Risultati per: Low Back Pain: raccomandazioni

Introduction
Heart failure with preserved ejection fraction (HFpEF) is characterised by severe exercise intolerance, particularly in those living with obesity. Low-energy meal-replacement plans (MRPs) have shown significant weight loss and potential cardiac remodelling benefits. This pragmatic randomised trial aims to evaluate the efficacy of MRP-directed weight loss on exercise intolerance, symptoms, quality of life and cardiovascular remodelling in a multiethnic cohort with obesity and HFpEF.

Methods and analysis
Prospective multicentre, open-label, blinded endpoint randomised controlled trial comparing low-energy MRP with guideline-driven care plus health coaching. Participants (n=110, age ≥18 years) with HFpEF and clinical stability for at least 3 months will be randomised to receive either MRP (810 kcal/day) or guideline-driven care for 12 weeks. Randomisation is stratified by sex, ethnicity, and baseline Sodium Glucose Cotransporter-2 inhibitor (SGLT2-i) use, using the electronic database RedCap with allocation concealment. Key exclusion criteria include severe valvular, lung or renal disease, infiltrative cardiomyopathies, symptomatic biliary disease or history of an eating disorder. Participants will undergo glycometabolic profiling, echocardiography, MRI for cardiovascular structure and function, body composition analysis (including visceral and subcutaneous adiposity quantification), Kansas City Cardiomyopathy Questionnaire (KCCQ) and Six-Minute Walk Test (6MWT), at baseline and 12 weeks. An optional 24-week assessment will include non-contrast CMR, 6MWT, KCCQ score. Optional substudies include a qualitative study assessing participants’ experiences and barriers to adopting MRP, and skeletal muscle imaging and cardiac energetics using 31Phosphorus MR spectroscopy.

Statistical analysis
Complete case analysis will be conducted with adjustment for baseline randomisation factors including sex, ethnicity and baseline SGLT2-i use. The primary outcome is the change in distance walked during the 6MWT. The primary imaging endpoint is the change in left atrial volume indexed to height on cardiac MRI. Key secondary endpoints include symptoms and quality of life measured by the KCCQ score.

Ethics and dissemination
The Health Research Authority Ethics Committee (REC reference 22/EM/0215) has approved the study. The findings of this study will be published in peer-reviewed journals.

Trial registration number
NCT05887271.

Objectives
Neonatal pain prevention is not only a humanistic but also an ethical imperative. Fitting with the principles of family-centred care, parental involvement in neonatal pain management plays an active role in infant development and parental well-being. However, the process of parental involvement faces constant challenges. To help structure and implement a family engagement programme in neonatal pain management in the neonatal intensive care unit (NICU), we conducted a scoping review to identify facilitators and barriers to parental involvement in neonatal pain management.

Methods
We conducted the scoping review using the Arksey and O’Malley framework. PubMed, Cochrane Library, Web of Science, CINAHL, Scopus, Wanfang database (Chinese), CNKI (Chinese), VIP database(Chinese) and SinoMed (Chinese) were searched systematically for relevant studies published in English and Chinese from inception up to October 2023. We categorised the facilitators and barriers based on the socioecological model and analysed the results thematically in each category.

Results
Ten English qualitative studies were included in the final analysis. The 34 facilitators and 41 barriers extracted were grouped into 4 domains of the socioecological model framework. Of the 10 facilitator themes, the most critical theme was informational and emotional support. Of the 10 barrier themes, the most frequently reported theme was restricted policies and resources.

Conclusions
Our review highlights the essential roles of intrapersonal and interpersonal factors in parental involvement in pain management while suggesting the interconnectedness of factors in various domains within the context of the socioecological model. It implies that most interventions require development and administration at both intrapersonal and interpersonal levels. Regarding the macrolevel, a broad programme with clear regulatory approaches and targeted guidelines could be developed in the future to drive innovations in NICU pain management mode.

An international panel of dermatologists released a consensus statement on the off-label use of low-dose oral minoxidil (LDOM) for patients with hair loss, creating a prescription framework for clinical practice.

