Search Results for: Passo 12. Ripulire in modo mirato le cartelle cliniche degli assisiti

Introduction
Non-pharmacological interventions, including musculoskeletal manipulations (MMs), have been proven effective for musculoskeletal disorders.

Objectives
To evaluate if MMs, including osteopathic manipulation and chiropractic care, are effective to improve quality of life, pain intensity and function in older adults with musculoskeletal disorders.

Design
Systematic review.

Data sources
A systematic search was conducted on MEDLINE/PubMed, EMBASE, Scopus, Web of Science, CINAHL, Cochrane Library, from database inception up to 2 January 2025.

Eligibility criteria
Randomised controlled trials, controlled non-randomised trials and open label trials evaluating the efficacy and safety of MM such as osteopathic manipulation, chiropractic manipulation, myofascial release, craniosacral therapy, as monotherapy or adjunctive therapies in older people (age ≥65 years) with musculoskeletal disorders. The main outcomes included pain intensity, functionality and quality of life. Additionally, other related outcomes were considered, such as medical use duration, mood, mobility, motion, strength and endurance. Finally, we considered any adverse events.

Data extraction and synthesis
Selection and data extraction were performed independently by two authors. The effect estimates for each study were performed using Review Manager V.5.14. Continuous outcomes were analysed using the mean difference (95% CI). The methodological quality of the included studies was assessed using the Cochrane Risk of Bias tool 2 (RoB 2). No meta-analysis was performed.

Results
Five parallel randomised controlled trials were included, with a total sample size of 676 participants (41.6% women with a mean age of 77.3 years): 34 with chronic pain, 265 with neck pain and 377 with low back pain. MMs were not effective in patients with chronic pain, neither in pain intensity nor in functionality. For neck pain, considering the main outcomes, only in one of the two studies was there a statistically significant improvement in neck pain intensity only at week 12 for spinal manipulative treatment (SMT)+home exercise (HE) compared with HE alone (ES=–0.90 (95% CI –1.46 to –0.34); p=0.002). For low back pain, SMT+HE showed a statistically significant reduction in pain at 12 weeks compared with HE (ES=–0.79 (95% CI –1.39 to –0.19) p=0.010. For neck pain and low back pain, no statistically significant improvement in functional status and quality of life was observed with MM compared with any control group. RoB 2 showed a high risk of bias in three studies and some concerns in the others. At the domain level, the lowest risk was observed in the randomisation process (80% with some concerns). All five studies reported adverse events, none of which were serious.

Conclusions
This review provides limited and inconclusive evidence about MM to improve quality of life, pain management and functional status in older adults with musculoskeletal disorders. However, MM appears to be generally safe and well-tolerated.

PROSPERO registration number
CRD42023473203.

Introduction
Neoadjuvant (chemo)radiotherapy (n(C)RT) followed by resection with total mesorectal excision (TME) constitutes the standard treatment for patients with locally advanced rectal cancer of the middle and lower third. However, n(C)RT has demonstrated no significant impact on overall survival but is associated with adverse effects, including impaired sphincter and sexual function. We hypothesise that omitting n(C)RT in selected patients with a clear circumferential resection margin (CRM) >1 mm as determined through preoperative MRI is not inferior regarding local recurrence rate within 3 years after surgery. That treatment approach may show fewer adverse effects and be more cost-effective.

Methods and analysis
Selective neoadjuvant therapy of rectal cancer patients (SELREC) is a randomised controlled, parallel-group, open, multicentre, non-inferiority trial. The experimental intervention involves performing TME surgery without n(C)RT. In contrast, the control intervention adheres to German S3-guidelines, incorporating neoadjuvant radiotherapy (nRT) with a dosage of 5×5 Gy or a total of 50.4 Gy. Additionally, if applicable, concomitant chemotherapy (CT) based on 5-fluorouracil is administered, followed by TME surgery within less than 12 weeks. Adjuvant treatment according to guidelines is allowed depending on the (y)pTNM stage.
The inclusion criteria for this study encompass adult patients with primary adenocarcinoma of the rectum in whom the main tumour mass is located less than 12 cm away from the anal verge, as assessed via proctoscopy. Additionally, eligible participants are required to have a preoperative tumour stage determined by MRI of either T1 or T2 with lymph node involvement (N1) or T3 with no lymph node involvement (N0) or with lymph node involvement (N1) and no distant metastases (M0). The assessment of a clear CRM >1 mm, based on MRI, is another prerequisite for inclusion. A total of 1074 patients in approximately 35 centres are planned to be allocated to the trial.
The primary endpoint of the trial is local recurrence within 3 years after surgery. The primary estimand is based on the full analysis set using a logistic mixed model (margin 3%). The first secondary endpoint is no/minor low anterior resection syndrome (LARS) score at 2 years after surgery, and further secondary endpoints include survival outcomes and quality of life. Safety analysis involves describing the frequencies of major intervention-specific complications, such as the acute toxicity of n(C)RT according to CTCAE and perioperative morbidity and mortality according to Clavien-Dindo criteria.
SELREC is financially supported by the German Federal Ministry of Education and Research.

Ethics and dissemination
This trial has been prospectively registered in the German Clinical Trials Register.
Previously, the study had been approved by the responsible ethics committee of Heidelberg and the local ethics committees of the collaborating institutions before patient enrolment. Any protocol deviation that has an impact on relevant parameters such as study design, endpoints or patient safety will be reported to the responsible ethics committees.
The results will be published in a peer-reviewed scientific journal and on institutional websites.

Trial registration number
German Clinical Trials Register DRKS00030567.

Introduction
Thin endometrium poses a major therapeutic challenge in assisted reproductive technologies by compromising pregnancy success and live birth outcomes. A substantial proportion of patients remain refractory to existing therapies. Preliminary evidence suggests acupuncture may improve endometrial thickness (EMT). This study aims to assess the effect of acupuncture against sham acupuncture for women with thin endometrium.

Methods and analysis
This study is a single-centre, randomised, sham-controlled trial conducted at a specialised acupuncture hospital in Beijing, China. A total of 120 women with thin endometrium will be randomised (1:1) to receive 36 sessions of acupuncture or sham acupuncture over 12 weeks. The primary outcome is the EMT at week 12. Secondary outcomes are endometrial pattern, uterine arterial blood flow parameters (Pulsatility Index, Resistance Index and the ratio of peak systolic to end-diastolic blood flow velocities), endometrium blood flow, serum oestradiol concentration, clinical pregnancy rate and Self-Rating Anxiety Scale Scores.

Ethics and dissemination
This study has been approved by the ethics committee of the Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences (approval no.: S2024-04-23-1). Each participant will be required to provide written informed consent before enrolment. Findings will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number
ITMCTR2024000053.

Via libera ad una nuova molecola dal comitato Ema, si riduce la progressione della malattia

Objectives
To explore healthcare workers’ (HCWs) experiences, barriers and facilitators in managing patients with symptoms of possible breast, cervical or colorectal cancer.

Design
A qualitative in-depth interview study with HCWs managing patients with breast, cervical and colorectal cancer symptoms. We also conducted workshops with a group of HCWs to check the credibility of the interview findings.

Setting
The study was conducted with staff working in primary, secondary and tertiary public health facilities in the Eastern and Western Cape in South Africa (SA), and Harare and Bulawayo and their referral provinces in Zimbabwe.

Participants
HCWs with experience in managing patients with symptoms of possible breast, cervical or colorectal cancer were recruited for the study. Participants were purposively sampled based on region, healthcare level and job role. A total of 56 participants (26 in SA and 30 in Zimbabwe) participated in the in-depth interviews. 26 (12 in SA and 14 in Zimbabwe) participated in four clinical advisory group workshops across both countries.

Results
Drawing on the Model of Pathways to Treatment, HCWs’ perceptions of patient-level factors influencing the diagnostic interval included financial limitations, patients’ absence and delays in attendance. Healthcare provider and system factors included: challenges with referral and feedback systems; training needs; low awareness of protocols and guidelines; inappropriate and suboptimal clinical assessments; and broader socioeconomic factors and resource limitations.

Conclusion
Improving the timely diagnosis of breast, cervical and colorectal cancer in Southern Africa necessitates targeted strategies that address both patient-related, provider and health-system delays.

Introduction
Ischaemia–reperfusion (I/R) injury remains a major challenge in heart transplantation, with mortality risk increasing significantly when allograft ischaemic time exceeds 4 hours. Non-ischaemic heart preservation (NIHP), using continuous hypothermic perfusion, has shown promise in preliminary studies for reducing I/R injury and improving outcomes. This randomised controlled trial aims to compare NIHP with standard static cold storage (SCS) in adult heart transplantation.

Methods and analysis
The trial is a prospective, open-label, multicentre, single-blinded, randomised controlled trial including 66 adult heart transplant recipients across four Swedish hospitals. Participants will be randomised into 1:1 ratio to NIHP or SCS preservation groups and undergo a 12-month follow-up period. The primary outcome is 1-year survival free from acute cellular rejection or retransplantation. Secondary outcomes include quality of life, I/R injury markers, graft function and adverse events. Substudies will evaluate renal function using MRI and continuously monitor physical activity and heart rhythm via wearable devices. Analysis will follow intention-to-treat principles, with time-to-event analysis using Cox proportional hazard models and Kaplan-Meier estimates.

Ethics and dissemination
The study has been approved by the Swedish Ethical Review Authority. It will be conducted according to the Declaration of Helsinki and relevant local and international regulations. Results will be published in peer-reviewed journals following Consolidated Standards of Reporting Trials guidelines.

Trial registration number
NCT04066127.

Objectives
Investigate the impact of a 10-week whole-food plant-based (WFPB) community programme on weight and type 2 diabetes up to 36 months postintervention.

Design
Randomised waitlist-controlled trial.

Setting
Community-based General Practice clinic classified as ‘Very Low-Cost Access’ in Gisborne, the main city of the Tairāwhiti region of New Zealand.

Participants
Adults (n=56) aged 30–72 years, with obesity (Body Mass Index (BMI) ≥30) and glycated haemoglobin (HbA1c≥40 mmol/mol) in the last 6 months. Of the participants, 59% identified as Māori and 5% as Pasifika.

Intervention
A 10-week programme consisting of 2 hours, two times per week sessions (40 hours total), involving skills-based learning and health education.

Primary and secondary outcome measures
Primary measures were changes in weight, BMI and HbA1c. Secondary measures included changes in cholesterol, waist circumference, exercise levels, plant-based and non-plant-based dietary scores and association with Big Five Inventory personality traits. The primary endpoint was assessed at post-treatment (10 weeks), with follow-up at 6 and 36 months postintervention.

Results
Differences between the intervention and waitlist control groups at 10 weeks were compared with independent samples t-tests. In intention-to-treat analyses, the intervention group demonstrated significantly greater weight loss of 3.3 kg (95% CI (0.8 to 5.7), p

Objectives
To evaluate factors associated with clinic follow-up after traumatic spinal injury (TSI) in Tanzania, focusing on demographic, injury-related and hospital variables. We hypothesised that socioeconomic and injury-specific factors would predict follow-up adherence.

Design
Retrospective observational cohort study.

Setting
Tertiary government referral centre for neurosurgery and orthopaedics in Dar es Salaam, Tanzania.

Participants
443 adults with TSI admitted between September 2016 and October 2021. Inclusion criteria included survival to discharge and availability of the discharge date. Patients with missing data were excluded.

Primary and secondary outcome measures
Primary outcomes were any clinic follow-up and 1-year follow-up post-discharge. Secondary outcome was time to loss of follow-up. Logistic regression was used to identify factors associated with follow-up, and Kaplan-Meier survival analysis assessed follow-up duration.

Results
Of 443 patients (85.8% male, median age 34 years), 52.4% returned for follow-up. Independent factors associated with return included private insurance (adjusted OR (aOR) 2.69, 95% CI 1.38 to 5.45, p=0.005), involvement in a road traffic accident (aOR 2.15, 95% CI 1.22 to 3.83, p=0.009), lumbar injuries (aOR 2.26, 95% CI 1.30 to 4.00, p=0.004), neurological improvement at discharge (aOR 3.52, 95% CI 1.72 to 7.64, p=0.001) and hospital stays shorter than 24 days (aOR 1.63, 95% CI 1.07 to 2.47, p=0.022). Among those who returned, only 25.4% completed 1 year of follow-up. Predictors of 1-year follow-up included being female (aOR 4.87, 95% CI 2.31 to 10.56, p

Introduction
Chronic low back pain (LBP) is among the world’s leading causes of disability and declines in quality of life. Despite considerable financial and research investment, current interventions demonstrate only modest success or are associated with deleterious side effects. Furthermore, most treatment efforts are directed towards LBP that has already become chronic, rather than interventions capable of preventing pain chronicity in the first instance. Transcranial direct current stimulation (tDCS), a portable and cost-effective form of non-invasive brain stimulation, presents a potential means of targeting acute pain and preventing the transition to chronic pain. However, this approach has been limited primarily to experimental settings that require intensive appointments and specialist expertise. Thus, this assessor-blinded, participant-blinded, and therapist-blinded, randomised controlled trial aims to explore the effectiveness of home-based tDCS for improving pain and disability in people with acute LBP. This may provide insight into the potential for tDCS to expedite recovery from acute LBP and prevent pain chronicity.

Methods and analysis
40 individuals with acute LBP (onset

Introduction
Obstructive sleep apnoea (OSA) affects 1–5% of the paediatric population, including 55–90% of children with Down syndrome (DS), and has been associated with negative effects on neurocognitive development, cardiovascular health, immune development and quality of life. In-lab attended polysomnography (PSG) is currently the gold standard for the diagnosis of OSA in children, but it poses challenges due to the burden on families and limited testing facilities. Home sleep apnoea testing (HSAT), an unattended sleep test done at home, is an accepted alternative for adults but lacks sufficient evidence to be used clinically for the evaluation of OSA in children. HSAT may be especially beneficial for children with DS or others with sensory issues or those who struggle with sleeping in a laboratory setting overnight.

Methods and analysis
This single-centre trial compares HSAT to PSG for the diagnosis of OSA in children, including those with DS. The trial will enrol 317 children 5–12 years old, including approximately 100 with DS. The primary outcome is the diagnostic accuracy of HSAT compared with PSG for OSA evaluated through ROC. Secondary outcomes include the agreement between HSAT and PSG for therapeutic decision-making and comparison of preference and acceptability of HSAT versus PSG. This trial seeks to evaluate HSAT as an alternative diagnostic tool for paediatric OSA, potentially expanding testing options for clinicians and families.

Ethics and dissemination
This study has been approved by the Institutional Review Board at Children’s Hospital of Philadelphia (#21–0 19 533). Informed consent will be obtained from all participants, and no identifiable data will be reported.

Trial registration number
NCT05382754.

Objectives
There are still some controversies regarding the role of nuclear medicine practitioners in delivering imaging findings to the patients as well as content and magnitude of information to be delivered. The aim of the study was to identify the expectations of patients regarding the communication of results from a nuclear imaging examination.

Design
A national survey was conducted among patients who underwent a nuclear imaging examination. In each participating centre, a questionnaire was administered to the patients.

Setting
Primary care in France.

Participants
The study involved 723 patients from 12 French Nuclear Medicine departments (university hospitals, general hospitals, comprehensive cancer centres and private centres).

Outcome measure
The primary endpoint was to determine the proportion of patients expressing a wish to consult a nuclear medicine physician at the end of the imaging session and to assess the rationale underlying this preference.

Results
Our results indicate that a significant majority (73.2%) of patients prefer to meet primarily with the nuclear medicine physician to receive an explanation of the imaging findings. Concerning the disclosure of these results, 66.1% of the patients prefer to receive an explanation from the nuclear medicine physician, either alongside or instead of the requesting physician alone. Furthermore, nearly all patients (96.1%) who wish to meet with the nuclear medicine physician also indicate their willingness to receive the examination results, even if they are unfavourable.

Conclusions
This study underscores the clear preference of patients to interact with nuclear medicine specialists and benefit from their expertise, irrespective of whether the results are positive or negative. This emphasises the critical need for implementing standardised recommendations across countries and ensuring adequate training for nuclear physicians to actually meet this demand. This aspect is likely to distinguish a nuclear medicine physician from a scan interpreter.

Objective
A delayed diagnosis of pituitary adenomas (PAs) can lead to increased morbidity and reduced quality of life. The aim was to estimate diagnostic delay and investigate the concordance between patient-reported symptoms and the medical record documentation in patients with PA.

Design
Cross-sectional study.

Setting
Seven university hospitals.

Participants
654 patients: non-functioning PA (NFPA, 314), prolactinoma (118), acromegaly (164) and Cushing’s Disease (CD, 58).

Data collection
Questionnaires and medical record extraction.

