Medical Research Ethics Committee Research Articles

Adjustments of non-invasive ventilation and mechanically assisted cough by combining ultrasound imaging of the larynx with transnasal fibre-optic laryngoscopy: a protocol for an experimental study

IntroductionApplication of non-invasive positive airway pressure may provoke laryngeal responses that obstruct the airways, especially in patients with disturbed laryngeal control. To control and adjust for this, transnasal fibre-optic laryngoscopy...

Effects of the Intermittent Theta Burst Stimulation of the Cerebellar Vermis on Balance Recovery After Stroke: A Study Protocol for a Randomized Controlled Trial.

BackgroundThe recovery of balance function is a critical segment in the rehabilitation treatment of stroke. The cerebellum is considered as the key structure involved in balance and motor control. The cerebellar vermis plays an important role in integrating vision, proprioception, and sensory skin input and may be a candidate stimulation target for regulating the motor network related with balance. However, evidence that the intermittent theta burst stimulation (iTBS) of cerebellar vermis can promote the recovery of balance function after stroke remains insufficient. Therefore, this study aims to explore the efficacy of the cerebellar vermis iTBS for the treatment of balance function in patients with stroke.Methods and AnalysisForty patients with stroke will be recruited in this prospective, randomized, sham-controlled trial. Participants will be randomized in a 1:1 ratio to receive either 15 sessions of cerebellar vermis iTBS (600 pulses) or sham stimulation. Additionally, a routine rehabilitation therapy follows the intervention. The primary outcome is the Berg Balance Scale, and the secondary outcomes are the Fugl–Meyer assessment of the lower extremity and modified Barthel index. The above outcomes will be assessed before intervention and at the end of each week. Pre- and post-iTBS resting-state functional magnetic resonance imaging (rs-fMRI) will be acquired, and the regional homogeneity, fractional amplitude of low-frequency fluctuation and functional connectivity will be calculated and analyzed.DiscussionThis protocol holds promise as a potential method to improve balance function in patients with stroke. If the outcomes of patients improve after the intervention, the study will provide new insights into improving balance function.Ethics and DisseminationThis study has been approved by the Medical Research Ethics Committee of Wuxi Mental Health Center (Wuxi Tongren Rehabilitation Hospital). Results will be disseminated through (open-access) peer-reviewed publications, networks of scientists, professionals, and the public and presented at conferences.Clinical Trial Registration Numberwww.chictr.org.cn, identifier ChiCTR2100052590.

A Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND): Protocol for a Prospective Study

BackgroundSome children with central nervous system (CNS) and solid tumors are at risk to develop ototoxicity during treatment. Up to now, several risk factors have been identified that may contribute to ototoxicity, such as platinum derivates, cranial irradiation, and brain surgery. Comedication, like antibiotics and diuretics, is known to enhance ototoxicity, but their independent influence has not been investigated in childhood cancer patients. Recommendations for hearing loss screening are missing or vary highly across treatment protocols. Additionally, adherence to existing screening guidelines is not always optimal. Currently, knowledge is lacking on the prevalence of ototoxicity.ObjectiveThe aim of the Study on Prevalence and Determinants of Ototoxicity During Treatment of Childhood Cancer (SOUND) is to determine the feasibility of audiological testing and to determine the prevalence and determinants of ototoxicity during treatment for childhood cancer in a national cohort of patients with solid and CNS tumors.MethodsThe SOUND study is a prospective cohort study in the national childhood cancer center in the Netherlands. The study aims to include all children aged 0 to 19 years with a newly diagnosed CNS or solid tumor. Part of these patients will get audiological examination as part of their standard of care (stratum 1). Patients in which audiological examination is not the standard of care will be invited for inclusion in stratum 2. Age-dependent audiological assessments will be pursued before the start of treatment and within 3 months after the end of treatment. Apart from hearing loss, we will investigate the feasibility to screen patients for tinnitus and vertigo prevalence after cancer treatment. This study will also determine the independent contribution of antibiotics and diuretics on ototoxicity.ResultsThis study was approved by the Medical Research Ethics Committee Utrecht (Identifier 20-417/M). Currently, we are in the process of recruitment for this study.ConclusionsThe SOUND study will raise awareness about the presence of ototoxicity during the treatment of children with CNS or solid tumors. It will give insight into the prevalence and independent clinical and cotreatment-related determinants of ototoxicity. This is important for the identification of future high-risk patients. Thereby, the study will provide a basis for the selection of patients who will benefit from innovative otoprotective intervention trials during childhood cancer treatment that are currently being prepared.Trial RegistrationNetherlands Trial Register NL8881; https://www.trialregister.nl/trial/8881International Registered Report Identifier (IRRID)DERR1-10.2196/34297

Effectiveness of Individual Feedback and Coaching on Shared Decision-making Consultations in Oncology Care: Protocol for a Randomized Clinical Trial.

BackgroundShared decision-making (SDM) is particularly important in oncology as many treatments involve serious side effects, and treatment decisions involve a trade-off between benefits and risks. However, the implementation of SDM in oncology care is challenging, and clinicians state that it is difficult to apply SDM in their actual workplace. Training clinicians is known to be an effective means of improving SDM but is considered time consuming.ObjectiveThis study aims to address the effectiveness of an individual SDM training program using the concept of deliberate practice.MethodsThis multicenter, single-blinded randomized clinical trial will be performed at 12 Dutch hospitals. Clinicians involved in decisions with oncology patients will be invited to participate in the study and allocated to the control or intervention group. All clinicians will record 3 decision-making processes with 3 different oncology patients. Clinicians in the intervention group will receive the following SDM intervention: completing e-learning, reflecting on feedback reports, performing a self-assessment and defining 1 to 3 personal learning questions, and participating in face-to-face coaching. Clinicians in the control group will not receive the SDM intervention until the end of the study. The primary outcome will be the extent to which clinicians involve their patients in the decision-making process, as scored using the Observing Patient Involvement–5 instrument. As secondary outcomes, patients will rate their perceived involvement in decision-making, and the duration of the consultations will be registered. All participating clinicians and their patients will receive information about the study and complete an informed consent form beforehand.ResultsThis trial was retrospectively registered on August 03, 2021. Approval for the study was obtained from the ethical review board (medical research ethics committee Delft and Leiden, the Netherlands [N20.170]). Recruitment and data collection procedures are ongoing and are expected to be completed by July 2022; we plan to complete data analyses by December 2022. As of February 2022, a total of 12 hospitals have been recruited to participate in the study, and 30 clinicians have started the SDM training program.ConclusionsThis theory-based and blended approach will increase our knowledge of effective and feasible training methods for clinicians in the field of SDM. The intervention will be tailored to the context of individual clinicians and will target the knowledge, attitude, and skills of clinicians. The patients will also be involved in the design and implementation of the study.Trial RegistrationNetherlands Trial Registry NL9647; https://www.trialregister.nl/trial/9647International Registered Report Identifier (IRRID)DERR1-10.2196/35543

Health-promoting work schedules: protocol for a large-scale cluster randomised controlled trial on the effects of a work schedule without quick returns on sickness absence among healthcare workers

IntroductionIn shift work, quick returns refer to transitions between two shifts with less than 11 hours available rest time. Twenty-three per cent of employees in European countries reported having quick...

Gatekeeper training for vendors to reduce pesticide self-poisoning in rural South Asia: a study protocol for a stepped-wedge cluster randomised controlled trial

IntroductionPesticide self-poisoning kills an estimated 110 000–168 000 people worldwide annually. Data from South Asia indicate that in 15%–20% of attempted suicides and 30%–50% of completed suicides involving pesticides these...

The predictive value of preoperative frailty screening for postoperative outcomes in older patients undergoing surgery for non-metastatic colorectal cancer

The predictive value of preoperative frailty screening for postoperative outcomes in older patients undergoing surgery for non-metastatic colorectal cancer

Ethics framework for citizen science and public and patient participation in research

BackgroundCitizen science and models for public participation in health research share normative ideals of participation, inclusion, and public and patient engagement. Academic researchers collaborate in research with members of the public involved in an issue, maximizing all involved assets, competencies, and knowledge. In citizen science new ethical issues arise, such as who decides, who participates, who is excluded, what it means to share power equally, or whose knowledge counts. This article aims to present an ethics framework that offers a lens of understanding and heuristic guidelines to deal with ethical issues in citizen science.MethodsWe conducted seven case studies between 2015 and 2021 to attune and validate the ethics framework for the context of citizen science. The cases related to studies with older adults, people with a psychiatric vulnerability, people dependent on community care, people who are unemployed or living in poverty or both, and young adults with respiratory disease.ResultsEthics in citizen science reaches beyond the ethical issues in traditional biomedical and health research. It entails more than following procedures about informed consent and privacy and submitting a proposal to a Medical Research Ethics Committee. Ethics in citizen science relates to everyday ethical issues during the study, including relational and moral complexities concerning collaboration, sharing power, and democratic decision-making. Dealing with these issues requires ethics work of researchers. This entails seeing ethically salient issues and reflecting on everyday ethical issues. Ethics work consists of seven features: framing work, role work, emotion work, identity work, reason work, relationship work, and performance work. All are relevant for researchers in citizen science.ConclusionsEthical issues in citizen science often relate to power differentials, partnership, and collaboration between academics and non-academics. The ethics framework prepares researchers for the work needed in citizen science to act responsibly and offers a heuristic guide to reflect on ethics. Reflection on ethics is a pathway towards ethical citizen science, especially if researchers collaboratively reflect in partnership with non-academics who are subject to the moral issue.

The Physical Activity and Fitness in Childhood Cancer Survivors (PACCS) Study: Protocol for an International Mixed Methods Study.

BackgroundSurvivors of childhood cancer represent a growing population with a long life expectancy but high risks of treatment-induced morbidity and premature mortality. Regular physical activity (PA) may improve their long-term health; however, high-quality empirical knowledge is sparse.ObjectiveThe Physical Activity and Fitness in Childhood Cancer Survivors (PACCS) study comprises 4 work packages (WPs) aiming for the objective determination of PA and self-reported health behavior, fatigue, and quality of life (WP 1); physical fitness determination (WP 2); the evaluation of barriers to and facilitators of PA (WP 1 and 3); and the feasibility testing of an intervention to increase PA and physical fitness (WP 4).MethodsThe PACCS study will use a mixed methods design, combining patient-reported outcome measures and objective clinical and physiological assessments with qualitative data gathering methods. A total of 500 survivors of childhood cancer aged 9 to 18 years with ≥1 year after treatment completion will be recruited in follow-up care clinics in Norway, Denmark, Finland, Germany, and Switzerland. All participants will participate in WP 1, of which approximately 150, 40, and 30 will be recruited to WP 2, WP3, and WP 4, respectively. The reference material for WP 1 is available from existing studies, whereas WP 2 will recruit healthy controls. PA levels will be measured using ActiGraph accelerometers and self-reports. Validated questionnaires will be used to assess health behaviors, fatigue, and quality of life. Physical fitness will be measured by a cardiopulmonary exercise test, isometric muscle strength tests, and muscle power and endurance tests. Limiting factors will be identified via neurological, pulmonary, and cardiac evaluations and the assessment of body composition and muscle size. Semistructured, qualitative interviews, analyzed using systematic text condensation, will identify the perceived barriers to and facilitators of PA for survivors of childhood cancer. In WP 4, we will evaluate the feasibility of a 6-month personalized PA intervention with the involvement of local structures.ResultsEthical approvals have been secured at all participating sites (Norwegian Regional Committee for Medical Research Ethics [2016/953 and 2018/739]; the Oslo University Hospital Data Protection Officer; equivalent institutions in Finland, Denmark [file H-19032270], Germany, and Switzerland [Ethics Committee of Northwestern and Central Switzerland, project ID: 2019-00410]). Data collection for WP 1 to 3 is complete. This will be completed by July 2022 for WP 4. Several publications are already in preparation, and 2 have been published.ConclusionsThe PACCS study will generate high-quality knowledge that will contribute to the development of an evidence-based PA intervention for young survivors of childhood cancer to improve their long-term care and health. We will identify physiological, psychological, and social barriers to PA that can be targeted in interventions with immediate benefits for young survivors of childhood cancer in need of rehabilitation.International Registered Report Identifier (IRRID)DERR1-10.2196/35838

Older patients' perspectives on illness and healthcare during the early phase of the COVID-19 pandemic.

