Table 4. Implementation strategies in the various health system and professional settings grouped by complex intervention effects results.
| Reference | Population and setting | Implementation strategies | Absolute Difference % | Framework mapping | Study Quality and design |
|---|---|---|---|---|---|
| Group 1: Results significantly favour complex intervention | |||||
| Uyar [36] 2018 USA |
Healthcare Professionals: All gynaecology oncology providers non-specified Patients: All women with EOC Healthcare Institution: Academic cancer centre |
Education for patients and healthcare professionals Handouts for patients EMR documentation of GC/GT and/or referral GC at MDT or documentation of GC and GT outcomes Scheduling GC appointments directly at gynaecology clinic Rates of GC/GT recommendation in EHR (Electronic Health Record) |
Outcome 1. Rates of GC/GT recommendation in EHR + 67.7% (95% CI 59.8–75.6) p value not provided Outcome 2. GC referral +51.2% (95% CI 43.9–58.5, p ≤0.001) Outcome 3. GC completion +54% (95% CI 45.3–62.8, p ≤0.001) GT completion +13.2% (95% CI 3.3–23.3, p = 0.007) Outcome 4 Patients identified with BRCA mutations + 3.6% (95% CI -9.4–16.5, p = 0.68) |
Service: Effectiveness • GC referral • GC completion • GT completion • Patients with identified gene mutations Equity • GT access • GC referrals • GT undertaken Client: Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation • access to knowledge and information Process Engaging • key stakeholders Executing |
Fair Quality Cohort study with historical control Single site health system and no analysis on confounding variables or regression analysis on the characteristics inherent in the control verses the intervention population or health system |
| Brown [38] 2018 USA |
Healthcare Professionals Gynaecology oncologists Breast surgeons Genetic counsellors Patient navigators Advanced care providers Patients: All women with EOC Triple Negative Breast Cancer < 60years Breast Cancer < 45 years Healthcare Institution: Comprehensive not-for-profit system with more than 900 care locations in 2 states, including academic medical centres, hospitals, freestanding emergency departments, health care pavilions, physician practices, and outpatient surgical centres. |
Patient navigators in gynaecologic oncology and breast surgery clinics. Increase volume of GC and telemedicine consults Education to all gynaecologic oncologists, breast surgeons, and advanced care providers on guidelines Referral to GC was made a standard of practice |
Outcome 1. GC referral EOC +59.7% (95% CI 50.2–69.4, p<0.05) TNBC < 60 yrs +21.2% (95% CI 10.6–31.8, p<0.05) BrCa < 45 yrs +6.3% (95% CI -1.0–13.5) p value not provided Outcome 2. GT completion EOC +29% (95% CI 16.8–41.2, p<0.05) TNBC < 60 yrs +26.6% (95% CI 14.9–38.4, p<0.05) BrCa < 45 yrs +15.7% (95% CI -7.5–6.1, p<0.05) Outcome 3. Patients identified with BRCA mutations EOC +7.5% (95% CI– 7.9–23, p = 0.53) TNBC < 60 yrs +0.22% (95% CI -8.2–12.6) p value not provided BrCa < 45 yrs -0.54% (95% CI -7.2–6.1) p value not provided |
Service: Effectiveness • GT undertaken • GC referrals Equity • GT access • GC referrals • GT undertaken Client: Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation • access to knowledge & information • available resources Process Engaging • key stakeholders |
Poor Quality Case series with no comparator to control |
| Miesfeldt [41] 2018 USA |
Healthcare Professionals: Pathologist Surgeon Patient navigator—Oncology Nurse Patients: All colorectal and uterine cancer Healthcare Institution: Medical Centre Cancer Institute’s Cancer Risk and Prevention Clinic—community hospital and a state tertiary centre with a GC-supported cancer genetic program |
Triggered GC referral after abnormal IHC and MSI Pathology communication via e-mail to surgeon Patient navigator to ensure follow through to GC for abnormal IHC and MSI |
Outcome 1. GC referral I: 16/16 (100.0) C:12/12 (100.0) p value not provided Outcome 2. GC completion +45.8% (95% CI 13.6–78.1, p = 0.020) Outcome 3. GT completion +12.9% (95% CI -24.7–50.4) p value not provided Outcome 4. Patients identified with BRCA mutations +28.8% (95% CI -21.5–79.2) p value not provided |
