What to write
Contextual elements that interacted with the interventions
Observed associations between outcomes, interventions and relevant contextual factors
Unintended consequences such as benefits, harms, unexpected results, problems or failures associated with the intervention(s)
Explanation
One of the challenges in reporting healthcare improvement studies is the effect of context on the success or failure of the intervention(s). The most commonly reported contextual elements that may interact with interventions are structural variables including organisational/practice type, volume, payer mix, electronic health record use and geographical location. Other contextual elements associated with healthcare improvement success include top management leadership, organisational structure, data infrastructure/information technology, physician involvement in activities, motivation to change and team leadership.1 In this example, the authors provided descriptive information about the structural elements of the individual practices, including type of practice, payer mix, geographical setting and use of electronic health records. The authors noted variability in improvement in diabetes and asthma measures across the practices, and examined how characteristics of practice leadership affected the change process for an initiative to improve diabetes and asthma care. Practice leadership was measured monthly by the community based practice coach at each site. For analyses, these scores were reduced into low (0–1) and high (2–3) groups. Practice change ratings were also assigned by the practice coaches indicating the degree of implementation and use of patient registries, care templates, protocols and patient self-management support tools. Local leadership showed no association with most of the clinical measures; however, local leadership involvement was significantly associated with implementation of the process tools used to improve outcomes. The authors use tables to display these associations clearly to the reader.
In addition, the authors use the information from the coaches’ ratings to further explore this concept of practice leadership. The authors conducted semistructured focus group interviews for a sample of 12 of the 76 practices based on improvement in clinical measures and improvement in practice change score. Two focus groups were conducted in each practice including one with practice clinicians and administrators and one with front-line staff. Three themes emerged from these interviews that explicated the concept of practice leadership in these groups. While two of the themes reflect contextual elements that are often cited in the literature (visionary leader and engaged team), the authors addressed an unexpected theme about the role of the middle (operational) manager. This operational leader was often reported to be a nurse or nurse practitioner with daily interactions with physicians and staff, who appeared to be influential in facilitating change. The level of detail provided about the specifics of practice leadership can be useful to readers who are engaged in their own improvement work. Although no harms or failures related to the work were described, transparent reporting of negative results is as important as reporting successful ones.
In this example, the authors used a mixed methods approach in which practice leadership and engagement was quantitatively rated by improvement coaches as well as qualitatively evaluated using focus groups. The use of qualitative methods enhanced understanding of the context of practice leadership. This mixed methods approach is not a requirement for healthcare improvement studies as the influence of contextual elements can be assessed in many ways. For example, Cohen et al simply describe the probable impact of the 2009 H1N1 pandemic on their work to increase influenza vaccination rates in hospitalised patients,2 providing important contextual information to assist the reader’s understanding of the results.
Example
Quantitative results
In terms of QI efforts, two-thirds of the 76 practices (67%) focused on diabetes and the rest focused on asthma. Forty-two percent of practices were family medicine practices, 26% were pediatrics, and 13% were internal medicine. The median percent of patients covered by Medicaid and with no insurance was 20% and 4%, respectively. One-half of the practices were located in rural settings and one-half used electronic health records. For each diabetes or asthma measure, between 50% and 78% of practices showed improvement (ie, a positive trend) in the first year.
Tables 2 and 3 show the associations of leadership with clinical measures and with practice change scores for implementation of various tools, respectively. Leadership was significantly associated with only 1 clinical measure, the proportion of patients having nephropathy screening (OR=1.37: 95% CI 1.08 to 1.74). Inclusion of practice engagement reduced these odds, but the association remained significant. The odds of making practice changes were greater for practices with higher leadership scores at any given time (ORs=1.92–6.78). Inclusion of practice engagement, which was also significantly associated with making practice changes, reduced these odds (ORs=2.41 to 4.20), but the association remained significant for all changes except for registry implementation
Qualitative results
Among the 12 practices interviewed, 5 practices had 3 or fewer clinicians and 7 had 4 or more (range=1–32). Seven practices had high ratings of practice change by the coach. One-half were NCQA (National Committee for Quality Assurance) certified as a patient-centered medical home. These practices were similar to the quantitative analysis sample except for higher rates of electronic health record use and Community Care of North Carolina Medicaid membership…
Leadership-related themes from the focus groups included having (1) someone with a vision about the importance of the work, (2) a middle manager who implemented the vision, and (3) a team who believed in and were engaged in the work….Although the practice management provided the vision for change, patterns emerged among the practices that suggested leaders with a vision are a necessary, but not sufficient condition for successful implementation.
Leading from the middle
All practices had leaders who initiated the change, but practices with high and low practice change ratings reported very different ‘operational’ leaders. Operational leaders in practices with low practice change ratings were generally the same clinicians, practice managers, or both who introduced the change. In contrast, in practices with high practice change ratings, implementation was led by someone other than the lead physician or top manager..”3
Training
The UK EQUATOR Centre runs training on how to write using reporting guidelines.
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