Evaluation Protocol Research Articles

Health mediation intervention at the base of a social housing complex in Seine-Saint-Denis, France: a mixed-methods, realistic evaluation protocol.

Health mediation, similar to health navigation in the United States or Canada, is known by various terms worldwide. In France, health mediation has historically been implemented by civil society organizations to support hard-to-reach populations. Health mediation is increasingly considered by health authorities as a valuable tool for health promotion to reduce health inequalities. However, systematic evaluations of its effects are scarce, making it difficult for decision-makers to generalize health mediation as a health policy. Our study aims to bridge this gap, by framing a research protocol to evaluate a health mediation intervention. The intervention consists of setting up a biweekly mobile booth using an 'outreach' approach at the base of a social housing complex in 12 neighborhoods of Seine-Saint-Denis with marked indicators of social deprivation. We chose a realistic evaluation approach and a mixed-methods methodology, which is the best fit for assessing complex interventions such as the one we aim to assess. Realistic evaluation is a relatively new approach, and sharing studies based on this type of epistemological and methodological approach is required. This study aims to contribute to the reflection on and the production of standard tools to ensure that the use of this evaluation approach is improved.

Human Papillomavirus Infection and Cytological Atypia in Female Allogeneic Hematopoietic Stem Cell Transplantation Recipients.

Female recipients of allogeneic hematopoietic stem cell transplantation are at high risk of developing human papillomavirus (HPV)-associated lesions and (pre)cancer. We describe the results of a cervical cancer screening program in these women. From 2010 to 2022, 70 female recipients of allogeneic hematopoietic stem cell transplantation in our institution entered a standardized protocol of gynecological evaluation. HPV testing, Papanicolaou smear, and thorough gynecological examinations were conducted in all the women. The cumulative prevalence of HPV infection was 21.4% (15/70). Ten of 70 women (14.3%) had a positive HPV test result in the first gynecological evaluation and 5 additional women (7.1%) became positive during follow-up. Thirteen women (18.5%) presented cytohistological lesions (3 high-grade lesions and 10 low-grade lesions). Twenty-nine women (41.4%) showed HPV-negative reactive atypical abnormalities related to the conditioning treatment, which closely mimicked HPV-associated lesions, which spontaneously disappeared during follow-up. Gynecological evaluation should be maintained over time, as a significant proportion of these women may become HPV positive during follow-up. Reactive benign, atypical changes related to the treatment, which closely mimic HPV-associated lesions, are a frequent finding in these women. HPV testing is a key tool for the evaluation of these patients, as it allows for identifying women at risk and excluding cytological mimickers.

A prehospital protocol for geriatric agitation

Approximately 10% of geriatric patients (adults over the age of 65) transported via ambulance will have a mental status altered from baseline, otherwise known as delirium. Many of these patients will be agitated, posing a management challenge for EMS practitioners. Existing protocols for delirium in the pre-hospital setting were designed for younger adults, who have different etiologies and different levels of tolerance for medications than most older adults. ED-based protocols have already been created to aid in the treatment of patients with this condition. Yet, their applicability is limited, as many involve elaborate diagnostics not available in the prehospital environment. Furthermore, many protocols recommend using medications that are not recommended for older adults. Thus, we created an evidence-based protocol for the prehospital evaluation and treatment of agitated geriatric patients. Our protocol puts specific emphasis on safely avoiding unnecessary administration of and/or high dosages of psychotropic medications. We also emphasize practical management, including non-pharmacologic treatment of this condition in older adults.

Helping people with psychosis with a low-cost intervention DIALOG+: protocol for the economic evaluation in a randomised control trial in India and Pakistan

BackgroundApproximately 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...

Surgical Site Infection after Craniotomy in Neuro-Oncology (SINO): A protocol for an international prospective multicentre service evaluation across the United Kingdom and Ireland.

