Effectiveness of non-pharmacological interventions for pain management in patients with cancer:a protocol for systematic review and network meta-analysis

Introduction
Pain management in patients with cancer is a critical aspect of oncological care, yet remains challenging with current pharmacological therapies. Non-pharmacological interventions, offering potential benefits without the adverse effects of drugs, have gained attention. However, the effectiveness of these diverse non-pharmacological interventions is not well understood, creating a gap in clinical practice. This study aims to conduct a systematic review and network meta-analysis (NMA) to evaluate the efficacy of various non-pharmacological interventions for pain management in patients with cancer, providing evidence-based guidance for clinicians and patients.

Methods and analysis
A systematic review and Bayesian NMA will be performed. To assess the efficacy of interventions for cancer pain, we will search six electronic databases: Cochrane Library, Web of Science, PubMed, EMBASE, PsycINFO and the Cumulative Index to Nursing and Allied Health Literature, focusing on identifying randomised controlled trials. Literature screening should be independently performed by two reviewers. A NMA will evaluate the efficacy of various non-pharmacological interventions for cancer pain. A second NMA will compare the efficacy of different non-pharmacological interventions in relieving pain interference in patients with cancer pain. Bayesian 95% credible intervals will be used to estimate the pooled mean effect size for each treatment, and the surface under the cumulative ranking area will be employed to rank the effectiveness of the treatments.

Ethics and dissemination
Ethical approval is not required for this systematic review of the published data. Findings will be disseminated via peer-reviewed publication.

PROSPERO registration number
CRD42024483025.

Leggi
Novembre 2024

Effect of diet on the management of hypertension and type 2 diabetes mellitus in adults from low-income and middle-income countries: protocol for a systematic review of randomised controlled trials

Introduction
Hypertension and type 2 diabetes mellitus (T2DM) are two highly prevalent non-communicable diseases worldwide, both leading to disability and premature mortality in low-and-middle-income countries (LMICs). Nutritional interventions towards a healthier dietary pattern or food and nutrients intake have an important role on the management of this disease. This systematic review aims to evaluate the effect of nutritional interventions on the management of blood pressure and glycaemia in adults with hypertension and T2DM from LMICs.

Methods and analysis
We will conduct a systematic review of randomised controlled trials (RCTs) on the effect of nutritional interventions on blood pressure and glycaemia in adult patients with hypertension and T2DM. Literature search will be conducted in MEDLINE, EMBASE, Scopus, Cochrane and Web of Science databases from anytime until April 2024. Nutritional interventions would have been applied in addition to regular or standard treatment, which is prescribed and/or provided by the healthcare system. Studies in English and Spanish will be selected and reviewed by two independent reviewers. Risk of bias will be assessed using the Cochrane tool for RCTs. Heterogeneity and publication bias will be estimated using the I2 and Egger’s test, respectively.

Ethics and dissemination
Ethics approval was not required for this systematic review, considering there was no direct data collection or participation of patients. The investigators will write a manuscript of the final detailed report with the study development and main findings to be published in a peer- reviewed journal. The main findings may be shared with academia partners and groups working on similar topics in LMICs, in addition to policymakers and authorities in these countries.

PROSPERO registration number
CRD42023483847.

Leggi
Ottobre 2024

Breadth and visibility of childrens lower limb chronic musculoskeletal pain: a scoping review

Objective
To identify the types of conditions reported in peer-reviewed literature that result in chronic musculoskeletal lower limb pain in children and adolescents and explore the alignment of these conditions with the chronic pain reporting codes indexed in the International Classification of Diseases 11th Revision (ICD-11).

Design
This scoping review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources
Five electronic databases were searched (Medline, EMBASE, PsycINFO, CINAHL and the Cochrane Library).

Eligibility criteria
Articles involving children and adolescents under 18 years and reporting on chronic musculoskeletal pain of the lower limb were included.

Data extraction and synthesis
We assigned an ICD-11 code to each condition based on details reported in the study. We recorded whether any of the presenting conditions were linked to an ICD-11 chronic pain manifestation code.

