Available data in the scientific literature is not always sufficient to make a clear Health Technology Assessment (HTA) recommendation without any other source of data. Contextual data and local expertize are an important source of data that cannot be ignored in HTA process. Despite a lack of evidence in the scientific literature, a technology can be recommended in a given context. We illustrate this by a case study about biplane angiography for vascular neurointervention.

A systematic review was conducted. The level of evidence was assessed by the grid of Downs and Black. An analysis of the context in our setting was also conducted. The main outcomes were: radiation doses, clinical complications, procedure times, purchase cost, impact on teaching programs, confidence of clinicians in the technology, quality of care, and volume of activity. A committee constituted of managers, clinical experts, physicians, physicists and HTA experts was created to produce a recommendation about biplane technology acquisition.

A list of 257 citations was obtained yielding 9 eligible articles for analysis. Despite the lack of evidence found in the literature (median of Downs and Black: 3/32), the biplane system appears to reduce ionizing radiation and medical complications as well as shorten procedure time. Contextual data indicated that biplane system could improve operator's confidence, which could translate into reduced risk, especially for complex procedures. We estimate that a minimum of 50 cases can be done in our context (University hospital center covering a population of 306,322 people) with a higher level of patient safety. In addition, the biplane system can support our institution in advanced procedures teaching program.

Given on the advantages provided by the biplane technology in our setting, the committee has recommended its acquisition. However, this technology should be implemented with a responsibility in collecting outcome data to optimize clinical protocol in doses of ionizing delivered.

Health Technology Assessment (HTA) methods are usually applied to the evaluation of drugs, devices, and procedures. We have used HTA to promote evidence-based decision-making on topics relating to staffing and career development for healthcare professionals. Interventions to reduce the stress associated with caring for patients who need repeated hospitalization such as patients with sickle cell disease are thought to improve job satisfaction and nurse retention, but is there scientific evidence to support them?

We systematically searched Medline, CINAHL, PsycINFO, Cochrane, and Joanna Briggs Institute databases for published studies evaluating interventions targeting healthcare personnel. Searches combined tems for sickle cell disease with terms for job stress, turnover, and other career-related outcomes. We evaluated the quality of individual studies using standardized checklists and constructed evidence tables.

We found one randomized trial (RCT) of an education program for nurses and physicians, a pre-post analysis of a communication skills and cultural awareness program, and a case study of a nurse support group. The RCT found that an education program significantly improved participants attitude towards patients but did not measure any outcomes relating to caregiver stress or job satisfaction. The pre-post study found that a communication skills program significantly improved nurses confidence in their ability to communicate with patients. The case study reported that nurses found the support group useful and felt their attitudes were improved, but there was no control group to compare their responses to. The education program was graded as moderate-strength evidence and the other programs had low-strength evidence. There was no meta-analysis or other data synthesis of the results because of the differing interventions and outcome measures.

There have been few quantitative scientific evaluations of the effectiveness of interventions to reduce the stress nurses feel when caring for sickle cell disease patient. The studies that have been published have favorable conclusions towards these interventions, but the strength of evidence is not high.

Information specialists and others searching for Health Technology Assessments (HTAs) can use the ISSG Search Filter resource (SFR) to identify filters to incorporate into search strategies. This can save time and effort when designing searches and create more efficient searches that retrieve fewer and possibly more relevant database records (link available here: https://sites.google.com/a/york.ac.uk/issg-search-filters-resource/home).

What are search filters? Search filters are collections of search terms designed to retrieve selections of records from bibliographic databases. Some filters are designed to retrieve records of specific study designs such as randomized controlled trials (RCTs) or systematic reviews; others aim to retrieve records relating to other features or topics such as the age or gender of study participants.

Search filters may be designed to be sensitive, precise or balanced between sensitivity and precision.

When would you use a search filter in HTA? Search filters can be added to search strategies to limit to specific study types, for example, RCTs, mixed methods studies, systematic reviews. They can also be used when searching for other aspects of HTA such as patient views or specific age groups.