Service: Effectiveness • GT undertaken • GC referral • GC apt uptake Equity • GT access • GC referrals • GT undertaken Client: Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation • available resources Process Engaging • key stakeholders |
Poor quality Case series with no comparator for control |
| Heald [44] 2013 USA |
Healthcare Professionals: Genetic Counsellor Colorectal Surgeon Pathologist Patients: All patients with colorectal cancer Healthcare Institution: Academic and tertiary (2 regional community hospitals) and primary care centres (multiple family health centres) |
Triggered EMR GC referral after abnormal IHC and MSI to surgeon EMR documentation of GC/GT and/or referral via email GC embedded to increase communication of abnormal IHC to patients and facilitate referral Shared GC e-mail to review all abnormal MSI and IHC from pathologist to GC |
Outcome 1. GC referral GC v No GC +44.7% (95% CI 28.1–60.5, p<0.001) GC & Surgeon v No GC +26.5% (95% CI -1.2–54.2, p = 0.023) Outcome 2. GC completion GC v No GC +39.8% (95% CI 20.9–58.8, p<0.001) GC & Surgeon v No GC +32.0% (95% CI 0.017–64) p value not provided Outcome 3. GT completion GC v No GC +39.8% (95% CI 21.1–58.5, p<0.001) GC & Surgeon v No GC +19.2% (95% CI -13.4–51.7) p value not provided Outcome 4. Patients identified with LS GC v No GC +22.5% (95% CI 7.7–37.2) GC & Surgeon v No GC +1.2% (95% CI -17.8–20.2) p value not provided Outcome 5. Time to appointment GC v No GC1–413 days p<0.001 GC & Surgeon v No GC -164 days p value not provided |
Service: Effectiveness • GT undertaken • GC referral • GC apt uptake Timeliness • Time to GC apt Equity • GT access • GC referral • GT undertaken Client: Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation • available resources Process Engaging • key stakeholders |
Fair Quality Cohort study with historical control Single site health system with no analysis on confounding variables or regression analysis on the characteristics inherent in the control verses the intervention population or health system Less than 80% of population followed up |
| Senter [34] 2017 USA |
Healthcare Professionals: Gynaecology oncology and cancer genetics health professionals-unspecified Patients: All women with EOC Healthcare Institution: Large academic medical comprehensive cancer centre |
GC embed in oncology services EMR documentation of GC/GT and/or referral Scheduling GC appointments directly at gynaecology clinic |
Outcome 1. GC referral +22.8% (95% CI 16.7–29.4, p<0.00001) Outcome 2. GC completion +45.5% (95% CI 33.6–57.6, p<0.00001) Outcome 3. Time to gain access to GC I: 1.67 months C:2.52 months P< 0.01 |
Service: Effectiveness • GC referral • GC and GT completion Equity • GT access • GC referrals • GT undertaken Timeliness • Time to GC apt CFIR Inner setting Readiness for implementation • available resources Process Engaging • key stakeholders |
Good quality Cohort study with historical control |
| Group 2: Results trend towards complex or single unit intervention | |||||
| Hanley [45] 2018 USA |
Healthcare Professionals: Family practitioners General obstetrician Gynaecologists Medical and gynaecology oncologists Patients: All patients with serous, endometroid and clear cell ovarian cancer type Healthcare Institution: State wide Hereditary cancer program |
Education to healthcare professionals on GC and GT referral guidelines for ovarian cancer Smart text including standard recommendation to refer to GC included on the pathology report |
Outcome 1. GC and GT completion by histopathology Serous +13.7% (95% CI 7.6–19.1) (OR = 4.70; 95% CI 2.89–7.62) Endometrioid -6.3% (95% CI -6.4 to– 2.4) Clear cell -3.3% (95% CI -6.2 to -0.4) Unknown -4.2% P< 0.001 serous vs endometroid and clear cell cancers getting GT after 2010 Outcome 2. Patients identified with BRCA Serous histopathology +6.2% (95% CI -6.1 to 19.4, P = 0.519) Outcome 3. Cancer prevention Familial predictive GT uptake and mutation identification Carrier tests +0.73% p = 0.071 Family members identified as BRCA +0.56% p = 0.009 Carrier tests per serous histopathology + 0.76% P = 0.098 Family members identified as BRCA positive +0.65% P = 0.012 |
