To develop a core outcome set (COS), an agreed minimum set of outcomes to measure and report in all studies evaluating the introduction and evaluation of novel surgical techniques.
Agreement on the key outcomes to measure and report for safe and efficient surgical innovation is lacking, hindering transparency and risking patient harm.
(I) Generation of a list of outcome domains from published innovation-specific literature, policy/regulatory body documents, and surgeon interviews; (II) Prioritization of identified outcome domains using an international, multi-stakeholder Delphi survey; (III) Consensus meeting to agree the final COS. Participants were international stakeholders, including patients/public, surgeons, device manufacturers, regulators, trialists, methodologists and journal editors.
7,972 verbatim outcomes were identified, categorized into 32 domains, and formatted into survey items/questions. 410 international participants (220 professionals, 190 patients/public) completed at least one round 1 survey item, of which 153 (69.5%) professionals and 116 (61.1%) patients completed at least one round 2 item. 12 outcomes were scored 'consensus in' ('very important' by ≥70% of patients and professionals) and 20 'no consensus'. A consensus meeting, involving 19 professionals and 10 patient/public representatives, led to agreement on a final 8-domain COS. Six domains are specific to a surgical innovation context modifications, unexpected disadvantages, device problems, technical procedure success, whether the overall desired effect was achieved, surgeons'/operators' experience. Two domains relate to intended benefits and expected disadvantages.
The COS is recommended for use in all studies prior to definitive RCT evaluation to promote safe, transparent, and efficient surgical innovation.
The COS is recommended for use in all studies prior to definitive RCT evaluation to promote safe, transparent, and efficient surgical innovation.
The incidence of brachial plexus birth injury (BPBI) in the United States is declining and now occurs in <1 per 1,000 births.
The gold standard for predicting the need for early intervention remains serial examination.
Early treatment of BPBI with reconstructive surgery requires the ability to perform both interposition nerve grafting and nerve transfers.
Given the heterogeneity of lesions, the evidence is largely limited to retrospective comparative studies and case series.
Given the heterogeneity of lesions, the evidence is largely limited to retrospective comparative studies and case series.
To evaluate whether different hypertension phenotypes, namely, isolated systolic hypertension (ISH), isolated diastolic hypertension (IDH) and systolic/diastolic hypertension (SDH) have a differential outcome effect by clinic and ambulatory blood pressure (BP) measurements.
We prospectively evaluated in 569 never-treated patients with sustained hypertension (age 52.6 ± 11.6 years; men 55%; clinic BP 150 ± 15/95.5 ± 10 mmHg, systolic/diastolic; 24-h ambulatory BP 128.9 ± 12.6/80.6 ± 9.7) the incidence of major cardiovascular (CV) events within 5 years, after adjustment for confounders, including the rate of BP control and the weighted follow-up BP.
All participants received antihypertensive drug treatment (mean number of drugs 1.9 ± 1.1; follow-up visits 4.6/patient). Average clinic BP achieved during follow-up was 136 ± 12.6/83.9 ± 9.4 mmHg, with 39% of participants having clinic BP less than 140/90 mmHg in at least 75% of their visits, and 24% in 25-75% of visits. Prevalence of hypertension phenotypes defined using BP differed from that using ambulatory BP, whereas integration of both BP measurements reclassified the initial phenotype to another in 18% of participants. Although, no differential outcome effect was observed between clinic IDH and SDH assessed using clinic or ambulatory BP measurements, clinic BP-based ISH was associated with a higher outcome incidence than the IDH and SDH phenotypes (hazard ratio 4.8, 95% confidence interval 1.4-17.0, P = 0.015). ISH diagnosed by integration of clinic and ambulatory BP, also increased the outcome (hazard ratio 4.0, 95% confidence interval 1.0-15.6, P = 0.046).
In hypertensive patients at low/moderate CV risk, IDH and SDH phenotypes defined by clinic BP measurements, equally determined CV events but to a lower extent compared with ISH.
In hypertensive patients at low/moderate CV risk, IDH and SDH phenotypes defined by clinic BP measurements, equally determined CV events but to a lower extent compared with ISH.
Low-quality ambulatory blood pressure monitoring (ABPM) due to recurring artifacts may limit its clinical value. We evaluated the features and impact on BP control and patient management of ABPMs performed in Italian community pharmacies, according to their quality.
Twenty-four-hour ABPMs were obtained by a clinically validated, automated upper arm device and uploaded on a certified web-based telemedicine platform (www.tholomeus.net). The system automatically evaluated the quality of the recording according to current guidelines. In case of poor ABPM quality, the pharmacist was prompted to repeat the test. All the ABPMs were labeled as valid or invalid. Demographic and clinical characteristics of the patients and BP control were compared between the two groups.
A total of 45 232 ABPMs were obtained in as many patients through 812 pharmacies (87.7% recordings were valid). VX-478 Factors significantly associated with a better ABPM quality were younger age, use of antihypertensive medications, presence of at least one cardiovascular risk factor, concomitant disease or treatment, a test performed in the coldest months, and residence in the cooler northern regions of the country. The 24-h and daytime ambulatory BP level and the prevalence of ambulatory hypertension and white-coat hypertension were higher, and the prevalence of masked hypertension lower in patients with valid recordings. High odds of obtaining a valid recording were observed in patients repeating the ABPM.
Ambulatory BP telemonitoring is feasible in community pharmacies as long as potential predictors of unsuccessful outcomes are taken into account and adequately managed.
Ambulatory BP telemonitoring is feasible in community pharmacies as long as potential predictors of unsuccessful outcomes are taken into account and adequately managed.