Planned birth at 39+0–39+6 weeks in low-risk women was associated with lower odds of perinatal mortality and other adverse outcomes. Reductions in odds of adverse outcome were greater following scheduled caesarean section than induction of labour. Compared to expectant management, induction of labour was associated with lower odds of severe perineal trauma, shoulder dystocia, and caesarean birth. These findings generate further hypotheses that need to be tested in adequately powered randomised controlled trials.

Introduction
Non-adherence to tuberculosis (TB) treatment poses a significant challenge to effective TB management globally and is a major contributor to the emergence of multidrug-resistant TB. Although adherence to TB treatment has been widely studied, a comprehensive evaluation of the comparative levels of adherence in high- versus low-TB burden settings remains lacking. The objective of this systematic review and meta-analysis is to assess the levels of adherence to TB treatment in high-TB burden countries compared to low-burden countries. Additionally, it seeks to identify the unique facilitators and barriers to treatment adherence in these distinct settings.

Methods and analysis
This systematic review and meta-analysis will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols Statement. Using key medical subject heading terms and free-text terms related to TB treatment adherence, a systematic search of the literature will be performed in Medline, Embase, CINAHL, Scopus, Global Health and the Cochrane Databases of Systematic Reviews. A medical librarian will assist with developing the search strategy. Two independent reviewers will independently screen studies against predefined inclusion and exclusion criteria at both the title/abstract and full-text stages. Working in duplicate, the same two reviewers will independently extract relevant study and outcomes data, including study descriptors, TB burden, adherence levels and adherence measures, from eligible studies. Countries will be classified according to TB burden based on the WHO’s high-burden country list from the post-2015 era (2015–2025). The quality of the included studies will be appraised using the Cochrane Risk of Bias tool and the Newcastle-Ottawa Scale. Qualitative data will be appraised using the Critical Appraisal Skills Programme tool. Studies will be pooled using the DerSimonian-Laird random-effects meta-analysis. Additionally, a meta-synthesis of the qualitative data from the included studies may be conducted to identify emergent themes related to facilitators and barriers of TB treatment adherence in high- vs low-TB burden countries.

Ethics and dissemination
Ethics approval is not required for this study as it does not involve the recruitment or collection of data from participants. The findings from this systematic review and meta-analysis will be disseminated through publication in peer-reviewed journals, presentations at scientific conferences, and via social media channels to enhance visibility, particularly within programmatic and policy spheres.

PROSPERO registration number
CRD42021273336

Background
Worldwide, lung cancer (LC) is the second most frequent cancer and the leading cause of cancer related mortality. Low-dose CT (LDCT) screening reduced LC mortality by 20–24% in randomised trials of high-risk populations. A significant proportion of those screened have nodules detected that are found to be benign. Consequently, many individuals receive extra imaging and/or unnecessary procedures, which can have a negative physical and psychological impact, as well as placing a financial burden on health systems. Therefore, there is a need to identify individuals who need no interval CT between screening rounds.

Methods and analysis
The aim of this study is to identify risk factors predictive of LC, which are known at the time of the scan, in patients with LDCT screen-detected lung nodules. The MEDLINE and EMBASE databases will be searched and articles that are on cohorts or mention cohorts of screenees with nodules will be identified. A data extraction framework will ensure consistent extraction across studies. Individual participant data (IPD) will be collected to perform a one-stage IPD meta-analysis using hierarchical univariate models. Clustering will be accounted for by having separate intercept terms for each cohort. Where IPD is not available, the effects of risk factors will be extracted from publications, if possible. Effects from IPD cohorts and aggregate data will be reported and compared. The PROBAST (Prediction model Risk Of Bias ASsessment Tool) will be used for assessment of quality of the studies.

Ethics and dissemination
Ethical approval was not required as this study is a secondary analysis. The results will be disseminated through publication in peer-reviewed journals and presentations at relevant conferences.

PROSPERO registration number
CRD42022309515

Objectives
To map the scope of available evidence on relationships between multimorbidity patterns and functioning among adults in low- and middle-income countries (LMICs), and describe methods used.

