Streamlining Protocols-From Strategy to Implementation. Doreen Ramogola-Masire Botswana UPenn Partnership June 2014

Transcription

1 Streamlining Protocols-From Strategy to Implementation Doreen Ramogola-Masire Botswana UPenn Partnership June 2014

2 Botswana-UPenn Partnership Partnership between Government of Botswana, University of Botswana and University of Pennsylvania; active since 2001 Capacity building across: clinical care teaching research and global health programs more than 150 full-time staff

3 Botswana National Cervical Cancer Prevention Strategy HPV DNA test project SECONDARY PREVENTION :Screening & treatment Year 1 Year 2 Year 3 Year 4 Year 5 PRIMARY PREVENTION: HPV Vaccine demonstration project

4 Summary of Key Elements of the Cervical Cancer Prevention Strategy For Botswana Screen age group at least once in 5 years Francistown, Selibe-Phikwe, Maun, Mahalapye and Lobatse Aim for coverage of 80% Utilize existing Pap screening infrastructure, with visual inspection after acetic acid (VIA) as alternative method Link women to treatment Cryotherapy Loop electrosurgical excision procedure (LEEP) (following Colposcopy) Record data in a format that can be evaluated to inform next strategy

5 Original Scale Up Sites

6 Thinking About Operationalizing the Strategy It is relatively easier to run pilot projects Implementing a national public health program is complex and challenging

7 Cervical Cancer Prevention in HIV-Infected Women Using the "See and Treat" Approach in Botswana Pilot prevention project started 2009 Primary Clinic: Bontleng Nurse led clinic Screening with VIA Picture taken with camera - enhanced digital imaging (EDI) Treatment with Cryotherapy Women with severe abnormalities referred All pictures reviewed by team weekly Referral Clinic: PMH Physician led Colposcopy/LEEP service Colp and LEEP Also provide Colposcopy/LEEP service for patients with abnormal Pap Smears

8 The Process Start small and use of lessons learned from pilot program Make protocols as evidence-based as possible Develop an African/Botswana Solution Keep in mind the resources available Get protocols into use

9 Lessons Learned From The Pilot Think through the whole process Patient flow Information flow both clinical and lab based Keep it simple Streamlining of the information collection forms Standardize where possible Management algorithms Ensure all relevant stakeholders affected are involved Supply chain Reusing supplies that can be autoclaved Inventory management critical

10 Evidence-Based Understanding the current evidence WHO guidelines ASCCP guidelines etc Talking to experts in the field Use of locally generated evidence

11 Developing African/Botswana Solution Get local stakeholder involvement and buy in Customising protocols developed in South Africa by Lyn Denny and in Zambia by Grosbeck Parham and colleagues Leverage expertise in the continent and elsewhere Lyn Denny, Grosbeck Parham Advisors: CDC Atlanta-Sara Forhan ASCP ASCCP NCI, PRRR And many more

12 Keep in Mind Resources Available Especially when under pressure from the politicians! Utilize available evidence in the context of available resources-eg we needed to: Set up screening and treatment sites Train new providers Set up new supply chain Maintaining quality at multiple levels around the country Think about data collection and management Understanding capacity Laboratory services-what volume of work they can cope with Personnel at all levels

13 Forms These ensure key information elements are collected Initial and Follow up VIA examination Initial and Follow up Colposcopy/LEEP examination Results

14 Algorithms These aid decision making: Triaging of Pap smear results at the lab and clinics Clinical guidance to nurses and doctors doing procedures VIA/Cryotherapy, including follow up Colpo/LEEP, including follow up Management of Histology Results

15 ALGORITHM #1 PAP SMEAR RESULTS - MANAGEMENT ALGORITHM PAP SMEAR results Normal (NILM) LSIL or ASCUS ASC-H HSIL AGC/AGC-FN/AIS *Abnormal Endometrial Cells Cancer (SCC or Adenocarcinoma) If HIV Repeat PAP SMEAR 5 years If HIV+ Repeat PAP SMEAR 3 years Repeat PAP SMEAR after 1 year Refer for COLPOSCOPY Endo Sampling Refer for URGENT COLPOSCOPY PAP SMEAR results after 1 year Normal (NILM) LSIL or ASCUS ASC-H HSIL AGC/AGC-FN/AIS *Abnormal Endometrial Cells Cancer (SCC or Adenocarcinoma) If HIV If HIV+ Repeat PAP SMEAR 5 years Repeat PAP SMEAR 3 years Refer for COLPOSCOPY Refer for URGENT COLPOSCOPY *All women with Pap smear showing: 1. ABNORMAL endometrial cells regardless of age 2. Presence of NORMAL Endometrial Cells in a patient 40 yrs or over should be referred for endometrial sampling Endo Sampling

