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Table 4 Data extraction template

From: Medical device procurement in low- and middle-income settings: protocol for a systematic review

No.

Question/item

Tick if applicable

Answer (if applicable)

   

Example answers below

1.

Study ID + bibliographic information

  

2.

Type of record

  

Is the record a guideline/recommendation/policy document or an academic article?

  

Is the document part of a greater study/document? (if so, appraise that document as well but link information relating to evidence)

  

Are the authors contactable?

  

3.

Institution of origin and who the institution reports to

  

Record institution (if this is an academic article, record university)

  

Why did the institution develop the record?

  

Under what remit does the institution operate? (e.g. if university was commissioned to develop record, record how the institution commissioning the research will use the record, if specified)

  

4.

Setting/country of origin and any information regarding the below (note if specified in record)

  

Economic and development indicators: HDI level, GDP, GDP/capita, Health expenditure as % GDP, % total government expenditure or medical device expenditure as % of health budget

  

What does the disease burden look like? Is any epidemiological evidence presented?

  

How is health care funded?

  

What other factors related to country/countries in question are mentioned (e.g. income inequality, access to health care, national security, infrastructure, health service infrastructure)?

  

5.

Methodological data: Answers to be recorded to the below questions from the record considered.

  

1) Is prioritization of medical device purchasing/selection explicit?

  

a) If yes, describe the method presented in the record and further evaluate below questions.

  

2) Is it clear who/what institutions hold the responsibility for medical device management?

  

a) If yes, note the institutions and their remit (e.g. national, international).

  

3) Are budget impact (national, local or by facility level) or national health care/service funding policies mentioned and if so is any relation to procurement or prioritisation made explicit?

  

4) Is health technology assessment mentioned?

  

Health technology assessment example phrases: evidence base; clinical and cost effectiveness data; HTA appraisal systems; HTA process—i.e. timing, cost, staffing, expertise, national/international remit.

  

a) If yes, is it clear how the HTA evidence is integrated into the prioritisation and procurement decisions? Describe the mechanism.

  

b) Is it clear who is responsible for HTA appraisal and for issuing recommendations? Who has access to the HTA evidence? How is this disseminated?

  

5) Are direct care providers mentioned?

  

Examples of direct care providers: nurses, medics, volunteers etc.

  

a) If so, is it clear what their influence on purchasing/prioritisation is? (e.g. do they directly commission, do they prefer certain suppliers)

  

b) Are any issues regarding staff training and ability to deliver services mentioned? (e.g. staff may not be trained to use a particular device)

c) Is it clear how staff is involved in the maintenance of medical devices?

  

6) Are care pathways or clinical guidelines mentioned?

  

Examples of clinical guidelines: WHO guidelines for diabetes management, etc.

  

a) Is it clear what clinical guidelines or care pathway information was used in device selection or prioritisation?

  

7) Is health needs assessment mentioned?

  

a) If yes, what are the health priorities of the population in question and how were they derived in the HNA process?

  

b) Is it clear how the health needs assessment informed procurement decisions?

  

8) Are commissioning strategies for health services and equipment mentioned?

  

For example: Afghanistan’s MSH guide on “Equipment for BPHS for Health Posts” refers to a national procurement strategy so both documents would need to be evaluated and the national procurement strategy would form the basis for the guide assessed.

a) If yes, record what types of strategies are mentioned? (e.g. national, international)

  

b) If yes, what is the relation of said strategy to the current record being assessed? Does one form the basis of the other, do they operate complementarily and is adherence to one or the other or both mandatory?

  

c) Follow up on the national or local strategy and undertake a record assessment.

  

9) Are health service delivery facilities (e.g. hospitals, health centres, mobile units) mentioned?

  

a) If yes, which facilities are directly mentioned?

  

b) If yes, is it clear which medical devices are a priority for each facility or facility level?

  

c) If yes, are ambient conditions of the facility necessary for device performance mentioned? (e.g. running water, electricity availability)

  

d) If yes, and if a device list is present, is it clear if device purchasing was restricted to a particular class of devices: e.g. consumables that do not require electricity, mobile devices that need little maintenance, etc.

  

10) Does the record mention expert advice on the device procurement/prioritisation?

  

a) If yes, what kind of expert would be consulted and what documentation do said experts provide to inform device procurement/prioritisation?

  

11) Are particular standards regarding devices mentioned? Mentions of standardization regarding devices could include naming specific brands, product specifications, specific suppliers, specific regulatory nomenclatures)

  

12) Are any costs mentioned in the record?

  

a) If so, record which costs are mentioned.

  

13) Are execution strategies mentioned in regards to particular health campaigns? (either of national or international importance)

  

Examples include: HIV/AIDS campaigns which are commissioned through UNAIDS

  

a) If yes, who/what institution advises on device procurement and prioritisation?

  

b) Is it clear what the recommendations regarding device procurement are? Note down recommendations.

  

14) Are more up to date versions of lists/guidelines/methods of the same record present?

  

a) If yes, appraise newer record versions as well.

  

15) Is evidence of evaluation strategies regarding procurement lists, guides, methods present?

  

a) What evaluation strategies are mentioned?

  

b) Who undertakes said evaluations?

  

c) Is it clear what evidence is being used to inform evaluations?

 

6.

Equipment related data: Answers to be recorded to the below questions.

  

1) What are the main categories of equipment included in record?

  

a) Renewable supplies

  

b) Surgical supplies

  

c) Condition specific

  

d) Record the equipment categories mentioned.

  

2) How detailed is the equipment specification? (i.e. are measurements mentioned; is a description provided;)

  

3) How many distinct products are mentioned?

  

4) Is a mix of devices mentioned and is it clear if certain devices are complementary (i.e. they need to be used in conjunction with one another)?

  

5) Does the list mention how many items of one product to purchase?

  

6) Are any national/regional device coverage targets set? (i.e. how many devices/institution/region

  

7) Is any cost data present and if so, note down what cost data is available.

  

8) Is any information on installation available and if so, note what recommendations are given.

  

9) Is any information on maintenance available and if so, note what recommendations are given.

  

10) Is any information on necessary ambient conditions supplied and if so, note what said conditions are. (i.e. “needs constant electricity supply”)

  

11). Is any recommendation regarding device disposal given and if so note what said recommendation is.

  

7.

Capacity building: Answers to be recorded to the below questions.

  

1) Does the record outline any strategies for training people in medical device purchasing or medical device management?

  

a. If yes, record what said strategies are.

  

8.

Notes

  

Recording of any additional information that seems of relevance.

  

Example: WHO Priority Medical Devices frequently refers to diagnostic coding systems and disability classification systems.

  
  1. Provided as Excel spreadsheet to reviewers. Data extraction template provided to reviewers.