putting everything together drug resistance survey.ppt · To define responsibilities of all team members For approval of the study by the Ministry of Health Putting everything together:

Putting everything together:

drug resistance survey protocol

development, budget and checklist

Putting everything together:

drug resistance survey protocol

development, budget and checklist

Wayne van GemertWayne van GemertWHO Stop TB Department, Geneva

TB surveillance and surveys: a training workshop for consultants

Geneva - 24-27 May 2011

Why do we need a protocol?Why do we need a protocol?Why do we need a protocol?Why do we need a protocol?

� To solidify details in a single document that can be shared

and referred to

� To define responsibilities of all team members

� For approval of the study by the Ministry of Health

Putting everything together: drug resistance survey protocol development, budget and checklist

TB surveillance and surveys: a training workshop for consultants – 24-27 May 20112

� For approval of the study by the Ministry of Health

� For approval of the study by ethical bodies

� For fundraising purposes / to justify budget

Main elements of a protocolMain elements of a protocol

Introduction and background

Objectives

Sampling

Intake of patients and logistics

Laboratory methods

Trainings



(see Annex 6)

Trainings

Survey monitoring plan

Data management and analysis

Ethical clearance

Human resources

Detailed budget

Elements of a survey protocolElements of a survey protocol

1. Introduction and background

� Country profile- population, relevant geographical/climatic

conditions, administrative divisions, anything relevant that

might affect the sampling frame of the survey

� Epidemiological situation of:

� TB, including smear positive case notifications by diagnostic

centre



centre

� MDR-TB, if anything known (past surveys, routine data)

� HIV (and TB/HIV)

� National TB control programme (NTP) information, including:

� Strategy

� Operational design

� Drug regimens used


1. Introduction and background (continued)

� Management of patients with MDR-TB

� Treatment outcome data: TB and MDR-TB cohort analysis

� TB laboratory network:

� Design

� Quality assurance system, including:



� Internal quality assurance

� External quality assurance, including SRL link

� Health care providers not formally linked to the NTP

� Private sector

� Penitentiary services

� Other non-NTP public providers of TB care


2. Objectives of the survey (clearly in paragraph or list format)

– To determine the frequency of drug resistance patterns of first-

line anti-TB drugs among new smear-positive TB cases in the

[public] sector of [city/country name];

– To determine the frequency and drug resistance patterns of

first-line anti-TB drugs among previously treated smear-positive

TB cases in the [public] sector of [city/country name];



TB cases in the [public] sector of [city/country name];

– To determine the frequency and drug resistance patterns of

second-line anti-TB drugs in strains with confirmed resistance to

isoniazid and rifampicin; and

– To determine the association between drug-resistant TB and

HIV status (And age? sex? Other risk factors: substance abuse,

history of incarceration, etc…?)


3. Survey sampling

� Sampling frame- geographic area and sectors (civilian, etc)

� Survey design:

� 100% sampling of diagnostic centres

• For how many months?



� Cluster sampling

• How many and how large is a cluster?

• List of clusters at diagnostic centres

� Sample size and the statistical basis for its calculation


4. Intake of patients and logistics

� Intake period

� Rotate the intake by region to alleviate burden?

� Inclusion and exclusion criteria

� Include:

� Smear-positive patients



� Smear-positive patients

� Children?

� Exclude:

� Smear-negative

� Extrapulmonary patients

� Patients who have already started treatment


4. Intake of patients and logistics (continued)

� Sputum collection process

� How specimens will be managed at diagnostic centres /

intermediate labs / central lab / to SRL (?)

� How specimens/isolates will be transported

� Patient interview process Annex 9



� Patient interview process

� Recording forms:

� Clinical information form

� Sputum shipment form

� Laboratory results form

Annex 9


5. Laboratory methods

� Use of microscopy, media preparation, culture and

identification

� Chosen methods for DST and diagnostic algorithm

� Established system of quality assurance

� Internal quality control of DST and other laboratory



� Internal quality control of DST and other laboratory

processes

� External quality assurance, including proficiency testing in

advance, rechecking of samples, pre-survey onsite

assessments

� Biosafety measures


6. Trainings

� Training plan for all involved staff, including responsibilities, timing, location, topics, forms, etc.