Service: Effectiveness • GT undertaken • GC uptake Equity • GT access • GT undertaken Client: Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation • access to knowledge and information Process Engaging • key stakeholders |
Fair to poor quality Cohort study with historical control Multisite health system but with no analysis on confounding variables or regression analysis on the characteristics inherent in the control verses the intervention population or health system Unclear how many patients were followed up |
| Petzel [46] 2014 USA |
Healthcare Professionals: Gynaecology oncologists Genetic Counsellor Patients: All women with EOC Healthcare Institution: Primary academic metro Women’s Cancer Centre |
EMR referral to GC EMR documentation of GC referral Use of referral guidelines and checklist |
Outcome 1. GC referral +12.7% (95% CI -0.04–25.4, P = 0.053) Outcome 2. GC completion +9.9% (95% CI– 0.41–20.4) p value not provided |
Service: Effectiveness • GC referrals • GC uptake Equity • GT access • GC referral • GT undertaken CFIR Inner setting Readiness for implementation • access to knowledge and information Process Engaging • key stakeholders |
Good quality Cohort study with historical control Single site with regression analysis on the characteristics inherent in the control verses the intervention population or health system but no analysis on confounding variables |
| Cohen [43] 2016 Australia |
Healthcare Professionals: Geneticist Genetic Counsellor Oncologists Patients: All patients with EOC < 70 years old Healthcare Institution: Metropolitan hospital |
Genetics attendance at an MDT tumour board meeting in gynaecology oncology | Outcome 1. GC referral +25% (95% CI 13.6–36.4, P < 0.0001) Outcome 2. GC completion -7.4% (95% CI– 16.8 to 1.9) p value not provided GT completion -16% (95% CI -32.9 to– 0.14) p value not provided Outcome 3. Patients identified with BRCA mutations +1.9% (95% CI -22.9–26.9) p value not provided |
Service: Effectiveness • GC referral • GT undertaken Equity • GT access • GC referral • GT undertaken Client: Cancer prevention • Identification of hereditary Cancer CFIR Process Engaging • key stakeholders |
Fair Quality Cohort study with historical control State-wide health system with no analysis on confounding variables or regression analysis on the characteristics inherent in the control verses the intervention population or health system |
| Lobo [55] 2018 Spain |
Healthcare Professionals Medical oncologist Cancer Nurse Psychologist General Surgeon Gynaecologist Patients: Breast cancer patients Healthcare Institution: Single site urban hospital, Madrid Spain |
Oncologist led pathway and communication MDT oncology led |
Outcome 1. Eligible for GC referral +0.97% (95% CI -3.3–5.3) p value not provided Outcome 2. GC referral +25.4% (95% CI 16.4–34.3, p < 0.0001) Outcome 3.GT completion -11% (95% CI -23.3–0.069) p value not provided Outcome 4. Patients identified with BRCA mutations -5% (95% CI -18–8) p value not provided Outcome 5. Cancer prevention management impact +22% (95% CI -16.2–60.3, p = 0.03) |
Service Effectiveness • GC referral • GC completion • GT completion Client Equity • GT access GC referral Cancer prevention • Identification of hereditary Cancer • cancer prevention strategies up taken CFIR Inner setting Readiness for implementation • available resources Process Engaging • key stakeholders |
Fair Quality Cohort study with historical control Single site health system and no analysis on confounding variables or regression analysis on the characteristics inherent in the control verses the intervention population or health system Unclear how many patients followed up |
| Group 3: Results with unclear complex intervention effect | |||||
| George [29] 2016 UK |
Healthcare Professionals: Gynaecology oncologist Specialist nurse Medical oncologist Genetic Counsellor Patients: All women with EOC Healthcare Institution: Publicly funded cancer unit at a major treating centre |
Education for healthcare professionals Testing protocol pathway Handouts for patients and healthcare professionals Standardised letters for results Standardised consent form |