Results
From 12 343 records, 418 papers were included. There were 124 unique conditions associated with chronic lower limb pain, the most commonly reported being chronic widespread musculoskeletal pain (24 studies) and juvenile idiopathic arthritis (26 studies). Only 11.1% of presenting conditions were linked to an ICD-11 chronic pain manifestation code.

Conclusion
Most presenting conditions associated with chronic pain in the lower limb do not have a chronic pain manifestation code in the new global standard for recording health information. This means chronic pain associated with common lower limb conditions may remain invisible in global statistics.

Leggi
Ottobre 2024

Comparison of the efficacy and safety of low-dose antihypertensive combinations in patients with hypertension: protocol for a systematic review and network meta-analysis

Introduction
Hypertension, a prevalent cardiovascular disease globally, poses significant health risks and economic burden. Evolving treatment targets necessitate more intensive strategies, such as low-dose triple or quadruple drug combinations. However, a systematic comparison of different low-dose antihypertensive combinations is still lacking. The aim of the present study is to systematically and comprehensively evaluate the blood pressure-lowering effect and the associated safety of diverse low-dose polypharmacy combinations in patients with hypertension.

Methods and analysis
In this systematic review and network meta-analysis, randomised controlled trials comparing diverse low-dose polypharmacy combinations with placebo or active treatments in patients with hypertension will be eligible for inclusion. The primary outcomes are a reduction in systolic/diastolic blood pressure, the rate of target blood pressure, adverse effects, serious adverse effects and all-cause dropout after treatment. PubMed, Web of Science, Embase, Cochrane Library, Chinese Science Citation Database, Wanfang Medical Network, VIP Database and clinical trial registries will be systematically searched for relevant studies published from inception date to 18 January 2024. No language restrictions will be applied during the search process. Two independent reviewers will identify eligible trials and extract the data. Traditional pairwise meta-analysis will be conducted to analyse direct comparisons. A frequentist approach will be used to analyse the primary outcome for network comparisons, and cumulative rank probabilities will present the treatment hierarchy of all endpoints. Sensitivity analysis will be conducted using a Bayesian framework under a random-effects model. Subgroup analyses will be conducted according to sample size, quality of study and sponsorship, if the data allow. The Cochrane Risk of Bias Tool 2.0 will be used to assess the quality of the included studies. The Grading of Recommendations, Assessment, Development, and Evaluation system will be used to assess the strength of evidence.

Ethics and dissemination
Since this study relies solely on published literature, no ethics approval is necessary. The results will be submitted to a peer-reviewed journal.

PROSPERO registration number
CRD42024503239.

Leggi
Ottobre 2024

Major financial problems, low mental well-being and reduced HIV/STI testing among sex workers in the Netherlands during the COVID-19 pandemic: a repeated cross-sectional survey

Objectives
To determine associations between the banning of sex work during the COVID-19 pandemic, and work, financial problems, mental well-being and HIV/sexually transmittable infection (STI) testing among sex workers in the Netherlands.

Design
Two cross-sectional online surveys. The first survey covered two time-periods: pre-COVID-19 (1 January 2019 to 31 December 2019) and period 1 (15 March 2020 to 1 July 2020). The second survey covered period 2 (1 January 2021 to 31 December 2021).

Setting
The Netherlands

Participants
In total, 106 (first survey) and 196 (second survey) sex workers participated. Most of the participants in the first and second survey were cisgender women (respectively, 76.4% and 66.5%), followed by cisgender men (respectively, 12.3% and 15.7%) and the combination of transgender men, transgender women, non-binary or other (respectively, 11.3% and 17.6%). Most participants were born in the Netherlands (respectively, 61.4% and 69.7%).

Primary and secondary outcome measures
We provide descriptive statistics of self-reported work during and prior to COVID-19 measures, financial problems due to COVID-19 measures and HIV/STI testing and mental well-being during the COVID-19 pandemic. We also performed logistic and linear regression analyses to identify risk factors associated with reporting financial problems due to COVID-19 measures, not testing for HIV/STIs and lower mental well-being during the COVID-19 pandemic.