� Separate training needs for: diagnostic centre coordinators, clinicians, laboratory staff

� Training topics:

• Enrolment of study subjects



• Enrolment of study subjects

• Use and management of clinical information forms

• Determining previous anti-TB treatment

• Registration of specimens

• Management/transport of specimens at each level

• Laboratory techniques

• Registration of laboratory results and management of laboratory forms


7. Survey monitoring plan

� Supervisory trips of the coordination team to the diagnostic

centres a few weeks after start of enrolment

� Monitoring of procedures: patient enrolment and laboratory

� Troubleshooting

� Check registers to ensure that all eligible patients are being



� Check registers to ensure that all eligible patients are being

enrolled

� Re-interviewing of a subsample patients

� Organization of a midterm central meeting to discuss progress

and problems


8. Data management and analysis

� Development of a database

� Data collection plan

� Double entry

� Data monitoring

� Data analysis



� Data analysis


9. Ethical clearance

� Availability of treatment for patients

� If DR-TB treatment is not yet available, start preparations in

parallel

� Patient consent form

� Patient should be informed and not exploited



� Patient should be informed and not exploited

� Confidentiality of patient data

� Data collection, management, analysis, storage

� Ethical review panel


10. Human resources

� Identification of national coordination team members

� Should cover the main three operational levels

1.Programme management (Logistics, collection of patient clinical information, supervision)

2.Laboratory

3.Epidemiology / statistics (sampling, data management and analysis)



3.Epidemiology / statistics (sampling, data management and analysis)

� Team members usually consist of:

�Principal investigator

�NTP manager, or someone designated

�NRL manager, or someone designated

�Epidemiologist / Statistician

� Responsibilities of each coordination team member

Budgeting

Budgeting for a drug resistance surveyBudgeting for a drug resistance survey

A drug resistance survey budget:

� Should be detailed

� Should be created in advance

� Should identify the source of funds

� By line item, if coming from different funding sources

� Average survey costs: 100,000-150,000 USD



� Average survey costs: 100,000-150,000 USD

Item Type of unit Cost/unit # units Total

Human resources

Principal investigator 0

Laboratory principal investigator 0

Information technology specialist 0

Laboratory technician(s) 0

Logistics staff (e.g. drivers, data entry,

secretarial) 0

0

Consumables

General (e.g. stationary, printing…)

0

Sputum containers 0

Reagents 0

Pure substances 0

Other ( ) 0

0

Equipment

Safety cabinet 0

Centrifuge 0

Computer 0

Other, including inspissator,

refrigerators ( ) 0

0

Meetings

Initial meeting, follow-up meeting 0

Per diem 0

Transportation of attendees 0

Meeting room costs 0

0

Training

Training of personnel for intake 0

Subtotal

Subtotal

Subtotal

Subtotal

Annex 8




Per diem 0



0

Collection and domestic transport of

specimens

Transport containers, packaging 0

Transport costs (fuel, air/bus,

postage)

0

Collection and international transport

of specimens to SRL*



postage) 0

0

SRL costs

Visit 0

Proficiency testing costs 0

ID and DST costs, including human

resources 0

0

Supervision

Per diem 0

Transportation of supervisor 0

0

0

Subtotal

Subtotal

Subtotal

Subtotal

TOTAL

Subtotal


Human resources






secretarial) 0

0

Consumables


0

Sputum containers 0

Reagents 0

Pure substances 0

Other ( ) 0

0

Equipment

Safety cabinet 0

Centrifuge 0

Computer 0


refrigerators ( ) 0

0

Meetings


Per diem 0



0

Training


Subtotal

Subtotal

Subtotal

Subtotal

Note:

•Lines depend on the team

•A survey is added work

•Incentives motivate staff = a better product




Per diem 0



0


specimens



postage)

0





postage) 0

0

SRL costs

Visit 0



resources 0

0

Supervision

Per diem 0


0

0

Subtotal

Subtotal

Subtotal

Subtotal

TOTAL

Subtotal

= a better product

•Contract external people if needed


Human resources






secretarial) 0

0

Consumables


0

Sputum containers 0

Reagents 0

Pure substances 0

Other ( ) 0

0

Equipment

Safety cabinet 0

Centrifuge 0

Computer 0


refrigerators ( ) 0

0

Meetings


Per diem 0



0

Training


Subtotal

Subtotal

Subtotal

Subtotal

Note:

•Some items may need to be purchased centrally and distributed to diagnostic centres to ensure quality




Per diem 0



0


specimens



postage)

0





postage) 0

0

SRL costs

Visit 0



resources 0

0

Supervision

Per diem 0


0

0

Subtotal

Subtotal

Subtotal

Subtotal

TOTAL

Subtotal

ensure quality


Human resources






secretarial) 0

0

Consumables


0

Sputum containers 0

Reagents 0

Pure substances 0

Other ( ) 0

0

Equipment

Safety cabinet 0

Centrifuge 0

Computer 0


refrigerators ( ) 0

0

Meetings


Per diem 0



0

Training


Subtotal

Subtotal

Subtotal

Subtotal




Per diem 0



0


specimens



postage)