Given its proximity to the central nervous system, surgical site infections (SSIs) after craniotomy (SSI-CRAN) represent a serious adverse event. SSI-CRAN are associated with substantial patient morbidity and mortality. Despite the recognition of SSI in other surgical fields, there is a paucity of evidence in the neurosurgical literature devoted to skin closure, specifically in patients with brain tumors. The primary objective of this service evaluation is to ascertain the incidence and the risk factors associated with SSI-CRAN. The secondary objectives would be a) to ascertain the incidence of SSI-CRAN in sutured versus stapled wounds, after accounting for patient, surgical and hospital confounders of SSI-CRAN and b) to determine the percentage of patients with gliomas that begin adjuvant oncological treatment in patients with infection versus those without infection. Surgical Site Infection after Craniotomy in Neuro-Oncology (SINO) is a international prospective multicentre service evaluation that will include patients with an intracranial neoplasm, both primary and secondary neoplasms, treated with cranial surgery (including biopsy). Consecutive paediatric (<18 years) and adult (≥18 years) patients diagnosed with a brain tumour, undergoing cranial surgery between 1st October 2024 and 1st December 2024 will be included. Prospective data will be collected with a follow-up of 90 days.

Return to Sport After Partum in Patients With Diastasis of the Rectus Abdominis Muscles: Ultrasound Evaluation and Rehabilitation Protocol.

Diastasis rectus abdominis is a condition in which the rectus abdominis muscles separate and move laterally, causing stretching of the linea alba tissue with weakness of the abdominal wall. Although it can lead to hernia of the abdominal viscera, diastasis rectus abdominis is not a hernia in itself. This condition is common among women during pregnancy and the postpartum period and can significantly affect their quality of life and their return to sports activity. Unfortunately, information on the incidence, risk factors, prevention, and treatment of diastasis rectus abdominis are limited. We conducted a pilot prospective observational study on 37 patients who practiced sports at high levels (at least 3 times a week with amateur/competitive competitions) who underwent ultrasound measurements of the distance between the rectus abdominis muscles at the level of the xiphoid process, supraumbilical, umbilical, and subumbilical at time (T0), after 2months from the rehabilitation protocol (T1), and then after 4months of rehabilitation protocol (T2) from approximately 3months after giving birth, and we saw an early return to sport. Our data analysis reveals that there is an initial decrease in diastasis during the first 2months with 3 weekly physiotherapy activity sessions in all 4 measurements. One session takes place on site with physiotherapists, while the other 2 are carried out at home using the rehabilitation protocol provided by the medical staff. At the 4-month follow-up, the improvement was similar to the previous follow-up. Of the 37 women analyzed, 6 were referred to the surgeon; 2 for hernias and 4 for diastases greater than 4cm. The remaining women benefited from a conservative approach. Patients undergoing the rehabilitation protocol showed improvements in all 4 measures, as well as their early return to sport.

Three-dimensional assessment of root changes after Le Fort I osteotomy

The study aim was to assess the volumetric, linear, and morphological changes of the maxillary incisor, canine, and premolar roots following Le Fort I osteotomy. Sixty patients (585 teeth) were included retrospectively from among individuals who underwent combined orthodontics and orthognathic surgery. The study group comprised 30 patients who underwent orthodontics and one-piece Le Fort I osteotomy, while the control group consisted of 30 patients who underwent orthodontics and bilateral sagittal split osteotomy but no maxillary surgery. CBCT scans were obtained at four time points: preoperative, 6 months, 1 year, and 2 years postoperative. A fully automated three-dimensional evaluation protocol was utilized to assess root changes of the maxillary teeth. Significant differences in the apical and middle parts of the teeth were observed between the study and control groups at 1 and 2 years postoperative, with greater percentage changes in the study group (all P < 0.05). Greater root remodelling in the canines, first and second premolars was observed in the study group (all P < 0.005). Spearman correlation analysis indicated a positive relationship between root remodelling and maxillary advancement, with larger advancements contributing to increased root remodelling in the apical and middle root parts (both P < 0.05). These findings can be valuable for surgeons and orthodontists in evaluating root changes.

Standardising risk perception assessment: The CORE APP training and competition evaluation protocol

Standardising risk perception assessment: The CORE APP training and competition evaluation protocol

Reference Values of Touch Sense Threshold from an Adult Brazilian Cohort

Semmes-Weinstein monofilaments have been widely used in clinical practice to evaluate touch sense in healthy subjects and in the population of risk of neuropathies as Diabetes Mellitus and leprosy patients. It is an effective and low-cost clinical tool indeed, however, it is an instrument of low sensitivity with subjective responses. In the 1980s, a procedure was proposed for the psychophysical assessment of touch sense by sine-wave electric current stimulation. This assessment was based on studies that suggested sinusoidal electric stimuli of several different frequencies would excite sensory fibers of different diameters, increasing the selectivity of the stimulation. This study aims to evaluate and describe touch sense perception threshold of a healthy Brazilian cohort using sine-wave electric stimulation. Reference values of Current Perception Threshold (CPT) were registered in upper limb nerves of 100 healthy subjects, 57 (male) and 43 (female). All subjects had the ulnar, median, and radial nerves evaluated with a sine-wave electric stimulator called NEUROSTIM® to quantify the CPT for the frequencies 1Hz, 250Hz and 3000Hz. The CPT reference values for the Ulnar Nerve varied between 484µA - 1003µA for the 3000Hz frequency, 168µA - 322µA for the 250Hz and 122µA - 571µA for the 1Hz frequency. For the Median Nerve varied between 468µA - 1321µA for the 3000Hz frequency, 168µA - 386µA for the 250Hz and 168µA - 437µA for the 1Hz frequency. For the Radial Nerve varied between 516µA - 1350µA, 144µA - 533µA and 173µA - 342µA for each frequency respectively. The NEUROSTIM evaluation protocol seems to be effective, objective, and able to be replicated for touch sense evaluation in healthy subjects. Having CPT reference values to a Brazilian adult healthy cohort can help professionals in the clinics to have a better understanding, management and treatment of diseases affecting touch sense, such as leprosy, diabetes mellitus and others.

Integrating exoskeletons in the construction sector: a systematic review of empirical evaluation tools and future directions

PurposeThis study aims to evaluate and synthesize literature on exoskeleton implementation in the construction industry to understand their current applications, evaluate existing research approaches and identify critical areas for future investigation. Through a comprehensive analysis of empirical studies, the research seeks to establish a clear roadmap for advancing exoskeleton adoption in construction work.Design/methodology/approachThis study conducts a systematic literature review following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. By searching relevant databases and applying predefined inclusion criteria, the review focused on empirical studies that evaluate the effectiveness and acceptance of exoskeletons in construction. Both objective parameters (EMG data, Kinematic analysis, heart rate) and subjective parameters (user comfort, perceived exertion, usability surveys) were analyzed to assess how impactful are exoskeletons among construction workers.FindingsThe review identified 236 publications, of which 36 were included, revealing several critical insights: (1) A significant reliance on studies conducted in controlled environments, accounting for 77.78% of studies. (2) A limited representation of actual construction workers, mainly non-construction worker volunteers, which may affect the practical relevance of the findings. (3) A significant gap exists in standardized evaluation protocols, with researchers using varying assessment methods that hinder cross-study comparisons. (4) Predominantly short-term nature of existing studies. These findings highlight the need for more real-world testing, standardized evaluation frameworks and longitudinal studies.Originality/valueThis review contributes original insights into the deployment of exoskeletons in the construction sector, particularly highlighting the industry's gap in direct, in situ engagement with construction workers. It suggests that future research should prioritize long-term, onsite studies to achieve a more comprehensive understanding of exoskeletons’ impacts, thus supporting the development of targeted intervention strategies for reducing work-related musculoskeletal disorders (WMSDs) among construction workers.

Experimental Protocol for Color Difference Evaluation Under Stabilized LED Light.

There are two key factors to consider before implementing a color discrimination experiment. First, a set of color patches should be selected or designed for the specific purpose of the experiment to be carried out. Second, the lighting conditions should be controlled to eliminate the impact of lighting instability on the experiment. This paper addresses both of these challenges. It proposes a method to print pairs of color patches with non-noticeable color differences. It also proposes a method to stabilize the Spectral Power Distributions (SPDs) of a Light-Emitting Diode (LED) lighting system. Finally, it introduces an experimental protocol for a color discrimination study that will be performed thanks to the contributions presented in this paper.

Implementation and impact of NHS-funded tobacco dependence services in England: a mixed-method evaluation protocol

IntroductionTobacco smoking remains a leading cause of ill-health, premature mortality and a driver of health inequalities. To support smokers in England, a comprehensive approach to treating tobacco dependence is being...

Protocol for the economic evaluation of integrated community-based care compared with integrated facility-based care for HIV, hypertension and diabetes in Tanzania and Uganda (INTE-COMM trial)

Background The number of people living with multiple chronic conditions in sub-Saharan Africa is increasing, but health facilities are unable to meet demand. To improve health system capacity and access to care, community models of HIV care have been trialled in countries such as Tanzania and Uganda. However, no evidence exists to inform policymakers on the effectiveness and cost-effectiveness of integrated community-based models of care for HIV and chronic non-communicable conditions. This protocol outlines a within-trial economic evaluation to address this gap. Methods &amp; analysis We will estimate the costs and cost-effectiveness of integrated community-based care for HIV, hypertension and diabetes compared with facility-based care within the INTE-COMM pragmatic cluster-randomised trial in Tanzania and Uganda. Analyses will adopt a 52-week time horizon, the duration of trial follow-up. The full enrolled trial sample will be analysed from a societal perspective, comprising provider and patient perspectives. Economic costs will be estimated, which includes valuing inputs such as donated goods or time foregone by participants because of receiving care. For provider costs, participant case report forms will inform resource use along with data from facilities and community sites. Resources will be valued using project accounts, facility spending, and locally available cost data. Patient costs will be estimated based on a care-seeking and cost questionnaire administered to participants. Estimated costs will be analysed with co-primary trial outcomes on plasma viral load suppression, glycaemia and blood pressure control to calculate incremental cost-effectiveness ratios (ICER). We will also calculate ICERs for secondary trial outcomes related to health-related quality of life and wellbeing. Cost drivers and outcomes will be varied within confidence bounds in a two-way sensitivity analysis. We will investigate equity impact by estimating the mean difference in outcomes between integrated community-based and facility-based care across household socio-economic quintiles and by measuring whether participants incurred catastrophic health expenditures. Trial registration number The ISRCTN Registry: ISRCTN15319595. Registered on 07 June 2022: https://doi.org/10.1186/ISRCTN15319595

A comparative study evaluating three line immunoassays available for serodiagnosis of equine Lyme borreliosis: Detection of Borrelia burgdorferi sensu lato-specific antibodies in serum samples of vaccinated and non-vaccinated horses

Diagnosis of equine Lyme borreliosis (LB), an infection caused by members of the Borrelia burgdorferi sensu lato complex (Bbsl), is challenging due to the nonspecific clinical signs of the disease and due to the variety of non-standardized serological tests. Specific vaccine-induced antibodies against LB, providing an effective protection against the infection, complicate the issue further. The standard for the detection of specific antibodies against Bbsl is a two-tier test system based on an enzyme-linked immunosorbent assay (ELISA) or indirect fluorescent antibody test (IFA) for antibody screening combined with a qualitative, highly specific immunoassay (e. g. line immunoassay (LIA)) for confirmation. In this study, three LIAs available for detection of antibodies in equine serum samples were evaluated and compared. A total of 393 serum samples of 131 horses with known serostatus were used. It included groups of non-vaccinated horses, immunized horses (vaccinations against LB on days 0 and 14), and horses that had received an initial immunization plus an additional booster on day 180. Sera were collected on days 0, 135 and 210 of the study. Results were compared considering the tests’ sensitivity, specificity, diagnostic outcome, and the operability of each test. Agreements of the diagnostic results among the LIAs were calculated for overall test results and single antigen-antibody-complex signal results. They are presented as inter-rater agreement and statistic reliability, represented by the Fleiss’ kappa coefficient. Agreement scores ranged from poor to moderate depending on group and time-point of blood sample collection. Depending on LIA used, deficiencies were observed in the form of non-sufficient sensitivity of antigen signals on the LIA strips (especially for outer surface protein A (OspA) or variable major protein like sequence expressed (VlsE)) or as an inappropriate test interpretation of the OspA signal. Operability of the three LIAs was equally user-friendly with minor variations. In two LIAs, test-evaluation was simplified by a supplied scanner and evaluation software. To improve functionality of available LIAs for equine serum samples it is advisable to adjust sensitivity and specificity of single test antigen signals and establish appropriate evaluation protocols.