Design
Scoping review guided by a five-step methodological framework and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews reporting guidelines.

Data sources
PubMed/MEDLINE, Scopus, EBSCOhost (CINAHL) and Cochrane databases were searched from January 1976 to March 2023, plus reference lists of included studies.

Eligibility criteria for selecting studies
Peer-reviewed full-text articles or conference proceedings of any design, published in English or Afrikaans, involving adults ( >18 years) with multimorbidity living in LMICs. Studies had to refer to associations between multimorbid patterns of co-occurrence and functioning. Multimorbidity was defined as the coexistence of ≥2 diseases, including any combination of non-communicable, infectious and mental health conditions.

Data extraction and synthesis
Data were extracted independently by two reviewers using a piloted form. Findings were synthesised according to methodological approaches, multimorbidity-pattern epidemiology, evidence gaps/limitations and recommendations for future research. The International Classification of Functioning, Disability and Health framework was used to classify functional problems.

Results
Nine studies (total sample size: 62 003) were included, mainly from upper-middle-income Asian countries. Key methodological inconsistencies were identified in defining and operationalising multimorbidity, conditions included in determining patterns, statistical methods for pattern determination and functioning outcome measures. Five main multimorbidity pattern domains emerged: Cardio-Metabolic and Coronary Atherosclerotic, Musculoskeletal, Respiratory and Digestive/Visceral, Degenerative, and Mental Health-Related. Mobility limitations, instrumental activities of daily living, self-care and bowel/bladder problems were consistently linked to all pattern domains.

Conclusions
The limited and geographically skewed body of literature, along with methodological inconsistencies, hampers a comprehensive understanding of multimorbidity patterns and associations with functioning in LMICs. Future research should explore context-specific multimorbidity definitions, employ transparent methodologies, use standardised measures and incorporate diverse samples to inform tailored interventions and policies.

Objective
To study the behavioural factors associated with sustained cigarette smoking cessation, and those associated with a current smoker attempting to quit, among current and former cigarette smokers living in low-income South African communities.

Setting
Three low-income areas in South Africa.

Design
In-person surveys with structured questions that asked respondents about their cigarette smoking and quitting behaviour, sociodemographic information and behavioural attributes.

Participants
Current smokers were eligible to participate if they had smoked at least one cigarette in the week prior to the interview (n=569). Former smokers were eligible if they had ever smoked cigarettes regularly in the past and had abstained from smoking for at least 6 months (n=106).

Outcomes
(1) Abstinence from cigarette smoking for at least 6 months and (2) attempting to quit cigarette smoking in the past 12 months.

Results
Compared with low levels of self-control, high levels of self-control increase the odds of sustained cessation (OR=2.690, 95% CI: 2.480 to 2.917) and of making a quit attempt (OR=1.271, 95% CI: 1.254 to 1.288). Relative to low levels of stress, high levels of stress reduce the odds of sustained cessation (OR=0.938, 95% CI: 0.927 to 0.948) and of attempting to quit (OR=0.824, 95% CI: 0.666 to 1.019). Hyperbolic discounting reduces the odds of sustained cessation (OR=0.841, 95% CI: 0.822 to 0.862) while exhibiting more quitting self-efficacy increases these odds (OR=2.063, 95% CI: 1.745 to 2.439). Being impatient reduces the odds of making a quit attempt (OR=0.814, 95% CI: 0.702 to 0.943), as does a tendency to postpone important tasks (OR=0.784, 95% CI: 0.644 to 0.956).

Conclusions
Non-pharmacological cessation support to low-income smokers should challenge potential lifetime quitters to practice self-control, equip them with tools to manage stress, and tackle temptations to time-discounting. Existing healthcare infrastructure should be leveraged to question people who smoke about their behavioural attributes, and to use this information to deliver behavioural support that motivates and facilitates sustained smoking cessation.

New England Journal of Medicine, Volume 392, Issue 4, Page 383-394, January 23, 2025.