The ISSG SFR includes sections listing search filters to help identify adverse effects, aetiology, economic evaluations, health state utility values, public views, and quality of life.

How are filters used? A search filter is often used in combination with a topic search to restrict the search results to a specific type of record, for example, records reporting health state utility values or records of randomized controlled trials.

Further guidance on the use of search filters can be found in the SuRe Info Search Filters chapter.

In contrast to bibliographic databases, trial registries do not offer the option of formulating complex search queries, thus making targeted searches more difficult. However, ClinicalTrials.gov (CT.gov) and the International Clinical Trials Registry Platform (ICTRP) offer different search features that may help compensate this limitation. Our aim was to determine the importance of search features (for example, searches using synonyms or, additionally in CT.gov, automatic inclusion of further search fields) for trial registry searches.

We conducted a project called “Trial registry searches for studies of newly approved drugs” (1). One analysis investigated the question as to whether searches for different health conditions and interventions (new drugs) directly identified registry entries with the search terms entered or whether certain search features were responsible for this. We searched CT.gov and ICTRP for different conditions and interventions using the advanced search interface. For each search, we documented the synonyms listed in the two registries. We imported the registry entries into EndNote and evaluated whether the search terms used were available in the corresponding search fields (condition; intervention).

For CT.gov, 96 registry entries on 18 interventions and 190 entries on 12 conditions were analysed. Of these, twenty-three (24 percent) entries for interventions and thirty-eight (20 percent) for conditions were identified by search features, not by search terms. For ICTRP, 32 entries on 10 interventions and 100 entries on 9 conditions were analysed. Of these, five (16 percent) entries for interventions and eight (8 percent) for conditions were identified by search features.

Trial registry search features have an important impact on the sensitivity of searches. Many studies are not identified by the search terms entered, but by searches using synonyms and, additionally in CT.gov, by automatic inclusion of further search fields. Moreover, search features in CT.gov are more effective than in ICTRP – even though the same search terms are used, they consistently yield higher sensitivities.

With increasing resource pressures on health systems, rapid developments in innovative technologies and limited numbers of skilled assessors, there is a need to establish sustainable methods to provide advice on healthcare technologies for decision makers. The European Network for Health Technology Assessment (EUnetHTA) has been testing an approach of collaborative production of rapid Health Technology Assessments (HTAs) and adaptation of these locally. The Scottish Health Technologies Group (SHTG) participated in two collaborative and adaptation projects to test whether this could save time and resource, whilst providing a product as robust and relevant as if developed locally. Concurrently the Scottish Intercollegiate Guidelines Network (SIGN) has been exploring ways to develop clinical guidelines more efficiently, including the use of rapid HTAs to inform recommendations.

Having established the relevance of the topics to NHS Scotland, SHTG participated as peer reviewers for EUnetHTA reviews on mitral valve repair and mechanical thrombectomy. On completion, SHTG summarized their content to fit with the well-accepted rapid review report format used in Scotland. Content was supplemented with a review of economic evidence, currently not included in the European reports, local epidemiological information and recently published studies. The thrombectomy report and associated Advice Statement were used by a small expert group to update a SIGN clinical guideline recommendation.

Providing advice through adaptation proved feasible and acceptable to stakeholders. Limited time was saved because of the supplementary work undertaken, and lessons have been learned about what should and should not be done in future .The guideline recommendation was updated and made available more quickly than similar previous updates.

Further such collaborations and adaptations will be pursued as this appears to be a sustainable approach for the future. The process could be aided by EUnetHTA publishing forward work plans and also by the inclusion of economic information, with details of the decision-making context provided, to allow assessment of its relevance locally.

