Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multicentre, randomised controlled trial with integrated Quintet Recruitment Intervention (RaCeR 2)

Introduction
Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation.

Methods and analysis
The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022.

Trial registration number
ISRCTN11499185.

Leggi
Aprile 2024

Appraising the quality standard of clinical practice guidelines related to central venous catheter-related thrombosis prevention: a systematic review of clinical practice guidelines

Objective
To evaluate the quality and analyse the content of clinical practice guidelines regarding central venous catheter-related thrombosis (CRT) to provide evidence for formulating an evidence-based practice protocol and a risk assessment scale to prevent it.

Design
Scoring and analysis of the guidelines using the AGREE II and AGREE REX scales.

Data sources
Pubmed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and the Chinese Biomedical Literature, and the relevant websites of the guideline, were searched from 1 January 2017 to 26 March 2022.

Eligibility criteria
Guidelines covering CRT treatment, prevention, or management were included from 1 January 2017 to 26 March 2022.

Data extraction and synthesis
Three independent reviewers systematically trained in using the AGREE II and AGREE REX scales were selected to evaluate these guidelines.

Results
Nine guidelines were included, and the quality grade results showed that three were at A-level and six were at B-level. The included guidelines mainly recommended the prevention measure of central venous CRT from three aspects: risk screening, prevention strategies, and knowledge training, with a total of 22 suggestions being recommended.

Conclusion
The overall quality of the guidelines is high, but there are few preventive measures for central venous CRT involved in the guidelines. All preventive measures have yet to be systematically integrated and evaluated, and no risk assessment scale dedicated to this field has been recommended. Therefore, developing an evidence-based practice protocol and a risk assessment scale to prevent it is urgent.

Leggi
Marzo 2024

Empiric use of standard triple therapy in Helicobacter pylori eradication does not require readjustment in the clarithromycin resistance cut-off point

We appreciate the considerations of Hsu et al about the recommendation of empiric first-line therapies in our Maastricht VI/Florence consensus report for the management of Helicobacter pylori.1 2 We fully agree that H. pylori eradication therapy should aim at a cure rate of ≥90%. This also meets the expectation of patients as referred by the authors from a real-world expectation survey of the Asia-Pacific region.3 However, we disagree that the cut-off for clarithromycin resistance, at least for now, is too high at 15% for triple therapy consisting of proton pump inhibitor (PPI), amoxicillin and clarithromycin used as empirical first-line option.2 Hsu et al suggest a cutoff for clarithromycin resistance at or below 5 % for the empirical use of PPI-amoxicillin-clarithromycin and base their claim on a recent systematic review.4 However, this review has several relevant limitations: First, the…

Leggi
Marzo 2024

Should intermittent pneumatic compression devices be standard therapy for the prevention of venous thromboembolic events in major surgery? Protocol for a randomised clinical trial (IMPOSTERS)

Introduction
Venous thromboembolism (VTE) is a recognised postsurgical risk. Current prevention methods involve low molecular weight heparin (LMWH), graduated compression stockings (GCS), and intermittent pneumatic compression devices (IPCDs). Australian guidelines, commonly adopted by surgeons, recommend LMWH with GCS and/or IPCDs. IPCDs pose clinical risks, increase care burden, are poorly tolerated, and are costly single-use plastic items. Utilising only LMWH and GCS, without IPCDs, could be more practical, patient-friendly, and cost-effective, with added environmental benefits.

Methods
This is a multicentre, prospective, two-arm randomised controlled non-inferiority trial at five New South Wales (NSW) hospitals, in Australia. We propose to randomise 4130 participants in a 1:1 ratio between arm A: LMWH+GCS+IPCDs (n=2065) or arm B: LMWH+GCS (n=2065). The primary outcome of interest is symptomatic VTE (deep vein thrombosis/pulmonary embolism) identified at the day 30 phone follow-up (FU), confirmed by ultrasound or imaging. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation. Secondary outcomes are quality of life at baseline, days 30 and 90 FU using the 5-level European Quality of Life Score, compliance and adverse events with IPCDs, GCS, and LMWH, as well as healthcare costs (from the perspective of the patient and the hospital), and all-cause mortality. The trial has 90% power to detect a 2% non-inferiority margin to detect a reduction rate of VTE from 4% to 2%.