BackgroundEqual access to healthcare is a core principle in Norway’s public healthcare system. The COVID-19 pandemic challenged healthcare systems in the early phase – in particular, related to testing and hospital capacity. There is little knowledge on how older people experienced being infected with an unfamiliar and severe disease, and how they experienced the need for healthcare early in the pandemicAimTo explore the experiences of older people infected by COVID-19 and their need for testing and hospitalisation.Research designAn explorative and descriptive approach, with qualitative interviews conducted in October 2020.Participants and research contextSeventeen participants above 60 years of age hospitalised due to COVID-19 during spring 2020 were recruited 6 months after discharge.Ethical considerationsEthical approval was granted by the Regional Committee for Medical and Health Research Ethics in South-Eastern Norway (155425).FindingsThe main finding was that the informants experienced vulnerability and arbitrariness. This finding was supported by three sub-themes: experiences with a severe and unfamiliar disease, the strict criteria and the importance of someone advocating needs.DiscussionParticipants described varying access to healthcare. Those who did not meet the national criteria to be tested or hospitalised struggled against the system. Findings reveal arbitrary access to healthcare, in contrast to Norway’s ethical principle of fair and just access to health services. Moreover, to access and receive necessary healthcare, informants were dependent on their next-of-kin’s advocacy.ConclusionEven when dealing with an unfamiliar disease, health professionals’ assessments of symptoms must be performed with an ethical obligation to applicate competent appraisal and the exercise of discernment; this is in line with care ethics and ethical standards for nurses. These perspectives are a significant part of caring and the intension of doing good.

Implementation and evaluation of a physical activity counselling programme in primary care among cancer survivors: SoDA study protocol

IntroductionPhysical activity (PA) favourably affects various health outcomes in cancer survivors, but little is known about how to implement a PA programme in primary care. We therefore aim to implement...

Professionals' narratives of interactions with patients' families in intensive care.

Background: ICU patients’ family members are in a new, uncertain, and vulnerable situation due to the patient’s critical illness and complete dependence on the ICU nurses and physicians. Family members’ feeling of being cared for is closely linked to clinicians’ attitudes and behavior.Aim: To explore ICU nurses’ and physicians’ bedside interaction with critically ill ICU patients´ families and discuss this in light of the ethics of care.Research design: A qualitative study using participant observation, focus groups, and thematic narrative analysis.Participants and research context: Data were gathered from July 2017 to August 2019, in four ICUs in Norway through 270 h of fieldwork and seven focus groups with ICU nurses and physicians.Ethical considerations: The Regional Committee for Medical and Health Research Ethics and the Norwegian Centre for Research Data approved the study. Findings: Quality of ICU family care depends on nurses’ and physicians’ attitudes, behavior, and personality traits. Three main themes were identified: being attentive, an active approach, and degree of tolerance.Discussion: The findings are discussed in light of the ethics of care and empirical research from the intensive care environment.Conclusions: This study shows that attentive, active, and tolerant clinicians represent a culture of ethical care that gives families greater freedom of action and active participation in patient care. Clinicians must not bear sole responsibility for this culture; it must have a firm basis in the hospital and ICU and be established through training, interprofessional reflection, and support of clinicians.

Trust-building interventions to home-dwelling persons with dementia who resist care.

Providing care for a home-dwelling person with dementia who resists care is an ethical and practical complex and challenging task. Faced with a growing number of persons with dementia, the healthcare professional's understanding of how to best care for and prevent unnecessary use of coercion with persons with dementia is of key importance. The aim of this study was to explore the use of trust-building interventions in home-dwelling persons with dementia resisting care, as described by health professionals in documents of decisions of forced treatment and care. A qualitative thematic document analysis inspired by critical realism was conducted. Descriptions of trust-building interventions were extracted from 88 documents of forced treatment and care for home-dwelling persons with dementia, receiving home healthcare, in 2015 and 2016. Approved by the Regional Committee for Medical and Health Research Ethics, reference number 2017/788, and controlled by the Norwegian Centre for Research Data, reference number 54897. The study adhered to the guidelines of the Declaration of Helsinki. We found that "balancing safe care with the person's integrity" was an overarching theme that permeated the descriptions of trust-building interventions in the study. Three main themes were identified when the data were analyzed: safeguarding care, protecting integrity, and optimizing the environment. Health professionals balanced on a thin line between care and integrity when met with resistance from person with dementia. However, the trust-building interventions used in the most challenging situations did not differ from the interventions used in general in dementia care. Two knowledge gaps were identified: how to perform appropriate assessments of situations of home-dwelling persons with dementia when met with resistance to care, and whether environmental initiatives may also benefit home-dwelling persons with dementia who are not easily cared for.

