Table 2 Classification of terms reported in the literature
Categories of classification system | Criteria of classification system | Terms used in articles |
|---|---|---|
A-Health outcomes and benefits of intervention | Number of criteria: 6 | Number of terms: 44 |
A1: Health benefits: 7 terms, cited 10 times | · A1 – health benefits [13, 31, 38, 50], potential health gain [44], enhanced health outcomes [44], relative advantage [51], health effects [30], additional effects [22], incremental health gain [43] | |
A2: Efficacy/effectiveness: 11 terms, cited 29 times | · A2 – efficacy [13, 47], efficacy/effectiveness [10, 19, 20, 25, 27, 28, 44, 48], effectiveness [14, 22, 26, 32–34, 48], clinical benefit [19, 22, 24, 42, 47], clinical impact [45], clinical merit [22], relative clinical benefit in relation with current standards [16], determine relative value for degree of benefit against benchmarks [16], magnitude of treatment effect [22], response rate [43], onset and duration of treatment/program effect [43] | |
A3: Life saving: 4 terms, cited 5 times | · A3 – prolongation of disease-free survival [42], saving life [19], life expectancy gains [13], average life-year benefit per patient [13, 33] | |
A4: Safety: 11 terms, 19 times | · A4 – side effects [33, 41, 47], unintended consequences [40], safety [9, 22, 26, 31], safety and tolerability [10, 19, 20], risks [20, 22], risk management [44], harm [42], adverse effects [32], inconvenience [22], risk of event [22], reduction in symptomatic toxicity compared with standard therapy [42] | |
A5: PRO: 10 terms, 17 times | · A5 – patients reported outcomes [10], quality of life [19, 42, 44, 52], impact on quality of life [22, 43], number of QALYs gained per patient [36, 39], disability adjusted life years [13], likely impact on patient [16], patient preference [25], patient autonomy [26, 35, 40], relative value to patient [16], best for patient [38] | |
A6: Quality of care: 1 term, 1 time | · A6 – overall gain in quality of care [44] | |
B-Type of health benefit | Number of criteria: 2 | Number of terms: 12 |
B1: Population effect (prevention): 6 terms, 11 times | · B1 – public health interest [10], population effects [19], prevention [19, 28], prevention of ill health [44], social impact [13, 22, 33], social benefit [13, 22, 33] | |
B2: Individual effect (medical service): 6 terms, 7 times | · B2 – type of medical service [10], relief/prevention of symptoms/complications of disease [42], health gain or maintenance [44], individual effects [19], individual impact and benefit [13, 33], the composition of the health gain [39] | |
C-Impact of the disease targeted by intervention | Number of criteria: 4 | Number of terms: 21 |
C1: Disease severity: 2 terms, 9 times | · C1 – severity of disease [9, 10, 13, 19, 30, 37, 39, 47], impact of the disease/condition on quality of life [43] | |
C2: Disease determinants: 2 terms, 2 times | · C2 – determinants (the factors responsible for the persistence of the burden) [17], characteristics of target condition [22] | |
C3: Disease burden: 7 terms, 13 times | · C3 – burden of disease [9, 13, 22, 33], disease burden [17, 25, 45, 48], burden of illness [22], burden of therapy [22], cost to treat disease [33], cost to prevent disease [33], national cost of the disease/condition to the healthcare system [43] | |
C4: Epidemiology: 10 terms, 16 times | · C4 – prevalence [9, 13], number of potential beneficiaries [35, 37, 40], indirect beneficiaries [40], size of population [10, 19], prevalence and incidence of disease [23, 25, 43], number of residents benefiting [44], number of clients served [43], number of patients [47], social/demographics [22], incidence [22] | |
D-Therapeutic context of intervention | Number of criteria: 4 | Number of terms: 18 |
D1: Treatment alternatives: 5 terms, 13 times | · D1 – treatment alternatives [13, 22], availability of alternatives [16, 19, 25, 42, 44, 47], availability of effective intervention and preventable [13], alternatives [35, 40, 45], benchmark comparators [16] | |
D2: Need: 8 terms, 16 times | · D2 – comparative interventions limitations (unmet needs) [10], need [19, 22, 28, 38, 42, 44, 49], clinical impact (need and trends) [24], emergencies and need [13], apparent need [14], clinical need [36, 41, 50], desirability of effects [40], meets patient’s basic need [38] | |
D3: Clinical guidelines & practices: 4 terms, 7 times | · D3 – evidence-based guidelines [13, 33, 36], best practice [14], clinical guidelines [10, 23], academic health center research (establishing/or using best practice) [24] | |
D4: Pre-existing use: 1 term, 1 time | · D4 – pre-existing prescribing of the drug [47] | |
E-Economic impact of intervention | Number of criteria: 9 | Number of terms: 36 |
E1: Cost: 3 terms, 11 times | · E1 – cost per patient [19], costs [19, 20, 22, 27, 32, 42, 44, 47, 51], unit cost [22] | |
E2: Budget impact: 6 terms, 11 times | · E2 – budget impact on health plan [10, 19, 25, 47], total budget impact [30], budget impact [32, 45, 47], usage and cost implications of competing new drugs if approved [16], affordability [25], operating and start-up costs [43] | |
