Comparison between the open and the laparoscopic approach in the primary ventral hernia repair: a systematic review and meta-analysis.

BACKGROUND: Ventral hernia repair underwent various developments in the previous decade. Laparoscopic primary ventral hernia repair may be an alternative to open repair since it prevents large abdominal incisions. However, whether laparoscopy improves clinical outcomes has not been systematically assessed. OBJECTIVES: The aim is to compare the clinical outcomes of the laparoscopic versus open approach of primary ventral hernias. METHODS: A systematic search of MEDLINE (PubMed), Scopus, Web of Science, and Cochrane Central Register of Controlled Trials was conducted in February 2023. All randomized controlled trials comparing laparoscopy with the open approach in patients with a primary ventral hernia were included. A fixed-effects meta-analysis of risk ratios was performed for hernia recurrence, local infection, wound dehiscence, and local seroma. Meta-analysis for weighted mean differences was performed for postoperative pain, duration of surgery, length of hospital stay, and time until return to work. RESULTS: Nine studies were included in the systematic review and meta-analysis. The overall hernia recurrence was twice less likely to occur in laparoscopy (RR = 0.49; 95%CI = 0.32-0.74; p < 0.001; I2 = 29%). Local infection (RR = 0.30; 95%CI = 0.19-0.49; p < 0.001; I2 = 0%), wound dehiscence (RR = 0.08; 95%CI = 0.02-0.32; p < 0.001; I2 = 0%), and local seroma (RR = 0.34; 95%CI = 0.19-0.59; p < 0.001; I2 = 14%) were also significantly less likely in patients undergoing laparoscopy. Severe heterogeneity was obtained when pooling data on postoperative pain, duration of surgery, length of hospital stay, and time until return to work. CONCLUSION: The results of available studies are controversial and have a high risk of bias, small sample sizes, and no well-defined protocols. However, the laparoscopic approach seems associated with a lower frequency of hernia recurrence, local infection, wound dehiscence, and local seroma.

Preoperative risk factors for early postoperative bleeding after Roux-en-Y gastric bypass surgery: a systematic review and meta-analysis.

PURPOSE: Although bariatric surgery is an effective intervention for obesity, it comes with risks such as early postoperative bleeding (EPB). Identifying preoperative risk factors for this complication can help patients' risk stratification and optimization. We performed a systematic review and meta-analysis to find predictors for early postoperative bleeding after Roux-en-Y gastric bypass (RYGB). METHODS: We conducted a systematic review, searching PubMed, Cochrane Library, and Web of Science until November 2023. We performed a random-effects meta-analysis to explore preoperative risk factors associated with early postoperative bleeding after RYGB. Sources of heterogeneity were explored by leave-one-out analyses. RESULTS: 23 studies were included, comprising 232,488 patients. Male gender (meta-analytical RR = 1.42, 95%CI = 1.21-1.66, I2 = 18%, Q Cochran test p-value = 0.29) and revisional surgery (meta-analytical RR = 1.35, 95%CI = 1.12-1.62, I2 = 22%, Q Cochran test p = 0.21) were associated with higher risk of EPB. On average, patients with EPB were older than the remainder (MD for the mean age = 2.82 years, 95%CI = 0.97-4.67, I2 = 0.00%, Q Cochran test p = 0.46). Except for hypertension (meta-analytical RR = 1.33, 95%CI = 1.02-1.73, I2 = 66%, Q Cochran test p < 0.0001), comorbidities were not associated with a higher risk of EPB. CONCLUSION: Preoperative risk factors, including age, gender, hypertension, and revisional bariatric surgery, are associated with early postoperative bleeding after RYGB. Further primary studies, with higher methodological quality, are required to detail more risk factors.

Co-Designing Digital Technologies for Improving Clinical Care in People with Parkinson's Disease: What Did We Learn?

The healthcare model is shifting towards integrated care approaches. This new model requires patients to be more closely involved. The iCARE-PD project aims to address this need by developing a technology-enabled, home-based, and community-centered integrated care paradigm. A central part of this project is the codesign process of the model of care, exemplified by the active participation of patients in the design and iterative evaluation of three sensor-based technological solutions. We proposed a codesign methodology used for testing the usability and acceptability of these digital technologies and present initial results for one of them, MooVeo. Our results show the usefulness of this approach in testing the usability and acceptability as well as the opportunity to incorporate patients' feedback into the development. This initiative will hopefully help other groups incorporate a similar codesign approach and develop tools that are well adapted to patients' and care teams' needs.

Personalised Gait Recognition for People with Neurological Conditions.

There is growing interest in monitoring gait patterns in people with neurological conditions. The democratisation of wearable inertial sensors has enabled the study of gait in free living environments. One pivotal aspect of gait assessment in uncontrolled environments is the ability to accurately recognise gait instances. Previous work has focused on wavelet transform methods or general machine learning models to detect gait; the former assume a comparable gait pattern between people and the latter assume training datasets that represent a diverse population. In this paper, we argue that these approaches are unsuitable for people with severe motor impairments and their distinct gait patterns, and make the case for a lightweight personalised alternative. We propose an approach that builds on top of a general model, fine-tuning it with personalised data. A comparative proof-of-concept evaluation with general machine learning (NN and CNN) approaches and personalised counterparts showed that the latter improved the overall accuracy in 3.5% for the NN and 5.3% for the CNN. More importantly, participants that were ill-represented by the general model (the most extreme cases) had the recognition of gait instances improved by up to 16.9% for NN and 20.5% for CNN with the personalised approaches. It is common to say that people with neurological conditions, such as Parkinson's disease, present very individual motor patterns, and that in a sense they are all outliers; we expect that our results will motivate researchers to explore alternative approaches that value personalisation rather than harvesting datasets that are may be able to represent these differences.

Validation of quantitative gait analysis systems for Parkinson's disease for use in supervised and unsupervised environments.

BACKGROUND: Gait impairments are among the most common and impactful symptoms of Parkinson's disease (PD). Recent technological advances aim to quantify these impairments using low-cost wearable systems for use in either supervised clinical consultations or long-term unsupervised monitoring of gait in ecological environments. However, very few of these wearable systems have been validated comparatively to a criterion of established validity. OBJECTIVE: We developed two movement analysis solutions (3D full-body kinematics based on inertial sensors, and a smartphone application) in which validity was assessed versus the optoelectronic criterion in a population of PD patients. METHODS: Nineteen subjects with PD (7 female) participated in the study (age: 62 ± 12.27 years; disease duration: 6.39 ± 3.70 years; HY: 2 ± 0.23). Each participant underwent a gait analysis whilst barefoot, at a self-selected speed, for a distance of 3 times 10 m in a straight line, assessed simultaneously with all three systems. RESULTS: Our results show excellent agreement between either solution and the optoelectronic criterion. Both systems differentiate between PD patients and healthy controls, and between PD patients in ON or OFF medication states (normal difference distributions pooled from published research in PD patients in ON and OFF states that included an age-matched healthy control group). Fair to high waveform similarity and mean absolute errors below the mean relative orientation accuracy of the equipment were found when comparing the angular kinematics between the full-body inertial sensor-based system and the optoelectronic criterion. CONCLUSIONS: We conclude that the presented solutions produce accurate results and can capture clinically relevant parameters using commodity wearable sensors or a simple smartphone. This validation will hopefully enable the adoption of these systems for supervised and unsupervised gait analysis in clinical practice and clinical trials.

Guidelines on exercise testing and prescription for patients at different stages of Parkinson's disease.