Objective
To evaluate the feasibility of implementing family-integrated newborn care (FINC) for hospitalised preterm and low birthweight infants in Ethiopia. Despite the WHO’s call for family engagement in newborn care, evidence of the feasibility of implementation remains scarce.

Design
An observational feasibility study employing a mixed-methods design comprising a quantitative cross-sectional survey among 157 healthcare providers (HCPs) and a qualitative Participatory Rural Appraisal.

Setting
The study was conducted in 30 neonatal care units (NCUs) of hospitals in Tigray, Northern Ethiopia.

Participants
HCPs who were on duty in NCUs during the data collection period were included in the study.

Analysis
Descriptive statistics were obtained for the quantitative data using STATA V.16, while qualitative data were coded and analysed using a framework analysis approach with qualitative data analysis software (Atlas.ti V.9).

Results
In total, 157 HCPs were enrolled with a mean (SD) age of 32 (±6.8) years. Participants scored a higher weighted mean score for implementability (0.75) and a lower mean score for adaptability (0.50). Out of the 157 HCPs, the majority perceived that FINC was technically implementable (96%), conceptually acceptable (74%) and ethically correct (88%). Furthermore, 49% perceived that integrating FINC into the existing system was technically manageable, while 52% agreed that it was expandable to other healthcare facilities. However, HCPs reported lower confidence regarding its practicality (32%), integration (31%) and adaptability (16%). NCU space (97%), number of NCU rooms (87%) and increased risk of infection (83%) were perceived as potential challenges to the feasibility of FINC. More importantly, only 33% of HCPs felt that there was an organisational demand to consider FINC in NCUs. Furthermore, there was a statistically significant variation in the mean score for acceptability and perception of additional burden between age groups (p=0.04).

Conclusions and recommendations
The current study shows that FINC is conceptually acceptable, technically implementable and expandable to other settings, with weighted mean scores of 0.75, 0.72 and 0.66, respectively. However, its practicality (0.53), integration (0.52) and adaptability (0.50) could be generally constrained mainly by the poor organisational infrastructure related to NCU space and infection prevention measures. Addressing motivational, attitudinal and competency gaps of NCU HCPs, along with organisational capacity, would be required.

In patients achieving a median LDL level of 35 mg/dL, neuropsychological testing found no change in cognitive function after 5 years of follow-up.

Introduction
Musculoskeletal pain is the second leading cause of disease burden in Australia, and there is a need to investigate new models of care to cope with the increasing demand for health services. This paper describes the protocol for a randomised controlled trial investigating whether a physiotherapist-led triage and treatment service is non-inferior for improving function at 6 months and superior for reducing treatment waiting times, compared with usual care for patients with musculoskeletal pain referred to public hospital outpatient physiotherapy clinics.

Methods and analysis
A total of 368 participants (184 per arm) will be recruited from six public hospitals located in metropolitan Sydney, Australia. We will recruit adult patients newly referred to a public hospital physiotherapy outpatient clinic with a musculoskeletal condition that is typically managed by a physiotherapist (eg, back or neck pain, osteoarthritis, rehabilitation postorthopaedic surgery and sporting injuries). Participants will be randomised 1:1 to the physiotherapist-led triage and treatment service or usual care. A physiotherapist will telephone participants in the intervention group and match them to different modes and types of care based on baseline characteristics. Participants at low risk of poor outcomes (assessed by the Keele STarT MSK tool) will be given simple advice and education during this call and instructed to call back if their symptoms do not improve in 6 weeks. Participants at medium risk of poor outcomes or requiring postoperative rehabilitation will be offered a course of telehealth (videoconference) physiotherapy targeting exercise-based self-management. Participants at high risk of poor outcomes and/or with potential nonprogressive radiculopathy will be offered a course of usual clinic-based physiotherapy as per all participants in the usual care group. Physical function (Patient Specific Functional Scale) at 6 months postrandomisation and waiting time (time from randomisation to first treatment) are coprimary outcomes. Secondary outcomes include other patient outcomes (eg, pain), health resource use, adverse events, process measures (eg, adherence) and costs.

