Evaluating the impact of investing in the industry of clinical practice guidelines for health systems

Rationale: This research has been conducted to facilitate evidence-informed policymaking and to help health-care policymakers in Saudi Arabia to decide whether or not a sustainable investment in the CPG industry is socially and economically viable. Objectives: The objective is to investigate: (i) whether the clinical practice guidelines help to improve clinical practice and save costs, and (ii) the views in Saudi Arabia about implementing clinical practice guidelines. Methods: The study employs mixed methods, including: (i) a literature review to evaluate the benets of implementing clinical practice guidelines, and (ii) an online survey to investigate views about implementing the guidelines' benets. Results: (i) The clinical practice guidelines do help in improving clinical practice, but the evidence about their impact on saving costs is insucient in the literature. (ii) The survey demonstrated a high level of awareness among health system actors in Saudi Arabia of the importance of having nationally unied clinical guidelines. Recommendations: Investment in the clinical practice guidelines industry seems socially and economically viable.


Introduction
Clinical practice guidelines (CPGs) relate to clinical matters, generally dealing with clinical conditions or symptoms, and are usually meant for use by health-care providers and other health-care actors such as health services managers, payers, patients, and their caregivers. Clinical guidelines are standardised recommendations for health-care practitioners on how to diagnose and treat medical conditions systematically to ensure that patients receive optimal health care. These clinical guidelines usually summarise the most updated medical knowledge and weigh the bene ts and harms of diagnostic and treatment procedures to provide statements that include recommendations based on recent high-quality medical evidence or health technology assessment with a view to optimising patient care. Therefore, they should be reviewed and updated regularly. Clinical guidelines are not legally obligatory. They assist healthcare practitioners and patients in deciding on appropriate health care for particular clinical circumstances, which means that health-care providers do not have to follow the recommendations if they believe they are not suitable for some patients based on their clinical judgments, but deviations from guidelines must be justi ed (1)(2)(3).
Clinical guidelines are meant to enhance the effectiveness and quality of care, decrease variations in clinical practice, and reduce the costs from unnecessary medical procedures, preventable mistakes, and adverse events. Quality improvement initiatives are associated with CPGs, as evidence-informed recommendations constitute the basis for identifying core outcomes and measurable standards of care (2). Both health-care regulators and payers can use measurable standards of care. Health-care regulators can use measurable standards to assess the performance of health-care providers and to monitor patient safety, while healthcare payers who adopt the strategy of performance-based pay or value-based health-care payment can use measurable standards to reward or penalise health-care providers. Furthermore, clinical guidelines can be used in local contexts as a reference for standardised medical procedures by health-care payers to estimate the local costs of health-care services.
In recent decades, several non-pro t organisations have invested in the CPG industry worldwide, including the World Health Organization (WHO), the National Institute for Health and Care Excellence (NICE), the Scottish Intercollegiate Guidelines Network (SIGN), and the Australian National Health and Medical Research Council (NHMRC). The investment usually includes CPG development, reporting, adoption, contextualisation or adaptation, evaluation, and implementation (2). The continuing innovations in healthcare technologies and the growing amount of medical evidence used in this eld can be overwhelming and require consistent investment of more resources in the CPG industry.
However, investing in the CPG industry may have unintended consequences. First, they may fail to change practice. Dissemination strategies can be distinguished as being either active or passive. The active or dynamic dissemination approach, which is preferred among health-care practitioners, involves procedures such as proactive education of health-care practitioners, electronic reminder systems, and audit and feedback, while the passive dissemination approach is mainly based on publishing or mailing updated information (4)(5)(6)(7)(8). Taking diabetes CPGs as an example, the evidence shows that the level of diabetes CPG awareness among health-care providers, which is considered an indicator of greater adherence to the guidelines, ranges between 75% and 89% in Turkey, the United States, and China. In comparison, it is around 51% in Saudi Arabia (6). The low level of CPG awareness among health-care providers may lead to lowering the value that is supposed to be returned from investing in the CPG industry.
Second, CPGs may face professional resistance. Some health-care practitioners do not follow CPGs, as they argue that each patient has different needs, particularly in terms of medicine. These reasons and unsustainable resources for investment may lead health-care policymakers to be hesitant to commit to such investment. However, this can be addressed if health system policymakers use a more proactive strategy for dissemination and link the quality initiatives with the payment systems to health-care providers, which would increase the level of CPG awareness among health-care providers intuitively.
Third, insu cient investment in the CPG industry may also lead to unintended consequences related to using low-quality clinical guidelines not updated according to the most recent and high-quality evidencebased medicine or health technology assessment, which may lead to patients being prevented from receiving the most effective treatments available in the market or sometimes being over treated, which will in turn affect patients' health outcomes and the cost of care (2,(9)(10)(11).
Taking their promise and unintended consequences together, there are contradictory opinions among healthcare policymakers about the importance of sustained investment in the CPG industry to providing uni ed national CPGs that can be used locally as a reference by health system actors, including health-care providers, regulators, and payers, and consequently whether such investment would have a signi cant impact on quality of care measures such as patients' health outcomes and the cost of care. In view of these tensions, this research has been conducted to facilitate evidence-informed policymaking and to help healthcare policymakers in Saudi Arabia to decide whether or not sustainable investment in the CPG industry is socially and economically viable. This is done through answering the following questions:

Methods
Mixed methods research techniques were used to evaluate the impact of investing in the industry of CPGs for health systems.
1. In the rst part of the research, a literature review was carried out to summarise available evidence that evaluates the bene ts of implementing CPGs, which include: improvement of clinical practices and reduction of the cost of care.
2. The second part of the study comprised a brief online survey sent to selected professionals in the health-care industry (COVID-19 prevented face-to-face interviews) to discover their perceptions about the bene ts of having and implementing uni ed national CPGs for health systems.

Literature Review
Information sources A literature review was conducted by searching PubMed, Google Scholar, Cochrane library, and CPG providers' websites, where reviews could potentially be found about the impact of their clinical guidelines, in order to identify the most applicable English-language publications without time restriction (up to July 2020). The following key words were used in the search strategy for PubMed, Google Scholar, and Cochrane library: bene t analysis, impact analysis, effectiveness, cost-effectiveness, clinical guidelines, clinical practice guidelines, clinical pathways, quality, value, cost. Moreover, the reference lists of identi ed papers were reviewed to locate other relevant publications not identi ed in the database search.

Study design
The literature review includes any report, review, or systematic review of empirical research that reviewed the impact of the implementation of CPGs for any health condition(s) on quality of care, patient outcomes, or cost of care.

Principal outcomes
The major outcomes of interest are the bene ts, harms, or limitations that are reported as a result of implementing CPGs. Bene ts could refer to improvements in quality performance metrics and patient outcomes after implementing CPGs. These might include, for example, a reduction in length of stay in hospitals, a reduction in the mortality rate among patients with a speci c health condition, a decrease in the number of hospitals and emergency admissions or in the number of patients who developed health complications from a particular disease. Also, bene ts might refer to improvements in the status of healthcare spending as a result of implementing clinical guidelines.

Analysis
All information that is collected from reports and papers were summarised and analysed descriptively.

Data collection
A brief online survey was sent to selected professionals in the health-care industry (COVID-19 prevented face-to-face interviews) to discover their views about the bene ts of having and implementing uni ed national CPGs for health systems. The questionnaire was sent to a purposive sample of candidates who have experience with decision-making or contributing to policymaking, and it asked them the following questions: Do you know the purpose of CPGs?
Do you think having a national/uni ed reference for clinical practice guidelines is essential?
What bene ts might health-care regulators obtain from having a national/uni ed reference of CPGs?
What bene ts might health-care providers obtain from having a national/uni ed reference of CPGs?
What bene ts might health-care payers obtain from having a national/uni ed reference of CPGs?

Analysis
The obtained answers were summarised and analysed thematically.