A new minimally invasive, non-excisional, surgical browlift technique with minimal scarring: a protocol for a prospective observational study

Background The aim of this study is to prospectively evaluate the new minimal invasive (MINE) browlift technique with possibly superior results and minimal visible scarring. Methods A prospective observational study will be performed on all available data from patients who will undergo a browlift procedure in the Haaglanden Medical Center from 1-6-2021 till 31-5-2022. Our goal is to include at least 50 patients (1 per week). Inclusion criteria are: patients with medical (i.e. brow-ptosis, facial paralysis) or cosmetic indication, patients with sufficient understanding of the Dutch or English language and willingness to participate in extra study specific follow-up moments and filling in of questionnaires. Exclusion criteria are: <18 years of age and patients with previous brow or eyelid surgery. Patients will be photographed pre- and postoperatively using the VECTRA camera. The database management software Castor will be used to store and collect the data from the questionnaire. The Medical Research Ethics Committee found this study not eligible to be submitted to the Dutch Medical Research Involving Human Subjects Acts (WMO). Written informed consent will be obtained from all patients. Results Outcomes measures to be evaluated include: scarring after procedure; functionality of eyebrow movement; amount of correction in brow ptosis, measured in VECTRA; longevity of procedure in months; aesthetic result as assessed by questionnaires; and adverse effects of the procedure.

Study protocol ROTATE-trial: anterior cruciate ligament rupture, the influence of a treatment algorithm and shared decision making on clinical outcome\u2013 a cluster randomized controlled trial

BackgroundAnterior cruciate ligament (ACL) rupture is a very common knee injury in the sport active population. There is much debate on which treatment (operative or non-operative) is best for the individual patient. In order to give a more personalized recommendation we aim to evaluate the effectiveness and cost-effectiveness of a treatment algorithm for patients with a complete primary ACL rupture.MethodsThe ROTATE-trial is a multicenter, open-labeled cluster randomized controlled trial with superiority design. Randomization will take place on hospital level (n = 10). Patients must meet all the following criteria: aged 18 year or older, with a complete primary ACL rupture (confirmed by MRI and physical examination) and maximum of 6 weeks of non-operative treatment. Exclusion criteria consists of multi ligament trauma indicated for surgical intervention, presence of another disorder that affects the activity level of the lower limb, pregnancy, and insufficient command of the Dutch language. The intervention to be investigated will be an adjusted treatment decision strategy, including an advice from our treatment algorithm. Patient reported outcomes will be conducted at baseline, 3, 6, 12 and 24 months. Physical examination of the knee at baseline, 12 and 24 months. Primary outcome will be function of the knee measured by the International Knee Documentation Committee (IKDC) questionnaire. Secondary outcomes are, among others, the Tegner activity score, the Knee injury and Osteoarthritis Outcome Score (KOOS) and the 9-item Shared Decision Making Questionnaire (SDM-Q-9). Healthcare use, productivity and satisfaction with ((non-)operative) care are also measured by means of questionnaires. In total 230 patients will be included, resulting in 23 patients per hospital.DiscussionThe ROTATE study aims to evaluate the effectiveness and cost-effectiveness of a treatment algorithm for patients with a complete primary ACL rupture compared to current used treatment strategy. Using a treatment algorithm might give the much-wanted personalized treatment recommendation.Trial registrationThis study is approved by the Medical Research Ethics Committee of Erasmus Medical Center in Rotterdam and prospectively registered at the Dutch Trial Registry on May 13th, 2020. Registration number: NL8637.

Effect of high-intensity exercise on cardiorespiratory fitness, cardiovascular disease risk and disease activity in patients with inflammatory joint disease: protocol for the ExeHeart randomised controlled trial

IntroductionInflammatory joint disease (IJD) is associated with increased risk of cardiovascular disease (CVD) fostered by systemic inflammation and a high prevalence of CVD risk factors. Cardiorespiratory fitness (CRF) is an...

Digital auscultation as a novel childhood pneumonia diagnostic tool for community clinics in Sylhet, Bangladesh: protocol for a cross-sectional study

IntroductionThe WHO’s Integrated Management of Childhood Illnesses (IMCI) algorithm for diagnosis of child pneumonia relies on counting respiratory rate and observing respiratory distress to diagnose childhood pneumonia. IMCI case defination...

Coproducing Knowledge of the Implementation of Complex Digital Health Interventions for Adults with Acquired Brain Injury and their Communication Partners: Protocol for a Mixed Methods Study.

