Articles: outcome-assessment-health-care.
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JAMA internal medicine · Apr 2021
Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval.
Numerous cancer drugs have received accelerated approval from the US Food and Drug Administration (FDA) based on clinical trial outcomes that are otherwise not acceptable for traditional FDA approval; the accelerated approval process allows outcomes based on surrogate measures that are only reasonably likely to estimate clinical benefits. In England, the National Institute for Health and Care Excellence (NICE) evaluates the clinical benefits and cost-effectiveness of drugs after they have received regulatory approval and issues recommendations regarding their coverage in the National Health Service (NHS). However, the level of concordance between European and FDA decision-making in the context of drugs qualifying for FDA accelerated approval is unknown. ⋯ In this cohort study, 30 cancer drug indications that were granted accelerated approval by the FDA were not subsequently reviewed by either European regulators or NICE, and 12 drugs were denied authorization or coverage owing to insufficient safety, clinical efficacy, or cost-effectiveness. National Health Service coverage of cancer drugs given FDA accelerated approval commonly required additional price concessions, restrictions to approved indications, or review of additional data.
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Cochrane Db Syst Rev · Feb 2021
Review Meta AnalysisSkin care interventions in infants for preventing eczema and food allergy.
Eczema and food allergy are common health conditions that usually begin in early childhood and often occur together in the same people. They can be associated with an impaired skin barrier in early infancy. It is unclear whether trying to prevent or reverse an impaired skin barrier soon after birth is effective in preventing eczema or food allergy. ⋯ Skin care interventions such as emollients during the first year of life in healthy infants are probably not effective for preventing eczema, and probably increase risk of skin infection. Effects of skin care interventions on risk of food allergy are uncertain. Further work is needed to understand whether different approaches to infant skin care might promote or prevent eczema and to evaluate effects on food allergy based on robust outcome assessments.
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Cochrane Db Syst Rev · Jan 2021
Review Meta AnalysisTelerehabilitation for chronic respiratory disease.
Pulmonary rehabilitation is a proven, effective intervention for people with chronic respiratory diseases including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD) and bronchiectasis. However, relatively few people attend or complete a program, due to factors including a lack of programs, issues associated with travel and transport, and other health issues. Traditionally, pulmonary rehabilitation is delivered in-person on an outpatient basis at a hospital or other healthcare facility (referred to as centre-based pulmonary rehabilitation). Newer, alternative modes of pulmonary rehabilitation delivery include home-based models and the use of telehealth. Telerehabilitation is the delivery of rehabilitation services at a distance, using information and communication technology. To date, there has not been a comprehensive assessment of the clinical efficacy or safety of telerehabilitation, or its ability to improve uptake and access to rehabilitation services, for people with chronic respiratory disease. ⋯ This review suggests that primary pulmonary rehabilitation, or maintenance rehabilitation, delivered via telerehabilitation for people with chronic respiratory disease achieves outcomes similar to those of traditional centre-based pulmonary rehabilitation, with no safety issues identified. However, the certainty of the evidence provided by this review is limited by the small number of studies, of varying telerehabilitation models, with relatively few participants. Future research should consider the clinical effect of telerehabilitation for individuals with chronic respiratory diseases other than COPD, the duration of benefit of telerehabilitation beyond the period of the intervention, and the economic cost of telerehabilitation.
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Observational Study
[Diabetic patient control in Primary Care: Influence of service portfolio and other factors].
To study the effect of the type of follow-up according to Service Portfolio and other associated factors, in the reduction of HbA1c levels in people with a new diagnosis of type 2 diabetes and poor initial control. ⋯ Glycaemic control was improved in patients with a new diagnosis of diabetes in which optimal follow-up is performed as proposed in the Service Portfolio.
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Arch Orthop Trauma Surg · Oct 2020
Outcomes after implementation of an open fracture clinical pathway.
Open fractures are associated with high rates of complication, morbidity and high economic costs. To improve outcomes, an open extremity fracture clinical pathway that protocolized surgical management and encouraged multidisciplinary collaboration was implemented in our institution. This study evaluates the clinical outcomes before and after the implementation of the pathway. ⋯ This study demonstrates that the implementation of an open extremity fracture clinical pathway significantly reduces the proportion of external fixation surgeries, length of hospital stay, and number of operations in patients with open tibial and femur fractures, without compromising complication rates.