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| ID | Type | Description | Link |
|---|---|---|---|
| 332 | Other Grant/Funding Number | NIHR School for Primary Care Research |
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| Name | Class |
|---|---|
| Newcastle University | OTHER |
| University College, London | OTHER |
| University of Manchester | OTHER |
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Multi-centre, non-randomised, non-controlled quasi-experimental study with nested qualitative study and economic appraisal.
Improving the identification of patients at high risk of cardiovascular disease in primary care, caused by conditions such as familial hypercholesterolaemia (FH), is a well-recognised national priority to prevent morbidity and mortality by early effective intervention.
This study will prospectively evaluate the clinical utility of the new primary care FH identification tool (FAMCAT) for identifying undiagnosed FH in routine primary care practice; and to assess its appropriateness, acceptability and cost-effectiveness.
This study will answer the following research questions (RQ):
RQ(1) & (3) will be answered by a quasi-experimental diagnostic accuracy study; RQ(2) & (5) answered by qualitative study; RQ (4) answered by economic appraisal and RQ(6) informed by all previous studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAMCAT | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAMCAT | Other | The intervention is a computer-based software algorithm (FAMCAT) for use in general practice with a family history questionnaire. |
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| Measure | Description | Time Frame |
|---|---|---|
| Detection of genetically confirmed new FH cases using case identification tool (FAMCAT) | Efficacy measure: Proportion (%) of genetically-confirmed FH cases Proportion (%) of genetically-confirmed FH cases | Through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of FAMCAT | Efficacy measure: representativeness of qualitative interview sample. Key themes will be identified from qualitative interview transcripts of patient experience of participating in the study, acceptability of the study procedures (ie. location of blood test clinic appointments, waiting time to receive test results) , and appropriateness of methods of contact with study participants (ie. format and content of study materials, communicating test results). Key themes on usability will be identified from qualitative interview transcripts of health care professionals who used the FAMCAT tool clinically (ie. search criteria for clinical records, interpretation of results) |
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Inclusion Criteria:
Patients - General practices
Patients - Secondary care
Staff
Nominal Group
Exclusion Criteria:
Patients - General practices
Patients - Secondary care
Staff
Nominal Group
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| Name | Affiliation | Role |
|---|---|---|
| Nadeem Qureshi, DM | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Primary Care, University of Nottingham | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34635577 | Derived | Qureshi N, Akyea RK, Dutton B, Leonardi-Bee J, Humphries SE, Weng S, Kai J. Comparing the performance of the novel FAMCAT algorithms and established case-finding criteria for familial hypercholesterolaemia in primary care. Open Heart. 2021 Oct;8(2):e001752. doi: 10.1136/openhrt-2021-001752. | |
| 34521694 | Derived |
| Label | URL |
|---|---|
| Funder website | View source |
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We do not have consent from participants to share their data for the purposes of future research.
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| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Through study completion, an average of 2 years. |
| Appropriateness of FAMCAT | Efficacy measure: representativeness of qualitative interview sample. Key themes will be identified from qualitative interview transcripts of patient experience of appropriateness of methods of contact with study participants (ie. format and content of study materials, communicating test results). | Through study completion, an average of 2 years. |
| Usability of FAMCAT | Efficacy measure: representativeness of qualitative interview sample. Key themes on usability will be identified from qualitative interview transcripts of health care professionals who used the FAMCAT tool clinically (ie. search criteria for clinical records, interpretation of results) | Through study completion, an average of 2 years. |
| Self-reported anxiety measures for use in a future trial | Anxiety measured using 6 item Spielberger State-Trait Anxiety Inventory (STAI). The total score will be calculated at study entry, after receiving genetic test results and 12- 15 months after genetic tests results received | Baseline to 15 months after genetic test results reported |
| Self-reported lifestyle change measures for use in a future trial | Stages of change for smoking cessation and physical activity will be measured. The five stages of change will be dichotomised into: (1) pre-contemplation, contemplation and preparation and (2) action/maintenance. The distribution of proportions for each measure will be presented at study entry, after receiving genetic test results and 12- 15 months after genetic tests results received | Baseline to 15 months after genetic test results reported |
| Beliefs about predisposition to coronary heart disease | Beliefs on causes for heart disease were assessed using 8 items, from a total of 18 items, which comprise the 'Causes of my illness' subscale in the Revised Illness Perception Questionnaire, IPQ-R. The distribution of data for each one of the 8 questions will be presented at study entry, after receiving genetic test results and 12- 15 months after genetic tests results received | Baseline to 15 months after genetic test results reported |
| Cost-effective FAMCAT threshold to identify genetically confirmed FH | Efficacy measure: Primary analysis: Incremental cost-effectiveness ratio (ICER) of FAMCAT compared to Simon-Broome criteria; Sensitivity analysis: Incremental costeffectiveness ratio (ICER) of FAMCAT at different testing thresholds. Short-term model: 24 Months | through study completion, an average of 2 years |
| Qureshi N, Akyea RK, Dutton B, Humphries SE, Abdul Hamid H, Condon L, Weng SF, Kai J; FAMCAT study. Case-finding and genetic testing for familial hypercholesterolaemia in primary care. Heart. 2021 Dec;107(24):1956-1961. doi: 10.1136/heartjnl-2021-319742. Epub 2021 Sep 14. |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |