WikiJournal Preprints/Purchasing High-Cost Medical Equipment in Hospitals in OECD Countries: A Systematic Review Protocol

Introduction
According to the World Health Organization (WHO), medical devices and equipment are essential for good health system performance. Without their adequate design, selection and distribution, there could be a heightened risk of patient safety incidents, poor patient outcomes and security alerts, as well as potential inefficiencies and waste.

The process of medical device and equipment selection or acquisition refers to how it is purchased. Medical device and equipment purchasing, more comprehensively known as procurement, goes beyond basic contracting between the supplier and health provider; it requires consideration of user needs, technical maintenance, training needs, adequate consumables, and how they are disposed. The WHO has provided guidelines for medical device procurement to improve health systems, but their usability in practice has not been tested. Evidence suggests that the processes surrounding purchasing medical devices and equipment, specifically within hospitals, are currently not optimised. For example, a 2016 government review found unwarranted variation and calculated that up to £1bn of the country's £9bn procurement spend could be saved via adopting more efficient best practices and modern systems. A more recent scoping literature review of the logistics function in hospitals demonstrated that logistics functions could be highly inefficient and fragmented.

Understanding how purchasing occurs in hospitals can help us uncover why some of these inefficiencies exist by exploring the inner workings of the environment, protocols, behaviors and organization of purchasing staff and purchasing departments, and thereby identifying areas for improved practices. However, to our knowledge, there are no comprehensive reviews that demonstrate existing approaches, practices and methods used for purchasing medical devices and equipment within hospitals, specifically in high-income settings. The most similar existing reviews that we found so far include a review of methods for procurement of medical devices and equipment focusing specifically on low- and middle-income countries, a realist review of the theoretical and empirical literature on procurement and supply chain management practices more generally, and a rapid evidence assessment of literature from the non-health sector to inform health purchasing and supply chain management. None of these systematically searched for academic studies that focussed on the internal workings of a hospital to identify current practices and understand purchasing behaviors, processes and approaches.

Objective
We propose to conduct a systematic literature review to identify studies that describe how high-cost medical equipment is purchased in hospitals in high-income settings. Specifically, this entails identifying any process, procedure, method, or approach used within a hospital to decide which equipment would be purchased.

We focus on high-cost medical equipment because we recognise that the process and potential funding sources for higher-cost equipment differ from lower-cost devices and commodities (which tend to be bought in higher volumes). Our interest is specifically in how decisions come to be made about final purchases. Higher-cost equipment tends to involve a decision-making process more than 'routine' items, therefore targeting studies that describe such interactions and processes in hospitals rather than the set-up or infrastructure for all materials and supplies. We limit our study to high-income countries cognizant of an existing systematic review that has already been conducted for low- and middle-income countries by Diaconu et al. (2017).

Furthermore, two distinctions need to be made clear: First, we note that a large body of work focuses on Health Technology Assessment (HTA), which evaluates technology's impacts in specific healthcare contexts compared to alternatives. Not all technologies will have gone through an HTA exercise, and not all technologies that are assessed through a national or small-scale HTA will eventually be purchased. Therefore, our review focuses on the steps after such assessment by focusing on whether and how the final purchasing decision is made and whether the equipment was assessed through an HTA exercise. Second, we acknowledge that medical equipment purchasing sits within other activities in hospitals, including materials management, logistics, finance and procurement specialist departments, and overall health technology management (comprising the domains of planning, needs assessment, selection, procurement, donations, inventory, installation and maintenance). For a broader view of how the medical device and equipment purchasing function of a hospital fits within its wider activities, we refer readers to the WHO procurement process resource guide.

Methods
We will follow the Cochrane recommendations in conducting this systematic review and PRISMA guideline in reporting the protocol.