Registration of trial protocols has become increasingly important in recent years. In the context of systematic reviews, published trial protocols facilitate the identification of studies. Data recorded in trials registers requires standardization to assist with ease of identification, and availability of the most current protocol version. Searching sources of trial protocols, for example trials registers, has issues relating to currency, coverage, functionality and indexing. An empirical study was conducted in the context of a funded systematic review, to establish; the proportion of trial protocols retrievable, the most effective retrieval methods, barriers to retrieving protocols, and whether the most easily retrieved protocol copy remains the document of record.

In a systematic review of primary care interventions for medically unexplained symptoms, seventy-four trials were identified as potential included studies. To search for the seventy-four trial protocols, multiple sources and methods were utilized to identify the the differential coverage of sources and the relative efficiency of retrieval methods. Retrieval methods included searching trials registers and bibliographic databases, internet searching, checking journal websites and contacting authors.

Results included; (i) number of trial protocols that were referenced in the corresponding study publication(s), (ii) percentage of protocols indexed in each checked source, including MEDLINE and various trials registers, (iii) number of authors that responded to email contact, (iv) number of authors that provided a reference to, or copy of, the protocol. Information on when the trial protocol was published, funding sources, and trial registration, was also recorded.

Conclusions are made regarding the coverage of different sources of trial protocols. This will enable Information Specialists to prioritize retrieval methods for identifying trial protocols to inform future search methods guidance. The main barriers to retrieving protocols are discussed together with recommendations for future empirical studies.

A high-level, rapid review (1) was conducted on oxygen therapy issues studied in the past 10 years in acute care settings. The main objective was to determine the appropriateness/inappropriateness of use, safety issues, and quality of care associated with oxygen prescription, administration, and monitoring. The results from this review were used to inform an upcoming provincial oxygen summit.

The Health Technology Assessment review (1) used a standardized rapid review approach: a comprehensive search of literature (published in English from 2005 to 2016), study selection using a priori developed criteria, and a qualitative synthesis of the results. Iterative interactions with the requester were necessary to clarify and refine the research questions, scope, and inclusion criteria.

Twenty-four audit studies were reviewed, the majority published after 2011, in the United Kingdom, and also in single institutions. Twelve studies reported effects after implementing interventions for improvement of oxygen prescription. Many studies had caveats on design, data reporting, and outcomes, or they lacked an explanation of the methods of analysis. Studies conducted in rural settings, and on infants and children were unavailable. The reported issues with oxygen therapy included: a lack or an inconsistency of compliance with guidelines, local policies, and standards; inappropriate prescription and administration; variability in practice among healthcare providers; and suboptimal monitoring, including poor standards of medical chart documentation for patients receiving oxygen therapy, such as incomplete details on flow rate and oxygen concentration.

Possibly due to the general tendency to publish research findings that have statistically significant results, relatively few publications were found in the literature search. The universal use of oxygen therapy and the enrolment of consecutive patients in some of the studies increase the applicability of the findings to other institutions. The rapid review provided a timely synthesis of the available, credible research for use by local stakeholders for further discussions and planning.

Thorough documentation and clear reporting are essential when conducting a comprehensive literature search for a health technology assessment (HTA) or systematic review. The ultimate goal of this process is transparency and reproducibility with the added benefit of increasing the reader's confidence in the research. Thorough documentation of the search also allows for critical appraisal of the methodology used and facilitates future updating of a review (1,2).

It has been found that large numbers of systematic review searches are inadequately documented and there is little consensus on best practices for reporting standards (3).

As part of the SuRe Info Project, we conducted a review of all current reporting standards relevant to HTAs and systematic reviews in addition to looking at the published literature on this topic in order to synthesize the evidence in this area and create a standard set of agreed upon recommendations.

We conducted a comprehensive search of Medline, Embase, and LISA (Library & Info Studies Abstracts) databases. We also examined the Equator Network (http://www.equator-network.org/) website. Reference lists of included studies and reporting guidelines were also consulted. Eleven reporting guidelines and eight studies were included in the review by two independent reviewers. Anything published before 2006, that was not a research article (other than the guidelines), and/or that did not provide new recommendations (that is, a review of another set of recommendations) was excluded.

After collecting data on the suggested reporting elements described in the literature, we pooled our results to create an overarching list of the most commonly recommended elements to describe and the most commonly recommended methods to use when documenting a comprehensive search. Not only did these elements pertain to documenting the search strategy for the final report, but they also pertained to the protocol and the abstract of a review.

It is hoped that this overview of the literature and compilation of the evidence will clarify some of the confusion that seems to exist when documenting and reporting searches and perhaps it will even help to reduce the existence of poorly described strategies in the research literature.

In both health care and social services it is important to continuously summarize and analyze existing research in the form of systematic reviews. At the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) (www.SBU.se) we collect the evidence gaps identified by systematic reviews in a database. These evidence gaps are methods used in health care/social services for which there is not enough good quality research available. By analyzing this database we can highlight populations or methods where evidence gaps are more frequent. This knowledge can be used to find areas that might need assistance in developing research structure and also when arranging research prioritization processes involving patients, consumers and clinicians.

Systematic reviews and evidence maps (methodical collections of systematic reviews) are used by SBU to identify evidence gaps. SBU has adapted the James Lindh alliance approach to give patients, consumers, relatives and clinicians the opportunity to give their view of what research they find most important to execute. SBU also collaborates with governmental research funders to communicate the content of the SBU database.

A prioritizing process regarding evidence gaps within Attention Deficit Hyperactivity Disorder (ADHD)-treatment has been finalized (1). This was accomplished by people with ADHD and caretakers, as well as clinicians and staff. Another prioritization process on the topic of treatments for injuries after vaginal birth is ongoing. In November 2016 the Swedish government presented the research policy bill where they, based on analyses of the SBU database, pointed out areas of specific importance in future research.

It is of great importance that evidence gaps get addressed and that new research is promoted in order to fill these gaps. In areas where there are numerous gaps, prioritizations involving different stakeholders is needed. Considering areas with large amounts of evidence gaps the primary focus might be on building infrastructure surrounding research before research calls can be directed towards these areas.

There are different devices, systems and technologies for people with disabilities. It's necessary to provide information on the effectiveness of products in the market and competitiveness in terms of price-quality, and providing an endorsement in the acquisition of technologies that improve their quality of life. The use of eye tracking devices is growing and its implementation in different areas has attracted the attention of several developers. Therefore the need to generate a product that evaluates the functionality of such devices is necessary in order to avoid unnecessary expenses when acquiring or repairing one of these devices.

An interface was created with different functionalities such as the location of the coordinates in which the pointer is located, standardized graphic interface design to provide statistical data that allow an objective result for its subsequent analysis and an endless number of design possibilities.

The tests performed were of accuracy and precision where the subject was asked to follow the instructions given and observe a sequence of points, especially the points located at the ends of the monitor as these are the critical points in which there is less coincidence between the cursor and the gaze.

The results obtained provided information on the performance of the tracking device. In this way it was possible to establish that the accuracy of the ocular tracker: it was ± 12.83 pixels on the horizontal axis and ± 10.66 pixels on the vertical axis. The precision was ± 9.8 pixels on the horizontal axis and ± 14.23 pixels on the vertical axis.

This shows the use phenomenon caused due to the limited mobility of the eyes in the vertical axis in comparison to the horizontal mobility. The precision data obtained indicate that, because the movement on the vertical axis is smaller, there is a less continuous spectrum of positions on the axis, which translates to less precision.

The data obtained can be used to compare with the results of the test with other eye tracking devices and thus this could serve as a tool to select an eye tracking device according to the user's need and his economical capabilities.

Increasingly, ambulance services offer alternatives to transfer to the emergency department (ED), when this is better for patients. The introduction of electronic health records (EHR) in ambulance services is encouraged by national policy across the United Kingdom (UK) but roll-out has been variable and complex.

Electronic Records in Ambulances (ERA) is a two-year study which aims to investigate and describe the opportunities and challenges of implementing EHR and associated technology in ambulances to support a safe and effective shift to out of hospital care, including the implications for workforce in terms of training, role and clinical decision-making skills.

