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The Next Generation Network (NGN) vision is tending towards the convergence of internet and mobile services providing the impetus for new market opportunities in combining the appealing services of internet with the roaming capability of mobile networks. However, this convergence does not go far enough, and with the emergence of new coexistence scenarios, there is a clear need to evolve the current architecture to provide cost-effective end-to-end communication. The LOOP project, a EUREKA-CELTIC driven initiative, is one piece in the jigsaw by helping European industry to sustain a leading role in telecommunications and manufacturing of high-value products and machinery by delivering pioneering converged wireless networking solutions that can be successfully demonstrated. This paper provides an overview of the LOOP project and the key achievements that have been tunneled into first prototypes for showcasing next generation services for operators and process manufacturers.

Purpose: We aimed to compare the long-term outcomes of small-head (28 mm) metal-on-metal (MoM) total hip arthroplasty (THA) to ceramic-on-polyethylene (CoP) THA using the same cup., Methods: All primary elective MoM and CoP THAs performed 1998-2011 were prospectively included in a local registry. Patients were followed until 31 December 2022. Outcomes were all-cause revision, complications and mortality. The uncemented Morscher 28 mm monobloc press-fit cup was used in all THAs., Results: Overall, 3257 THAs were included, 864 MoM (mean age 63) and 2393 CoP THAs (mean age 72). Mean follow-up of the cohort was 12.9 years (maximum 26.8 years). Revision for any cause was performed in 85 MoM and 79 CoP THAs. Cumulative incidence of all-cause revision at 20 years was 13.2% (95% CI 10.6 to 16.3) in MoM and 6.3% (95% CI 4.8 to 8.3) in CoP group. Adjusted hazard ratio for all-cause revision was 1.88 (95% CI 1.34 to 2.65) comparing MoM vs. CoP. Diagnoses at revision were mainly aseptic loosening (33%) and adverse local tissue reactions (33%) in MoM and aseptic loosening in CoP group (44%). The smoothed hazard function revealed the largest difference in instantaneous revision rate between three and 14 years postoperative. After that period no difference was observed., Conclusion: Overall, the cumulative risk of all-cause revision was almost twice as high in patients with a small head MoM as compared to a CoP THA over the 20-year period. However, most of the excess in revisions among MoM patients occurred between three and 14 years postoperative., Competing Interests: Declarations. Human ethics and consent to participate: This study was approved and granted a waiver of informed consent by our institutional ethics committee. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)

The World Health Organization estimates that approximately 285 million people suffer from visual impairments, around 5% of which are caused by corneal pathologies. Currently, the most common clinical treatment consists of a corneal transplant (keratoplasty) from a human donor. However, worldwide demand for donor corneas amply exceeds the available supply. Lamellar keratoplasty (transplantation replacement of only one of the three layers of the cornea) is partially solving the problem of cornea undersupply. Obviously, cell therapy applied to every one of these layers will expand current therapeutic options, reducing the cost of ophthalmological interventions and increasing the effectiveness of surgery. Mesenchymal stem cells (MSCs) are adult stem cells with the capacity for self-renewal and differentiation into different cell lineages. They can be obtained from many human tissues, such as bone marrow, umbilical cord, adipose tissue, dental pulp, skin, and cornea. Their ease of collection and advantages over embryonic stem cells or induced pluripotent stem cells make them a very practical source for experimental and potential clinical applications. In this review, we focus on recent advances using MSCs from different sources to replace the damaged cells of the three corneal layers, at both the preclinical and clinical levels for specific corneal diseases.

Sleeve gastrectomy is a common bariatric procedure known for its safety and effectiveness, but postoperative complications like abscess formation, though rare, can occur. We report the case of a 37-year-old female who presented with atypical abdominal pain following a sleeve gastrectomy. Imaging revealed an abscess located away from the staple line. Surgical exploration and culture identified  Streptococcus anginosus  as the causative organism. This case emphasizes the importance of vigilant postoperative monitoring and early intervention to prevent complications. Proper management, including antibiotics and surgical drainage, is crucial for patient recovery., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Brito et al.)

Infantile hemangiomas (IHs) are common benign vascular tumors that affect infants. In this case report, we detail the natural course of an IH in an infant monitored over four months without medical intervention, illustrating the benign progression and potential for spontaneous stabilization of such lesions. The aim was to observe changes in the size and morphology of the hemangioma, alongside the infant's overall health and developmental milestones, through regular clinical assessments. This case presented a challenge as the patient's parents lacked English fluency, lacked healthcare access, and had low socioeconomic status. It highlights the importance of individualized patient care, advocating for careful observation and restraint in the application of pharmacological treatments when clinically unnecessary. The report contributes to existing pediatric dermatology knowledge by emphasizing the natural benign behavior of IH and the need for a balanced approach to treatment decisions, ensuring safe and favorable long-term outcomes for patients., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Gullabzada et al.)

Omental infarction is an uncommon cause of abdominal pain. The condition is often misdiagnosed due to its clinical similarity to more common abdominal pathologies like appendicitis and cholecystitis. This report presents the case of a 57-year-old female with a one-week history of left-sided abdominal pain, initially aggravated by eating and defecation. The patient, a long-term smoker with a complex medical history that includes deep vein thrombosis and pulmonary embolism, was hemodynamically stable on presentation. A CT scan revealed a nodular infiltration consistent with an omental infarct. Conservative management was pursued, resulting in symptom resolution by the third day of hospitalization. This case underscores the diagnostic challenges associated with omental infarction, particularly its differentiation from other causes of acute abdominal pain. It highlights the importance of considering rare etiologies in patients with atypical presentations and emphasizes the role of imaging, particularly CT scans, in accurate diagnosis. The patient's successful conservative management aligns with current recommendations, which advocate for non-surgical treatment in most cases. This approach avoids unnecessary surgical interventions and ensures a favorable prognosis with low complication rates in patients with prompt and appropriate management., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Brito et al.)

Introduction: Medical deserts are a growing phenomenon across many European countries. They are usually defined as (i) rural areas, (ii) underserved areas or (iii) by applying a measure of distance/time to a facility or a combination of the three characteristics. The objective was to define medical deserts in Spain as well as map their driving factors and approaches to mitigate them., Methods: A mixed methods approach was applied following the project "A Roadmap out of medical deserts into supportive health workforce initiatives and policies" work plan. It included the following elements: (i) a scoping literature review; (ii) a questionnaire survey; (iii) national stakeholders' workshop; (iv) a descriptive case study on medical deserts in Spain., Results: Medical deserts in Spain exist in the form of mostly rural areas with limited access to health care. The main challenge in their identification and monitoring is local data availability. Diversity of both factors contributing to medical deserts and solutions applied to eliminate or mitigate them can be identified in Spain. They can be related to demand for or supply of health care services. More national data, analyses and/or initiatives seem to be focused on the health care supply dimension., Conclusions: Addressing medical deserts in Spain requires a comprehensive and multidimensional approach. Effective policies are needed to address both the medical staff education and planning system, working conditions, as well as more intersectoral approach to the population health management., (© 2024 The Authors. The International Journal of Health Planning and Management published by John Wiley & Sons Ltd.)