Ethics and dissemination
This study has been approved by the Hunter New England Human Research Ethics Committee (2022/ETH02276) protocol V.10, 13 July 2023. Study findings will be presented at local and national conferences and in scientific research journals.

Trial registration number
ANZCTR12622001527752

Leggi
Febbraio 2024

Over-the-scope clips versus standard therapy in upper gastrointestinal bleeding

We read with high interest the randomised controlled trial (RCT) of Chan et al investigating over-the-scope clips (OTSC) versus standard therapy for the prevention of rebleeding in large (≥1.5 cm) peptic ulcers.1 However, this study and some aspects of study design deserve further critical evaluation and interpretation. One hundred patients with peptic ulcer bleeding and lesion size ≥1.5 cm were randomised to OTSC or standard treatment. In the intention-to-treat analysis, the primary endpoint of clinical rebleeding within 30 days was achieved in 10% with OTSC vs 18% with standard therapy. The difference was statistically not significant. Two previously published RCTs assessing OTSC first-line therapy in non-variceal upper gastrointestinal (GI) bleeding have shown superiority to standard treatment.2 3 In both trials, only high-risk patients were included (eg, patients with haemodynamic instability or Rockall Score ≥7). The only selection criterium in the study of Chan et al…

Leggi
Febbraio 2024

Comparing Low- or Standard-Dose Alteplase in Endovascular Thrombectomy: Insights From a Nationwide Registry

Stroke, Ahead of Print. BACKGROUND:Timely intravenous thrombolysis and endovascular thrombectomy are the standard reperfusion treatments for large vessel occlusion stroke. Currently, it is unknown whether a low-dose thrombolytic agent (0.6 mg/kg alteplase) can offer similar efficacy to the standard dose (0.9 mg/kg alteplase).METHODS:We enrolled consecutive patients in the multicenter Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke who had received combined thrombolysis (within 4.5 hours of onset) and thrombectomy treatment from January 2019 to April 2023. The choice of low- or standard-dose alteplase was based on the physician’s discretion. The outcomes included successful reperfusion (modified Thrombolysis in Cerebral Infarction score, 2b–3), symptomatic intracerebral hemorrhage, 90-day modified Rankin Scale score, and 90-day mortality. The outcomes between the 2 groups were compared using multivariable logistic regression and inverse probability of treatment weighting-adjusted analysis.RESULTS:Among the 2242 patients in the Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke, 734 (33%) received intravenous alteplase. Patients in the low-dose group (n=360) were older, had more women, more atrial fibrillation, and longer onset-to-needle time compared with the standard-dose group (n=374). In comparison to low-dose alteplase, standard-dose alteplase was associated with a lower rate of successful reperfusion (81% versus 87%; adjusted odds ratio, 0.63 [95% CI, 0.40–0.98]), a numerically higher incidence of symptomatic intracerebral hemorrhage (6.7% versus 3.9%; adjusted odds ratio, 1.81 [95% CI, 0.88–3.69]), but better 90-day modified Rankin Scale score (functional independence [modified Rankin Scale score, 0–2], 47% versus 31%; adjusted odds ratio, 1.91 [95% CI, 1.28–2.86]), and a numerically lower mortality rate (9% versus 15%; adjusted odds ratio, 0.73 [95% CI, 0.43–1.25]) after adjusting for covariates. Similar results were observed in the inverse probability of treatment weighting-adjusted models. The results were consistent across predefined subgroups and age strata.CONCLUSIONS:Despite the lower rate of successful reperfusion and higher risk of symptomatic intracerebral hemorrhage with standard-dose alteplase, standard-dose alteplase was associated with a better functional outcome in patients receiving combined thrombolysis and thrombectomy.

Leggi
Febbraio 2024