Our study includes a scoping review of relevant issues and a baseline assessment of progress in all UK ambulance services in implementing EHR. These will inform four in-depth case studies of services at different stages of implementation, assessing current usage, and examining context.

The scoping review identified themes including: there are many perceived potential benefits of EHR, such as improved safety and remote diagnostics, but as yet little evidence of them; technical challenges to implementation may inhibit uptake and lead to increased workload in the short term; staff implementing EHR may do so selectively or devise workarounds; and EHR may be perceived as a tool of staff surveillance.

Our scoping review identified some complex issues around the implementation of EHR and the relevant challenges, opportunities and workforce implications. These will help to inform our fieldwork and subsequent data analysis in the case study sites, to begin early in 2017. Lessons learned from the experience of implementing EHR so far should inform future development of information technology in ambulance services, and help service providers to understand how best to maximize the opportunities offered by EHR to redesign care.

Hyperhidrosis is characterized by uncontrollable excessive sweating, which occurs at rest, regardless of temperature. As part of a wider study exploring the clinical and cost effectiveness of alternative treatments for primary hyperhidrosis, a survey of United Kingdom (UK) dermatologists was conducted to gain a better understanding of current clinical practice in the area and inform economic model inputs.

The survey was conducted by means of an online survey tool, “Qualtrics”. It was circulated to members of the British Association of Dermatologists. Topics covered included treatments typically administered, medication dosages prescribed, effectiveness of treatments, adverse events related to treatments and resource use associated with individual treatments.

Forty-five respondents from forty-two different dermatology units completed the survey. The majority of clinicians (83 percent) prescribed more than one medication - most commonly oxybutynin and propantheline bromide. The next most commonly reported treatments were: iontophoresis, botulinum toxin and curettage.

Respondents were asked to indicate dosage, frequency and details about follow-up visits related to medication use. Doses prescribed were largely consistent with British National Formulary (BNF) recommendations. For other treatments, dermatologists were asked to indicate duration of the procedure, job title of the treatment provider and details about monitoring visits. Results were similar to the findings from the literature and previously conducted interviews with clinicians.

Respondents were asked to indicate the dropout rates for each type of treatment due to lack of effectiveness and adverse events. Dropout rates were relatively high for both reasons.

The results highlight the wide range of treatments for hyperhidrosis currently administered by dermatologists across the UK, and the variation in current clinical practice. This variation highlights the lack of evidence-based guidance underpinning practice and the importance of clinical surveys as a complement to usual data collection methods.

Along with the exponential growth of technology, the use of mobile devices in health, or mHealth, has been quickly becoming a viable practice to strengthen health systems, especially in low-resource settings. Nevertheless, the majority of mHealth interventions are pilot efforts which mostly lack robust design and evidence about the use of mHealth in public health. This study assessed the use of a bi-directional Short Message Service (SMS) in disease surveillance in Vietnam and aimed to bring evidence in improving engagement of health staff as well as the quality of reporting.

Eighty health staff from fourty communes of Hoa Binh and Hung Yen provinces were trained and participated in two 6-month pilots: one with one-way, and one with a bi-directional SMS system for assisting in error screening, and reminder and feedback provision to report two diseases: influenza and diarrhea using cell phones. After each examination and checking-in onto the paper logbook, participants reported the case by texting an SMS to a designated number and made notes of successfully reported cases. A central data repository server was set up to collect SMS reports, and aggregate reported patient data. Engagement of health staff and quality of the reporting work were assessed by the evaluation of the qualitative questionnaires, and the comparison of the texted SMS reports to the patient logbooks.

With the use of a two-way versus one-way SMS system, participants were 4.6 times more likely (95 percent Confidence Interval, CI 3.93-5.44, p< .001) to send correctly formatted text reports, and 3.4 times more likely (95 percent CI 2.72-4.33, p< .001) to have precise information in their texted messages. Results also revealed that while their position, age, or gender of participants did not statistically influence the results, ethnicity and management roles did.

