Table 2.
HTA report with data for each decision criterion of the EVIDEM framework ('Lite' highly synthesized version)*
| Overview | ||||||
|---|---|---|---|---|---|---|
| Disease: | Type of intervention: Cervical cytology test | |||||
| Liquid Based Cytology (LBC) | ||||||
| Intervention: | Indication: Screening for cervical cancer in women | |||||
| Cervical cancer | ||||||
| Setting: | Administration: Liquid based cytology (LBC) requires physician to obtain | |||||
| Discovery Health, South Africa | cells from the cervix and to place the head of the spatula/brush or rinse it into a vial with preservative fluid. The pathologist then extracts the cells into a microscopy slide and the cells are examined in the usual way | |||||
| Comparator(s): Conventional pap smears (i.e., conventional cytology, CC) where the brush containing the sample is smeared onto the slide, thereby transferring the cells | ||||||
| Data included:Data available from public domain | ||||||
| MCDA matrix criteria | Highly synthesized information | Scoring of intervention | ||||
| Disease impact | Not severe | Very severe | ||||
| D1 | Disease severity | Disease symptomatic only when spreading from cervix: vaginal bleeding, post-coital spotting, vaginal discharge, pelvic or low back pain. | 0 | 1 | 2 | 3 |
| Late stages: severe anemia, weight loss and uncontrolled release of urine and feces through the vagina | ||||||
| Survival: < 18 months in 50% of untreated patients | ||||||
| D2 | Size of population | Incidence in South Africa: 9/100,000 white women; 40/100,000 black women | Very rare disease | Very common disease | ||
| 0 | 1 | 2 | 3 | |||
| Intervention | ||||||
| I1 | Clinical guidelines | LBC is not included in any guidelines.South African guidelines recommend at least 3 pap smears test per lifetime | Not recommended | Strong recommendation | ||
| 0 | 1 | 2 | 3 | |||
| I2 | Comparative interventions limitations | Sensitivity: 74% - relatively low; Specificity: 87%;Unsatisfactory sample: 3%Low screening uptake: 2.8% black women; 18.8% white women | No or very minor limitations | Major limitations | ||
| 0 | 1 | 2 | 3 | |||
| I3 | Improvement of efficacy/effectiveness | Meta-analyses of RCTs (n = 28,736 vs 39,377): Sensitivity: 80% - difference with CC = 6.4% (95% CI: -6.5 to 18.8%)Specificity: 82% - difference with CC = - 4.0% (95% CI: -19.9 to 10.6%) Unsatisfactory samples: ThinPrep = 2.2% and Sure Path = 0.82%; difference with CC: ThinPrep = -0.8% and Sure Path = -2.5% | Lower than comparators | Major improvement | ||
| 0 | 1 | 2 | 3 | |||
| I4 | Improvement of safety & tolerability | Safety and tolerability do not differ between LBC and conventional cytology | Lower than comparators | Major improvement | ||
| 0 | 1 | 2 | 3 | |||
| I5 | Improvement of patient reported outcomes | Patient reported outcomes: No data - fewer recalls and fewer inadequate specimens with LBC may improve quality of lifeConvenience: no need to return for HPV testing in case of a positive result | Lower than comparators | Major improvement | ||
| 0 | 1 | 2 | 3 | |||
| I6 | Public health interest | Screening programs for cervical cancer in South Africa: mortality decreased by 50% for white women, 40% for Asian women but rose for black women between 1960's 1990's. and Considerable interest to improve screening methods and uptake. | No risk reduction | Major risk reduction | ||
| 0 | 1 | 2 | 3 | |||
| I7 | Type of medical service | Goal of intervention: improve outcome of the disease due to early detection; 5-years survival ranging between close to 100% for early stage and 5% to 15% for late stage | Minor Service | Major Service (e.g. cure) | ||
| Economics | ||||||
| E1 | Budget impact on health plan | Intervention price: LBC - R180.00; CC - R103.10Incremental cost per pt screened with LBC: R76.90Annual projected budget impact per 1000 women: R76,900 | Substantial additional spending | Substantial savings | ||
| 0 | 1 | 2 | 3 | |||
| E2 | Cost-effectiveness of intervention | Cost per life-year gained: R764,000Cost per QALY gained: R758,000 | Not cost-effective | Highly cost-effective | ||
| 0 | 1 | 2 | 3 | |||
| E3 | Impact on other spending |
Incremental colposcopy cost per patient over lifetime horizon: R 8 (excludes drug cost, see E1)No available data on other spending (including treatment of cancer and pre-cancer) |
Substantial additional spending | Substantial Savings | ||
| 0 | 1 | 2 | 3 | |||
| Quality of evidence | ||||||
| Q1 | Adherence to requirements of decisionmaking body | Not applicable for case study | Low adherence | High adherence | ||
| Q2 | Completeness and consistency of reporting evidence | Quality score: Clinical data:75% - primary and secondary outcome measures as well as sensitivity analyses not clearly specified; Economic evaluation: 50% - disaggregated cost not reported; incomplete reporting of effectiveness outcomes | Many gaps/inconsistent | Complete & consistent | ||
| 0 | 1 | 2 | 3 | |||
| Q3 | Relevance and validity of evidence | Quality score: Clinical data:75% -most relevant outcome not assessed (morbidity and mortality due to cervical cancer);Economic evaluation: 75% - Canadian screening coverage and HPV epidemiology not completely applicable for South African private payer setting | Low relevance/validity | High relevance/validity | ||
| 0 | 1 | 2 | 3 | |||
* The full HTA report is available online at http://www.evidem.org/tiki/?page=CCLBC-RecordMenu