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☐ ☆ ✇ BMJ Open

Randomised, controlled clinical trial evaluating the effects of preoperative insomnia treatment on postoperative pain control and recovery: a protocol for the Promoting Sleep to Alleviate Pain-Arthroplasty (PROSAP-A) trial

Por: Bjurström · M. F. · Bothelius · K. · Maathz · P. · Jernelöv · S. · Kraepelien · M. · Rosenström · A. H. C. · Niklasson · A. · Smith · M. T. · Olmstead · R. · Irwin · M. R. · Finan · P. H. · Kosek · E. — Julio 30th 2025 at 11:57
Introduction

Sleep is a biological necessity with vital effects on all tissues and organs of the body. Preoperative sleep disturbance is associated with increased postoperative pain intensity and opioid consumption. Given that insomnia is a potentially modifiable risk factor, interventions targeting sleep prior to surgery may improve postoperative pain control and enhance key outcomes of recovery.

Methods and analysis

Promoting Sleep to Alleviate Pain-Arthroplasty (PROSAP-A) is a randomised, parallel group, two arm, controlled trial evaluating the effects of preoperative sleep-promotion on postoperative pain control, brain health and physical recovery. The main objective is to investigate whether preoperative insomnia treatment in patients scheduled to undergo total knee arthroplasty (TKA) or total hip arthroplasty (THA) may improve acute postoperative pain control. 100 adults with insomnia disorder (Insomnia Severity Index score >10 and confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for persistent insomnia disorder), scheduled to undergo primary TKA or THA, will be randomised to preoperative cognitive behavioural therapy for insomnia (CBT-I) or an active comparator control intervention, sleep education therapy (SET). Both interventions will be delivered over 4 weeks in hybrid format through a digital self-guided platform in combination with weekly telehealth video sessions with a psychologist (CBT-I) or research nurse (SET). A video-assisted booster session will be provided 1–2 weeks postoperatively. The primary outcome measure is acute postoperative pain intensity, averaged over the first 7 postoperative days (POD). Secondary outcome measures include long-term postoperative pain control, changes in quantitative sensory testing variables (eg, temporal summation, conditioned pain modulation), sleep, cognition (eg, attention, memory, processing speed, executive function), mental health, health-related function, physical activity, quality of life and blood biomarkers. Participants will undergo on-site evaluation preoperative (preintervention and postintervention) and 6 months postoperative. Additional remote assessments will take place during POD1–7, 3 and 12 months postoperative.

Ethics and dissemination

The Swedish Ethical Review Authority has approved the PROSAP-A trial protocol. Results will be published in international peer-reviewed journals and summaries will be provided to funders and participants of the trial.

Trial registration number

NCT06145516.

☐ ☆ ✇ BMJ Open

Updating global estimates of pathogen-attributable diarrhoeal disease burden: a methodology and integrated protocol for a broad-scope systematic review of a syndrome with diverse infectious aetiologies

Por: Colston · J. M. · Flynn · T. G. · Denton · A. H. · Schiaffino · F. · Majowicz · S. E. · Devleesschauwer · B. · Di Bari · C. · Minato · Y. · Kosek · M. N. — Abril 3rd 2025 at 13:14
Introduction

Sustaining declines in global infectious disease burden will increasingly require efforts targeted to specific aetiological agents and common transmission pathways, particularly in this era of global change and human interconnectivity accelerating transmission and emergence of infectious pathogens. Systematic reviews and meta-analyses can be an effective and resource-efficient method for synthesising evidence regarding disease epidemiology for a wide range of pathogens and are the evidence source used by initiatives like the Planetary Child Health and Enterics Observatory (Plan-EO) and the WHO to determine the aetiology-specific epidemiology of diarrhoeal disease. Therefore, we developed this integrated systematic review methodology and protocol that aims to compile a database of published prevalence estimates for 17 diarrhoea-causing pathogens as inputs for disease burden estimation.

Methods and analysis

We will seek estimates of the prevalence of each endemic enteric pathogen estimated from published population-based studies that diagnosed their presence in stool samples from both asymptomatic subjects and those experiencing diarrhoea. The pathogens include the enteric viruses adenovirus, astrovirus, norovirus, rotavirus and sapovirus, the bacteria Campylobacter, Shigella, Salmonella enterica, Vibrio cholerae and the Escherichia coli (E. coli) pathotypes enteroaggregative E. coli, enteropathogenic E. coli, enterotoxigenic E. coli and Shiga-toxin-producing E. coli and the intestinal protozoa Cryptosporidium, Cyclospora, Entamoeba histolytica and Giardia. Meta-analytical methods for analyses of the resulting database (including risk of bias analysis) will be published alongside their findings.

Ethics and dissemination

This systematic review is exempt from ethics approval because the work is carried out on published documents. The database that results from this review will be made available as a supplementary file of the resulting published manuscript. It will also be made available for download from the Plan-EO website, where updated versions will be posted on a quarterly basis.

PROSPERO registration number

CRD42023427998.

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