9 1 Clinical Guidelines And Protocols

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Clinical guidelines and care protocols



Clinical guidelines and care protocols are intended to provide information, based on an appraisal of the current best evidence of clinical and cost-effectiveness, regarding therapeutic interventions for given conditions. These protocols address the integrity and security of patient data, how medication is administered, how medical staff interact with the patient, and hospital / clinic policy.
One of the most important clinical protocols is the security of patient data and the possession of well-protected storage platforms to prevent the theft of private information.

What are protocols and guidelines?

Protocols are agreed frameworks outlining the care that will be provided to patients in a designated area of practice.
Guidelines are sets of evidence-based recommendations that aid decision-making about care in specific health systems and resource settings.
Practice guidelines - Diagnostic and treatment guidelines are systematically developed, evidence-based recommendations for assisting physicians in making specific clinical circumstances.
Protocols are locally adapted procedures, lists of systematically produced interventions or algorithms, and steps to follow in certain situations.
The protocols are developed by representatives of all professionals involved in patient care.

The importance of protocols and guidelines

Because each research unit addresses different scientific problems with different methods, particular units may need to develop their own specific rules or guidelines regarding the prevention of academic misconduct. Such rules or guidelines should be provided to all new investigators when they start work in the unit.
Importance of Standards in Business Quality
Having an established set of standards and protocols can increase the quality of the services rendered or products created. Standards and protocols allow for managers and supervisors to outline the correct way to accomplish something.

Importance of Following Health Protocols : Exemple ; Covid-19


The only way we can limit the spread of COVID-19 is to strictly adhere to health protocols.
During these challenging times, we must rely on one another to do the right thing and remain vigilant in our everyday practices to help reduce the risk to those around us.

Social Distancing, Wear Face Coverings in Common Spaces, Avoid Parties or Social Gatherings Outside of Health Protocols, COVID vaccination…

COVID-19 Vaccine is used for the prevention of coronavirus disease 2019 (COVID-19) in people aged at least 18 years. COVID-19 Vaccine contains a molecule called messenger RNA (mRNA) that contains instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. COVID-19 Modern Vaccine does not contain the virus itself and cannot cause COVID-19. Animal studies do not indicate harmful effects with respect to pregnancy or lactation. Data on immunocompromised persons (persons with weakened immune systems) are limited. Immunocompromised individuals may, however, be vaccinated because they may be at increased risk for COVID-19 disease.

Examples of Medical Protocols

Acute Care Hospitals Protocols

for: heparin administration
insulin infusion
management of patients having seizures
pain management
wound care
ADL/progressive mobility
dietary management

Rehabilitation Hospitals Protocols

for: self-administration of Metered Dose Inhalers
self-administration of small volume nebulizers

Long-Term Care Protocol

for: anticoagulants for atrial fibrillation

School Health Protocol

for: Heparin IV Lock Care

Home Care

Not currently using

Type of guidelines and protocols


Chronic obstructive pulmonary disease (COPD) is the only leading cause of death with rising morbidity and mortality. Clinical practice guidelines to optimize pharmacotherapy for patients with COPD have been updated based on promising results of randomized clinical trials
Patients with a clinical diagnosis of COPD, confirmed by spirometry, who presented to the ambulatory clinics, were enrolled.The primary outcome was provider's adherence to the 2007 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
Subjects were categorized as guideline-concordant who received a rescue inhaler (all patients), or at least one long-acting bronchodilator (stage II), or at least one long-acting bronchodilator plus an inhaled corticosteroid (stage III-IV).
Clinical information and type of provider were recorded. Provider type was classified as primary care physician (PCP), pulmonologist, or co-management by both.
Among 450 subjects who met study criteria, 246 (54.7%) received guideline-concordant treatment. Age, sex, race, disease severity, and co-morbidities were not associated with guideline adherence.


