Effect of compression by elastic bandages on pain and function in individuals with knee osteoarthritis: protocol of a randomised controlled clinical trial

Introduction
Although compression is used to control pain in knee osteoarthritis (KOA), its clinical application is poorly supported, and there is a lack of scientific evidence to support its clinical use. As a low-cost and accessible protocol, compression using elastic bands could be a non-pharmacological intervention to reduce pain and improve physical function in individuals with KOA. This study aims to evaluate the effects of compression on pain and function in individuals with KOA.

Methods and analysis
A randomised controlled clinical trial will be conducted. Individuals with KOA (n=90; both sexes; between 40 and 75 years old) will be allocated to three groups (n=30/group): compression (compression by the elastic bandage on the affected knee, once a day for 20 min, on four consecutive days); sham (same protocol, but the elastic band is placed around the affected knee without compression) and control (no intervention). The individuals in the three groups will be evaluated 1 day before the first intervention, 1 day after the last intervention, and at the 12th and 24th weeks after the end of the intervention. Pain intensity by the Visual Analogue Scale and pain scale from Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) will be the primary outcomes. The secondary variables will be physical function assessed by the WOMAC questionnaire and physical tests (step test; 30 s sit and stand test; 40 m accelerated walk test). The Global Rating of Change Scale (GRC) will also be applied to quantify the volunteers’ perceived change.

Ethics and dissemination
The project was approved by the Human Research Ethics Committee of the Federal University of São Carlos, São Paulo, Brazil (3955692). The results will be published in peer-reviewed journals.

Trial registration number
NCT04724902.

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Novembre 2022

Effectiveness of self-management applications in improving clinical health outcomes and adherence among diabetic individuals in low and middle-income countries: a systematic review

Introduction
A variety of mobile health (mHealth) applications are available to monitor an individual’s health or lifestyle to make it convenient to access healthcare facilities at home. The usability of mHealth applications in controlling HbA1c (estimated average blood glucose) levels is unclear despite their increasing use. The burden of type 2 diabetes mellitus (T2DM) is high in low and middle-income countries (LMICs), with the highest burden in the Indian population. Our objective is to identify the effectiveness of mHealth applications in managing blood glucose levels of individuals with T2DM and to assess the impact of using mHealth applications in managing T2DM concerning health-promoting behaviour among the LMICs in the context of India.

Methods and analysis
The electronic databases included for search are PubMed, Ovid Medline, EBSCO, CINAHL, Scopus, Web of Science and the Cochrane Central Register of Controlled Trials; additional sources of the search will be grey literature available on diabetes management websites and reference lists of included studies. Studies published in the English language in indexed and peer-reviewed sources will be considered. Studies reporting the effectiveness of mobile applications in the management of T2D in LMICs will be eligible for inclusion. The Population-Intervention-Comparison-Outcomes framework and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement 2021 will be used for reporting. Data analysis will be carried out using narrative synthesis, and a meta-analysis may be conducted if we come across homogenous data for the outcome.

Ethics and dissemination
As this study is a systematic review, we will not be recruiting any participants for the study and hence will not require ethical approval. The study summary will be disseminated at a conference.

PROSPERO registration number
CRD42021245517.

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Novembre 2022

NET-RMDs study: networks of fatigue and pain in rheumatic and musculoskeletal diseases – protocol for an international cross-sectional study

Introduction
Fatigue and pain are the main symptoms of rheumatic and musculoskeletal diseases (RMDs). Healthcare professionals have a primary role in helping patients to manage both these symptoms, which are part of a complex network of co-occurring factors including sleep problems, psychological distress, social support, body weight, diet, inactive lifestyle and disease activity. The patterns of relationships (networks) between these factors and these symptoms, fatigue and pain, are largely unknown. The current proposal aims to reveal them using network estimation techniques. We will also consider differences in networks for subgroups of people with (1) different RMDs and (2) different clusters (profiles) of biopsychosocial factors.

Methods and analysis
Adults with at least one RMD will be recruited to this online cross-sectional observational project. To provide a complete overview, a large sample size from different countries will be included. A brief online survey, using 0–10 numeric rating scales will measure, for the past month, levels of fatigue and pain as well as scores on seven biopsychosocial factors. These factors were derived from literature and identified by interviews with patients, health professionals and rheumatologists. Using this input, the steering committee of the project decided the factors to be measured giving priority to those that can be modified in self-management support in community health centres worldwide. Network estimation techniques are used to detect the complex patterns of relationships between these biopsychosocial factors, fatigue and pain; and how these differ for subgroups of people with different RMDs and profiles.

