Question

Review the Evidence Pyramid with examples of each type of study. Randomized controlled trials (RCTs) are the gold standard for most therapy-related studies.

List some of the barriers to Clinical Practice Guidelines (CPGs) and organize them into categories, such as those related to evidence. How can these be overcome?

Answer 1

1)

Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment. Although no study is likely on its own to prove causality, randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome. This is because the act of randomization balances participant characteristics (both observed and unobserved) between the groups allowing attribution of any differences in outcome to the study intervention. This is not possible with any other study design.

In designing an RCT, researchers must carefully select the population, the interventions to be compared and the outcomes of interest. Once these are defined, the number of participants needed to reliably determine if such a relationship exists is calculated (power calculation). Participants are then recruited and randomly assigned to either the intervention or the comparator group. It is important to ensure that at the time of recruitment there is no knowledge of which group the participant will be allocated to; this is known as concealment. This is often ensured by using automated randomization systems (e.g. computer generated). RCTs are often blinded so that participants and doctors, nurses or researchers do not know what treatment each participant is receiving, further minimizing bias.

RCTs can be analyzed by intentionto-treat analysis (ITT; subjects analyzed in the groups to which they were randomized), per protocol (only participants who completed the treatment originally allocated are analyzed), or other variations, with ITT often regarded least biased. All RCTs should have pre-specified primary outcomes, should be registered with a clinical trials database and should have appropriate ethical approvals.

RCTs can have their drawbacks, including their high cost in terms of time and money, problems with generalisabilty (participants that volunteer to participate might not be representative of the population being studied) and loss to follow up.

Evidence-based evaluation

Scientific assessment in health care aims to identify interventions that offer the greatest benefits for patients while utilizing resources in the most efficient way. Scientific assessment is needed in health care both for established methods and for new medical innovations. Implementing evidence-based health care means that decisions are supported by the best available scientific evidence from rigorous trials as a complement to other knowledge and to input from patients and caregivers.Important health care decisions that concern a patient’s health should always proceed from the best available scientific evidence.

The evaluation begins with a clinically relevant question, followed by an efficient literature search and finally an evaluation of the evidence, applying strict rules for reliability and validity. This refers to a conscious and systematic effort to design clinical treatment in accordance with the best possible scientific evidence.

Level of evidence

In an evidence-based approach to evaluation of effectiveness, the randomized controlled trial (RCT) is the acknowledged standard and is considered to generate the highest level of evidence, followed by controlled trials.Trials without controls, case series, case reports, and finally expert opinions, generate low or insignificant evidence

RCTs in orthodontics

For example on what RCTs have told us about the treatment of Class II malocclusions, Meikle concluded: ‘if one asks whether RCTs have achieved their intended objective, or provided knowledge not previously available from retrospective studies or animal experimentation, the answer would have to be no’. This statement becomes even more important if one considers that Class II malocclusions are the topic of the specialty with the largest amount of RCTs available.

RCTs are not ‘working’ for crucial clinical orthodontic, we have to recall the primary goal of RCTs, which is to test whether an intervention works by comparing it to a control condition. Such a control condition could be no treatment, a placebo treatment or an alternative treatment. And here lies the problem, because orthodontics is a device-driven speciality! ‘Orthodontic treatments are not a series of pills that can be administered at random and evaluated blindly’ The opposite is the case, because in orthodontics even ‘invisible’ appliances are visible to the patients and even if hardly visible, in any case they are perceivable for the patient. This in turn excludes the possibility of orthodontic placebo treatments at least for the majority of the questions.

Of course there is always the alternative to design a RCT with an untreated control group. However, even if we would put aside ethical concerns, I can only think of only a few classical clinical orthodontic research questions that would warrant such a RCT study design. The latter is even more truth if we stay realistic and do not ignore the decades of available clinical experience in orthodontics. This includes to unconditionally asking for untreated control groups in ridiculous conditions in which no control group is required to derive a clinical relevant and valid answer. Some facts are simply not in need of a Level I evidence-based proof. This applies for example to the fact that malocclusions, at least severe ones do not self-correct. Reading the satirical call for an RCT on parachute use to prevent death and major trauma related to gravitation challenge.Such an RCT is urgently needed as ‘parachute effectiveness has never been proven by RCT.

2)

There are few identified barriers which include, but not limited to, the lack of support by the leadership, lack of financial resources, and behavioral inconsistency. Other barriers might be related to the physician himself such as the lack of agreement and confidence with specific guidelines as well as lack of motivation .Apart from that, the implementation process could also be hindered by system or process barriers ranging from the lack of familiarity and awareness, volume overload, to the time needed to stay informed. Several less frequently identified barriers are related to the perceived quality of the CPGs and evidence, or patient concerns, while specific guideline-related barriers may include the complexity, compatibility with existing values, need for extra resources or acquisition of new knowledge and skills.