Just over half of stable COPD patients receive guideline-concordant care. Co-management by a PCP and pulmonologist increases the likelihood of receiving guideline-concordant inhaler therapy.
The importance of evidence in guideline development
As previously discussed, the purpose of practice guidelines is to help decision-makers make informed decisions. At least three types of information and judgement are needed for practice 6 guidelines to lead to a rational conclusion. First, clinical judgement is needed to identify and diagnose health problems, to learn what health outcomes are important to the patient and to identify what diagnostic, preventive, treatment or rehabilitation options should be considered. Second, to estimate the effects of different options on health outcomes, judgements must be made about their effectiveness and adverse effects. Information on effectiveness and adverse effects should come from comparative studies, particularly systematic reviews of reliable and valid evidence. Taken together, these first two types of judgement and information provide estimates of the expected outcomes associated with the options considered. It is then necessary to make judgements about trade-offs between benefits, harms and costs. The core element of systematically developed evidence-based practice guidelines is an explicit and systematic review of the available comparative evidence. There is more likely to be agreement if good evidence is available. Moreover, if the process is explicit there is less likely to be unexplained variation between recommendations in different guidelines on the same topic. Those developing guidelines should consider prospectively what study designs are likely to provide valid, reliable data with which to answer their questions. First, it is important to be cautious about including non-randomized studies in a review of the effects of health care given the potential for bias, which generally leads to an overestimate of the effects. Non-randomized studies are, however, the studies of choice for establishing prognosis (cohort studies) and the accuracy of diagnostic tests (cross-sectional studies). Second, given the difficulties involved in locating all relevant studies and the risk of publication bias, extensive efforts are required to produce complete systematic evidence reviews. Given these problems, guideline developers should consider using existing reviews such as those produced by the Cochrane Collaboration or the US Agency for Health Care Policy and Research (AHCPR). Because medical knowledge and practice environments evolve continuously, guidelines have a shelf life after which they should be reassessed.

Evaluation of health care practice guidelines

Despite the proliferation of clinical guidelines, until recently there was uncertainty about their capacity to change clinical behaviour. Grimshaw & Russell have systematically and exhaustively searched for studies of guideline evaluations and published two reviews; an initial review including 59 studies (7) followed by an update with 91 (9). Of the studies, 34 addressed preventive care, 35 clinical care, and 22 prescribing or use of investigations. Two thirds were based in primary or ambulatory care. The review showed that most guidelines had expected positive effects on the process (81/87) and outcome (12/17) of health care. Most of the interventions were shown to have some effect at least some of the time, although the effect sizes varied enabling the reviewers to identify which aspects of guideline programmes were associated with greater effects on clinician performance. A summary of the factors influencing the successful implementation of guidelines is given in Table 1.

Table 1. Factors influencing the successful introduction of guidelines


General reminder of guidelin:

Although the Grimshaw & Russell review provides evidence of guideline effectiveness and an indication of the more effective strategies, there remain a number of limitations in the current evidence. First, most studies were of short duration and it is unclear whether the effects can be sustained. Second, the impact of guidelines on nurses has not been addressed in many studies. Third, the issues involved in dissemination and implementation of multiple guidelines, as required in non-specialist practice, has not been studied. Fourth, the cost-effectiveness of guideline programmes has received little attention to date. Finally, our relatively poor understanding of the clinical decision-making process, which is the key target of guidelines, hampers further elaboration of guideline implementation.

Ethical and legal aspects of health care guidelines

There are ethical and legal implications of many aspects of health care guidelines, including the distribution of health care resources, negligence, malpractice without negligence, and physician and patient autonomy. Probably the most important aspect relates to the distribution of health care resources, which has been one of the major motivations for guideline development. Explicitly or implicitly guidelines have both health care improvement and economic goals. Guidelines will always have foreseeable economic consequences, therefore the economic goals should be explicitly defined. There are at least four major potential economic goals of guidelines: first, to reduce unnecessary and harmful care; second, to encourage optimal care for acceptable costs; third, to encourage acceptable care for optimal costs, and fourth to encourage care in “the corridor” between the second and third goals above. The appropriate economic goal should be determined before decisions are made as to whether guidelines should have policy or reimbursement implications, on the definitions of appropriate care, or on who should be expected to use the guidelines. When economic goals are inconsistent, unrealistic, or unstated, the credibility and likelihood of implementation of guidelines is jeopardized.

