RCPs not only implement protocols, now they are also designing them.

 The role of respiratory care practitioners (RCPs) in effectively and efficiently implementing protocols is well established. Our experience indicates that appropriately trained RCPs are ideally suited to design as well as implement evidence-based protocols. The US Veterans Affairs Department (VA) hospitals have been using evidence-based guidelines to enhance excellence and accountability in health care.1

To further this objective, we developed an educational program to train RCPs in designing and implementing evidence-based protocols. Special emphasis was on developing rehabilitation and weaning protocols for spinal cord injured (SCI) patients. This article may be helpful to RCPs interested in designing similar clinical protocols.

Widespread adoption of protocols has resulted in numerous improved outcomes such as decreased time on mechanical ventilation, better allocation of respiratory care services, and lowered costs.2 The main advantage of protocols may be improved coordination of effort between clinicians. Several clinical protocols have been developed for weaning postoperative and COPD patients from mechanical ventilation,3 but protocols have been designed for weaning patients with cervical SCI and even fewer for rehabilitating this heterogeneous patient population.

Dimensions of the Challenge
Each year in the United States there are approximately 10,000 new cases of spinal cord injuries of which 10% to 15% involve the cervical spinal cord. Successful therapies for acute SCI have improved long-term survival and increased the cohort of patients with chronic SCI. The increasing number of chronic SCI patients underscores the need for effective evidence-based protocols for guiding respiratory rehabilitation and ventilator weaning. There is an emerging consensus that clinical decisions informed by results from randomized controlled trials (RCTs) may lead to improved interventions and optimal patient care outcomes.4,5 The RCT is the only tool with the power to improve the effectiveness and efficiency of care.6,7

Unfortunately, there are very few well-done scientific studies from which to draw the information needed to construct effective protocols. Many studies exhibit weak experimental designs with imprecise or insufficient characterization of interventions.

Research Training for RCPs
Designing evidence-based clinical protocols requires knowledge of current scientific evidence. Furthermore, the ability to analyze and apply findings from scientific articles requires a background in scientific research. Results from clinical studies must be examined critically to determine whether the data are plausible and whether conclusions make sense. Through our hospital-based training program, we endeavored to provide RCPs with sufficient experience in clinical research to enable them to design and implement evidence-based protocols knowledgeably.8

The program consisted of instruction in the following disciplines:
•    scientific methodology
•    experimental design
•    statistical analysis
•    techniques of evidence-based medicine
•    reviews of pertinent randomized controlled trials
•    rehabilitation and weaning of ventilator-dependent, high-tetraplegic patients
•    pathophysiology of spinal cord injury
•    bedside techniques for implementing protocols and gathering data.

Selected RCPs assumed a lead role in performing five tasks:
1.    constructing a clinical question
2.    identifying promising scientific abstracts
3.    obtaining articles from MEDLINE and other databases
4.    determining the strength of potentially useful articles using a semiquantitative method
5.    preparing articles for review by an interdisciplinary clinical team

Evidence-Based Medicine
Evidence-based medicine (EBM) is a process in which scientific literature is systematically searched to find answers to clinical questions.9 Databases contain millions of journal articles, only a few of which may offer data that address a clinical question.

Searching databases requires careful planning and a knowledge of the manner in which publications are indexed. Simple searches of MEDLINE may not be adequate and may reduce the yield of all RCTs below 50%. Clinical researchers should consult the Cochrane Controlled Trials Register (CCTR), a resource of over one quarter million hand-searched RCTs.10 Researchers should also consult an experienced medical librarian who can assist with searches of EMBASE, OVID, and other databases.11 An excellent tutorial for learning MEDLINE searching techniques is available at: [removed]http://www.nlm.nih.gov/bsd/pubmedtutorial/m1001.html[/removed].

An important question that must be addressed to determine if findings from an article should be used in designing a protocol is whether a study is valid. If not valid, the findings of a study should not be used in designing a protocol. Along with validity, other domains such as results and utility can be systematically assessed to determine the relative strength of an article. A number of excellent tools, such as checklists and forms, are available to gauge the overall strength of a scientific article. The Agency for Healthcare Research and Quality, the foremost federal agency charged with providing research support and policy guidance in health services research, has published a report titled Systems to Rate the Strength of Scientific Evidence.12

This report enables clinical researchers to select the right tool for evaluating individual scientific articles or large bodies of evidence. The contribution of this report in helping identify good science that can be translated into effective interventions at the bedside cannot be overstated.

Ultimately, clinical researchers will have to select the best assessment tool based on the clinical objectives they are trying to achieve.

After RCPs selected the best evidence, an interdisciplinary group reviewed the articles. Information from several articles was used to develop a protocol form. The form directed RCPs to perform rehabilitation and weaning interventions to help achieve specific clinical outcomes. The form was changed periodically to accommodate both the patient’s changing capabilities, conditions, and needs and advances in the scientific literature.13,14

In spite of our efforts to employ the most rigorous scientific evidence in designing our protocols, our protocol is only one of many that could have been used to rehabilitate and wean these complex patients. With the data we collected, it is possible that another team of clinicians could have rated the same randomized controlled trials somewhat differently leading to a slightly different protocol.

Bringing evidence-based practice to the bedside has increased in importance in recent years, as consumers, providers, policy makers, and purchasers continue to scrutinize the body of evidence on which medical decisions are based, so as to maximize the value of health care expenditures.15 We believe that RCPs with appropriate training can design good protocols and modify them as warranted, thus facilitating the rehabilitation and weaning of ventilator-dependent cervical SCI patients in an effective and efficient manner.

Charles J. Gutierrez, MS, RRT, is RT Program Leader, SCI/7N Sub Acute Care at James A. Haley Veterans’ Hospital, Tampa, Fla. Fred Haines, RRT, is RT SCI Specialist at James A. Haley Veterans’ Hospital.

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