Mitigating Data Leakage in a WiFi CSI Benchmark for Human Action Recognition.

Human action recognition using WiFi channel state information (CSI) has gained attention due to its non-intrusive nature and potential applications in healthcare, smart environments, and security. However, the reliability of methods developed for CSI-based action recognition is often contingent on the quality of the datasets and evaluation protocols used. In this paper, we uncovered a critical data leakage issue, which arises from improper data partitioning, in a widely used WiFi CSI benchmark dataset. Specifically, the benchmark fails to separate individuals between the training and test sets, leading to inflated performance metrics as models inadvertently learn individual-specific features rather than generalizable action patterns. We analyzed this issue in depth, retrained several benchmarked models using corrected data partitioning methods, and demonstrated a significant drop in accuracy when individuals were properly separated across training and testing. Our findings highlight the importance of rigorous data partitioning in CSI-based action recognition and provide recommendations for mitigating data leakage in future research. This work contributes to the development of more robust and reliable human action recognition systems using WiFi CSI.

A cell-based exploration of environmental and health impacts of food waste digestate for its sustainable reutilization.

Anaerobic digestion of food waste is increasingly utilized for bioenergy generation, producing a byproduct known as food waste digestate (FWD), which has potential applications as a fertilizer within the circular economy. However, accumulating numerous pollutants in FWD poses significant challenges to environmental management and human health. The complex nature of these pollutants complicates both targeted and non-targeted chemical analyses, making safety evaluations difficult. To address this, we developed a toxicity evaluation protocol based on comprehensive cellular effects to assess the safety profile of FWD. Our study found that human FHC cells were significantly more sensitive to FWD solutions, with 1.2-, 1.8-, and 1.7-fold greater sensitivity than GES-1, HepG2, and HEK293cells. We identified oxidative stress levels and the activation of the NF-κB signaling pathway as crucial and sensitive indicators of FWD-induced toxicity. Metabolomics analysis revealed that FWD triggered the activation of the inflammatory mediator regulation of the transient receptor potential channels pathway, indicating a cellular response aimed at mitigating damage through immune repair mechanisms. By comprehensively assessing these cellular and molecular indicators, we can better predict the potential human and environmental risks associated with FWD. This knowledge is essential for establishing safety guidelines and appropriate dilution ratios for FWD reutilization, enhancing environmental management practices within a circular economy framework.

Task-aware image quality estimators for face detection

Understanding the quality of face images plays a critical role in enhancing the efficiency of end-to-end face analytics systems, which perform tasks such as face detection, alignment, and recognition in a sequential manner. Recently, the development of face quality estimators (QEs) specifically for face recognition has received significant attention. However, in end-to-end face analytics systems, the performance of the face detector directly affects the face recognizer. Thus, assessing the suitability of an image for face detection before passing it on to face recognition can improve the resource utilization in such systems. In this research, we first introduce the detectability (DET) score of an image, a novel quality metric that links image quality to face detection performance. We use this DET score to design two novel QEs for face detection: supervised face detection quality estimator (SFDQE) and unsupervised face detection quality estimator (UFDQE). We also propose the mAP vs. reject protocol (mvR), a systematic evaluation protocol for assessing QEs in the context of face detection. In our experiments, we illustrate the effectiveness of SFDQE and UFDQE in determining the suitability of an image for face detection. Furthermore, we show the ability of our QEs to generalize; each is a powerful tool for image quality estimation in general object detection scenarios.