Outcome 1. GC and GT referral I: 207/207 100% C: NR p value not provided 2.Time to gain access to genetic test results I: Four-fold reduction in time to result C:NR p value not provided Outcome 3. Patients identified with BRCA mutations I: 33/207; 16% C: NR p value not provided Outcome 4. Treatment management I:132/207 (64%) 20/23 BRCA+—PARPi access C: NR I: 31/32 with mutations breast cancer surveillance C: NR p value not provided |
Implementation: Acceptability • Satisfaction with mainstreaming intervention Cost • implementation cost Service: Efficiency • Time to gain access to GT Effectiveness • GC referral • Patients with identified gene mutations Equity • GT access • GC referral Patient centeredness • Patients satisfaction with mainstreaming intervention Client: Cancer prevention • Identification of hereditary Cancer • Access to cancer prevention information • Referral for cancer prevention CFIR Intervention Characteristics • Cost Inner setting Readiness for implementation • access to knowledge and information Process Engaging • key stakeholders Characteristics of Individuals Self-efficacy |
Poor Quality Case series with no comparator to control Single site health system |
| Kentwell [33] 2017 Australia |
Healthcare Professionals: Gynaecology oncologist Specialist nurse Medical oncologist Genetic Counsellor Patients: All women with EOC Healthcare Institution: Publicly funded cancer unit at a major treating centre |
Education for healthcare professionals GC embed in oncology services GC at MDT or documentation of GC and GT outcomes Genetics led referral pathway and triage |
Outcome 1: GC referral +30.4% (95% CI 20.2–40.6, p≤0.001) Outcome 2. Time to gain access to GC and results GC referral I:2014–15–42 days 2015-16- 54.5 days GC referral to results 2014–15–106 days 2015-16- 140.5 days C: NR p value not provided Outcome 3. Patients identified with BRCA mutations I: 2014–2015 7/34; 20.6% 2015–2016 4/30; 13.3% C: NR p value not provided Outcome 4. Familial predictive GT uptake I:31/120 (28) C:NR p value not provided |
Implementation: Acceptability • Satisfaction with mainstreaming Service: Efficiency • Time to gain access to GT and results Effectiveness • GC referral • Patients with identified gene mutations Equity • GT access • GC referral Client: Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation -access to knowledge and information - available resources |
Poor Quality Case series with no control Single site health system |
| Tutty [48] 2019 Australia |
Healthcare Professionals: Genetic counsellors Geneticist Gynaecology oncologist Patients: Women with EOC Healthcare Institution: Urban Australian Familial Cancer Centre |
Genetic counsellor led telephone GC service for oncology services Genetics lead referral pathway and triage |
Outcome 1. GC referral I: 284 C: NR p value not provided 2. GC and GT completion I: 284 C: NR p value not provided Outcome 3. Patients identified with BRCA mutations I: 26/284; 9% 12/284; 4% variants of unknown significance (VUS) C: NR p value not provided |
Implementation: Acceptability • Satisfaction with TGC intervention Cost • Implementation cost Service: Efficiency • Cost of Resources to implement the intervention Effectiveness • GC referral and completion rate • GT completion • Patients with identified gene mutations Equity • GT access • GC referral Patient centeredness • Patients satisfaction with TGC intervention CFIR Intervention Characteristics • Cost Outer setting Needs & Resources of Those Served by the Organization Process Engaging • key stakeholders |
Poor Quality Case series with no comparator to control Single site health system |
| Bednar [35] 2017 USA |
Healthcare Professionals: Physicians Genetic counsellors Advanced practice providers Nurses Clinical managers Physician trainees Patients: All women with EOC Healthcare Institution: An academic cancer centre’s (regional and main campus clinics) |
Education and direct access to GT via gynaecology Email notifications to refer EMR documentation and referral to GC Integrated genetic counsellor in oncology Scheduling GC appointments to co-inside with gynaecology |