Results
In periods 1 and 2, respectively, 69.6% and 62.0% reported financial problems due to the COVID-19 measures. Among those who reported to have had sex with clients, the percentage not HIV/STI testing was: 4.5% (95% CI: 0.9; 12.5) pre-COVID-19, 28.2% (95% CI: 15.0; 44.9) in period 1, and 15.2% (95% CI: 9.7; 22.3) in period 2. In the multivariate analysis, reported financial problems due to the COVID-19 pandemic was associated with not HIV/STI testing (OR: 12.1, p

Leggi
Ottobre 2024

Influence of social media and the digital environment on international migration of health workforce from low- and middle-income countries post COVID-19 pandemic: a scoping review protocol

Introduction
Migration of the health workforce from low- and middle-income countries (LMCIs) is increasingly becoming a phenomenon of interest within migration governance systems. The COVID-19 pandemic aggravated health workforce shortages that have created job opportunities in high-income countries such as the USA, UK, Canada and Germany among others. Conditions of service in LMCIs are unattractive, leading to the search for better opportunities. The digital environment is becoming one of the facilitators of migration intentions due to the activities of recruitment agencies and the search for job opportunities on the World Wide Web. The digital environment creates opportunities for migration but also poses a security threat, economic loss and a brain drain to departure countries. However, there is a paucity of evidence on how the proliferation of advertisements on health workforce recruitment within social media, unsolicited emails and activities of recruitment agencies in the digital environment influence the migration of the health workforce and the implications of migration governance.

Method and analysis
This scoping review protocol describes a comprehensive systematic extraction and examination of existing literature to map key concepts and identify previous literature, noting the gaps in how social media and the digital environment are influencing the migration of the health workforce. We lean on Arksey and O’Malley’s scoping framework in developing this protocol. This involves the following: identifying research questions, searching for the literature, selecting articles or studies, charting the data and organising and reporting the outcome of the review. The review question is informed by the population, concept and context framework, which details the population as the health workforce (doctors, nurses, midwives and pharmacists), the key concepts as migration, social media and digital environment, and the context as LMICs. The search strategy was developed with the assistance of an experienced librarian who will work with the team to conduct a Peer Review of Electronic Search Strategies to evaluate titles, abstracts and full-text articles for inclusion from databases such as Scopus, PubMed, MEDLINE and Google Scholar. Additionally, we will search grey literature sources including online news media, social media platforms (Facebook, Instagram and Twitter), web pages of WHO, UN and migration-related agencies, and interfaces like EBSCO host. Two members of the team will screen titles and abstracts, and all team members will screen full text for data extraction. Data from grey sources will be converted to transcripts, coded and grouped into themes and subthemes consistent with thematic analysis strategies. All authors will be involved in the synthesis of the data. We intend to follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines in reporting the outcome of peer-review sources.

Ethics and dissemination
This is a scoping review protocol that addresses a subject of interest that poses no risk to individuals or groups. All the information will be retrieved from open sources only. The protocol was registered with the Open Science Framework registry (osf.oi/zan3q) to serve as an audit trail. Reports from the review will be published in peer-reviewed journals and presented at conferences.

Leggi
Ottobre 2024

Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study

Objectives
This study aims to determine the usage pattern, effectiveness and safety of oral tramadol 75 mg and dexketoprofen trometamol 25 mg fixed-dose combination (TRAM/DKP FDC) in the short-term treatment of moderate-to-severe acute pain in real-world clinical practice in Asia.

Design
Real-world, prospective, multicentre, observational, phase IV study.

Setting
13 tertiary-care hospital sites across the Philippines, Thailand, Malaysia and Singapore.

Participants
Adult patients aged 18–80 years prescribed TRAM/DKP FDC for the short-term (up to 5 days) treatment of moderate-to-severe acute pain.