In Saudi Arabia, data regarding the barriers and facilitators of the implementation of CPGs is scarce, and those available data mainly focuses on the adaption of EBM. Al-Almaie et al. found that the main barriers to the practice of EBM by the physicians appeared to be a lack of knowledge, basic skills facilities, and limited time. In another study, the major perceived barriers in practicing EBM were patient overload and lack of personal time. The respondents thought that the most appropriate way to encourage the EBM was by learning the skills of EBM, followed by using evidencebased guidelines developed by the colleague. These results, although not directly applicable, pave the way for more detailed studies in all aspects of EBM practice and implementation in the Saudi Arabia.

Wahabi et al investigated the barriers and facilitators on the implementation of a specific CPG, the Pediatrics Asthma Management Protocol (PAMP). They studied physicians’ adherence to the PAMP in an emergency department with the objective of examining the compliance of the healthcare providers. They also reviewed the patients’ chart to investigate the compliance of the healthcare providers to eight recommendations of the PAMP whereby in the event of non-compliance, a focus group interview was conducted to determine the reasons that led to the noncompliance. They found that organizational barriers and the lack of an implementation strategy for the protocol, in addition to the attitude and beliefs of the healthcare providers, are the main factors behind the non-compliance to the CPG.

These few studies have not looked at the problem from the perspective of physicians in Saudi Arabia. Findings from studies in western or Asian countries cannot be completely extrapolated to local physicians, as there may be unique difference or unidentified factors. Most studies done in Saudi Arabia focused on single specific guidelines. There exist a gap in the understanding of the barriers and facilitators related to guideline implementation. This understanding is critical for development of effective and targeted guideline implementation strategies. In this investigation, we aimed to identify and explore the factors that may have acted as general barriers or facilitators on the implementation of the CPGs by physicians in Saudi Arabia.

Materials and Methods

Setting and participants

This was a descriptive cross-sectional study conducted in several tertiary hospitals in the Riyadh area. The study survey was distributed to available physicians working in the universities and government hospitals in the city of Riyadh. As per the latest census, there are 6715 physicians in Riyadh. The survey was carried out on 215 physicians. The proposal was first submitted to the Institutional Review Board (IRB) of each institution for approval and obtained an expedited approval due to the observational nature of the study. After identifying eligible participants, verbal consent was obtained from each participant where the study aims, objectives, and potential values were explained. All participants were treated with respect from the time they were approached, even if they refused enrolment, as well as throughout their participation. The generated data was stored after each participant was coded appropriately to ensure confidentiality. Hence, none of the research output data was traceable to any participant.

The survey was based on the instrument developed by Peters et al.The survey design consisted of three main sections. The first section covered the physicians’ demographics and relevant characteristics including their nationality, place of work, specialty and current position, in addition to their experience with CPGs. The second section was the barriers and facilitator assessment tool which addressed the physicians’ views on the different barriers and facilitators presented to them. The questions required the respondents to indicate how much they agreed or disagreed with each statement. Every question had five answers scored on a scale which is as follows: 1-strongly disagree through to 5-strongly agree. The third component consisted of open ended questions regarding the barriers and facilitators. The survey was pilot-tested on a small group of physicians to improve its clarity and limit response bias.

The survey was delivered manually to an appropriate sample of physicians. The survey was delivered through the secretarial services of the respective departments. The surveys were distributed on different working days of the week to the physicians available on those days. If the response rate was low, the next approach was to deliver the survey by hand directly to the physicians and wait for its completion. The recruited physicians were given the option to refer the survey to a colleague if they believed someone else in their department was better able to answer the questions.

Statistical analysis

The data was analyzed using SPSS (SPSS, version 21). Descriptive statistics (frequencies and percentages) were used to represent the demographic characteristics of participating physicians. A score was calculated for the barriers and facilitators assessment tool for each participant. The Kruskal-Wallis H test was used to determine the difference in the barriers and facilitators assessment tool score in the different demographics groups. Chi-Square test was used to determine the effect of different demographic variables on the implementation of CPGs in practice. Pearson correlation was used to test the correlation between the barriers and facilitators assessment tool score and the reasons physicians gave to choose particular CPGs. A step-wise multiple linear regression was performed to assess the correlation between demographics and the barriers and facilitators assessment tool score. For all analysis, 2 tailed P<0.05 was considered as statistically significant

A total of 157 physicians completed the survey. Most of the physicians who responded were residents and registrars at the percentage of 39.4 and 34.8, respectively, which reflected the staffs’ demographic. The majority of the respondents were male (63.7%). Only 14.6% of the physicians had over 20 y of medical experience. The majority of the respondents were junior physicians with 0-5 y of experience (38.2%). Saudi nationals comprised 43.3% of the respondents

Barriers and facilitator assessment tool

In this investigation, we explored factors that may have acted as general barriers or facilitators of CPGs use by physicians by conducting a survey on 157 physicians. The analysis shows that a high percentage of physicians were using CPGs in their practice. Most participants used CPGs because they are evidence-based, while only 40.1% implemented guidelines as per instructed by the institution. This highlights a structural barrier where there is a lack of support by the leadership, hence the physicians make independent choices in deciding on whether or not to implement guidelines. This barrier has been pointed out in several studies carried out in various settings. Moreover, Chapman et al. has observed that if a team practice is tailored according to the team head, the choice of which CPG to adopt might change if a new team head is appointed.