Ethics and dissemination
This trial has approval from the Sydney Local Health District Human Research Ethics Committee (RPAH Zone; X24-0090 and 2024/ETH00585). Recruitment will commence in September 2024 and is expected to be completed by December 2025 with follow-ups completed by December 2026. The results of the trial will be submitted for publication in reputable international journals and presented at relevant national and international conferences.

Trial registration number
ANZCTR (ACTRN12624000947505).

Introduction
Minimally invasive cardiac surgery (MICS) is important for enhanced recovery in cardiac surgery. However, the incidence of chronic postsurgical pain (CPSP) is high and is associated with worsened quality of recovery and life, as well as raised short-term or long-term mortality. The mechanism is not clear, and there is still a lack of safe and effective preventive measures.

Methods and analysis
The Paravertebral Adjunctive Dexamethasone Palmitate Reducing chronic pain After cardiac surgery (PANDORA) trial is a parallel-group, double-blinded, randomised controlled, single-centre study recruiting 902 participants undergoing MICS. Participants will be randomised in a 1:1 ratio to dexamethasone palmitate (D-PAL) emulsion group and dexamethasone (DSP) group. To investigate the effect of a single bolus perineural administration of D-PAL as an adjuvant treatment to a standard thoracic paravertebral block (TPVB) with ropivacaine decreases the incidence of CPSP in adult patients as compared with single bolus perineural administration of DSP combined with ropivacaine in TPVB. The primary endpoint is the incidence of chronic postoperative pain at 3 months following surgery defined as per the updated International Classification of Diseases. CPSP is defined as a new development of pain or increase in the intensity of pain at the surgical area or projected onto the innervation area of a nerve in this area after a surgical procedure that persists for at least 3 months. The nature and intensity of pain will be evaluated with a Brief Pain Inventory Short Form (BPI-SF) questionnaire.

Ethics and dissemination
The trial was approved by the Ethics Committee of Xijing Hospital, the First Affiliated Hospital of Air Force Military Medical University (KY20232194-C-1). Results will be submitted for publication in peer-reviewed journals and presented at academic meetings.

Trial registration number
ClinicalTrials.gov, NCT05920967.

Background
Magnetic resonance-guided transurethral ultrasound ablation (MR-TULSA) is a new focal therapy for treating localised prostate cancer that is associated with fewer adverse effects (AEs) compared with established treatments. To support large-scale clinical implementation, information about cost-effectiveness is required.

Objective
To evaluate the cost–utility of MR-TULSA compared with robot-assisted radical prostatectomy (RARP), external beam radiation therapy (EBRT) and active surveillance (AS) for patients with low- to favourable intermediate-risk localised prostate cancer.

Design, setting and participants
A Markov model was developed targeting 60-year-old men diagnosed with low- to intermediate-risk localised prostate cancer over a time horizon of 40 years from the German Statutory Health Insurance (SHI) perspective. To assess the robustness of the results, deterministic and probabilistic sensitivity analyses were performed.

Intervention
Four different treatment strategies were compared: minimally invasive MR-TULSA, two definitive approaches (RARP and EBRT) and one observational strategy (AS).

Outcome measurements and statistical analysis
Outcomes were measured in overall costs, quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER).

Results
AS generated the highest number of QALYs (12.67), followed by MR-TULSA (12.35), EBRT (12.35) and RARP (12.20). RARP generated the lowest costs ( 46 997) over one patient’s lifetime, while MR-TULSA was a slightly more expensive alternative (48 826). The incremental cost-effectiveness ratio (ICER) of AS compared with RARP was 11 600 per QALY and of MR-TULSA compared with RARP was 12 193 per QALY, while EBRT was dominated. At a willingness-to-pay of 20 000 per QALY, the probability of being cost-effective is 44% for AS, 25% for RARP, 25% for MR-TULSA and 6% for EBRT.

Conclusions
All treatment options for 60-year-old men diagnosed with low- to intermediate-risk localised prostate cancer are affected by considerable uncertainty. Accepting high follow-up costs by applying a higher willingness-to-pay, AS is the most favourable treatment option.