E3: Broad financial impact: 7 terms, 7 times | · E3 – impact on other spending [10], financial impact on government [13], economic impact [45], economics [22], national medical costs per-year [39], cost-saving [33], national saving in costs of absence per year [39] | |
E4: Poverty reduction: 1 terms, 3 times | ||
E5: Cost-effectiveness: 5 terms, 23 times | · E5 – cost-effectiveness [9, 10, 13, 14, 17, 20, 22, 25–27, 30, 34, 37, 39, 41, 44], economic evaluations [27], cost and consequences [9, 13, 14, 41], pharmacoeconomic analysis [23], cost utility expressed as cost per QALY [22] | |
E6: Value: 2 terms, 3 times | ||
E7: Efficiency and opportunity costs: 6 terms, 10 times | · E7 – efficiency of intervention [31], efficiency [10, 19, 22, 23, 44], opportunity costs [10], opportunity costs to the population/society [16], best within available resources [38], interdependencies [50] | |
E8: Resources: 5 terms, 6 times | · E8 – resources [17, 51], variation in rate of use [45], available resources [13], resources implications [50], volume of activity [13] | |
E9: Insurance premiums: 1 term, 1 time | · E9 – impact on health insurance premiums [9] | |
F-Quality and uncertainty of evidence | Number of criteria: 6 | Number of terms: 34 |
F1: Evidence available: 7 terms, 9 times | · F1 – evidence [22, 42, 45], proof [22], scientific evidence [47], current level of knowledge [17], time of assessment in technology development [35], timelines of review [45], therapy mechanism of action [23] | |
F2: Strength of evidence: 14 terms, 20 times | · F2 – strength of evidence [16, 44], quality of evidence [47], quality of data and past decisions [47], quality of data [22], quality [26], validity of evidence [10, 19], related degree of knowledge certainty [23], certainty [48], consistency [19, 22, 44], consistent [38], completeness and consistency of reporting evidence [10], openness [26, 44], selection of studies [35, 40], precision of treatment effect [22] | |
F3: Relevance of evidence: 5 terms, 8 times | · F3 – relevance of evidence [10, 19], representativeness of users (studies vs. real world) [35, 40], level of generalization [35, 40], effectiveness in real practice [22], evidence of effectiveness [44] | |
F4: Evidence characteristics: 5 terms, 7 times | · F4 – normative characteristics of study [35, 40], choice of endpoints [35, 40], clinical trial data [47], multiple randomized trials or meta-analysis/single randomized trial of reasonable size/small randomized trial [42], phase II [53] | |
F5: Research ethics: 2 terms, 4 times | · F5 – research ethics [35, 40], informed consent [26, 40] | |
F6: Evidence requirements: 1 term, 1 time | · F6 – adherence to requirement of decision making body [10] | |
G-Implementation complexity of intervention | Number of criteria: 9 | Number of terms: 57 |
G1: Legislation: 6 terms, 6 times | · G1 – legal arrangements [40], legislative issues [22], medical liability [40], human rights legislation [23], legal implications [45], conformity of programs [22] | |
G2: Organizational requirements and capacity to implement: 15 terms, 17 times | · G2 – system requirements [25], physical environment [44], environment [22, 26], system capacity [10], local capacity [17], ability to implement [38], implementation [22], organization’s structure [51], organizational burden [49], logistics [36], process [28], well-organized [38], organizational feasibility [22, 25], feasibility of delivery [16], deliverability [48] | |
G3: Skills: 6 terms, 6 times | · G3 – knowledge and skills [51], nature of staff [51], clinical education and training [44], human resources availability [17], recruitment and retention of staff [44], attracting/retaining scarce clinical staff [44] | |
G4: Flexibility of implementation: 7 terms, 8 times | · G4 – flexibility [51], reversibility [51], trialiability [51], revisability [51], ability to evaluate [22], provision for revision/appeals [38], engagement [26, 48] | |
G5: Characteristics of intervention: 6 terms, 8 times | · G5 – characteristics of intervention [22], complexity of the intervention [51], components of technology [35], autonomy of the intervention [38], autonomy [17, 26, 46], convenience [42] | |
G6: Appropriate use: 3 terms, 3 times | · G6 – appropriate use of intervention [10], appropriateness [44], appropriate setting/level of service [43] | |
G7: Barriers and acceptability: 3 terms, 4 times | · G7 – acceptability [22, 48], responsiveness [44], controversial nature of proposed technology [45] | |
G8: Integration and system efficiencies: 9 terms, 9 times | · G8 – system integration (best use of elements of healthcare system) [34], integration into local community [44], ease of integration [22], impact on other services [40], links to other services [44], compatibility [22], reduction of the monitoring [33], reduction of waiting list size [33], impact [22] | |
G9: Sustainability: 2 terms, 4 times | ||
H-Priorities, fairness and ethics | Number of criteria: 7 | Number of terms: 55 |
H1 Population priorities: 5 terms, 5 times | · H1 – perspective and current priority [13], target and priority-setting [14], known priorities [44], population priority [10], coverage of selected conditions [13] | |