Inclusion criteria
We will include both primary and secondary studies if they meet the following criteria:
 * The study includes a description of the process (approach, methods, practices) for the purchase (also known as procurement or acquisition) of high-cost medical devices and/or equipment in a hospital setting
 * HTA studies will be included only if they are hospital-based (also known as mini-HTA or hospital-based HTA) studies and are reported to have influenced or led to the purchasing decision or a final purchase
 * The study proposes or describes a proposed model of the purchasing processes (approaches, practices, methods) of high-cost medical devices/equipment for a hospital setting
 * The study setting is one or more hospitals or departments within a hospital
 * The study reports on any stage in the purchasing process for high-cost medical devices/equipment in hospitals, including device evaluation, planning and needs assessment, and procurement.
 * The intended or final purchased product is a single or a group of high-cost (also known as high-value or capital) medical devices or equipment.
 * All study designs are included.
 * All studies conducted between 2000-2020 to represent 'current' processes reported in hospitals.

Exclusion criteria
Studies will be excluded based on the following criteria:

Study scope

 * The study reports only on the purchase of pharmacological agents or vaccines or body organs, tissues, and cells
 * The study is about the purchasing/procurement of services, workforce, or other purchases made in hospitals
 * The study is about lower-cost medical equipment. We are conscious that no financial value can be given across hospitals globally for identifying what constitutes high cost. We, therefore, selected studies in which the authors themselves identified the products as 'high-value' or 'high-cost' or specified they were 'capital' expenditures. For other articles, we applied the following criteria:
 * Any single-use medical devices will be excluded, as they are assumed to be lower cost.
 * Studies that do not clarify the type of device/equipment as the subject of the study will be excluded.
 * Studies that refer to bulk or high-volume purchases are assumed to be about low-cost devices/equipment and are excluded.
 * The study is about hospital building equipment, stationary, or hospital materials that are not considered medical devices/equipment
 * The study is only about Health Technology Management (HTM) improvements or clinical engineering function in hospitals, more generally, if there is no mention or implications for purchasing/procurement.
 * The study is about HTA for national agencies that inform procurement decisions, but there is no indication that the HTA exercise informed the process and/or decision for purchasing within the hospital.
 * The study is about HTA in a hospital (also known as mini-HTA or hospital-based HTA) and has no reported link to influencing the procurement process.
 * Papers about medical or surgical procedures when procurement and/or purchasing processes provide context to the study but are not the paper's focus.

Setting

 * The study is based in a country not included in OECD membership at the time of the study. We used this OECD membership list to apply a standardised criterion for 'high-income' countries.
 * The study is about group purchasing arrangements among hospitals. We limit the review to the studies of processes within a hospital. Studies related to group purchasing arrangements tend to focus on financial value, and we are interested in the procedures and approaches within hospitals.
 * The study is about the process by a national or central agency that makes standard specific recommendations for medical device/equipment to be purchased in hospitals

Study type

 * Non-academic articles, news, webpages, notes are excluded, even if they describe current practices in hospitals.
 * Commentaries and editorials from experts, professionals and/or academics that only offer advice on procurement practices, even if based on real-world experience, will be excluded.
 * Conference papers with no full text available excluded.

Language

 * Studies reported in languages other than English (no time and resources available for translation)

The excluded papers that contain useful information for the introduction or discussion sections of the final report will be kept separately outside the screening process.

Systematic search
We will search the following databases, including conference proceedings and grey literature with no limitations to document type or publication date:


 * Cost-Effectiveness Analysis Registry
 * EconLit and ProQuest Dissertations & Theses A&I via ProQuest
 * Embase via Ovid SP (1974 – search date)
 * Health Management and Policy Database via Ovid SP
 * IEEE Xplore Digital Library
 * International HTA Database
 * MEDLINE and MEDLINE in Process via Ovid (1946 – search date)
 * NHS EED via CRD Web
 * Science Citation Index-Expanded, Conference Proceedings Citation Index-Science, and Emerging Sources Citation Index via Web of Science
 * Scopus
 * Zetoc conference search