The study showed that the use of a bi-directional SMS-based reporting system both significantly improved participants engagement in the reporting protocol, and greatly enhanced their reporting quality. The study demonstrated that robust evidence of a practical utilization of SMS in a disease reporting system to replace the traditional paper-based one has great potential for a scale-up and national-wide implementation.

In Brazil, the National Committee for Health Technology Incorporation in the public health system (CONITEC) advises the Ministry of Health about incorporation, exclusion and alteration of health technologies in Brazilian public health system (SUS). Decision making considers multiple criteria, included or not in legislation. This analysis was the first step for a multiple-criteria decision analysis (MCDA) building. This study aims to identify criteria that influence Health Technology Assessment (HTA) for SUS.

Five real cases of controversial recommendations of technology incorporation made by CONITEC were reviewed by listening to the plenary recordings and reviewing committee minutes. The choice was guided by convenience, with prioritization according to CONITEC's members, using a pre-defined standardized form. Weight in decision making was also raised and identified. Selected technologies judgments were: Trastuzumab for metastatic/advanced Breast Cancer; Fingolimod for Multiple Sclerosis; Clozapine, Lamotrigine, Olanzapine, Quetiapine and Risperidone for Bipolar Affective Disorder; Hematopoietic stem cell transplantation for Sickle Cell Disease; and Positron Emission Computed Tomography (PET-CT) for Lung Cancer and for hepatic metastasis from Colorectal Cancer.

The choice of different technologies allowed verifying specific criteria used for the incorporation of each type of technology, as well as the similar criteria discussed and used by all these technology types. In addition, some identified criteria were specific to the Brazilian reality, such as: “Incorporation by other countries”, “Potential technologies without registration in Brazil” and “Off-label use”. These criteria were not previously identified in studies conducted in other countries. Some criteria have been identified in all decisions, such as: efficacy, disease severity, quality and confidence in the evidences, logistic challenges for implementation, unmet needs, budget impact and treatment costs. Relative impact of cost-effectiveness was considered low.

CONITEC's recordings are an important source to understand the Brazilian decision-making process. To identify the important criteria can help to standardize and improve the HTA process.

Historically, many Health Technology Assessment (HTA) bodies were developed with a focus on addressing rapidly rising drug costs and the unique need to evaluate each drug as a de novo entity. The degree to which the unique needs for evaluating technologies vis a vis drugs are reflected in distinct HTA methods and activity is to date understudied.

We examined HTA's reviews of two technologies: WATCHMAN™, a device to reduce the risk of stroke in certain patients and Alair™, a procedure-based treatment for severe asthma. Both technologies have been extensively reviewed by HTA bodies and payers in many countries. These HTA reviews are compared to a convenience sample of these HTA's bodies reviews of drugs and qualitative differentiators between these two categories explored.

The differences and similarities (for example, in rigor and necessity of evidence) between US Section 510(k) clearances, US premarket approval (PMA), and US new drug application (NDA) regulatory pathways have not been clearly understood by HTA or reflected in their methodologies employed. Additionally, emergent methodologies such as Bayesian statistical analyses may encounter challenges within technologies reviews. HTA bodies may not be cognizant of development timelines or the timelines of comparators. Finally, HTA bodies may overestimate device adoption rates.

The differences in evidence requirements for regulatory approval between US 510(k), US PMA, and US NDA pathways have not been reflected in different methodological approaches within HTA bodies reviews. Opportunities and novel methods are needed for HTA bodies to derive imputed comparisons between technologies that may have inherently incongruent timelines. Finally, HTA bodies could benefit from methods to more accurately estimate projected adoption curves. Challenges exist using frameworks, paradigms, and methodologies initially established for, and commonly used for, pharmaceuticals on device evaluations; leaders of HTA methods can improve the situation by providing guidance and recommendations for more appropriate HTA methods to evaluate devices.