Evaluation of a single-dose HPV vaccine strategy for promoting vaccine, health, and gender equity.

Although several countries have adopted a single-dose human papillomavirus (HPV) vaccination strategy, many other countries continue to include multiple doses in their vaccination programmes. There are ethical reasons to transition to a single-dose strategy. We discuss how a single-dose HPV vaccination strategy advances equity in three dimensions: vaccine equity, health equity, and gender equity. Adopting a single-dose strategy eases pressure on vaccine supply, lowers programme costs, and is easier to distribute. This change facilitates vaccine procurement and implementation programmes (contributing to vaccine equity) and reaching hard to reach people or populations (contributing to health equity). A lower number of cases of HPV-related diseases that stem from greater vaccine distribution reduces the burden on women, who are at a higher risk of HPV-related disease or who act as caregivers, which prevents them from accessing opportunities that contribute to their empowerment (contributing to gender equity). Thus, pursuing the single-dose HPV vaccination programme strategy is ethically desirable.

Expediting approval for medical countermeasures to address high burden disease: an ethical justification to move beyond emergency use authorisation.

Addressing global health crises requires a receptive and expedient policy environment to minimise delays in making available potentially life-saving technologies. Over time, the policy environment has adapted to ensure that communities have expedited access to promising technologies, such as vaccines, that can mitigate morbidity and mortality. Emergency authorisations are one such policy mechanism. While these have been employed successfully for several diseases, such as influenza, Ebola and COVID-19, the policy mechanism is tied to contexts where key bodies have designated the disease an 'emergency', whereas no equivalent mechanism exists for those failing to acquire the designation (eg, malaria and tuberculosis). In this paper, we examine ethical issues associated with emergency authorisations. We argue that there is no moral difference between those diseases considered emergencies and many that fail to be designated as such with respect to impact on affected communities. Thus, tying access to an expedient policy mechanism for approval to an emergency designation is ethically unjustified-it should be based on considerations of risks and benefits, the disease burden and the values of the communities that carry those risks and not contingent on if the disease is designated an emergency. We suggest the need to further enhance the policy environment to ensure access to similar expedited approval programmes irrespective of if a disease is an emergency. Levelling the field for access to expedited approval programmes across diseases can help in moving towards achieving global health equity but is not a panacea.

Regional needs assessment for emergency physician audit and feedback.

OBJECTIVES: Audit and feedback is widely used to improve physician performance. Many data metrics are being provided to physicians, yet most of these are driven by the regulatory environment. We sought to conduct a needs assessment of audit and feedback metrics that were most useful to clinicians within our health care region. METHODS: We conducted a Web-based survey of five clinical practice sites in our region and asked that physicians rank 49 clinical practice metrics. In addition, we assessed their readiness for audit and feedback and their preferences for data confidentiality. We collected data on duration of training, gender, and site of practice (academic v. community) allowing for comparison between groups. RESULTS: A total of 104 emergency medicine physicians participated in the survey (52.3% response rate). There was a significant readiness for participation in audit and feedback activities. Top ranked metrics were emergency department return rates and colleague's assessment of collegiality and quality of care, which were common across all sites. Small yet significant differences were noted between genders and academic v. community practitioners. CONCLUSION: This study represents the first regional analysis of physician preferences for audit and feedback activities and implementation. It demonstrates that physicians are interested in audit and feedback activities and provides a roadmap for the development of a regional audit and feedback structure. It will also be used as a guiding document for regional change management.

The evolution of GRADE (part 3): A framework built on science or faith?

