METHODS: It is timely at this juncture - as clinicians and researchers begin to grapple with the "invasion" of digital technologies - to review the strengths and weaknesses of these outcome measures.
RESULTS: This paper discusses advances (including an enhanced understanding of PD itself, and the development of clinimetrics as a field) that have led to improvements in the COMs used in PD; their strengths and limitations; and factors to consider when selecting and using a measuring instrument.
CONCLUSIONS: It is envisaged that in the future, a combination of COMs and technology-based objective measures will be utilized, with different methods having their own strengths and weaknesses. Judgement is required on the part of the clinician and researcher in terms of which instrument(s) are appropriate to use, depending on the particular clinical or research setting or question.
DESIGN: Recommendations from a working group of international experts in macular degeneration outcomes registry development and patient advocates, facilitated by the International Consortium for Health Outcomes Measurement (ICHOM).
METHODS: Modified Delphi technique, supported by structured teleconferences, followed by online surveys to drive consensus decisions. Potential outcomes were identified through literature review of outcomes collected in existing registries and reported in major clinical trials. Outcomes were refined by the working group and selected based on impact on patients, relationship to good clinical care, and feasibility of measurement in routine clinical practice.
RESULTS: Standardized measurement of the following outcomes is recommended: visual functioning and quality of life (distance visual acuity, mobility and independence, emotional well-being, reading and accessing information); number of treatments; complications of treatment; and disease control. Proposed data collection sources include administrative data, clinical data during routine clinical visits, and patient-reported sources annually. Recording the following clinical characteristics is recommended to enable risk adjustment: age; sex; ethnicity; smoking status; baseline visual acuity in both eyes; type of macular degeneration; presence of geographic atrophy, subretinal fibrosis, or pigment epithelial detachment; previous macular degeneration treatment; ocular comorbidities.
CONCLUSIONS: The recommended minimum outcomes and pragmatic reporting standards should enable standardized, meaningful assessments and comparisons of macular degeneration treatment outcomes. Adoption could accelerate global improvements in standardized data gathering and reporting of patient-centered outcomes. This can facilitate informed decisions by patients and health care providers, plus allow long-term monitoring of aggregate data, ultimately improving understanding of disease progression and treatment responses.
METHODS: We conducted an observational crossover bench study to compare the cannula-to-Melker with the scalpel-bougie technique in a porcine tracheal model. Twenty-eight anesthetists participated. The primary outcome was time taken for device insertion. Secondary outcomes were first-pass success rate, incidence of tracheal trauma, and technique preference. We also compared the data on outcome measures with the data obtained in a similar workshop a year ago.
RESULTS: The scalpel-bougie technique was significantly faster than the cannula-to-Melker technique for cricothyroidotomy (median time of 45.2 s vs. 101.3 s; P = 0.001). Both techniques had 100% success rate within two attempts; there were no significant differences in the first-pass success rates and incidence of tracheal wall trauma (P > 0.999 and P = 0.727, respectively) between them. The relative risks of inflicting tracheal wall trauma after a failed cricothyroidotomy attempt were 6.9 (95% CI 1.5-31.1), 2.3 (95% CI 0.3-20.7) and 3.0 (95% CI 0.3-25.9) for the scalpel-bougie, cannula-cricothyroidotomy, and Melker-Seldinger airway, respectively. The insertion time and incidence of tracheal wall trauma were lower when the present data were compared with data from a similar workshop conducted the previous year.
CONCLUSIONS: This study supports the use of a scalpel-bougie technique for cricothyroidotomy by anesthetists and advocates a yearly training program for skill retention.