Based on the results obtained, most physicians believed the CPG is a good starting point for their self-study and would like to know more about it before they decide to implement it. This indicates that the physicians would like to participate in the process of choosing which CPG to implement in their practice which is a theme that has been identified in other studies. A lack of participation of the target group of users in the development of the protocol and original guidelines was a significant barrier in the implementation of the pediatric asthma guidelines in the emergency department in Saudi Arabia. It can be argued that the physicians in this study perceived their lack of awareness of the guideline and a lack of knowledge as a barrier to implementation. This has been one of the most reported barriers across studies in this topic This lack of knowledge could be divided into two types; first, the lack of knowledge about the guideline itself which has been labeled as awareness in some studies and second, lack of knowledge in the usage or application of the guidelines, which has been labeled as skills in other studies

An awareness of a CPG is an essential step to implement it; however, physicians can be aware of the CPG but choose not to implement it. This phenomenon speaks of acceptability, at least from a clinician’s perspective, and suggests that the implementation would be greatly aided by efforts to disseminate information about the program more widely. Basic knowledge is essential, but not sufficient, and other modalities of dissemination have to be employed.

There is an evidence of physicians who firmly believed that CPGs are not limiting and leave enough room for their autonomy and the incorporation of patient’s wishes. This apparent autonomy seems to be a unique finding in this study. McGuire et al. described an autonomy-supporting leadership where most staffs viewed their leadership as being “supportive”, but also emphasized that their leadership delegated decisions and execution to the program-level leaders. With regards to the patients’ preferences, Lugtenberg et al. found that it was one of the most perceived barriers to adherence, which is contrary to the case in this study.

In addition, most respondents perceived that CPGs are handy to use even when they reported difficulties in changing routines and habits to follow guidelines. The majority of participants agreed that most of the barriers presented to them were not apparent in their practice except two barriers which were a lack of cooperation from other colleagues in implementing the CPGs in addition to those who assumed that the implementation of guideline would require financial compensation. Le et al. saw that in some practices, the practitioners prioritized time and resources on collective implementation activities and organized their everyday practice to support these activities. In another setting, a group of practitioners would discuss the guidelines collectively but the final decision on the implementation will be decided individually. As such, an active implementation support is an important facilitator for the adoption of the guideline.

In our study, Regression analysis exhibited that the implementation of guideline was not affected by the physician’s role, years of experience or nationality. However, there was a statistically significant difference between the male and female practitioners (P<0.5). This phenomenon has been scarcely studied and relatively overlooked. Feldman et al. found that female family physicians are most likely to have positive attitudes toward guidelines. A review by Berger in 2008 reported that the physicians’ gender influenced their clinical practice and physicians’ practice patterns are influenced by their own demographic characteristics. A previous work has found a more positive attitude towards the implementation of guidelines by younger physicians. In the Tunis study of internal medicine physicians, more recent graduates from the medical school were reported to have more positive attitudes toward guidelines. In this study, the analysis also showed that the physician’s ethnicity affected the application of CPGs, albeit weakly. Although this issue was not explored extensively in the literature, a study by Koo et al. found considerable differences in the practitioners' colorectal cancer screening practices in different ethnicities.

There are some limitations in the study that are worth mentioning. Although our response rate was around 62%, it may nevertheless limit the ability to generalize our findings, as those with a positive attitude toward guidelines may be overrepresented in our sample as well as male physicians. Apart from that, the investigated barriers were not based on a specific guideline, as the study of specific guidelines could have potentially yielded different patterns of barriers. Nonetheless, the general nature of the survey was expected to identify barriers that were representative across all guidelines in practice. Furthermore, any adherence was based on self-report and may represent an overestimate as a result of social desirability bias. However, all participants were assured anonymity and no identifying information was collected which should give the participant the freedom to complete the survey without any external pressure.

Most physicians in Saudi Arabia were receptive of the CPGs and will apply them in their practices if there are more leadership and structural support for the implementations. A lack of cooperation between colleagues is an important issue which needs to be addressed in order to find practical solutions. Moreover, by engaging physicians in the choice of CPGs and providing limited flexibility to accommodate their input and patients’ wishes will be a good motivator for them to implement CPGs. To make a CPG more accessible for practitioners, it should be rewrite and summarize in simpler terms. Each team needs to study their own specific barriers and facilitators in order to be able to address the problems specific to their setting and staffs.