RATIONALE, AIMS, AND OBJECTIVES: The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) framework has undergone several modifications since it was first presented as a method for developing clinical practice recommendations. In the previous two articles of this series, we showed that absent, in the first three versions of GRADE, is a justification (theoretical and/or empirical) for why the presented criteria for determining the quality of evidence and the components for determining the strength of a recommendation were included (and others not included) in the framework. Furthermore, it was often not clear how to operationalize and integrate the criteria/components when using the framework. In part 3 of this series, we examine the literature since version 3 to see if the GRADE working group has provided an overall justification scheme for GRADE or clear instruction on how to operationalize and integrate the criteria/components in the framework. METHODS: Narrative review. RESULTS: GRADE has undergone further modification since the last version was presented. In the recent literature, we see additional shifts in terminology (eg, "quality of evidence" is now "certainty of evidence"), clarification on the construct of certainty of evidence, continued emphasis on "transparency" and new emphasis on "trustworthiness," the addition of health equity as a component for determining strength of a recommendation, and the development of the Evidence to Decision frameworks. However, these modifications have done little to improve the justification scheme that sustains GRADE or clarify how to operationalize the criteria/components. CONCLUSIONS: If we desire that our clinical recommendations be based on scientific teaching rather than faith-based preaching, then the GRADE framework should be justified theoretically and/or empirically. Until such time that the working group provides a theoretical justification that the use of the GRADE framework should produce valid recommendations, and/or empirical evidence to support that it does, enthusiasm for the framework should be tempered.

How do we know if a clinical practice guideline is good? A response to Djulbegovic and colleagues' use of fast-and-frugal decision trees to improve clinical care strategies.

Clinical practice guidelines (CPGs) and clinical pathways have become important tools for improving the uptake of evidence-based care. Where CPGs are good, adherence to the recommendations within is thought to result in improved patient outcomes. However, the usefulness of such tools for improving patient important outcomes depends both on adherence to the guideline and whether or not the CPG in question is good. This begs the question of what it is that makes a CPG good? In this issue of the Journal, Djulbegovic and colleagues offer a theory to help guide the development of CPGs. The "fast-and-frugal tree" (FFT) heuristic theory is purported to provide the theoretical structure needed to quantitatively assess clinical guidelines in practice, something that the lack of theory to guide CPG development has precluded. In this paper, I examine the role of FFTs in providing an adequate theoretical framework for developing CPGs. In my view, positioning guideline development within the FFT framework may help with problems related to adherence. However, I believe that FTTs fall short in providing panel members with the theoretical basis needed to justify which factors should be considered when developing a CPG, how information on those factors derived from research studies should be interpreted, and how those factors should be integrated into the recommendation.

Examining the role of the physician as a source of variation: Are physician-related variations necessarily unwarranted?

RATIONALE, AIMS, AND OBJECTIVES: The physician is often implicated as an important cause of observed variations in health care service use. However, it is not clear if physician-related variation is problematic for patient care. This paper illustrates that observed physician-related variation is not necessarily unwarranted. METHODS: This is a narrative review. RESULTS: Many studies have attributed observed variations to the physician, but little attention is given towards discriminating between those variations that exist for good reasons and those that are unwarranted. Two arguments can be made for why physician-related variation is unwarranted. The first posits that physician-related factors should not play a role in management of care decisions because such decisions should be driven by science (which is imagined to be definitive). The second considers the possibility of supplier-induced demand as a factor driving observed variations. We show that neither argument is sufficient to rule out that physician-related variations may be warranted. Furthermore, the claim that such variations are necessarily problematic for patients has yet to be substantiated empirically. CONCLUSIONS: It is not enough to simply show that physician-related variation can exist-one must also show where it is unwarranted and what is the magnitude of unwarranted variations. Failure to show this can have significant implications on how we interpret and respond to observed variations. Improved measurement of the sources of variation, especially with respect to patient preferences and context, may help us start to disentangle physician-related variation that is desirable from that which is unwarranted.

Nuance and Noise: Lessons Learned From Longitudinal Aggregated Assessment Data.

BACKGROUND: Competency-based medical education requires frequent assessment to tailor learning experiences to the needs of trainees. In 2012, we implemented the McMaster Modular Assessment Program, which captures shift-based assessments of resident global performance. OBJECTIVE: We described patterns (ie, trends and sources of variance) in aggregated workplace-based assessment data. METHODS: Emergency medicine residents and faculty members from 3 Canadian university-affiliated, urban, tertiary care teaching hospitals participated in this study. During each shift, supervising physicians rated residents' performance using a behaviorally anchored scale that hinged on endorsements for progression. We used a multilevel regression model to examine the relationship between global rating scores and time, adjusting for data clustering by resident and rater. RESULTS: We analyzed data from 23 second-year residents between July 2012 and June 2015, which yielded 1498 unique ratings (65 ± 18.5 per resident) from 82 raters. The model estimated an average score of 5.7 ± 0.6 at baseline, with an increase of 0.005 ± 0.01 for each additional assessment. There was significant variation among residents' starting score (y-intercept) and trajectory (slope). CONCLUSIONS: Our model suggests that residents begin at different points and progress at different rates. Meta-raters such as program directors and Clinical Competency Committee members should bear in mind that progression may take time and learning trajectories will be nuanced. Individuals involved in ratings should be aware of sources of noise in the system, including the raters themselves.