Guideline developments in Europe

A number of countries in Europe have launched programmes for the systematic development and implementation of guidelines, although few are nationally coordinated. Finland, France, the Netherlands, Scotland and Sweden, for example, have some form of nationally coordinated programme. Many other countries have a range of local or national guideline activities run by professional medical, local and regional authorities or health research organizations. There are two main approaches to guideline development being followed in the nationally coordinated programmes; the top-down and bottom-up approaches. In France, for example, the centrally coordinated National Agency for the Development of Medical Evaluation (ANDEM) has produced an extensive series of national guidelines using a range of methods such as expert consensus conferences, systematic evidence-based development processes based on the US Agency for Health Care Policy and Research (AHCPR) methodology (taking up to two years per guideline), and less intensive medical references (taking up to six months per guideline). Regional dissemination along with local and national audits supported by legal and professional regulation have resulted in widespread awareness of the guidelines. The Swedish Council for the Evaluation of Medical Technology (SBU) uses expert groups to produce reviews based on systematic literature reviews. Since 1988 they have produced over 20 systematic reviews on the use and effectiveness of medical technology. Many of the reports are extensive, but some have been distributed as guidelines and the evaluation of one guideline on preoperative routines indicates it has had a major impact on practice. In the Netherlands, a nationally coordinated programme for setting clinical guidelines in general practice has followed a more bottom-up approach. A series of over 60 guidelines have been developed over seven years by general practitioners, rather than specialists, through the Dutch College of General Practice. The systematic evidence-based process followed is similarly rigorous to the French and Swedish programmes, with each guideline taking up to one and a half years and US $75 000 to develop. Core groups of five to eight experienced general practitioners develop the guidelines following set criteria; these are then reviewed by specialists and a randomly selected group of general practitioners. Dissemination has been mainly through a professional general practice journal. Extensive evaluation has been carried out on a number of the earlier guidelines which have in general been well received. The guidelines have been presented as a support for daily work and not a tool for controlling doctors. They are not seen by Dutch doctors as suitable for licensing or budgeting purposes, although evaluation suggests they have nevertheless been cost-effective

Guideline development in many other European

countries involves a mix of activities without systematic and explicit nationally agreed criteria such as those used in the French and Dutch initiatives. There is a considerable level of guideline activity in countries such as the United Kingdom. Many initiatives in the United Kingdom have been supported through funding from the National Health Service (NHS) Research and Development (R&D) Programme which now receives almost 1.5% of the total NHS budget. There are a number Royal College guideline programmes and a pilot English guidelines appraisal programme using explicit quality development criteria, while the NHS has a Centre for Reviews and Dissemination which undertakes two to four systematic reviews per year and distributes the results as research reports and compact guideline pamphlets aimed at decision-makers. The United Kingdom component of the Cochrane Collaboration and a number of evidence-based practice units have also been funded through the NHS R&D programme and are either directly or indirectly (through, for example, the production of evidence reviews and critical appraisal training programmes) involved in guideline development. There is also considerable guideline activity in Germany, with clear distinctions being made between mandatory guidelines and recommendations. There is no nationally coordinated approach although there have been national developments. The Association of Scientific Medical Societies (AWMF) have, for example, coordinated a library of over 170 Internet-based guidelines. A bottom-up initiative from the national Surgical Society has been based on developing clinical algorithms from experiences with individual patients. Quality assurance schemes in Germany have also been instrumental in the development of guidelines, which are clearly necessary for evaluation programmes. In Spain, guideline developments have focused more on preventive and public health activities. For example, the Spanish Society of Family and Community Medicine has drawn up, disseminated and supported the adoption of evidence-based recommendations for prevention. In eastern Europe, recent major political and economic changes have made guideline development difficult. Historically many central directives came through guidelines. While in some countries (such as the Russian Federation) it may be possible to build new guideline programmes based on previous structures, in other countries (such as the Czech Republic) guidelines are associated with the old political regimes and are now considered unacceptable. However, the development of health insurance programmes, decentralization of services, increased physician autonomy, increased international contact and availability of new technology, have led to major increases in cost and greater variation in care. As a result, there has been renewed interest in quality and cost control mechanisms such as guidelines.

Guideline developments outside Europe

The discussion included two presentations from the United States and one from New Zealand, and was not intended to provide a comprehensive review of international developments.



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