Study selection
The Impact of Guideline Implementation on improving clinical practice and cost savings from academic published papers.
Three out of four reviews examined reported improvements in clinical practice, including in health process, quality of care, and health outcomes. While only one of these four reviews examined the impact of CPGs on cost of care, it shows that reductions in cost ranged from 6% to 56%.
The two reviews that examined the impact of clinical pathways for hip and knee replacements generally revealed a reduction of complications and length of stay in hospital. But, before considering the effectiveness of implementing the clinical pathways for total hip and knee replacement therapies, the failure of accounting the length of stay in rehabilitation facilities should be considered because the cost of care would be shifted from acute care hospitals to rehabilitation facilities if patients were discharged earlier.
The one review that describes the impact of CPGs on oncology treatment revealed that compliance with the guidelines can lead to reducing the length of stay in hospital and complications, which should result in cost reduction without affecting patients' satisfaction. Another review assesses the impact of enhanced recovery after surgery protocols versus standard of care on preoperative outcomes of radical cystectomy and shows that the implementation of the protocols was associated with better quality of care and patient outcomes.
However, the review that evaluates the impact of implementing guidelines for mental care on improving clinical practice outcomes does not show any effect of treatment guidelines (Table 1). The Impact of Guideline Implementation on improving clinical practice and cost savings from CPGs providers reports.
From a search of CPG providers, it was found that NICE is reviewing the impact of their guidelines. NICE is a non-departmental public body in the United Kingdom, which is responsible for developing and providing national guidance and quality standards to improve health and social care. NICE has initiated resource impact analysis, which is also known as budget impact analysis, to assess nancial changes in the use of resources as a result of implementing guidelines. NICE considers resource impact analysis for each guideline ve years after the guideline's publication and focuses on the costs or savings resulting from implementing the guideline during those ve years; cost-saving estimates are not considered to be signi cant if they are less than £5 million for England (23). NICE has published several resource impact analysis reports for several guidelines that show signi cant annual cost savings as a result of implementing guidelines, ranging from £5.3 million to £17 million ( Figure 1). These guidelines pertain to diagnosis and assessment of recent onset chest pain, the use of UrgoStart to treat diabetic foot ulcers and leg ulcers, the use of virtual chromoendoscopy to assess colorectal polyps during colonoscopy, the use of HeartFlow FFR CT to estimate fractional ow reserve from coronary CT angiography, the use of Thopaz and portable digital systems to manage chest drains, diagnosis and management of chronic heart failure in adults, the use of the XprESS Multi-Sinus Dilation System to treat chronic sinusitis, abortion care, and diagnosis and management of diverticular disease (24) ( Table 2).

Survey Results
In the online survey, responses were received from 29 participants who were professionals in the health-care industry and familiar with the Saudi health system context. These comprised: 17 participants who were health-care providers, six who were health-care regulators, one who was a health-care payer on behalf of patients, and ve participants who were researchers in the health-care industry. Twenty-seven participants were fully aware of the purpose of CPGs. Of these, 24 agreed that having a national uni ed reference for CPGs is essential, while four participants neither agreed nor disagreed, and one participant disagreed.
The participants were also asked open questions about what bene ts health-care actors might gain from having a national uni ed CPG reference, and the answers received from 27 participants indicated the following: The benefits health-care regulators might gain In summary, the responses show that uni ed national CPGs would enable health-care regulators to optimise the quality of care services, including by protecting patient safety and preventing malpractice, and to reduce the number of medical errors by: Helping regulators to identify core outcomes and measurable standards of care and collect meaningful data to monitor the quality of care, allowing the regulators to intervene and modify when needed to enhance health-care services. Furthermore, transparency and publishing these data to the public would help patients to choose better-performing health-care providers, and it would provoke positive competition between health-care providers to improve their standards of care. Also, these data would help health-care payers to reward or penalise health-care providers, mainly if the health-care payment system is connected to the quality initiative.
Providing a reliable, accountable, e cient reference to support regulators in creating standards for health-care-accredited training centres. Consequently, this would help in reducing unwarranted care practice variation and would improve the quality and safety of health care.
Supporting the development of national policies, in particular health bene ts packages, to minimise the gap in treatment plans through including the best health-care practices, and the most cost-effective medical procedures and treatments.
The benefits health-care providers might gain Most health-care providers agreed that updated national uni ed clinical guidelines would represent a trustworthy peer-reviewed approach to health care and offer providers a reference for best practices in health care customised to the local context. This could help providers to: Standardise treatment plans for safer practice that would minimise the number of patient complaints and enable correct management of expectations and avoid confusion, thereby protecting health-care providers against lawsuits. Furthermore, standardised medical practice would help providers to unify drug purchases and justify medical billings and claims.
Set the bar high among all local health-care providers so that patients bene t from additional services and competition among health-care providers.
One respondent, who was a health-care provider, claimed that guidelines could be bene cial in terms of optimising quality but argued that, in medicine, every case is unique so disagreed about having national uni ed CPGs guidelines.

The benefits health-care payers might gain
Most of the respondents agreed that having a national reference for standardised medical practices would help health-care payers' to: Unify drug purchases, standardise medical billing, and justify medical claims, which would make getting approval for treatment plans and cost tracking consistent Improve value and minimise ine cient costs to avoid nancial risks by excluding unnecessary care services and preventing waste and abuse that might be practised by health-care providers Use the core outcomes and measurable standards to compare providers' performance, which would create a better negotiation tool for comparing health-care service prices.