H2 : Access: 10 terms, 17 times | · H2 – population access [10], access [19, 27, 47, 49], equity of access improvement [13], access to care easier [31, 33, 34], distribution and access to healthcare [35, 40], accessibility [22, 44], equity of access [44], access to health system [22], geographical equity [43], timeliness of access [43] | |
H3 : Vulnerable and needy population: 9 terms, 11 times | · H3 – vulnerable population [37, 38], potential victims [40], particular social groups with high risk and/or increased vulnerability [23], compassion for the vulnerable [19], particularly needy/vulnerable groups [44], age of targeted group [13, 30], maternal mortality [13], quality of maternity care services [13], population equity [43] | |
H4: Equity, fairness and justice: 12 terms, 32 times | · H4 – equity [8, 13, 14, 19, 22, 25, 27, 40, 44, 46, 48], fairness [10, 14, 40, 44, 47], health equity [23, 26], equality [19, 26, 38], distributive justice [23, 25], formal justice [23], social justice [23], justice [26, 46], social injustice [40], addressing health status inequalities at a population level [44], human integrity and dignity [35, 40], basic human rights [35] | |
H5 : Utility: 2 terms, 3 times | ||
H6: Solidarity: 6 terms, 8 times | · H6 – solidarity [19, 25, 26], collectivism [26], mutuality [26], reciprocal trust [40], diversity [26], cohesion [26] | |
H7: Ethics and moral aspects: 11 terms, 14 times | · H7 – ethics [14, 22], ethical values [22], values [22], values and beliefs [51], consistency with societal values [22], ethical implications [45], moral obligation to implement a technology [35, 40], rule of rescue [25], priority to basic and necessary care [38], moral consequence of HTA [35, 40], moral challenges related to certain components of HTA [35] | |
I-Overall context | Number of criteria: 11 | Number of terms: 83 |
|  | I1: Mission and mandate of health system: 13 terms, 19 times | · I1 – goals of healthcare [52, 53], goals [21], beneficence [28], non-maleficience and justice [28], beneficence/non-maleficience [17, 26, 53], strategic fit [9, 23], medical and social worth [45], relevance [22], present social consensus, [17, 49] consensus regarding public funding of a therapy [17, 53], government mandate [17], national standards [24], healthcare context positioning [23] |
|  | I2: Overall priorities: 6 terms, 6 times | · I2 – national priorities [45], national or board priority [14], local and national priorities [8], international priorities [45], alignment with external directives [9], strategic direction [43] |
|  | I3: Financial constraints: 8 terms, 13 times | · I3 – budget constraints [13, 33, 45], cost-containment [42, 49], budget level [13, 19, 45], social economical context [16], limited provincial health resources [17], budget implementation challenges [17], economic feasibility [37], reliance of other services/sectors(on investment) [14] |
|  | I4: Incentives: 4 terms, 5 times | · I4 – financial incentives [28, 45], organizational support [16], donor involvement [31], incentives for compliance [20] |
|  | I5: Political aspects: 5 terms, 7 times | · I5 – political pressure [13, 19, 45], political components [52], politically and legally defensible decisions [42], politics [37], political impact [37] |
|  | I6: Historical aspects: 3 terms, 3 times | · I6 – historical components [52], past experiences [16], historical budgets [19] |
|  | I7: Cultural aspects: 7 terms, 10 times | · I7 – culture and religious convictions [19, 28, 47], stigma [28], compatibility with values [16], challenge of social and values arrangements [28, 47], conception of certain persons or disease [47], psychosocial implications [34], public preference [14] |
|  | I8: Innovation: 3 terms, 3 times | · I8 – perceived benefits of change [16], innovativeness [37], generation or application of knowledge [43] |
|  | I9: Partnership and leadership: 8 terms, 9 times | · I9 – partnership and networking [16], partnerships [9], maintaining relationship [42], leadership [16], community development [53], academic commitments: research and education [9, 23], partnership and collaboration across organizations [43], contribution to position as a learning organization [43] |
|  | I10: Citizen involvement: 3 terms, 3 times | · I10 – citizenship [53], ownership [53], enabling health literacy (empowerment) [53] |
|  | I11: Stakeholders interests and pressures: 23 terms, 28 times | · I11-stakeholders pressure [52], advocacy [16, 45], pressure from physician and patients groups and past decisions [32], clinical expert opinions [37], patient representative group opinions [37], power relations among stakeholders [28], user of the technology interests [47], challenge the relationship between patient and physician [47], professional prestige [28, 47], clinicians excitement and decisions in other hospitals [32], public reaction and public accountability [28], HTA’s producer interest [28, 47], company activities [32], researchers ethics interests [28, 47], third party agents involved [47], recommendations made by other countries [13], status in other jurisdictions [49], current status of public funding in other jurisdictions [17], drugs used in other hospitals [32], expressed demand [14, 37], patient demand [32], expected level of interest (patient and medical) [34], entitlement [28] |