Outcome 1–3. GC referral I:561/1214 (46.2%) main campus clinic PCGT 84/151 (55.6%) regional clinic 653/1214 (53.8%) outside institution C: NR p value not provided I: AGCR 33/34 (97%) signed GC electronic referrals 14/72 (19.4%) email referrals C: NR p value not provided Outcome 4. GT completion I: 1214/1423 (85.3%) C: NR p value not provided Outcome 5. Patients identified with BRCA mutations I: 217/1214 (17.9%) C: NR p value not provided Outcome 6. Time to gain access to GC Absolute difference -119 days p value not provided |
Service: Effectiveness • GT undertaken • GC referral • GC apt uptake Equity • GT access • GC referral • GT undertaken Timeliness • Time to GC apt Client: Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation • available resources Process Engaging • key stakeholders Executing |
Poor Quality Case series with no comparator to control |
| Bednar [39] 2019 USA |
Healthcare Professionals: Genetic counsellor Gynaecology oncologists Advanced practice registered nurses Patients Ovarian and uterine cancer patients Healthcare Institution: Regional hospital–single site with a gynaecology oncology clinic |
Education for healthcare professionals Integrated GC in gynaecology EMR tracking and referral with e-mail notifications to refer |
Outcome 1. GC referral I: 48/57 (84.2%) C: NR (p = 0.02) Outcome 2. GC and GT completion I: 43/48 (89.6%) completed GC 39/43(90.7%) completed GT C: NR (p = 0.03) Outcome 3. Patients identified with mutations I: 8/39 (20.5%) C: NR p value not provided |
Service: Effectiveness • GT undertaken • GC referral • GC apt uptake • TT undertaken Equity • GT access • GC referrals • GT/TT undertaken Client: Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation • access to knowledge & information • available resources Process Engaging • key stakeholders Executing |
Poor Quality Case series with no comparator to control Single site health system |
| Percival [30] 2016 UK |
Healthcare Professionals: Clinical nurse specialist in oncology Medical oncologists Patients: All women with EOC Healthcare Institution: Single centre urban hospital |
Online education on pre-test GC for nurses Written information on BRCA testing for patients Written information for results significance Competency certificate after training complete for nurses Clinical Nurse specialist providing pre-test GC |
Outcome 1. Patient satisfaction No difference in patient satisfaction between those consented by a nurse or a doctor No patients refused GT, or requested a GC appointment before GT. |
Implementation: Acceptability • Satisfaction with mainstreaming intervention Client: Patients satisfaction with mainstreaming intervention CFIR Inner setting Readiness for implementation • access to knowledge and information Outer setting Needs & Resources of Those Served by the Organization Characteristics of Individuals Self-efficacy Process Engaging • key stakeholders |
Poor quality Case series with no comparator to control Single site health system |
| Rahman [32] 2017 UK |
Healthcare Professionals: Medical/clinical oncologists Patients: All women with EOC Healthcare Institution: Tertiary oncology centre |
Education for healthcare professionals Testing protocol pathway Handouts for patients and healthcare professionals Standardised letters for results Standardised consent form |
Outcome 1. GT completion I: 122/NR C: NR p value not provided Outcome 2. Patients identified with BRCA mutations I: 18/122 (14.8%) C: NR p value not provided Outcome 3. Time to gain access to GT, results & GC referral I: The time from sample receipt to result was between 14–48 working days—GC referral between 12–43 working days after MGT results -20/56 (36%) had MGT within 1 month of diagnosis C: NR No stats Outcome 4. Treatment management impact I: 11/18 (67%) no change in management 6/18 (33%) access PARP inhibitors C: NR No stats Outcome 5. Familial predictive GT uptake I: 11/ 15 family members of BRCA carriers having predictive GT C: NR No stats |
Service: Effectiveness • GT undertaken Equity • GT access • GT undertaken Timeliness • Time to access GT, results and GC referral Client: Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation • access to knowledge and information Process Engaging • key stakeholders |
Poor Quality Case series with no comparator to control Single site health system |
| Plaskoinska [31] 2016 UK |
Healthcare Professionals: Genetic Counsellor Oncologist Study co-ordinator Patients: All women with EOC Healthcare Institution: Rural and urban publicly funded hospitals of different sizes, ranging from smaller district general hospitals to large regional centres |
Written information on pre-test GC for patients Genetics co-ordinated mainstreaming pathway Post–test GC by GC |
Outcome 1. GT completion I: 232/281 (83%) C: NR p value not provided Outcome 2. Patients identified with BRCA mutations I: 18/232 (8%) C: NR p value not provided Outcome 3. Time to gain access to genetic test results I: Consent to results delivery 46 working days C: NR p value not provided |
Implementation: Acceptability -Satisfaction with mainstreaming intervention Cost • Implementation cost Service: Effectiveness • GC referral • GT undertaken Equity • GT access • GC referrals • GT undertaken Efficiency -Time to gain access to GT results Patient centeredness -Patients satisfaction with mainstreaming intervention Client: Cancer prevention • Identification of hereditary Cancer CFIR Intervention Characteristics • Cost Outer setting Needs & Resources of Those Served by the Organization Process Engaging–key stakeholders |
Poor Quality Case series with no comparator to control Single site health system |
| Cohen [47] 2016 USA |
Healthcare Professionals: Medical Oncology Gastroenterology Surgery Pathology Laboratory Medical Genetics Genetic Counselling Patients: Patients with colorectal cancer Healthcare Institution: An outpatient cancer care centre for oncology patients treated at a tertiary academic National Cancer Institute (NCI)-designated Comprehensive Cancer Consortium |
Triggered GC referral after abnormal IHC and MSI Handouts on referral process for LS for healthcare professionals Results tracking by nurse Shared GC e-mail to review all abnormal MSI and IHC Electronic communication with doctor Scheduling GC and CRC clinic appointments synchronously |
Outcome 1. GC referral +9.4% (95% CI -7.9–26.8) p value not provided Outcome 2. Completion of GC +9.4% (95% CI -7.9–26.8) p value not provided Outcome 3. GT completion +10% (95% CI -47.6–67.6) p value not provided |
Service: Effectiveness • GT undertaken • GC apt uptake Equity • GT access • GT undertaken CFIR Inner setting Readiness for implementation • available resources Process Engaging • key stakeholders |
Poor Quality Cohort study with historical control Single site health system with no analysis on confounding variables or regression analysis on the characteristics inherent in the control verses the intervention population or health system |
| Kemp [40] 2019 UK |
Healthcare Professionals: All gynaecology oncology and cancer genetics health professionals unspecified Patients: Breast cancer patients Healthcare Institution: Publicly funded cancer unit at a major treating centre–cancer genetics services available |
Education for healthcare professionals Testing protocol pathway Handouts for patients and healthcare professionals Standardised letters for results Standardised consent form |
Outcome 1: GT completion I: 1184/1184 (100%) C: NR p value not provided Outcome 2. GC completion after GT I: 115/117 (98.3%) C:NR p value not provided Outcome 3. Patients identified with BRCA mutations I: 117/1184 (9.9%) C: NR p value not provided |
Implementation: Acceptability • Satisfaction with mainstreaming intervention Service: Effectiveness • GT completion • Patients with identified gene mutations Patient centeredness • Patients satisfaction with mainstreaming intervention Equity • GT access • GT undertaken Client: Cancer prevention • Identification of hereditary Cancer CFIR Intervention Characteristics • Cost Inner setting Readiness for implementation • access to knowledge & information Outer setting Needs & Resources of Those Served by the Organization Characteristics of Individuals Self-efficacy Process Engaging |
Poor Quality Case series with no comparator to control Single site health system |
| Richardson l [54] 2020 Canada |
Healthcare Professionals: Oncologists Genetic counsellor Patients: Breast and ovarian cancer patients Healthcare Institution: Population state based cancer program in Canada |
Oncologist led pathway and communication Education for healthcare professionals Written information for clinician use Standardised consent form |
