Dimension 1

The guiding principles for good practices are grouped into 4 dimensions.
In this section you will find all the guiding principles associated to one of
the dimensions. Under each guiding principle you can find the available TOOLS and
read the PROPOSED SOLUTIONS TO POTENTIAL PROBLEMS.

Dimension 1

The assessment process

Excellent HB-HTA units design, manage, carry out, review and improve the assessment process to generate valuable, tailored information for hospital decision-makers. The assessment report should be relevant and reliable, carried out in an unbiased and transparent manner with involvement of stakeholders. Assessment results and recommendations should be properly communicated to hospital stakeholders.

Guiding principle 1

HB-HTA report: scope, hospital context and informational needs

The HB-HTA report clearly states its goal and scope, reflects the hospital context and takes into account the informational needs of hospital decision-makers.



TOOLS

TOOL 2: Official (submission) form requesting an HB-HTA assessment
TOOL 3: Example of scoping of an HB-HTA report (PICO, TICO questions)
TOOL 4: AdHopHTA mini-HTA template
SHOW PROPOSED SOLUTIONS TO POTENTIAL PROBLEMS
Description of potential problems Proposed solutions
1.1 The goal and scope of the HB-HTA report are unclear or represent a point of contention. Define the TICO (Technology, Intervention, Comparison, Outcome) question and be specific with regard to inclusion and exclusion criteria. Make sure that everybody understands and agrees on what is going to be assessed.
Make a formal contract with stakeholders of the HB-HTA process including a detailed time plan and a description of what should be done if the time plan is not met. An informal agreement could also help, but make sure that all the team involved understands the process of assessment and what will happen if commitment from people is weak.
1.2 The new HT is not well defined. The intervention is adapted to the specific needs of the patient, and thus the content of the intervention will vary from patient to patient. Initially, align expectations of project stakeholders.
Clearly define inclusion and exclusion criteria and do not start the assessment process before the TICO (Technology, Intervention, Comparison, Outcome) question is clearly defined and agreed with stakeholders.
1.3 It is difficult to identify a comparator for the assessed HT, e.g. in the case of medical devices which do not have any alternative. Discuss with the applicant clinician in order to identify the closest comparator. Remember that “no treatment” is also a comparator.
1.4 The new technology seems too different from the comparator to be directly comparable (e.g. prostate cancer radical surgery vs. radioactive seed implantation therapy).
  • Use cost-utility analysis to increase comparability of efficiency.
  • Look for natural effectiveness measures that could be applied to both systems.
1.5 The information necessary for doing the assessment is not available in the hospital. Very few hospitals have proper clinical databases to be used for the assessment. Information published in the literature, especially that from healthcare contexts with similar characteristics, can be useful.
Economic information could also be difficult to obtain, especially if micro-costing is considered. In this case, aggregated costs or approximate costs available from the finance department can be used. Costs from other similar hospitals in the country may be also helpful (e.g. DRG from the MoH for similar hospitals).
1.6 The HT requested is also planned in a neighbouring hospital and this leads to overlap of activities. Contact the other hospital (or the regional healthcare system) to explore whether a joint assessment can be done and a shared use of the HT is possible.

Guiding principle 2

HB-HTA report: methods, tools and transferability

The HB-HTA report is performed systematically using good practice methods and appropriate tools. It should be done in a way that can be adapted by other hospitals (transferability).



TOOLS

TOOL 4: AdHopHTA mini-HTA template
TOOL 5: Examples of HB-HTA reports
TOOL 6: AdHopHTA checklist for good-quality HB-HTA reports
TOOL 7: Types of recommendations in HB-HTA reports
TOOL 8: Links to relevant methodological guidance and databases
TOOL 9: List of calculators to be used in the assessment process
TOOL 10: Websites of hospitals with an HTA unit or activity and other HB-HTA doers
SHOW PROPOSED SOLUTIONS TO POTENTIAL PROBLEMS
Using appropriate methods and tools

Description of potential problems

Proposed solutions

2.1

Involvement of hospital staff who are not familiar with HB-HTA (e.g. economists working for the financial and administrative department) generates confusion in the understanding of concepts. Therefore it is difficult to obtain the right data from the hospital staff not familiar with HB-HTA.

Involve hospital staff in the whole process of HB-HTA. Explain what data you need and make sure that it is understandable for hospital staff not familiar with HB-HTA.

2.2

The HB-HTA report fails to find any studies or evidence in the scientific literature, because the technology is too new to be studied thoroughly and published in peer-review journals.