0





postage) 0

0

SRL costs

Visit 0



resources 0

0

Supervision

Per diem 0


0

0

Subtotal

Subtotal

Subtotal

Subtotal

TOTAL

Subtotal


Human resources






secretarial) 0

0

Consumables


0

Sputum containers 0

Reagents 0

Pure substances 0

Other ( ) 0

0

Equipment

Safety cabinet 0

Centrifuge 0

Computer 0


refrigerators ( ) 0

0

Meetings


Per diem 0



0

Training


Subtotal

Subtotal

Subtotal

Subtotal

Note:

•Ideally three central meetings of representatives from each participating centre-before, during, and after




Per diem 0



0


specimens



postage)

0





postage) 0

0

SRL costs

Visit 0



resources 0

0

Supervision

Per diem 0


0

0

Subtotal

Subtotal

Subtotal

Subtotal

TOTAL

Subtotal

before, during, and after

•Coordinating team should meet biweekly/monthly


Human resources






secretarial) 0

0

Consumables


0

Sputum containers 0

Reagents 0

Pure substances 0

Other ( ) 0

0

Equipment

Safety cabinet 0

Centrifuge 0

Computer 0


refrigerators ( ) 0

0

Meetings


Per diem 0



0

Training


Subtotal

Subtotal

Subtotal

Subtotal

Note:

•Trainings can be centralized, regionalized, or at each diagnostic




Per diem 0



0


specimens



postage)

0





postage) 0

0

SRL costs

Visit 0



resources 0

0

Supervision

Per diem 0


0

0

Subtotal

Subtotal

Subtotal

Subtotal

TOTAL

Subtotal

or at each diagnostic centre


Human resources






secretarial) 0

0

Consumables


0

Sputum containers 0

Reagents 0

Pure substances 0

Other ( ) 0

0

Equipment

Safety cabinet 0

Centrifuge 0

Computer 0


refrigerators ( ) 0

0

Meetings


Per diem 0



0

Training


Subtotal

Subtotal

Subtotal

Subtotal




Per diem 0



0


specimens



postage)

0





postage) 0

0

SRL costs

Visit 0



resources 0

0

Supervision

Per diem 0


0

0

Subtotal

Subtotal

Subtotal

Subtotal

TOTAL

Subtotal


Human resources






secretarial) 0

0

Consumables


0

Sputum containers 0

Reagents 0

Pure substances 0

Other ( ) 0

0

Equipment

Safety cabinet 0

Centrifuge 0

Computer 0


refrigerators ( ) 0

0

Meetings


Per diem 0



0

Training


Subtotal

Subtotal

Subtotal

Subtotal




Per diem 0



0


specimens



postage)

0





postage) 0

0

SRL costs

Visit 0



resources 0

0

Supervision

Per diem 0


0

0

Subtotal

Subtotal

Subtotal

Subtotal

TOTAL

Subtotal


Human resources






secretarial) 0

0

Consumables


0

Sputum containers 0

Reagents 0

Pure substances 0

Other ( ) 0

0

Equipment

Safety cabinet 0

Centrifuge 0

Computer 0


refrigerators ( ) 0

0

Meetings


Per diem 0



0

Training


Subtotal

Subtotal

Subtotal

Subtotal

Note:

•Discuss with the partner SRL in advance what are their needs

•Pre-survey visit, post-




Per diem 0



0


specimens



postage)

0





postage) 0

0

SRL costs

Visit 0



resources 0

0

Supervision

Per diem 0


0

0

Subtotal

Subtotal

Subtotal

Subtotal

TOTAL

Subtotal

•Pre-survey visit, post-survey visit to discuss findings, visit during the survey if problems are found


Human resources






secretarial) 0

0

Consumables


0

Sputum containers 0

Reagents 0

Pure substances 0

Other ( ) 0

0

Equipment

Safety cabinet 0

Centrifuge 0

Computer 0


refrigerators ( ) 0

0

Meetings


Per diem 0



0

Training


Subtotal

Subtotal

Subtotal

Subtotal




Per diem 0



0


specimens



postage)

0





postage) 0

0

SRL costs

Visit 0



resources 0

0

Supervision

Per diem 0


0

0

Subtotal

Subtotal

Subtotal

Subtotal

TOTAL

Subtotal

Thanks!

Documents

putting everything together drug resistance survey.ppt · To define responsibilities of all team members For approval of the study by the Ministry of Health Putting everything together: