Table 3.
Inventory of criteria for assessing the organizational impact of medical innovations. List of references used in Table 3: (2, 10-12, 14, 16-19, 23, 24, 26-121).
|
DOMAINS (occurrences) | |
| Criteria (occurrences) |
Example(s) |
| Sub-criteria (occurrences) | |
|
SURROUNDINGS (n=169) | |
| Legislation (n=31) | Approval need; Innovation compatible with current legislation; Procedural complexity; Legislative and regulatory requirements; Authorization and safety requirements; Ownership and liability; Responsibility; Professional insurance need; Changes in risk of damage suits. |
| Cooperation (n=79) | Changes in the cooperation with other actors/sectors; New partnership development; Well suited to joint ventures; Changes in the way medical staff work together (knowledge sharing); Impact on partnership and collaboration; Impact on innovation research; Capacity to stimulate research. |
| (De)centralization (n=25) | Changes in accessibility; Changes in market regulation; Changes in equity of health care; Ability to reach whole target region/population; Number of operational site within a given territory; Distribution within a given territory (number of sites per area, number of patients per area); Average access time/distance. |
| Coordination (n=21) | Consequences on organization involved; Consequences on partnership activity; Consequences on whole health care system; Opportunity to harmonize the practices. |
| Communication (n=16) | Changes in mode of communication; Changes in frequency of communication; Changes to the content; Changes to the communication medium. |
| Information (n=16) | Changes in mode of information; Changes to the content; Changes to the information medium. |
| Vigilance (n=8) | Changes in mode of bottom-up/top-down reports; Changes in vigilance process; Changes in surveillance requirements. |
|
Environment (n=7) |
Environment impact; Environment impact of production; Environment impact of use; Environment impact of implementation. |
|
TASK (n=148) | |
| Workflow (n=118) | |
| Performance (n=24) | Number of procedures performed; Number of patients treated; Number of beds dedicated; Hospital bed occupancy; Possible impact on operating room productivity. |
| Intervention characteristics (n=15) | Operating time; Number of different steps. |
| Hospital stay (n=8) | Average length of stay; hospital stay; Number of rehospitalization; Number of days in intensive care; Number of days in resuscitation unit. |
| Associated activities (n=6) | Number of associated physical examination; Number of medical appointment; Number of lifestyle and dietary measures; Patient autonomy and privacy. |
| Time period management (n=6) | Time a patient has to attend; Number of patients on the waitlist. |
| Activity profile (n=5) | Part of activity dedicated to innovation. |
| Implementation (n=79) | |
| Planning (n=18) | Delay of implementation; Planning period (duration); Number of planning meetings; Transition period (duration). |
| Method (n=13) | Number of implementation steps; Flexibility of implementation; Possibility to implement a trial test; Possibility to reproduce a clinical trial method. |
| Success (n=4) | Use of performance indicators is possible. |
| Process of care (n=19) | |
| Inappropriate use (n=8) | Risk of inappropriate use. |
| Quality of care (n=6) | Change in quality of care; Change in continuity of care; Changes in out of hours medical services. |
| Patient recruitment (n=5) | Change in personal empowered to recruit; Change in decision-making tree; Change in process to remember patient to attend intervention; Changes in process to ensure patient attend intervention. |
| Quality control (n=16) | |
| Control (n=9) | Changes in frequency of monitoring; new audit needed. |
| Indicators (n=4) | Number of indicators; Change in type of indicators; Changes in complexity of data collection. |
| Risks management (n=3) | Changes in risk mapping (type of risk, frequency, severity, control); Changes in procedures of reporting events (sentinel/adverse); Changes in number of reporting events (sentinel/adverse). |
| Pathways (n=14) | |
| Area (n=9) | Change in area/sector involvement; Task shifting between health professionals; Task shifting on patient/caregiver; Change in social/professional roles and identity. |
| Chronology (n=5) |
Change in pathway steps chronology; Number of modified/added/deleted pathway steps. |
|
PEOPLE (n=122) | |
| Training (n=33) | Learning curve; Continuing professional development; Duration of training; Training needed; Number of training courses; Number of trainees; Support staff training. |
| Human resources (n=32) | Changes in staff requirements (working hours); Additional staff requirement; Dedicated staff needed; Changes in medical staff/patient ratio; Reduction in staff/redeployment of staff on other activities; Availability of workforce |
| Knowledge/skills (n=17) | Availability of expertise; Skills requirements; Number of practitioners authorized. |
| Working environment/conditions (n=15) | Impact on work environment; Comfort of caregivers/medical staff. |
|
Health and safety at work (n=3) |
Protective measures needed; Changes in level of risk (accidental blood exposure, chemical risk, infectious risk, radiation exposure, carrying of heavy loads, repetitive gestures, risk of musculoskeletal conditions); Changes in
occupational medicine monitoring (examinations, frequency). |
|
TECHNOLOGY (n=100) | |
| Resources (n=85) | |
| Material resources (n=119) | Compatible with existing equipment; Compatible with existing software; Purchase of equipment or consumables needed; Enough available resources; Operational requirements; Additional/new equipment requirements; Resources availability. |
| Financial resources (n=21) | Changes in part of budget allocation; Changes in payment arrangement; Financial resources requirements; Wage modifications. |
| Infrastructure (n=25) | |
| Premises (n=13) | Investment in additional areas requirements; Dedicated area requirements; Proximity to other area requirements. |
| Work (n=12) | Work requirements; Work period. |
| Innovation characteristics (n=23) | |
| Complexity (n=12) | Enlightened patient decision; Science popularization. |
| Use (n=6) | Changes in maintenance; Life expectancy. |
| Managing (n=5) |
Changes in purchase process; Changes in supply process; Changes in supplier; Product manageability; Changes in conditions of storage. |
|
STRUCTURE (n=97) | |
| Acceptability (n=29) | Patients/relatives/patient groups acceptability; General population acceptability; Caregiver acceptability; Stakeholders acceptability; Controversial nature; Innovation requested by patient groups; Conflict of interest; Barriers to uptake; Stakeholders pressures; Social influences (support from, trust/respect, past experience). |
| Culture, values, missions (n=17) | Alignment with mandate/scope/mission/culture/values of health care system; cultural acceptability; Congruence; Precedence; Institutional limitations. |
| Strategy (n=16) | Priority status; Political priorities; Changes in attractiveness; Changes in market shares; Alignment with objectives of health care system. |
| Management (n=15) | Changes in hierarchy; Changes in professional liability; Changes in health care structure management; Changes in administration of healthcare system; management problems and opportunities. |
| Procedures (n=13) | Changes in document system; Changes in quality assurance manual; Organizational changes requirements; Complexity of change management. |