Objective: The study objective was to assess the benefits of del Nido cardioplegia compared with cold blood cardioplegia solution in terms of myocardial protection during adult cardiac surgery., Methods: A total of 474 adult patients undergoing coronary artery bypass grafting, heart valve surgery, thoracic aortic surgery, or combined procedures were randomized to the del Nido cardioplegia group (n = 234) or the cold blood cardioplegia solution group (n = 240) after provided informed consent. The primary end points assessed inotropic support requirements, severe cardiovascular events, and troponin trend within the first 48 hours of intensive care unit stay. Reperfusion arrhythmias, aortic crossclamp and cardiopulmonary bypass times, and other clinical perioperative variables were considered as secondary end points., Results: No statistically significant differences were found regarding postoperative inotropic support requirements or the incidence of severe cardiovascular events. The del Nido cardioplegia group showed a higher return to spontaneous sinus rhythm (P< .001), a lower number of defibrillation attempts (P< .001), and an earlier peak troponin value in the postoperative period. Peak blood glucose levels and intravenous insulin requirements were significantly lower in the del Nido cardioplegia group. We found no significant differences regarding aortic crossclamp or cardiopulmonary bypass time. We did observe a lower incidence of postoperative stroke in the del Nido cardioplegia group (2.6% vs 6.7%; P= .035)., Conclusions: del Nido cardioplegia can be used safely and with comparable outcomes compared with traditional cardioplegia solutions. Additional advantages over glycemic control, reperfusion arrhythmias, and its comfortable redosing interval make del Nido an interesting alternative for myocardial protection in adult cardiac surgery. A significant decrease in postoperative stroke will require further research to shed light on the results of this study. VIDEO ABSTRACT., (Copyright © 2022 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021., Methods: We systematically reviewed the medical literature for a random selection of hip and knee implants to identify all peer-reviewed clinical investigations published within 10 years before and up to 20 years after regulatory approval. We report study characteristics, methodologies, outcomes, measures to prevent bias, and timing of clinical investigations of 30 current implants. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines., Results: We identified 2912 publications and finally included 151 papers published between 1995 and 2021 (63 on hip stems, 34 on hip cups, and 54 on knee systems). We identified no clinical studies published before Conformité Européene (CE)-marking for any selected device, and no studies even up to 20 years after CE-marking in one-quarter of devices. There were very few randomized controlled trials, and registry-based studies generally had larger sample sizes and better methodology., Conclusion: The peer-reviewed literature alone is insufficient as a source of clinical investigations of these high-risk devices intended for life-long use. A more systematic, efficient, and faster way to evaluate safety and performance is necessary. Using a phased introduction approach, nesting comparative studies of observational and experimental design in existing registries, increasing the use of benefit measures, and accelerating surrogate outcomes research will help to minimize risks and maximize benefits.

Nationwide challenges with the lack of access to mental health care for youth have prompted efforts to integrate mental health into pediatric primary care. Kansas Kids Mental Health Access Program (KSKidsMAP) was developed to promote mental health workforce development through primary-care practitioners (PCPs) by offering free access to consultations, training, and care coordination. Kansas Kids Mental Health Access Program, a federally funded pediatric mental health care access program (PMHCA), is highly interprofessional in nature, and recommendations reflect the team composition and collaboration efforts. Therefore, a mixed-methods study was conducted to assess the type of recommendations provided to PCPs who requested case consultation services. Seven themes were identified: (1) psychotherapy; (2) diagnostic evaluation; (3) community resources; (4) pharmacotherapy; (5) patient resources and toolkits; (6) education; and (7) other health recommendations. This study highlights the multifaceted approach of KSKidsMAP in addressing PCPs' pediatric mental health concerns.

Small bowel obstruction (SBO) refers to the inability of contents to pass through the lumen of the small intestine. This is a common surgical emergency in the United States. Although intra-abdominal adhesions are the predominant cause, SBO can occur secondarily to various etiologies, be it one cause or several. Management of SBO secondary to adhesions and metastasized rectal adenocarcinoma, complicated by pulmonary, hepatic, and ureteral disease, highlights the criticality of a multidisciplinary approach. We present a case of a 59-year-old male with SBO secondary to rectal adenocarcinoma. Treatment included surgical resection, acute stabilization, referral for outpatient surgical follow-up, and oncologic management., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Brito et al.)

Background: Knowledge of the base rate of signal changes consistent with distal biceps tendinopathy on magnetic resonance imaging (MRI) has the potential to influence strategies for diagnosis and treatment of people that present with elbow pain. The aim of this study is to measure the prevalence of distal biceps tendon signal changes on MRIs of the elbow by indication for imaging., Methods: MRI data for 1,306 elbows were retrospectively reviewed for mention of signal change in distal biceps tendon. The reports were sorted by indication., Results: Signal changes consistent with distal biceps tendinopathy were noted in 197 of 1,306 (15%) patients, including 34% of patients with biceps pain, 14% of patients with unspecified pain, and 8% of patients with a specific non-biceps indication. Distal biceps tendon changes noted on radiology reports were associated with older age, male sex, and radiologists with musculoskeletal fellowship training., Conclusions: The finding that distal biceps MRI signal changes consistent with tendinopathy are common even in asymptomatic elbows reduces the probability that symptoms correlate with pathology on imaging. The accumulation of signal changes with age, also independent of symptoms, suggests that tendon pathology persists after symptoms resolve, that some degree of distal biceps tendinopathy is common in a human lifetime, and that tendinopathy may often be accommodated without seeking care. Level of evidence: IV.

Patients with COVID-19 may develop abnormal inflammatory response, followed in some cases by severe disease and long-lasting syndromes. We show here that in vitro exposure to SARS-CoV-2 activates the expression of the human endogenous retrovirus (HERV) HERV-W proinflammatory envelope protein (ENV) in peripheral blood mononuclear cells from a subset of healthy donors, in ACE2 receptor and infection-independent manner. Plasma and/or sera of 221 COVID-19 patients from different cohorts, infected with successive SARS-CoV-2 variants including the Omicron, had detectable HERV-W ENV, which correlated with ENV expression in T lymphocytes and peaked with the disease severity. HERV-W ENV was also found in postmortem tissues of lungs, heart, gastrointestinal tract, brain olfactory bulb, and nasal mucosa from COVID-19 patients. Altogether, these results demonstrate that SARS-CoV-2 could induce HERV-W envelope protein expression and suggest its involvement in the immunopathogenesis of certain COVID-19-associated syndromes and thereby its relevance in the development of personalized treatment of patients., Competing Interests: HP, BC, JB, JP, and NQ receive compensation from GeNeuro-Innovation for their work. PK received consulting fees from GeNeuro SA. Other co-authors do not declare conflict of interest., (© 2023 The Author(s).)