BACKGROUND: Exercise is highly recommended in patients with Parkinson's disease (PD). Exercise-induced amelioration of motor, non-motor, and drug-induced symptoms are widely known. However, specific guidelines on exercise testing and prescription in PD are lacking. OBJECTIVE: This study reviews the literature on exercise-based approaches to the management of symptoms at each stage of the disease and evaluate: (1) the most suitable clinical exercise testing; (2) training programs based on testing outcomes and PD stage; (3) the effects of exercise on antiparkinsonian drugs and to suggest the most effective exercise-medication combination. METHODS: A systematic search was conducted using the databases MEDLINE, Google Scholar and, Cochrane Library using "Parkinson's Disease AND Physical therapy", "Training AND Parkinson", "Exercise", "Exercise AND Drug" as key words. In addition, references list from the included articles were searched and cross-checked to identify any further potentially eligible studies. RESULTS: Of a total of 115 records retrieved, 50 (43%) were included. From these, 23 were included under the rubric "exercise testing"; 20 focused on the effectiveness of different types of exercise in PD motor-functional symptoms and neuroprotective effects, throughout disease progression, were included under the rubric "training protocol prescription"; and 7 concern the rubric "interaction between exercise and medication", although none reported consistent results. CONCLUSIONS: Despite the lack of standardized parameters for exercise testing and prescription, all studies agree that PD patients should be encouraged to regularly train according to their severity-related limitations and their personalized treatment plan. In this manuscript, specific guidelines for tailored clinical testing and prescription are provided for each stage of PD.

Feasibility of a Mobile-Based System for Unsupervised Monitoring in Parkinson's Disease.

Mobile health (mHealth) has emerged as a potential solution to providing valuable ecological information about the severity and burden of Parkinson's disease (PD) symptoms in real-life conditions. Objective: The objective of our study was to explore the feasibility and usability of an mHealth system for continuous and objective real-life measures of patients' health and functional mobility, in unsupervised settings. Methods: Patients with a clinical diagnosis of PD, who were able to walk unassisted, and had an Android smartphone were included. Patients were asked to answer a daily survey, to perform three weekly active tests, and to perform a monthly in-person clinical assessment. Feasibility and usability were explored as primary and secondary outcomes. An exploratory analysis was performed to investigate the correlation between data from the mKinetikos app and clinical assessments. Results: Seventeen participants (85%) completed the study. Sixteen participants (94.1%) showed a medium-to-high level of compliance with the mKinetikos system. A 6-point drop in the total score of the Post-Study System Usability Questionnaire was observed. Conclusions: Our results support the feasibility of the mKinetikos system for continuous and objective real-life measures of a patient's health and functional mobility. The observed correlations of mKinetikos metrics with clinical data seem to suggest that this mHealth solution is a promising tool to support clinical decisions.

Swimming is compromised in Parkinson's disease patients.

BACKGROUND: A recent survey reported a high risk of drowning in Parkinson's disease (PD) patients. This study intended to assess PD patients' swimming ability and explore the disease-related characteristics that may affect this. METHODS: A cross-sectional study was conducted in idiopathic PD patients. The assessment included swimming in 2 different styles and the evaluation of isolated technical gestures. The primary outcome was the frequency of patients who were able to swim. Limb coordination, blockage episodes, and capacity to maintain the body in a horizontal position were also evaluated. RESULTS: Thirteen patients were evaluated. Three patients were able to swim according to the predefined definition. The inability to maintain the horizontal position and floatability were the main reasons identified for the decrease in swimming performance. CONCLUSIONS: Swimming ability is compromised in some PD patients. Further studies are needed to evaluate the global frequency of swimming difficulties in PD patients and their contributing factors. © 2019 International Parkinson and Movement Disorder Society.

Motor, cognitive and mobility deficits in 1000 geriatric patients: protocol of a quantitative observational study before and after routine clinical geriatric treatment - the ComOn-study.

BACKGROUND: Motor and cognitive deficits and consequently mobility problems are common in geriatric patients. The currently available methods for diagnosis and for the evaluation of treatment in this vulnerable cohort are limited. The aims of the ComOn (COgnitive and Motor interactions in the Older populatioN) study are (i) to define quantitative markers with clinical relevance for motor and cognitive deficits, (ii) to investigate the interaction between both motor and cognitive deficits and (iii) to assess health status as well as treatment outcome of 1000 geriatric inpatients in hospitals of Kiel (Germany), Brescia (Italy), Porto (Portugal), Curitiba (Brazil) and Bochum (Germany). METHODS: This is a prospective, explorative observational multi-center study. In addition to the comprehensive geriatric assessment, quantitative measures of reduced mobility and motor and cognitive deficits are performed before and after a two week's inpatient stay. Components of the assessment are mobile technology-based assessments of gait, balance and transfer performance, neuropsychological tests, frailty, sarcopenia, autonomic dysfunction and sensation, and questionnaires to assess behavioral deficits, activities of daily living, quality of life, fear of falling and dysphagia. Structural MRI and an unsupervised 24/7 home assessment of mobility are performed in a subgroup of participants. The study will also investigate the minimal clinically relevant change of the investigated parameters. DISCUSSION: This study will help form a better understanding of symptoms and their complex interactions and treatment effects in a large geriatric cohort.

Clinical trials in palliative care: a systematic review of their methodological characteristics and of the quality of their reporting.

BACKGROUND: Over the past decades there has been a significant increase in the number of published clinical trials in palliative care. However, empirical evidence suggests that there are methodological problems in the design and conduct of studies, which raises questions about the validity and generalisability of the results and of the strength of the available evidence. We sought to evaluate the methodological characteristics and assess the quality of reporting of clinical trials in palliative care. METHODS: We performed a systematic review of published clinical trials assessing therapeutic interventions in palliative care. Trials were identified using MEDLINE (from its inception to February 2015). We assessed methodological characteristics and describe the quality of reporting using the Cochrane Risk of Bias tool. RESULTS: We retrieved 107 studies. The most common medical field studied was oncology, and 43.9% of trials evaluated pharmacological interventions. Symptom control and physical dimensions (e.g. intervention on pain, breathlessness, nausea) were the palliative care-specific issues most studied. We found under-reporting of key information in particular on random sequence generation, allocation concealment, and blinding. CONCLUSIONS: While the number of clinical trials in palliative care has increased over time, methodological quality remains suboptimal. This compromises the quality of studies. Therefore, a greater effort is needed to enable the appropriate performance of future studies and increase the robustness of evidence-based medicine in this important field.

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in the Treatment of Gastric Cancer: Feasibility, Efficacy and Safety-A Systematic Review and Meta-Analysis.

Background: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) is an emerging technique for delivering chemotherapy directly to the peritoneum via a pressurized aerosol. Its growing attention stems from its effectiveness in treating peritoneal carcinomatosis (PC) originating from various primary tumors, with gastric cancer (GC) being among the most prevalent. This study aimed to systematically investigate PIPAC's therapeutic role in gastric cancer peritoneal metastasis (GCPM). Methods: The systematic review and meta-analysis followed the PRISMA 2020 guidelines, searching Pubmed, Web of Science, and SCOPUS databases. The meta-analysis of relative risks and mean differences compared patients undergoing one or two PIPAC sessions with those completing three or more, assessing various outcomes. Results: Eighteen studies underwent qualitative analysis, and four underwent quantitative analysis. Patients with three or more PIPAC procedures had shorter hospital stays (MD = -1.2; 95%CI (-1.9; -0.5); p < 0.001), higher rates of histopathological response (RR = 1.77, 95%CI 1.08; 2.90; p = 0.023), and significantly improved overall survival (MD = 6.0; 95%CI 4.2; 7.8; p < 0.001). Other outcomes showed no significant differences. Conclusions: PIPAC demonstrated efficacy in carefully selected patients, enhancing histopathologic response rates and overall survival without prolonging hospital stays. This study underscores the necessity for randomized controlled trials and precise selection criteria to refine PIPAC's implementation in clinical practice.

Fatigue-Related Changes of Daily Function: Most Promising Measures for the Digital Age.

Background: Fatigue is a prominent symptom in many diseases and is strongly associated with impaired daily function. The measurement of daily function is currently almost always done with questionnaires, which are subjective and imprecise. With the recent advances of digital wearable technologies, novel approaches to evaluate daily function quantitatively and objectively in real-life conditions are increasingly possible. This also creates new possibilities to measure fatigue-related changes of daily function using such technologies. Summary: This review examines which digitally assessable parameters in immune-mediated inflammatory and neurodegenerative diseases may have the greatest potential to reflect fatigue-related changes of daily function. Key Messages: Results of a standardized analysis of the literature reporting about perception-, capacity-, and performance-evaluating assessment tools indicate that changes of the following parameters: physical activity, independence of daily living, social participation, working life, mental status, cognitive and aerobic capacity, and supervised and unsupervised mobility performance have the highest potential to reflect fatigue-related changes of daily function. These parameters thus hold the greatest potential for quantitatively measuring fatigue in representative diseases in real-life conditions, e.g., with digital wearable technologies. Furthermore, to the best of our knowledge, this is a new approach to analysing evidence for the design of performance-based digital assessment protocols in human research, which may stimulate further systematic research in this area.