Main outcome measures
Primary endpoints were the proportion of patients prescribed TRAM/DKP FDC with different types of postsurgical and non-surgical treatments, and the average dosing frequency and duration of TRAM/DKP FDC treatment. Secondary endpoints were the proportion of patients achieving ≥30% pain reduction at 8 hours post the first dose (pain severity was assessed using the 11-point Numeric Pain Rating Scale); patient satisfaction at the end of treatment (based on a 5-point Patient Global Evaluation Scale (PGE)) and safety including the incidence of adverse drug reactions (ADRs).

Results
Among 599 patients (median age 44 years, 61.3% female) enrolled in this study, 68.61% (n=411) were postsurgical and 31.39% (n=188) were non-surgical patients. TRAM/DKP FDC was prescribed in a diverse group of postsurgical patients (eg, orthopaedic, general and cancer surgery) as well as in non-surgical conditions (eg, lower back pain and musculoskeletal pain). In the majority of patients, TRAM/DKP FDC was prescribed every 8 hours (65.94%) and for 5 days (78.80%). There was a significant reduction in pain intensity throughout the study and 65% of patients achieved ≥30% pain reduction from baseline at 8 hours post the first dose of TRAM/DKP FDC on day 1. 95.69% of patients were satisfied with the treatment (rated good, very good and excellent on the PGE scale). Overall, 13.9% of patients reported ADRs; most were mild to moderate in severity. The most common ADRs were nausea, vomiting and dizziness.

Conclusion
This study showed that TRAM/DKP FDC was used in diverse types of postsurgical and non-surgical patients in the real-world setting in Asia. It effectively reduced pain and was well tolerated with a high level of patient satisfaction.

Leggi
Ottobre 2024

High-load strength training compared with standard care treatment in young adults with joint hypermobility and knee pain: study protocol for a randomised controlled trial (the HIPEr-Knee study)

Introduction
Patients with generalised joint hypermobility, including knee hypermobility (GJHk), often experience knee pain and are typically managed with low-intensity strength training and/or proprioceptive training as part of standard care. However, not all patients experience satisfactory outcomes. High-load strength training may offer additional benefits, such as increased muscle cross-sectional area, neural drive and tendon stiffness, which may reduce pain and improve active knee joint stability during movement tasks and daily activities. So far, no randomised controlled trials (RCTs) have compared high-load strength training with traditional treatment strategies (standard care) for this patient group.

Methods and analysis
In this RCT, we aim to recruit patients with GJHk and knee pain from primary care physiotherapy clinics in the Region of Southern Denmark and via social media. Patients with competing injuries or experience with high-load strength training will be excluded. Patients will be randomised (1:1 ratio) to either 2 weekly sessions of high-load strength training or standard care for 12 weeks. The primary outcome is self-reported knee pain during an activity nominated by the patient as the most aggravating for their present knee pain measured using the Visual Analogue Scale for Nominated Activity (VASNA, 0–100; 0=no pain and 100=worst imaginable pain). This will be collected at baseline, 6 weeks, 12 weeks and 12 months. Secondary outcomes include self-reported knee function and adverse events (collected at baseline, 12 weeks and 12 months), objective measurements including a 5-repetition maximum single-leg press, proprioception and single-leg-hop for distance (collected at baseline and 12 weeks), and a range of other outcome measures such as fear of movement, tendon stiffness and global perceived effect. We aim to recruit 90 patients in total to detect a 10 mm group difference in the primary outcome with 80% power.

Ethics and dissemination
This study was funded by Independent Research Fund Denmark (grant number 2034-00088B) on 14 June 2022; the Regional Committees on Health Research Ethics for Southern Denmark approved it (S-20230050) on 30 August 2023. The first recruitment site opened on 15 February 2024, and the final results will be submitted to a peer-reviewed journal to inform rehabilitation strategies for symptomatic GJHk.Protocol version 1, dated 4 July 2024.

Trial registration number
NCT06277401.

Leggi
Ottobre 2024