As recommended, an information scientist will design, test, and run the searches. The search consists of three main blocks of setting (hospitals), product (medical equipment, high-cost), and process (purchasing or procurement). Because of the lack of standard terminology for reporting high-value (or high-cost) equipment, we will search for all medical devices and equipment and select the studies relating to high-value equipment during the screening process. We will run a scoping search before the final systematic search to capture some of the important literature to use as a gold standard set to test the systematic search. The following search strategy for MEDLINE via Ovid SP will be translated into the syntax of other databases:
 * 1) *Health Facilities/ or exp *Hospitals/ or exp *Hospital Departments/ or exp *"Equipment and Supplies, Hospital"/ or exp *Purchasing, Hospital/ or (Hospital or Hospitals or Hospice*).ti,ab.
 * 2) *"Equipment and Supplies"/ or exp *"Equipment and Supplies, Hospital"/ or exp *Biomedical Technology/ or (Device* or Equipment* or Supply or Supplies).ti,ab.
 * 3) exp *Purchasing, Hospital/ or *Value-Based Purchasing/ or exp *Technology Assessment, Biomedical/ or (Procur* or Purchas* or HTA or HTAs or miniHTA or miniHTAs or (Technolog* adj1 (Apprais* or Assess* or Evaluat*))).ti,ab.
 * 4) 1 and 2 and 3

Other search methods
To capture unindexed materials, we will extend the search to more grey literature using Google Scholar and Google. Besides, we will check the references of included studies (backward citation tracking) to identify more relevant studies. Furthermore, we will check the citations to the key cited papers among the included studies (forward citation tracking). In the context of this review, key cited papers are papers that have been cited in more than one included study and are likely to be cited in more relevant studies.

If we identify any journals that have not been indexed in the databases but have published at least two of the included studies, we will manually browse all issues of these journals to identify more relevant studies.

We will consider searching the websites that we find to be focused on the topic of this review using Google Site Search.

If we identify reviewers or experts that focus on the topic of this review, we will contact them to identify more relevant studies.

Study selection
We will use EndNote to remove the duplicates and Rayyan for screening the titles and abstracts. Two independent reviewers will pilot the screening for the first 500 titles to clarify the eligibility criteria. One reviewer will perform the title/abstract screening using a sensitive approach to include any relevant (Included Folder) or slightly relevant studies (Maybe Folder). At least two other independent reviewers will re-screen these two folders, and the disagreement will be resolved in weekly group discussions. We will obtain full-text for the papers marked as Included or Maybe by at least two reviewers. Two reviewers will screen each paper's full texts independently, and disagreements will be discussed and solved during bi-weekly group meetings. When disagreement continues, expert opinion will be sought from the third reviewer. Reason for exclusion will be recorded for any excluded paper at this stage.

Data extraction
We will design and test the data extraction form in Microsoft Excel to enter the following extracted data:
 * Year of publication: Year in which the study was published
 * Setting: Country in which the study took place, and number of hospitals included in the study
 * Product (equipment): Type of high-cost equipment that is the subject of the study (if specified)
 * Intervention: Purchasing process, approach or method outlined in the study
 * Main outcome or lessons learned: Outcomes, lessons and/or recommendations emerging from the study
 * Method: The research method adopted in the study
 * Limitation(s): Limitations of the study as reported by the study authors

One reviewer will extract the information from each study, and the work will be double-checked and, if necessary, completed by another reviewer. Any questions will be discussed in the bi-weekly meetings.

Data synthesis
We will summarise the information from the literature in tables and lists. Since this review will not make any analysis to make recommendations for practice, we will not conduct any quality assessment of the included studies; however, we will report the limitations listed by the researchers for their study.

Protocol registration
This review was registered in Open Science Framework (OSF).

Funding information
This project was initially funded through an internal grant from King's College London awarded to Saba Hinrichs-Krapels and later subsidised through the internal grant for the Delft Technology Fellowship awarded to Saba Hinrichs-Krapels.

Authors contribution
FS and SHK drafted this protocol. HB, BD, AC, JE commented on the draft protocol. All authors read and approved the final manuscript before submission.

Competing interests
The authors have no competing interest.

Ethics statement
This review will not be performed on any animal or human subjects.