The Efficacy and Safety of Physiotherapy in People with Dementia: A Systematic Review.

BACKGROUND: Physiotherapy has become increasingly relevant as a new therapeutic intervention for dementia. However, it is unclear which interventions are the most suitable. OBJECTIVE: This study sought to summarize and critically appraise the evidence on physiotherapy interventions in dementia. METHODS: A systematic review conducted using CENTRAL, MEDLINE, and PEDro databases, from their inception to July 2022, identified all experimental studies of dementia that included physiotherapy interventions. RESULTS: Of 194 articles included, the most frequently used interventions were aerobic training (n = 82, 42%), strength training (n = 79, 41%), balance training (n = 48, 25%), and stretching (n = 22, 11%). These were associated with a positive effect on several motor and cognitive outcomes. A total number of 1,119 adverse events were reported. CONCLUSION: Physiotherapy has several motor and cognitive benefits in dementia. Future research should focus on establishing a physiotherapy prescription protocol for people with mild cognitive impairment and for each stage of dementia.

Contributory Factors to Caregiver Burden in Parkinson's Disease.

Background: Although there is growing recognition of the relevancy of informal caregivers there is scarce information on the contributory factors of caregiver burden in Parkinson's Disease (PD). Objective: To identify the main associated factors to caregivers' burden in people caring for a person with PD. Methods: We analyzed the data set from a multinational online survey the Parkinson's real-world impact assesSMent (PRISM) focusing on medication use, comorbidities, health-related quality of life, relationship changes and the use of healthcare and supportive care resources by people with PD and their carers. Structured questionnaires including the Parkinson's disease quality of life questionnaire (PDQ-39), non-motor symptoms questionnaire (NMSQuest) and the Questionnaire for impulsive-compulsive disorder in Parkinson's disease (QUIP) were applied. Caregiver burden was assessed by the Zarit Burden Interview (ZBI). Results: In a cohort of 245 dyads (patient and respective caregiver), caregivers reported a mild to moderate burden. Carers' perception of PD impact in partnership, financial burden, hours of care, patient's age, hypersexuality and health-related quality of life (HRQoL) were found to be significant contributory factors to caregiver burden. Taken together these variables explained 66.8% of the variance in the Interpretation of the ZBI total score. Conclusions: Caring for a person with PD entails substantial burden, particularly when the caregiver perceives greater changes in partnership dynamics, dedicates more time to caregiving tasks, has financial burden, and when the patient is older, reports worst HRQoL and has sexual compulsive urges.