Outcome 1. Acceptability I: Patients indicated comfort and acceptability with the GT process—no difference between oncology clinic-based model (OCB) and the traditional model (TM). OCB M = 4.54, SD = 0.71 vs TM M = 4.52, SD = 0.69. See Table 5 below C: NR Outcome 2. GC completed +58.6% (95% CI 49–68) and +8.5% (95% CI -8.2–25) in person and videoconference P< 0.001 OCB vs TM Outcome 3. GT completed +8.5% (95% CI -8.2–25 and +7.6% (95% CI -9.4–25, p = 0.015) OCB vs TM Outcome 4. Patients identified with BRCA mutations +3.1% (95% CI -6.7–13) p = 0.507 OCB vs TM Outcome 5. Time to gain access to GT results -212 days P< 0.001 OCB vs TM |
Implementation: Acceptability • Satisfaction with mainstreaming intervention Service: Effectiveness • GT undertaken • GC referral Equity • GT access • GC referral • GT undertaken Client: Knowledge Acceptability Satisfaction Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation • access to knowledge & information • available resources Outer setting Needs & Resources of Those Served by the Organization Process Engaging • key stakeholders Reflecting & Evaluating |
Good to Fair quality Cohort study with concurrent control State-wide health system with analysis on confounding variables or regression analysis on the characteristics inherent in the control verses the intervention population or health system Representation of patient population selective–all patients didn’t complete survey. Small proportion of all patients included |
| Grinedal [53] 2020 Norway |
Healthcare Professionals: Medical oncologist General Surgeon Gynaecologist Genetic Counsellor Geneticist Patients: Breast cancer patients Healthcare Institution: Regional and urban hospital in Norway |
Education for healthcare professionals Testing pathway Written information for clinician use Standardised consent form |
Outcome 1. GC referral I:131/356 (36.8%) C: NR p value not provided Outcome 2. GC completion I:125/356 (34.6%) C: NR p value not provided Outcome 3. GT completion I:125/131 (95.4%) C: NR p value not provided |
Service: Effectiveness • GC referral • GC completion • GT completion Client: Equity • GT access • GC referral • GT undertaken CFIR Inner setting Readiness for implementation • access to knowledge & information • available resources Process Engaging • key stakeholders |
Poor Quality Case series with no comparator to control |
| Rumford [52] 2020 UK |
Healthcare Professionals: All gynaecology oncology health professionals unspecified Patients: EOC patients Healthcare Institution: Publicly funded cancer unit at a major treating centre |
Education for healthcare professionals Testing protocol pathway Handouts for patients and healthcare professionals Standardised letters for results Standardised consent form |
Outcome 1. GC referral I:255/268 (95%) C: NR p value not provided Outcome 2. GC and GT completion I:255/268 (95%) C: NR p value not provided Outcome 3. Patients identified with BRCA mutations I:34/255 (13.3%) C: NR p value not provided Outcome 4: Time to gain access to GT I: Turnaround time between blood sample and return of GT result was 20.6 (11–42) calendar days C: Turnaround time of 148.2 calendar days prior to I Outcome 5. Treatment management impact I: 9/34 received a PARPi 5/34 receiving platinum-based chemotherapy–clinician intent to initiate PARPi chemotherapy 15/34 still receiving first-line (adjuvant) treatment or in remission—not eligible for PARPi 5/34 ineligible to receive PARPi C: NR p value not provided |
Service: Efficiency • Time to gain access to GT Effectiveness • GC referral • GC completion • GT completion Client: Equity • GT access • GC referral • GT undertaken Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation • access to knowledge & information • available resources Process Engaging • key stakeholders |
Poor Quality Case series with no comparator to control Single site health system |
| McLeavy [51] 2020 UK |
Healthcare Professionals: Oncologist Patients: All EOC patients Healthcare Institution: Publicly funded tertiary referral centre |
Education for healthcare professionals Testing protocol pathway Handouts for patients and healthcare professionals Standardised letters for results Standardised consent form |