Look for grey literature and congress abstracts. Ask for real-life experience and expert opinion from hospitals already using the technology. Look at databases of clinical trials (e.g. https://www.clinicaltrial.gov/) to identify hospitals researching the technology and contact them.

2.3

Medical literature does not provide clinical information and cost drivers of the new HT (e.g. length of stay in each ward, operating time).

Try to contact different specialists in your hospital who may provide the information from their clinical experience.

If the HT has not been used in your hospital before, try to contact other hospitals in your region or country already using the HT to obtain this information.

2.4

Information on strategic aspects (one of the relevant domains of an HB-HTA report) is not readily available.

Ask clinicians, hospital economists and hospital managers about strategic aspects related to the introduction of the new HT in your hospital. Ask clinicians what impact the HT could have in other departments of the hospital. If the HT could affect other departments, ask them about the potential impact.

Ask clinicians or hospital managers if any other hospital in your region/country has already introduced the HT. Approach the manufacturer of the HT, who may inform you about the diffusion of the HT in your region or country.

2.5

The literature search and publication selection, when it is done by the applicant clinician, does not provide sufficient details to be confident that no selection bias has occurred.

Establish standards for literature search and description of the search results or use existing international standards.

2.6

The applicant clinician might not be comfortable with systematically synthesising and reporting the evidence basis (in those cases where the clinician performs the systematic review).

Be in close contact with the clinician in order to make sure he/she is guided towards good practice methods. Guidance, supervision and training might be required.

2.7

The applicant clinician tends to overestimate (or underestimate) the number of patients eligible for the new HT or some of the resource consumption variables (e.g. length of stay).

  • Ask applicant clinicians to select patients who would have been eligible for the new technology in the last years and count them.
  • Ask the hospital management for figures on discharges for the clinical condition from the last few years; search hospital databases (if available) for information on resource consumption.
HB-HTA report transferability
Description of potential problems Proposed solutions

2.8

HB-HTA reports are not always of good quality (e.g. the literature search is not done in a systematic way, the quality of the evidence is not assessed, economic methods or assumptions are not clearly described) which compromises the transferability of the HB-HTA reports to other settings.

  • Explicitly explain every step of the HT assessment process.
  • Use various quality checklists that have been produced (e.g. AdHopHTA quality checklist) to assure good quality of HB-HTA reports.
  • Address the limitations of the HB-HTA report.

2.9

Developing an HB-HTA report based on an external HTA report made by industry raises concerns about its objectivity.

Try to identify potential sources of biases in the industry’s report.

Address biases in the discussion section of your HB-HTA report or try to solve these biases.

2.10

It is unclear how to develop an HB-HTA report based on an external report that has a different perspective that misses clear the description of methods used or the sources of the data collected.

Contact the author of the external report and ask for more information.

Identify which elements in the external report are transferable to your setting and which you have to do on your own (e.g. follow the EUnetHTA HTA Adaptation Toolkit).

2.11

When trying to adapt information from a different HB-HTA report, it is difficult to separate what is generic and what is local information.

Use a reporting template for HB-HTA, such as the AdHopHTA mini-HTA template where information is presented in a structured way.

Proper use of references when writing an HB-HTA report helps other hospitals that would be interested in adapting the information. Local information could be referenced as “data from our hospital”.

Guiding principle 3

HB-HTA process: independent, unbiased and transparent with stakeholder involvement and communication

The HB-HTA process involves all relevant stakeholders. It is conducted in an unbiased and transparent manner, ensuring independence and it is properly communicated to hospital stakeholders.



TOOLS

TOOL 11: Communication materials to engage key hospital stakeholders
TOOL 12: List of all relevant stakeholders to ideally involve into the assessment process
TOOL 6: AdHopHTA checklist for good-quality HB-HTA reports
TOOL 13: Examples of conflict-of-interest statements
TOOL 14: Summary of tools and means to facilitate key stakeholders’ understanding of the results of HB-HTA reports and facilitate decision-making (examples)
SHOW PROPOSED SOLUTIONS TO POTENTIAL PROBLEMS
Involvement of relevant stakeholders

Description of potential problems

Proposed solutions

3.1

Key people at the hospital (clinicians, hospital manager, CEO, CMO) are not familiar with HB-HTA (e.g. they think that it is just an economic evaluation or consider it a tool to impede the adoption of innovations).