BackgroundThe Social Brain Toolkit, conceived and developed in partnership with stakeholders, is a novel suite of web-based communication interventions for people with brain injury and their communication partners. To support effective implementation, the developers of the Social Brain Toolkit have collaborated with people with brain injury, communication partners, clinicians, and individuals with digital health implementation experience to coproduce new implementation knowledge. In recognition of the equal value of experiential and academic knowledge, both types of knowledge are included in this study protocol, with input from stakeholder coauthors.ObjectiveThis study aims to collaborate with stakeholders to prioritize theoretically based implementation targets for the Social Brain Toolkit, understand the nature of these priorities, and develop targeted implementation strategies to address these priorities, in order to support the Social Brain Toolkit’s implementation.MethodsTheoretically underpinned by the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework of digital health implementation, a maximum variation sample (N=35) of stakeholders coproduced knowledge of the implementation of the Social Brain Toolkit. People with brain injury (n=10), communication partners (n=11), and clinicians (n=5) participated in an initial web-based prioritization survey based on the NASSS framework. Survey completion was facilitated by plain English explanations and accessible captioned videos developed through 3 rounds of piloting. A speech-language pathologist also assisted stakeholders with brain injury to participate in the survey via video teleconference. Participants subsequently elaborated on their identified priorities via 7 web-based focus groups, in which researchers and stakeholders exchanged stakeholder perspectives and research evidence from a concurrent systematic review. Stakeholders were supported to engage in focus groups through the use of visual supports and plain English explanations. Additionally, individuals with experience in digital health implementation (n=9) responded to the prioritization survey questions via individual interview. The results will be deductively analyzed in relation to the NASSS framework in a coauthorship process with people with brain injury, communication partners, and clinicians.ResultsEthical approval was received from the University of Technology Sydney Health and Medical Research Ethics Committee (ETH20-5466) on December 15, 2020. Data were collected from April 13 to November 18, 2021. Data analysis is currently underway, with results expected for publication in mid-2022.ConclusionsIn this study, researchers supported individuals with living experience of acquired brain injury, of communicating with or clinically supporting someone post injury, and of digital health implementation, to directly access and leverage the latest implementation research evidence and theory. With this support, stakeholders were able to prioritize implementation research targets, develop targeted implementation solutions, and coauthor and publish new implementation findings. The results will be used to optimize the implementation of 3 real-world, evidence-based interventions and thus improve the outcomes of people with brain injury and their communication partners.International Registered Report Identifier (IRRID)DERR1-10.2196/35080

Intravitreal injection of ranibizumab for treatment of macular edema secondary to retinal vein occlusion

ObjectiveThis study aims to evaluate the effect of ranibizumab for treatment of macular edema (ME) secondary to retinal vein occlusion (RVO).Patients and methodsThis is a prospective case series study that included 35 eyes of patients with ME due to RVOs. This study was conducted in Menoufia University Hospital during the period study from March 2018 till February 2020. The study protocol was approved by the medical research ethics committee of Faculty of Medicine, Menoufia University.ResultsThere was a significant improvement in the best-corrected visual acuity (VA) value in the fourth month postoperatively than preoperatively, whereas there was no change in the sixth month postoperatively than preoperatively (P1 < 0.025, P2 < 0.17, and P3 < 0.025, respectively). There was a significantly improvement in the central macular thickness (CMT) at 4 and 6 months postoperatively than preoperatively (P1 < 0.001, P2 < 0.001, and P3 > 0.037, respectively). Moreover, there was a significant positive correlation between preoperative CMT and Snellen VA, CMT at fourth month postoperatively, and CMT at sixth month postoperatively (P < 0.05).ConclusionsCMT and best-corrected VA were significantly improvement at 4 and 6 months postoperatively compared with preoperatively. In the current study, during the follow-up, no patients showed any severe local adverse events such as retinal detachment, retinal tears, endophthalmitis, or uveitis, and none showed progression to ischemia or rubeosis iridis. No patients experienced any systemic adverse effects. Finally, evaluation of the short-term effect of intravitreal ranibizumab injection can be used to predict the outcome of the therapy at 1 week and 1 month after injection for the ME secondary to RVO.

Human assumed central sensitisation (HACS) in patients with chronic low back pain radiating to the leg (CLaSSICO study)

IntroductionPatients with chronic low back pain radiating to the leg (CLBPr) are sometimes referred to a specialised pain clinic for a precise diagnosis based, for example, on a diagnostic selective...