Outcome 1. Acceptability I: Decision Regret Scale 9.14±12.397–14/29 (48.3%), reported no decision regret 26/29 (89.6%) were satisfied with their decision to pursue GT Participants produced relatively low MICRA scores regardless of mutation status C: NR p value not provided Outcome 2. GC completion I:170/170 (100%) C: NR p value not provided Outcome 3. GT completion I:170/170 (100%) C: NR p value not provided Outcome 4. Patients identified with BRCA mutations I:23/170 (13.5%) C:NR p value not provided |
Implementation: Acceptability • Satisfaction with decision to undergo GT Service: Effectiveness • GT completed • Patients with identified gene mutations Patient centeredness • Patients satisfaction with mainstreaming intervention Equity • GT access • GT undertaken Client: Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation • access to knowledge & information Outer setting Needs & Resources of Those Served by the Organization Process Engaging • key stakeholders |
Poor Quality Case series with no comparator to control Single site tertiary hospital setting |
| Group 4: Results trend towards the control | |||||
| Long [42] 2018 Australia |
Healthcare Professionals: Medical oncologist Surgeons Pathologist Genetic Counsellor and Geneticist Radiation oncologist Oncology nurses Oncology and genetics admin Palliative care Patients: Patients with colorectal cancer Healthcare Institution: NR |
Education Standardised text for pathology reports and interpretation handouts Handouts on referral process for LS for healthcare professionals EMR documentation of GC/GT and/or referral via email MDT documentation of GC and pathology outcomes Results tracking |
Outcome 1. Eligible for referral to GC Hospital A +7.24% (95% CI -2.3–17) Hospital B -1.88% (95% CI -9.4–5.6) Outcome 2. GC referral Hospital A -25% (95% CI -71-20) Hospital B +0.76% (95% CI -22-24) |
Service: Effectiveness • GC referral CFIR Inner setting Readiness for implementation • access to knowledge & information • available resources Process Engaging • key stakeholders Reflecting and evaluating |
Poor Quality Cohort study with historical control Two hospital sites but with no analysis on confounding variables or regression analysis on the characteristics inherent in the control verses the intervention population or health system |
| Swanson [37] 2018 USA |
Healthcare Professionals: Surgeon Allied health staff Nurse Administrative Resident and fellow, Medical oncologist Geneticist Genetic counsellors Patients: All women with EOC Healthcare Institution: A tertiary care centre |
Education for patients and healthcare professionals Family history collection proforma Handouts for patients EMR documentation of GC/GT and/or referral Testing protocol pathway Scheduling GC appointments directly at gynaecology clinic |
Outcome 1. GC referral +27.4% (95% CI 11.1–43.7, p = 0.02) Outcome 2. GC completion -27.8% (95% CI -46.7 to -9.1) p value not provided Outcome 3. GT completion +20.6% (95% CI 5.9–35.4) p value not provided Outcome 4. Patients identified with BRCA mutations - 17.9% (95% CI– 40.9–5.1, p = 0.17) |
Service: Effectiveness • GC referral • GC and GT completion Equity • GT access • GC referral • GT undertaken Client: Cancer prevention • Identification of hereditary Cancer CFIR Inner setting Readiness for implementation • access to knowledge and information Process Engaging • key stakeholders Executing |
Fair Quality Cohort study with historical control Single site health system and no analysis on confounding variables or regression analysis on the characteristics inherent in the control verses the intervention population or health system |
MDT multidisciplinary team, EMR electronic medical record, EHR electronic health record GC Genetic Counselling, GT Genetic testing, I intervention, C comparator, NR not recorded, TT tumour testing, UTS universal tumour screening, MSI microsatellite instability testing, IHC immunohistochemistry, TNBC triple negative breast cancer, BrCa breast cancer, CRC colorectal cancer, VUS variant of unknown significance, EOC epithelial ovarian cancer, LS Lynch syndrome, PARPi poly (ADP-ribose) polymerase inhibitor