Ethics and dissemination
Ethical approval of national Institutional Review Boards was obtained. The online survey includes an information letter and informed consent form. The findings will be disseminated via conferences and publications in peer-reviewed scientific journals, while public media channels will be used to inform people with RMDs and other interested parties.

Leggi
Novembre 2022

Correction: Accuracy of a self-report prescription opioid use diary for patients discharge from the emergency department with acute pain: a multicentre prospective cohort study

Daoust R, Paquet J, Williamson D, et al. Accuracy of a self-report prescription opioid use diary for patients discharge from the emergency department with acute pain: a multicentre prospective cohort study. BMJ Open 2022;12:e062984. doi:10.1136/ bmjopen-2022-062984
This article has been corrected since it was published online. A collaborator group “On behalf of the OPUM research group” has been added to the author byline.

Leggi
Novembre 2022

An Emoji-Based Visual Analog Scale Compared With a Numeric Rating Scale for Pain Assessment—Reply

In Reply Dr Moisset and colleagues call attention to considerations regarding the use in our recent study of an emoji-based VAS in an adult population. Even though the VAS has been traditionally used for children, this does not preclude the use of an emoji-based VAS in adults. A report by the Unicode Consortium estimates that 92% of the global online community uses emojis. Furthermore, a global emoji trend report by Adobe found that 90% of global users perceive emojis as a valuable tool for self-expression, and 89% believe emojis (as pictographs) facilitate easier communication across language barriers. Pictographic language systems have been historically used for communication in Egyptian hieroglyphics and Sumerian cuneiforms, and they are still used in Chinese characters today.

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Novembre 2022

Identification of barriers, enablers and interventions to inform deimplementation of low-value care in emergency medicine practice: A protocol for a mixed methods scoping review informed by the Theoretical Domains Framework

Introduction
Low-value care can lead to patient harm, misdirected clinician time and wastage of finite healthcare resources. Despite worldwide endeavours, deimplementing low-value care has proved challenging. Multifaceted, context and barrier-specific interventions are essential for successful deimplementation. The aim of this literature review is to summarise the evidence about barriers to, enablers of and interventions for deimplementation of low-value care in emergency medicine practice.

Methods and analysis
A mixed methods scoping review using the Arksey and O’Malley framework will be conducted. MEDLINE, CINAHL, EMBASE, EMCare, Scopus and grey literature will be searched from inception. Primary studies will be included. Barriers, enablers and interventions will be mapped to the domains of the Theoretical Domains Framework. Study selection, data collection and quality assessment will be performed by two independent reviewers. NVivo software will be used for qualitative data analysis. Mixed Methods Appraisal Tool will be used for quality assessment. Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews framework will be used to present results.

Ethics and dissemination
Ethics approval is not required for this scoping review. This review will generate an evidence summary regarding barriers to, enablers of and interventions for deimplementation of low-value care in emergency medicine practice. This review will facilitate discussions about deimplementation with relevant stakeholders including healthcare providers, consumers and managers. These discussions are expected to inform the design and conduct of planned future projects to identify context-specific barriers and enablers then codesign, implement and evaluate barrier-specific interventions.

Leggi
Novembre 2022

Physician consultation rates and characteristics among workers with chronic pain or headache who participated in a behavioural change program: a retrospective database analysis using real-world healthcare data

Objective
To assess the potential benefit of a behavioural change programme in working individuals with chronic pain or headache, in the form of increased physician consultation.

Design
Retrospective observational database study.

Setting
Members of employment-based healthcare insurance in Japan.

Participants
Individual-level data of working individuals aged

Leggi
Novembre 2022

Improving routine childhood immunisation outcomes in low-income and middle-income countries: an evidence gap map

Objective
To support evidence-informed decision-making, we created an evidence gap map to characterise the evidence base on the effectiveness of interventions in improving routine childhood immunisation outcomes in low-income and middle-income countries (LMICs).

Methods
We developed an intervention–outcome matrix with 38 interventions and 43 outcomes. We searched academic databases and grey literature sources for relevant impact evaluations (IEs) and systematic reviews (SRs). Search results were screened on title/abstract. Those included on title/abstract were retrieved for full review. Studies meeting the eligibility criteria were included and data were extracted for each included study. All screening and data extraction was done by two independent reviewers. We analysed these data to identify trends in the geographic distribution of evidence, the concentration of evidence across intervention and outcome categories, and attention to vulnerable populations in the literature.

Results
We identified 309 studies, comprising 226 completed IEs, 58 completed SRs, 24 ongoing IEs and 1 ongoing SR. Evidence from IEs is heavily concentrated in a handful of countries in sub-Saharan Africa and South Asia. Among interventions, the most frequently evaluated are those related to education and material incentives for caregivers or health workers. There are gaps in the study of non-material incentives and outreach to vulnerable populations. Among outcomes, those related to vaccine coverage and health are well covered. However, evidence on intermediate outcomes related to health system capacity or barriers faced by caregivers is much more limited.

