessments.

Surgical removal versus retention for the management of asymptomatic disease-free impacted wisdom teeth.

BACKGROUND: Prophylactic removal of asymptomatic disease-free impacted wisdom teeth is the 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 performed 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 review originally published in 2005 and previously updated in 2012 and 2016. 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: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 10 May 2019), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2019, Issue 4), MEDLINE Ovid (1946 to 10 May 2019), and Embase Ovid (1980 to 10 May 2019). The US National Institutes of Health Trials Registry (ClinicalTrials.gov)and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. . SELECTION CRITERIA: We included randomised controlled trials (RCTs), with no restriction on length of follow-up, comparing removal (or absence) with retention (or presence) of asymptomatic disease-free impacted wisdom teeth in adolescents or adults. We also 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 and in duplicate conducted the risk of bias assessments. When information was unclear, we contacted the study authors for additional information. MAIN RESULTS: This review update includes the same two studies that were identified in our previous version of the review: one RCT with a parallel-group design, which was conducted in a dental hospital setting in the United Kingdom, and one prospective cohort study, which was 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-certainty 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 effects 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 aspect of the adjacent second molar during a follow-up period of three to over 25 years. Very low-certainty 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 any of 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 asymptomatic disease-free impacted wisdom teeth should be removed or retained. Although retention of 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 very low certainty. 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 current lack of available evidence, patient values should be considered and clinical expertise used to guide shared decision-making with people who have asymptomatic disease-free impacted wisdom teeth. If the decision is made to retain these teeth, clinical assessment at regular intervals to prevent undesirable outcomes is advisable.

The Effect of Higher Level Computerized Clinical Decision Support Systems on Oncology Care: A Systematic Review.

BACKGROUND: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Problems and Promises of Health Technologies: The Role of Early Health Economic Modeling.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Early Assessment of Proof-of-Problem to Guide Health Innovation.

BACKGROUND: Although the relevance of both push and pull factors is acknowledged in models of innovation, needs, broadly defined, are rarely considered, whereas supply-driven innovation in publicly funded health systems carries the risk that it may not match the underlying problems experienced by patients and consumers. OBJECTIVES: To explore a mixed-methods, multistakeholder approach that focuses on pertinent problems when assessing the potential value of an innovation as applied to a case of surgical innovation in meniscus surgery. METHODS: Through interviews of stakeholders (n = 11) we sought to identify current problems of meniscus surgery in the Netherlands. On the basis of the subsequent problem definitions, we used stakeholder and literature input to quantify the room for improvement and stakeholder engagement to uncover possible barriers and facilitators to the implementation of the proposed innovation. RESULTS: Despite being enthusiastic about the ingenuity of the proposed innovation and seeing some potential for cost saving, most stakeholders (n = 10) agreed that there are no major problems in current meniscus surgery meriting the innovation. They even discerned pragmatic barriers that would challenge the potential cost savings. CONCLUSIONS: By adopting a problem-oriented multistakeholder approach to early health technology assessment, we were able to estimate the potential value of an innovation in its social context, finding that, beyond the initial enthusiasm, the proposed innovation was unlikely to resolve the problems distinguished by the stakeholders. We concluded that our multistakeholder, mixed-methods approach to early health technology assessment is feasible and helps foster more demand-driven innovations.

Implementation of stepped care for patients with chronic fatigue syndrome in community-based mental health care: outcomes at post-treatment and long-term follow-up.

BACKGROUND: Cognitive behavioural therapy (CBT) is an evidence-based treatment for chronic fatigue syndrome (CFS). Stepped care for CFS, consisting of a minimal intervention followed by face-to-face CBT, was found efficacious when tested in a CFS specialist centre. Stepped care implemented in a community-based mental health centre (MHC) has not yet been evaluated. AIMS: (1) To test the effectiveness of stepped care for CFS implemented in a MHC at post-treatment and at long-term follow-up; and (2) compare post-treatment outcomes of implemented stepped care with treatment outcomes of a CFS specialist centre. METHOD: An uncontrolled study was used to test effectiveness of stepped care implemented in a MHC (n = 123). The outcomes of implemented care were compared with the outcomes of specialist care reported in previous studies (n = 583). Data on outcomes from implemented stepped care were gathered at post-treatment and at long-term follow-up. Mixed models were used as method of analysis. RESULTS: Fatigue decreased and physical functioning increased significantly following implemented stepped care (both p < .001). The follow-up was completed by 94 patients (78%) within 1-6 years after treatment. Treatment effects were sustained to follow-up. Patients in the MHC showed less improvement directly following stepped care compared with patients in a CFS specialist centre (p < .01). CONCLUSION: Implemented stepped care for CFS is effective with sustained treatment gains at long-term follow-up. There is room for improvement when compared with outcomes of a CFS specialist centre. Some suggestions are made on how to improve stepped care.

Optimal search strategies for identifying moderators and predictors of treatment effects in PubMed.

BACKGROUND: Treatment effects differ across patients. To guide selection of treatments for patients, it is essential to acknowledge these differences and identify moderators or predictors. Our aim was to generate optimal search strategies (commonly known as filters) for PubMed to retrieve papers identifying moderators and predictors of treatment effects. METHODS: Six journals were hand-searched for articles on moderators or predictors. Selected articles were randomly allocated to a development and validation set. Search terms were extracted from the development set and tested for their performance. Search filters were created from combinations of these terms and tested in the validation set. RESULTS: Of 4407 articles, 198 were considered to be relevant. The most sensitive filter in the development set '("Epidemiologic Methods" [MeSH] OR assign* OR control*[tiab] OR trial*[tiab]) AND therapy*[sh]' yielded in the validation set a sensitivity of 89% [88%-90%] and a specificity of 80% [79%-82%]. CONCLUSIONS: The search filters created in this study can help to efficiently retrieve evidence on moderators and predictors of treatment effect. Testing of the filters in multiple domains should reveal robustness across disciplines. These filters can facilitate the retrieval of evidence on moderators and predictors of treatment effects, helping the implementation of stratified or personalised health care.