Discussion
The literature review shows there is a signi cant impact of implementing CPGs on improving clinical practice, including clinical process, quality of care, and patient outcomes, which ultimately lead to improved cost-e ciency or a reduction in the cost of care, but the impact on cost of care was not examined su ciently. However, the achievement of cost savings from implementing the guidelines ve years after publication are subject to several factors, including health-care provider training and adherence to CPGs, the affordability for local health-care resources to adopt new clinical pathways or new technology, and the availability and supply chain of health-care technology in the local market, which is in uenced by health-technology producer capacities and their capabilities of negotiation with the providers and buyers of care services regarding price. In addition, adherence to guidelines when lacking su cient local resources may lead to inequity issues and put care providers and payers under pressure because this may prevent all eligible patients with certain health conditions from having equal access to optimal care services. Other factors related to hospital management may be related to estimates of cost saving, such as quality improvement initiatives or policy changes in hospitals, the method used to translate CPGs into practice clinical pathways, and the introduction of case mix. Furthermore, considering pre-and post-implementation of guidance in the study design may result in overestimating the cost savings.
The survey results demonstrated a high level of awareness among health system actors in Saudi Arabia of the importance of having national uni ed clinical guidelines, although there still is no active body or organisation within the Saudi health system developing CPGs or adopting international guidelines and customising them to the local context to be used by health-care actors as a reference for standardised health care. Therefore, it is recommended that the government should invest in the CPG industry on the premise that it would lead to achieving the triple aims of value-based health care that improves quality of care and patients' outcomes and reduces unnecessary costs.
Although some health-care providers disagreed about having national uni ed CPGs-claiming that guidelines could be bene cial in terms of optimising quality but that every case is a unique experience in terms of medicine-the literature shows that when considering the practice improvement methods, all are harmonious with the complementary paradigms of both evidence-based practice as well as practice-based evidence. These include starting the process guidance, process monitoring, and outcome management, which aim to improve clinical practice by changing the behaviour of health care practitioners. It was claimed that mainly psychological, surgical, and physiotherapy interventions are different in this respect from health technology interventions, including pharmacological and medical device interventions where, following choice of medication or medical device to prescribe, there is little or no need for calibration (34). However, there are similarities. Both need calibration, especially considering that continuing innovations in health-care technologies and the growing amount of medical evidence used in this eld can be overwhelming and require consistent investment of more resources for calibration, and also considering the six dimensions of quality that include accessibility, acceptability to patients, appropriateness to patients need, equity, effectiveness and e ciency (2,35). Moreover, many have argued that the physicians should not only be the agent of the patient, but they should also be the steward of society's limited resources available for health care. If medical associations or groups who produce or develop guidelines consider a criterion of clinical effectiveness and cost-effectiveness, they could be taking a societal economic perspective. If guidelines are based only on clinical effectiveness and do not consider cost-effectiveness this would make physicians poor stewards of societal resources. In the United Kingdom, this dual role is recognised with the clinical practice groups incorporated into contracts between purchasers and providers (36). Elsewhere, health-care payers may play a role in limiting access to the optimal care services, for example, by applying co-payment policies for certain medicines or medical procedures (37).

Policy Implications
From the summarised evidence above, it can be concluded that investing in the CPGs industry is socially and economically viable. For e cient investment in CPGs, it is recommended that, rather than reinventing the wheel, policymakers could create a strategic partnership with one of the well-known organisations in the CPG industry such as NICE. Also, the strategic partnership could be with higher education institutes and medical associations in the country to support the new national body in providing evidence-based medicine and conducting health technology assessment to review and update clinical guidelines consistently. The CPGs should be adopted or developed locally, if possible, to best consider issues like value judgements, resource use, local context characteristics, and feasibility, which are aspects that may differ depending on the sector (public or private) or country contexts (38). In Canada, family physicians develop their own guidelines, which leads to greater compliance than when they receive guidelines developed by others (36). In Saudi Arabia, there are three entities with a role in improving clinical practices and the value of health care through evidence-based practice. These are the national centre for evidence-based health practice, which is part of the Saudi Health Council, the scienti c health societies which are part of the Saudi Commission for Health Specialities, and various health societies that come under the education institutions umbrella. However, their efforts are not completely coordinated nor perfectly integrated with a lack of su cient resources to provide uni ed national CPGs that can serve all local bene ciaries including health care providers either in public or private sectors, health care payers, health sector regulators, patients, and medical schools. Nevertheless, this research has shown that there is value in developing a set of CPGs for Saudi Arabia and that health policy and professional leaders are receptive to the idea. The next challenge will be to build consensus among the three entities to drive this agenda forward.