Personalized Integrated Care Promoting Quality of Life for Older People: Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: Alzheimer disease (AD) and Parkinson disease (PD) are the 2 most common neurodegenerative diseases affecting millions of people worldwide. The Personalized Integrated Care Promoting Quality of Life for Older People (PC4L) project proposes an integrated, scalable, and interactive care ecosystem that can be easily adapted to the needs of several neurodegenerative and chronic diseases, care institutions, and end user requirements. OBJECTIVE: The study protocol developed within the framework of the PC4L project aims to iteratively test the integrated platform and its modules, and focuses primarily on assessing the impact of the proposed solution (ie, the PC4L platform) on patients' quality of life, as well as its usability and feasibility on a large-scale sample size in 3 different scenarios (home, neurorehabilitation, and day care centers). METHODS: A prospective multicenter clinical study is conducted in 5 European countries (Germany, Italy, Portugal, Romania, and Spain) at 6 different pilot centers, for 3 months, in patients with PD, Parkinsonism, AD, and other dementias (ODs). Patients were randomized in a ratio of 1:1 to the intervention group (use of the PC4L system) or the control group (no intervention). The PC4L system consists mainly of a wristband for monitoring parameters such as steps and levels of physical activity, and the PC4L app, which includes different engaging functionalities. Both groups are assessed through baseline and end-of-study clinical evaluations, including assessment of quality of life through the EQ-5D-3L scale. RESULTS: The study protocol is part of a project approved and funded by the European Commission Horizon 2020 (grant agreement number 875221). The ethics committees of all involved centers reviewed and approved the study protocol. The study began with the recruitment phase in September 2022, and enrollment ended in February 2023. Recruitment is now closed (April 2023). The results of this study are expected to be published in summer 2023. A total of 558 patients, 279 per study group, were recruited. The results will allow to clarify the impact of PC4L on quality of life, will assess the empowerment of patients and the medical resources use, as well as the usability of the final version of the PC4L system. It will also provide information on the support of the system as a tool to facilitate the decision-making process. CONCLUSIONS: The PC4L project intends to test a technology-based, integrated, scalable, and interactive care platform on patients with neurodegenerative diseases and proposes a good coordinated care model between all involved actors. Future developments of the PC4L solution may involve caregivers and socio-health professionals in the decision-making process in order to facilitate efficient communication between all stakeholders and ensure reliable and protected access to data within Europe. TRIAL REGISTRATION: ClinicalTrials.gov NCT05538455; https://clinicaltrials.gov/study/NCT05538455. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47916.

PROCare4Life lessons learned.

PeRsOnalised Integrated CARE Solution for Elderly (PROCare4Life) was an EU-funded project that ran from January 2020 until June 2023, whose focus was to further develop and integrate previous ICT solutions developed by several previous EU-funded projects into a unique modular system able to support the autonomy and empowerment and to increase the Quality of Life (QoL) of elderly people living with Parkinson's, Alzheimer's, or similar dementia, having also tested the system for elderly people living with comorbidities. This article focuses on the methodology and results used to identify the internal lessons learned. PROCare4Life was developed using a codesign approach involving more than 2,000 participants whose input has been listened to and transformed into valuable changes of the system and also into lessons learned included in this case study report. Since the beginning of the implementation of PROCare4Life, there has been a commitment to make invisible knowledge visible through open discussion and including our lessons learned in each of our deliverables. In the last six months of implementation, qualitative research has been implemented by the PROCare4Life consortium to identify and select our most relevant challenges and recommendations for future projects and initiatives. PROCare4Life was highly impacted by the COVID-19 pandemic, and it is acknowledged in the lessons learned. However, the consortium has focused on the recommendations that could be more valuable for ordinary implementation of future projects and initiatives developing eHealth tools for elderly citizens living with conditions that might affect their cognitive or mobility capacities.

PeRsOnalised Integrated CARE Solution for Elderly (PROCare4Life) was an EU-funded project that ran from January 2020 until June 2023, aiming at improving the quality of life of older people living with Parkinson's, Alzheimer's or other dementia using ICT technologies. The term implementation refers to the process of putting a plan or idea into action. It is a complex process that involves multiple stages, including planning, execution, and evaluation. Implementation research is a growing field of health research that aims to study the factors that affect the implementation of health policies, programs, and practices. It can help identify the best strategies for introducing potential solutions into a health system or promoting their large-scale use and sustainability. For PROCare4Life, when using the term implementation it covers all the stages, including ideation and design phases, although focusing on the pilot 3 iterative codesign and testing of the system. Using daily life devices such as smartphones and smart watches, more than 2,000 people have contributed to co-creating PROCare4Life. The three profiles focused on were older people living with Parkinson's, Alzheimer's or other dementia, their main carers and their healthcare professionals, with an ICT system providing direct communication and allowing them to share their health status. Along the journey to develop PROCare4Life, our European consortium has learned many things that we have internally investigated and reported in this article. We have identified 20 challenges and 41 recommendations. We hope that our lessons learned might be inspiring and valuable for others, particularly future projects and initiatives developing eHealth tools for elderly EU citizens living with different conditions that might affect their cognitive or mobility capabilities.