Conclusions
There is valuable evidence available to decision-makers for use in identifying and deploying effective strategies to increase routine immunisation in LMICs. However, additional research is needed to address gaps in the evidence base.

Leggi
Novembre 2022

Study protocol of the BASINEL Study: a pragmatic randomised controlled trial investigating treatment versus no treatment of low-risk basal cell carcinomas in older persons

Introduction
Basal cell carcinomas (BCCs) represent 70% of all skin cancers. These tumours do not metastasise but are locally invasive if left untreated. There is a high incidence of BCC in the elderly, and clinicians frequently face important treatment dilemmas. The approach to BCC in the elderly should be investigated thoroughly.

Methods and analysis
Data on health-related quality of life (HrQoL), survival and complication rate will be examined in a treatment and a non-treatment arm (1:1 allocation). In the non-treatment arm, in vivo biological behaviour of low-risk BCCs in elderly patients will be examined. The main objective is to combine tumour characteristics with demographic data, in order to determine whether treatment will positively affect the patients’ HrQoL within a predetermined time frame. A monocentric randomised controlled trial (RCT) was designed at the Ghent University Hospital. The study population consists of patients with the minimum age of 75 years and a new diagnosis of (a) low-risk BCC(s). Patients in the treatment arm will receive standard care. Patients in the non-treatment arm will be closely monitored: the tumour will be intensively evaluated using multispectral dermoscopy, reflectance confocal microscopy and high-definition optical coherence tomography. All patients will be asked to fill in a questionnaire concerning their HrQoL at consecutive time points. Patient-reported side effects will be evaluated via an additional questionnaire.
Primary outcomes will include the difference in HrQoL and the difference in complication risks (treatment vs non-treatment) at different time points of the study. Secondary endpoints are the evolution of the BCCs in the non-treatment arm and the long-term survival in both study arms. Tertiary endpoint is the treatment effectiveness in the treatment arm. The sample size calculation was performed and resulted in a target sample size of 272 patients in this study with a 1:1 allocation.

Ethics and dissemination
Subjects can withdraw from participating in this study at any time for any reason without any consequences. Approval for this study was received from the Ethics Committee of the Ghent University Hospital on 26 August 2021.The results of this RCT will be submitted for publication in one or more international, peer-reviewed medical journals, regardless of the nature of the study results.

Trial registration number
ClinicalTrials.gov (NCT05110924).

Leggi
Novembre 2022

Efficacy of neuromuscular electrical stimulation with combined low and high frequencies on body composition, peripheral muscle function and exercise tolerance in patients with chronic kidney disease undergoing haemodialysis: a protocol for a randomised, double-blind clinical trial

Introduction
Neuromuscular electrical stimulation (NMES) as an adjunctive strategy to increase isolated muscular strength or endurance has been widely investigated in patients with chronic kidney disease (CKD) undergoing haemodialysis (HD). However, the efficacy of combined low and high frequencies, to improve both muscular strength and endurance, is unknown. This trial aims to evaluate the efficacy of this combined NMES strategy in this population.

Methods and analysis
This is a randomised controlled trial with blinded assessments and analysis. A total of 56 patients with CKD undergoing HD will be recruited and randomised to an NMES protocol. The evaluations will be performed on three different days at baseline and after 24 sessions of follow-up. Assessments will include the background, insulin-like growth factor, lactate measurement, malnutrition and inflammation score evaluation, an electrical bioimpedance examination, global muscular evaluation by means of the Medical Research Council scale, handgrip strength evaluation, muscular isokinetic evaluation of lower limbs, 6 min step test performance and quality of life (QoL) questionnaire with emphasis on physical function. The patients will be allocated in one of the following four groups: 1) combined low and high frequencies; 2) low frequency; 3) high frequency; and 4) sham stimulation with minimal intensity to generate only sensory perception (with no visible contraction). In all groups, the intensity throughout the session will be the highest tolerated by patient (except for control group). The primary endpoint is the change of peripheral muscle function (muscular strength and endurance). The secondary endpoints will be the changes of body composition; muscle trophism; exercise tolerance; QoL; and nutritional, inflammatory, and metabolic markers. The findings of this study are expected to provide valuable knowledge on how to optimise the NMES intervention, with improvements in both muscle strength and endurance.

Ethics and dissemination
This protocol has been approved by the Ethics Committee on Research with Humans of Hospital Sírio-Libanês (approval no. 24337707). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.

Trial registration number
NCT03779126

Leggi
Novembre 2022