At the beginning of each HB-HTA process, schedule a meeting with key people at the hospital to explain to them:

  • How the interaction with them during the assessment process will work (e.g. number of meetings, content of the meetings, etc).
  • What an HB-HTA report is.
  • What the different parts of an HB-HTA report are (highlighting the importance of the clinical, economic and organisational parts of the assessment).
  • What the TICO (Technology, Intervention, Comparison, Outcome) question is and how to use it. Always define the TICO question with the clinicians. Ask them what outcomes are clinically relevant to compare the new HT with standard care. Other outcomes may as well be relevant and should be asked to appropriate hospital professionals (e.g. finance, management, etc.).
  • What clinical evidence is and how to critically appraise it.

It is very important to involve all the relevant clinicians in the HB-HTA process and explain to them that there is an important part in the HB-HTA report devoted to the clinical performance (effectiveness and safety) of the new HT. Additionally, it is important to involve other hospital professionals involved with the decision (e.g. manager, person in charge of planning or buying the technology etc.) in the assessment.

3.2

Key stakeholders in the hospital are not eager to collaborate with the HB-HTA unit.

  • From scratch, involve key stakeholders as much as possible in the different activities you perform in your HB-HTA unit.
  • Invite them to be authors of HB-HTA reports or acknowledge them as co-authors (even though their contribution may be small), so that they feel involved in the process.
  • Inform stakeholders that the HB-HTA report will be circulated among key people in the hospital (CEO/CMO/leading clinicians) which will improve the prestige of contributors.
  • Every time you produce an HB-HTA report, share it with key stakeholders (clinicians, hospital manager) asking for comments and a review.
  • Include their name in any dissemination action you carry out (e.g. scientific publication, presentations, etc.)

3.3

Relevant stakeholders identified to be involved in the HB-HTA process have conflicts with each other and this makes management of the process difficult.

Be clear at the initial stage about the process and inputs expected from each stakeholder. Keep discussions scientific.

3.4

Applicant clinicians consider themselves to be the “only” experts able to assess the new HT.

  • Let the HB-HTA report undergo peer-review by an “external” expert.
  • Ask the applicant clinician to review it too, on the basis of a criteria checklist (all relevant aspects considered, all clinical studies considered etc.).
  • Involve the clinician in the assessment process, keep him/her informed and share the process and results in a transparent way.

3.5

Despite of an attempt to identify all relevant stakeholders and involve them in the HB-HTA process, important key stakeholders are overlooked.

Call a meeting of your HB-HTA unit’s team and think of relevant stakeholders to be involved in the HB-HTA process (clinicians, hospital manager, etc).

At the meeting with these key stakeholders, ask them if they can think of any other relevant people who should also be involved in the process (e.g. someone to contact to obtain specific data on costs, use of resources or clinical data).

Do not hesitate to involve relevant stakeholders later in the process if needed.

3.6

There is not enough time to consult patients during the assessment process.

Some other professional groups, such as nurses, could be engaged for stakeholder consultation work.

Unbiased, transparent and independent assessment process

Description of potential problems

Proposed solutions

3.7

The assessment process can be biased.

  • State your conflict of interest using standard forms, ask for the same statement from every contributor.
  • Ensure that your report is internally reviewed, make sure the reviewer was not involved previously in the part that he/she is reviewing.
  • Ask someone outside your unit for an external review of your report.

3.8

Applicant clinicians can be biased.

To increase the objectivity of the assessment, involve in the process an independent consultant with the same medical profile (specialty), but do not ignore the applicant clinician.

3.9

The participation of a member of the HB-HTA unit’s staff in a research project funded by a supplier leads to a potential conflict of interest.

Do not involve the staff member concerned in the HB-HTA of an HT from this supplier.

3.10

The manufacturer of an HT being assessed exerts pressure to use particular studies, evidence and/or methods.

Define in advance the role of manufacturers in the HB-HTA process (if any) and stick to this decision.

If the manufacturer belongs to the stakeholders, organise a meeting with him and explain the rationale of the HB-HTA process. Highlight methods used, justify why you are using a systematic literature review approach, explain why some evidence may not be considered as robust (according to the assessment of the quality or level of evidence).

Communication to hospital stakeholders

Description of potential problems

Proposed solutions

3.11

Some stakeholders that are involved in the final decision have not been taken into account during the scoping phase and do not understand the rationale and the concepts of the HB-HTA report.

  • Include an executive summary in the HB-HTA report, with clear sections that can be understood by clinicians, managers and other final decision makers.
  • When writing and presenting HB-HTA report results, be sure to explain in lay terms concepts and language that may be very technical.

3.12

The production of an HB-HTA report is decided, but not communicated to the stakeholders who are expecting to implement the technology.

Put in place a procedure establishing who is in charge of communicating this information to the stakeholders.