16 Botswana NCCPP* PAP SMEAR RESULTS MANAGEMENT ALGORITHM FOR CLINICS PAP SMEAR RESULTS If HIV Repeat PAP SMEAR 5 years Normal (NILM) If HIV+ Repeat PAP SMEAR 3 years LSIL or ASCUS Repeat PAP SMEAR after ONE year HSIL ASC-H Refer for COLPOSCOPY AGC/AGC-FN/AIS Abnormal Endometrial Cells at any age OR Normal Endometrial Cells, if patient is aged 40 Cancer (SCC or Adenocarcinoma) Refer for URGENT COLPOSCOPY (If second PAP SMEAR result is LSIL, ASCUS, HSIL, ASC-H, AGC, AGC-FN, AIS or CANCER, refer for COLPOSCOPY) Refer for ENDOMETRIAL SAMPLING *National Cervical Cancer Prevention Programme If unsure, please call the PMH Women s Health Clinic within the IDCC: /4, or

17 TABLE 1. NEW MANAGEMENT RECOMMENDATIONS FOR CERVICAL CYTOLOGY (PAP SMEAR) RESULTS [1] PAP RESULT NILM (Normal) LSIL or ASCUS HSIL ASC-H AGC or AGC-FN AIS SCC Adenocarcinoma RECOMMENDATION FOR MANGEMENT If HIV-negative -> repeat Pap smear 5 years If HIV-positive -> repeat Pap smear 3 years Repeat Pap smear 1 year If 2 nd LSIL or ASCUS result -> REFER for colposcopy REFER FOR COLPOSCOPY URGENT REFER FOR COLPOSCOPY NILM=Negative for intraepithelial lesion or malignancy HSIL= High grade squamous intraepithelial ASC-H= Atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion LSIL= Low grade squamous intraepithelial lesion ASCUS= Atypical squamous cells of undetermined significance AGC= Atypical glandular cells AGC-FN= Atypical glandular cells favour neoplasia AIS= Adenocarcinoma insitu SCC= Squamous cell carcinoma [1] NCCPP Five Year Comprehensive Cervical Prevention and Control Strategy( )

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19 ALGORITHM #2 VIA CLINIC: INITIAL VIA Pelvic Exam Findings Normal Abnormal Perform VIA Vulvar lesion Heavy Menses Discharge Clinical Cancer VIA Impression Return after menses for VIA Rx for infection Return 2 weeks for VIA Refer urgently to COLP Clinic Negative HIV-: Follow up at VIA clinic in 5 years HIV+: Follow up at VIA clinic in 3 years Positive Uncertain Inadequate (SCJ not entirely seen) Suspicious for Cancer Lesion Outside TZ Eligible Cryo *Not Eligible Cryo Defer Cryo to specified date No Cryotherapy performed? Refer to COLP Clinic Yes * Not Eligible for Cryo if: Follow up at VIA clinic in 1 year 1. Lesion Covers > 75% of cervix 2. Extends into cervical os 3. Lesion too thick for cryo 4. Atypical vessels / Punctations /Mosaicism 5. Suspicious for Cancer 6. Lesion outside TZ Consult if unsure at any stage.

20 Potential Challenges Algorithms not trickling down to clinic levels, especially the Pap smear results algorithm NCCPP engagement of District Health Teams The Lab not linking recommendations for cytology and histology to the algorithms Can lead to confusion amongst local clinic providers Discussions with Lab teams with constant feedback from pilot team Keeping track of new evidence becoming available Deciding when and how to incorporate it into protocols

21 The Most Important Thing.. Have the courage to accept the not so perfect and get going Remember-you can only steer a moving ship!