Introduction
Cervical cancer is the most diagnosed cancer and the leading cause of cancer-related death in 36 low- and middle-income countries, with the majority located in sub-Saharan Africa (SSA), South America and Southeastern Asia. The highest regional incidence and mortality occur in SSA. Despite the high efficacy and cost-effectiveness of the human papillomavirus (HPV) vaccine in preventing cervical cancer, its uptake remains unacceptably low in SSA. This scoping review aims to integrate evidence from SSA on social determinants of HPV vaccine uptake with complementary evidence on interventions to promote its uptake.

Methods and analysis
The proposed review will be conducted following the guidelines of the Joanna Briggs Institute Scoping Review Methodology Group. Additionally, a sequential explanatory design will guide the integration of determinant evidence with intervention evidence. This scoping review will be reported per the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews checklist. Six databases, PubMed/MEDLINE, LIVIVO, Google Scholar, BASE (Grey Literature), preprint databases (eg, OSF and medRxiv) and African Journals Online will be searched, with results limited to English language publications and those published from 2006 to 2024. Two forms will be used for data extraction from determinant and intervention studies by two independent reviewers. A narrative summary of evidence from both determinant and intervention studies will be conducted. Furthermore, a multilevel analysis will be conducted to explore the intersections of determinants across socioecological levels of health behaviour. A further integrative cross-study analysis of results from determinant and intervention studies will be conducted, where the determinant evidence will be used to interrogate the intervention evidence. Data will be presented in tables and matrices.

Ethics and dissemination
No ethical approval will be required for this study because it will be based on data collected from publicly available records. The review results will be disseminated widely through a peer-reviewed publication and other forums such as workshops, conferences and meetings with local health administrators, policymakers and other wider stakeholder engagements.

Background
Approximately 69%–89% of people with severe mental illnesses, particularly psychosis, experience a treatment gap in low- and middle-income countries (LMICs) due to factors such as low public spending on health and weak healthcare systems. The PIECEs project aims to assess the effectiveness and cost-effectiveness of a solution-focused resource-oriented approach (DIALOG+) for improving the quality of life and mental well-being of people with psychosis in India and Pakistan.

Methods
The research design of this analysis is an economic evaluation piggybacked on the PIECEs randomised control trial to test the feasibility of DIALOG+ in India and Pakistan. It implies a cost-utility analysis with a health system perspective. The costs include the cost of the intervention, the cost of healthcare providers and the cost to the household. The primary outcome will be quality-adjusted life years. Incremental cost, incremental effectiveness and incremental cost-effectiveness ratios will be calculated using linear regression models with a hierarchical data structure. A probabilistic sensitivity analysis will be carried out to test for the uncertainty surrounding the estimates of cost-effectiveness.

Discussion
This study will provide evidence of a patient-centred approach to improve the quality of community-based care for people with psychosis in India and Pakistan. The economic evaluation will support efforts to scale up low-cost healthcare interventions such as DIALOG+ to rural and unserved areas, which is otherwise challenging in the resource-constrained health systems in many LMICs.

Conclusion
The evidence on the cost-effectiveness of DIALOG+ will contribute to efforts to improve community-based care and the quality of life for millions of people suffering from mental health problems in India and Pakistan who experience psychosis.

Ethics and dissemination
This study is approved by the Queen Mary Ethics of Research Committee (UK), Institutional Ethics Committee of SCARF (India), IRD’s Independent Institutional Review Board (IRD_IRB_2021_01_005) (Pakistan), Karawan-e-Hayat Management Committee (Institutional Approval) (Pakistan), Jinnah Postgraduate Medical Centre Research Committee (NO.F.2-81/2021-GENL/60224/JPMC) (Pakistan), Aga Khan’s Ethics Research Committee (2021-5933-17533) (Pakistan) and National Bio-Ethics Committee, Pakistan (Ref: No.4–87/NBC-774/22/2037 Date: 17 May 2022).
The findings of this research will be widely disseminated through research publications and engagement with the communities and the healthcare providers in the public and not-for-profit sectors.

Trial registration number
ISRCTN13022816.