Journal of evaluation in clinical practice
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This study aimed to determine whether the label status of a medicine penetrates into the clinical reasoning of Australian medical practitioners and to explore the possible reasons for our findings using semistructured interviews with 14 Australian physicians. The interviews revealed 3 broad catalysts for off-label prescribing. The first of these was lack of awareness or understanding of the regulatory process in general and labels more specifically. ⋯ Although labels are of minimal clinical significance, there are real conceptual, practical, and moral problems associated with conflating "good" or "better" practice with "on-label" practice, and "bad" or "worse" practice with off-label prescribing as often occurs. To ascribe greater meaning to the term "off-label" than is warranted can have the unintended consequence of casting suspicion on and making it more difficult for physicians to provide appropriate clinical care. We conclude that labeling can, in some cases, provide assurances to both clinicians and patients that their medications have been demonstrated to be safe and effective, but that clinicians should be able to continue to prescribe responsibly off-label without having any stigma attached to their practice.
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Variation in the workup of rectal bleeding may result in guideline-discordant care and delayed diagnosis of colorectal cancer. Accordingly, we undertook this study to characterize primary care clinicians' initial rectal bleeding evaluation. ⋯ Workup of rectal bleeding was inconsistent, incomplete and discordant with guidelines in one-quarter of cases. Research and improvements strategies are needed to understand and manage practice and provider variation.
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The 6-minute walk test (6MWT) is widely used as a test of functional exercise capacity. Several studies have reported the minimal clinically important difference (MCID) for the 6MWT; however, the findings of the studies have not been examined in the context of one another. In this review, we aimed to summarize available information on the MCID for the 6MWT performed by patients with pathology. ⋯ Based on our findings, a change of 14.0 to 30.5 m may be clinically important across multiple patient groups.
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Observational Study
Cost of treatment of peripheral neuropathic pain with pregabalin or gabapentin in routine clinical practice: impact of their loss of exclusivity.
To analyze the effect of loss of exclusivity of data on the cost of treatment of peripheral neuropathic pain (PNP) with pregabalin or gabapentin in routine clinical practice. A retrospective observational study, with electronic medical records for patients enrolled at primary care centers managed by the health care provider Badalona Serveis Assistencials, who initiated treatment of PNP with pregabalin or gabapentin. The analysis used drugs and resources prices for year 2015. ⋯ The average study drug cost per patient was higher for pregabalin than for gabapentin; €214.6 (206.3) vs €157.4 (181.9), P < 0.001, although the cost of concomitant analgesic medication was lower; €176.5 (271.8) vs €306.7 (529.2), P < 0.001. The adjusted average total cost per patient was lower in those treated with pregabalin than in those treated with gabapentin; €2,413 (2119-2708) vs €3201 (2806-3.597); P = 0.002, owing to significantly lower health care costs; €1307 (1247-1367) vs €1538 (1458-1618), P < 0.001, and also non-health care costs; €1106 (819-1393) vs €1663 (1279-2048), P = 0.023, that was caused by a significantly lower use of concomitant medication, fewer medical visits to primary care, and fewer days of sick leave. After loss of exclusivity of both drugs, pregabalin continued to show lower health care and non-health care costs than gabapentin in the treatment of PNP in routine clinical practice.
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Randomized Controlled Trial
Application of systems thinking: 12-month postintervention evaluation of a complex health system intervention in Zambia: the case of the BHOMA.
Strong health systems are said to be paramount to achieving effective and equitable health care. The World Health Organization has been advocating for using system-wide approaches such as 'systems thinking' to guide intervention design and evaluation. In this paper we report the system-wide effects of a complex health system intervention in Zambia known as Better Health Outcome through Mentorship and Assessment (BHOMA) that aimed to improve service quality. ⋯ We applied an innovative approach to evaluate a complex intervention in low-income settings, exploring empirically how systems thinking can be applied in the context of health system strengthening. Although the intervention had some positive outcomes by employing system-wide approaches, we also noted unintended consequences.