Primary and secondary outcomes
Type of first healthcare contact, delay of PA diagnosis and patient-reported symptoms and symptoms documented in medical records.

Results
First healthcare contact was usually a general practitioner. Estimated time from symptoms to diagnosis varied from 10 years (9%). The longest diagnostic delays were observed in acromegaly and CD. A longer delay was observed in women compared with men (p0.6) and for menstrual irregularities in prolactinomas (Cohen’s kappa >0.7).

Conclusion
We report a large variation in symptom duration before diagnosis with a substantial diagnostic delay in patients with CD and acromegaly. An increased awareness about endocrine diseases in the general population and health professionals may contribute to earlier diagnosis of pituitary adenomas.

Introduction
As a disorder of gut–brain interaction, irritable bowel syndrome (IBS) is a common reason for patient visits in primary and specialist care settings. IBS is associated with recurrent abdominal pain, altered bowel habit, resulting in alternating constipation and diarrhoea, bloating, without serious organic diseases. The bidirectional relationship between IBS and psychological factor is also complex. Studies have suggested that tricyclic antidepressants can effectively control the concomitant symptoms of IBS, especially some severe and refractory symptoms. At present, the conventional treatment of IBS remains somewhat unsatisfactory. Studies have shown that the antidepressant effects of esketamine are rapid and significant, whether a single low dose of esketamine is effective in IBS deserves further investigation. In this study, we hypothesise that a single low dose of esketamine will be effective for IBS.

Methods and analysis
This is a single-centre, randomised, double-blind, placebo-controlled trial. Patients with IBS are divided into three levels according to the severity of IBS: mild, moderate and severe. 92 patients in the esketamine group and 92 patients in the control group who are scheduled for colonoscopy will be prospectively recruited in each level. The primary outcome is the IBS Severity Scoring System at baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy. The secondary outcome includes IBS-Quality of Life, Bristol Stool Form scale, Hospital Anxiety and Depression Scale, Patient Health Questionnaire-12 Somatic Symptom Score and adverse events. The allocation sequence is assigned by a random number table using a block randomisation method by SPSS (Version 26, IBM Inc., USA) Statistics software. All enrolled patients, anaesthesiologist B and researchers responsible for follow-up and data collection and analysis are therefore fully blinded. All data will be performed using SPSS Statistics software, and a p value

Objective
Coronary artery disease (CAD) is a main cause of incapacitating adverse cardiac events in aviation. Military aircrew ≥40 years in the Netherlands undergo a 5-year exercise ECG (X-ECG), which lacks precision to identify relevant CAD. The study aim was to identify the screening value of cardiac CT (CCT) in asymptomatic military aircrew.

Design
Prospective, single-centre, cross-sectional study.

Setting
Conducted at the Centre for Man in Aviation, Royal Netherlands Air Force. CT scans were performed at the University Medical Centre, Utrecht.

Participants
Asymptomatic military aircrew ≥40 years were asked to undergo CCT, with coronary artery calcium score (CACS) and coronary CT angiography (CCTA), following their aeromedical exam. CCT was performed in 211 participants (median age 49.3 years (43.6–52.8), 98% men, 65% pilots).

Outcome measures
The main objective was to determine the prevalence of relevant CAD. Clinically relevant CAD (CR-CAD) is defined as CACS ≥100 and/or a stenosis ≥50%. Aeromedically relevant CAD (AR-CAD) includes CR-CAD and/or a left main stenosis >30% or an aggregate stenosis ≥120%. Secondary objectives included assessing the prevalence of mild coronary stenosis (defined as 25%–49% stenosis), the presence of high-risk plaque (HRP) features and CCT safety.

Results
CR-CAD was found in 25 male aircrew (12%), with a CACS of ≥100 in 21 (10%) and a stenosis ≥50% in 10 (5%), including two with CACS 0. Two additional men had ≥120% aggregate stenosis, bringing total AR-CAD to 27 (13%). Twenty-nine men (14%) had mild stenosis. HRP features were present in 44 (21%). There were no CT-related complications. Of 196 participants who underwent X-ECG, seven showed abnormal results; one had relevant CAD.

Conclusions
Contrast-enhanced CCTA provides additional information both on high-risk features and obstructive CAD compared with CACS only. CCT is safe and is of additional value to X-ECG in a low-risk population with a high-hazard occupation.

Trial registration number
NCT05508893.

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