When guidelines don't guide: the effect of patient context on management decisions based on clinical practice guidelines.

PURPOSE: This study examines the influence of patient social context on physicians' adherence to clinical practice guidelines (CPGs). METHOD: Expert emergency medicine (EM) physicians and novice physicians (EM residents) were surveyed using an Internet-based program between January and July of 2013. Participants were presented clinical cases and were asked to indicate if they would order or prescribe a specified test or treatment. Cases were chosen from four domains where CPGs exist, and were constructed to include or exclude a "context variable" (CV). Both expert and novice physicians' CPG adherence rate in the CV condition was compared with that in the no CV condition. The CPG adherence rates in CV and no CV conditions were also compared between expert and novice EM physicians. RESULTS: Expert EM physicians (n = 28) were less likely to adhere to CPGs in the CV condition compared with the no CV condition (56% versus 80%, respectively; odds ratio [OR] = 0.32, 95% confidence interval [CI]: 0.17-0.53, P < .001). Experts were less likely to adhere to CPGs in the CV condition when compared with novice physicians (n = 28) (56% versus 67%; OR = 0.62, 95% CI: 0.39-1.0, P = .039). Expert and novice EM physicians did not differ in their adherence to CPGs in the no CV condition. CONCLUSIONS: Participants were sensitive to both the best clinical evidence of benefit, as recommended by CPGs, and patient context when determining how care should be managed.

Using small-area variations to inform health care service planning: what do we 'need' to know?

RATIONALE, AIMS AND OBJECTIVES: Allocating resources on the basis of population need is a health care policy goal in many countries. Thus, resources must be allocated in accordance with need if stakeholders are to achieve policy goals. Small area methods have been presented as a means for revealing important information that can assist stakeholders in meeting policy goals. The purpose of this review is to examine the extent to which small area methods provide information relevant to meeting the goals of a needs-based health care policy. METHODS: We present a conceptual framework explaining the terms 'demand', 'need', 'use' and 'supply', as commonly used in the literature. We critically review the literature on small area methods through the lens of this framework. RESULTS: 'Use' cannot be used as a proxy or surrogate of 'need'. Thus, if the goal of health care policy is to provide equal access for equal need, then traditional small area methods are inadequate because they measure small area variations in use of services in different populations, independent of the levels of need in those populations. CONCLUSIONS: Small area methods can be modified by incorporating direct measures of relative population need from population health surveys or by adjusting population size for levels of health risks in populations such as the prevalence of smoking and low birth weight. This might improve what can be learned from studies employing small area methods if they are to inform needs-based health care policies.

Medical practice variations: what the literature tells us (or does not) about what are warranted and unwarranted variations.

This paper examines the sources of practice variations and definitions of unwarranted variation, as derived from the literature. The literature suggests variables/factors related to patient health needs, doctor 'practice style' and environmental constraints/opportunities as sources of practice variations. However, this list is likely to be incomplete because of significant unexplained variation in each study. Furthermore, it is unclear which factors are sources of unwarranted variation because the reviewed studies do not clearly discriminate between those variations that are unwarranted and those that are not. It is also unclear if context plays a role in determining if and when a factor is unwarranted. The literature contains few frameworks of what constitutes unwarranted variation. Among those offered, more information is needed regarding the scientific basis for including the selected factors, and how to operationalize the framework provided a particular one is chosen. A clear and consistent framework for unwarranted variation, and a clear indication how each component factor could be measured and integrated can help investigators determine which variables should be included in their studies, such that the sources of unwarranted variations may be identified. A better understanding of the role of patient preference as a potential source of practice variations is also required.