델파이 기법을 이용한 간호술기 평가를 위한 프로토콜 개발: ‘환자확인’, ‘통증관리’, ‘욕창관리 및 낙상예방’과 ‘배액관 관리’

Objectives This study aimed to develop evidenced based evaluation protocols for independent nursing skills, focusing on newly added core nursing skills that align with the 4th-cycle certification standards set by the Korean Accreditation Board of Nursing Education. These skills include pain management, pressure ulcer care and fall prevention, drain care, and patient identification that is essential to patient safety. Methods A Delphi technique was applied to seek expert panel consultation to modify and complete the evaluation protocols for the skills of ‘pain management’, ‘pressure ulcer care and fall prevention’, ‘drain care’, and ‘patient identification’. Two rounds were conducted and analyzed with a panel of 20 full-time professors who teach core nursing skills and 2 clinical field experts. Results In the first expert survey, items with a CVR (Content Validity Ratio) value lower than 0.42 were deleted, and after reflecting on expert opinions, the second survey was conducted. All items in the second survey had CVR values higher than 0.91, ensuring content validity, and the stability of all items was less than 0.5, confirming the completion of the protocol. Conclusions As a result of this study, it is expected that the nursing skill evaluation protocol developed through the consensus of the nursing education expert panel will be expanded and that the evidence-based nursing skill evaluation protocol will provide a foundation for application in various situations within nursing education settings.

A Neighbourhood-oriented approach to foster healthy ageing in low socioeconomic older adults: development and protocol for evaluation through intervention mapping.

The rapid ageing of our society poses significant challenges, including an increase in chronic diseases and loneliness among older adults, leading to higher demands for care and support. Addressing these needs requires an integral approach, especially among older adults with low socioeconomic status (SES). This article details the development of the Neighbourhood Active & Connected (NAC) intervention, using the Intervention Mapping framework to expand an evidence-based physical activity intervention into a neighbourhood-oriented, holistic and systemic strategy for healthy ageing. NAC focuses on enhancing physical activity, social connectedness, and digital literacy. It was developed through co-creation with local stakeholders and low-SES older adults, ensuring optimal alignment with their needs and capabilities. Performance and change objectives were established based on literature consultation and an extensive need assessment, with intervention materials refined through engagement with the target group. The results of a large-scale cluster randomised controlled trial will be utilised to evaluate NAC's impact on physical activity, loneliness, social cohesion, health-related quality of life, and digital literacy among low-SES community-dwelling older adults. This paper aims to provide a detailed roadmap for researchers and practitioners to adapt, implement and evaluate similar interventions, promoting healthy ageing in low socio-economic contexts.

Protocol for the economic evaluation of paraprofessional-led case management and two brief culture-informed suicide prevention interventions for American Indian youth.

Background: Suicide is a leading cause of death among American Indian youth, reflecting the intergenerational consequences of colonization, historical trauma, racism, and the chronic underfunding of critical health and social services in Native communities. American Indian values, spiritualities, and cultural practices promote the physical, social, and emotional health of Native people, and there is a need for community-based case management approaches and culture-informed behavioral interventions that build from this strength. Cost and cost-effectiveness estimates are critical for policymakers in Tribal communities considering investing in such services. Objectives : Our objective will be to estimate the cost and cost-effectiveness for community-based paraprofessionals to deliver three preventive services to American Indian youth (aged 10-29): case management, New Hope (a brief intervention to reduce immediate suicide risk) and Elders' Resilience (a brief intervention incorporating Elders to increase connectedness, self-esteem, and cultural identity). Methods : We will conduct an economic evaluation as part of a Sequential Multiple Assignment Randomized Trial in a rural, reservation-based American Indian community in the Southwest. A five-year time horizon, societal perspective, and 3% discount rate will be used. An ingredients-based approach will estimate fixed program costs (e.g., intervention development, shared overhead) and variable program costs (e.g., labor and intervention delivery). Additional costs to the participants and healthcare payer will be estimated. Data collection methods will include key informant interviews, activity logs, expenditure reports and records review, direct observation, and medical chart review. Total cost estimates for each service will be divided by the respective numbers of participants reached to estimate relative cost-efficiency. Primary and secondary outcomes will be quality-adjusted life years and suicidal ideation, respectively. Incremental cost effectiveness ratios will be estimated. Discussion: We will develop much-needed estimates of the cost and cost-effectiveness of delivering community-based, paraprofessional-delivered case management and culture-informed suicide prevention interventions in a rural, reservation-based American Indian community in the Southwest. These estimates will fill a key gap for Tribal policymakers considering comparable services for their communities. Trial Registration: Clinical Trials NCT03543865, June 1, 2018.