Background: Half the US population uses drugs with anticholinergic properties. Their potential harms may outweigh their benefits. Amitriptyline is among the most frequently prescribed anticholinergic medicinal products, is used for multiple indications, and rated as strongly anticholinergic. Our objective was to explore and quantify (anticholinergic) adverse drug reactions (ADRs) in patients taking amitriptyline vs. placebo in randomized controlled trials (RCTs) involving adults and healthy individuals., Methods: We searched electronic databases from their inception until 09/2022, and clinical trial registries from their inception until 09/2022. We also performed manual reference searches. Two independent reviewers selected RCTs with ≥100 participants of ≥18 years, that compared amitriptyline (taken orally) versus placebo for all indications. No language restrictions were applied. One reviewer extracted study data, ADRs, and assessed study quality, which two others verified. The primary outcome was frequency of anticholinergic ADRs as a binary outcome (absolute number of patients with/without anticholinergic ADRs) in amitriptyline vs. placebo groups., Results: Twenty-three RCTs (mean dosage 5mg to 300mg amitriptyline/day) and 4217 patients (mean age 40.3 years) were included. The most frequently reported anticholinergic ADRs were dry mouth, drowsiness, somnolence, sedation, fatigue, constitutional, and unspecific anticholinergic ADRs. Random-effects meta-analyses showed anticholinergic ADRs had a higher odd's ratio for amitriptyline versus placebo (OR = 7.41; [95% CI, 4.54 to 12.12]). Non-anticholinergic ADRs were as frequent for amitriptyline as placebo. Meta-regression analysis showed anticholinergic ADRs were not dose-dependent., Discussion: The large OR in our analysis shows that ADRs indicative of anticholinergic activities can be attributed to amitriptyline. The low average age of participants in our study may limit the generalizability of the frequency of anticholinergic ADRs in older patients. A lack of dose-dependency may reflect limited reporting of the daily dosage when the ADRs occurred. The exclusion of small studies (<100 participants) decreased heterogeneity between studies, but may also have reduced our ability to detect rare events. Future studies should focus on older people, as they are more susceptible to anticholinergic ADRs., Registration: PROSPERO: CRD42020111970., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Brueckle et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background and Objectives: Patient experience measures tend to have notable ceiling effects that make it difficult to learn from gradations of satisfaction to improve care. This study tested 2 different iterative satisfaction measures after a musculoskeletal specialty care visit in the hope that they might have less ceiling effect. We measured floor effects, ceilings effects, skewness, and kurtosis of both questionnaires. We also assessed patient factors independently associated with the questionnaires and the top 2 possible scores., Methods: In this cross-sectional study, 186 patients completed questionnaires while seeing 1 of 11 participating orthopedic surgeons in July and August 2019; the questionnaire measured: (1) demographics, (2) symptoms of depression, (3) catastrophic thinking in response to nociception, (4) heightened illness concerns, and (5) satisfaction with the visit on 2 iterative satisfaction scales. Bivariate and multivariable analyses sought associations of the explanatory variable with the satisfaction scales., Results: There is a small correlation between the 2 scales ( r = 0.27; P < .001). Neither scale had a floor effect and both had a ceiling effect of 45%. There is a very small correlation between greater health anxiety and lower satisfaction measured with one of the scales ( r = -0.16; P = .05)., Conclusion: An iterative satisfaction questionnaire created some spread in patient experience data, but could not limit ceiling effects. Additional strategies are needed to remove ceiling effects from satisfaction measures., Competing Interests: All authors certify that they have no commercial associations (eg, consultancies, stock ownership, equity interest, and patent/licensing arrangements) that might pose a conflict of interest in connection with the submitted article., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Studies on the association of open tibia fractures and acute compartment syndrome (ACS) show confusing results, with some papers highlighting a positive association, and others failing to do so. The aim of this study was to determine if an open tibia fracture is at increased risk of ACS occurrence, when compared to a closed fracture., Hypothesis: Skin injury in the setting of an open tibia fracture does not prevent from ACS occurrence, because the energy transmitted to the limb during trauma may lead to soft tissue lesions, including skin lacerations and ACS., Patients and Methods: In total, 711 consecutive adult patients (mean age 44.6 years; 65.8% males) sustaining 725 tibia fractures between 01.01.2005 and 31.12.2009 were included in this retrospective study. The outcome measure was ACS. The following variables were assessed: soft tissue condition, age, sex, low- vs. high-energy injury, type of fracture, associated contiguous skeletal injury. A logistic regression model was used and adjustment was performed for age and sex., Results: ACS occurred in 10.4% of proximal intra-articular fractures, 10.4% of extra-articular fractures and 3.3% of distal intra-articular fractures, and in 8.7% of closed fractures, 7.8% of open Gustilo 1 fractures and 13.3% of open Gustilo 2 and 3 fractures. Open lesions were not associated with ACS when tibia fractures were considered as a whole. When stratifying by types of fractures, open Gustilo 2 and 3 lesions were associated with ACS in proximal intra-articular fractures (p=0.048). There was no association with closed or any type of open lesions for extra-articular fractures. There were not enough ACS cases among distal intra-articular fractures to draw conclusions., Discussion: As ACS may occur with any type of open tibia fractures, clinicians should not be wrongly reassured by an open fracture, assuming that the wound would relieve the pressure inside the muscle compartments. There is a weak association between open Gustilo 2 and 3 lesions and ACS in proximal intra-articular fractures only. These findings are important for surgeons treating these injuries, especially by intubated, sedated or obtunded patients., Level of Evidence: III; retrospective diagnostic study., (Copyright © 2021 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)

Introduction: Mild cognitive impairment (MCI) is a clinical syndrome characterised by persistent cognitive deficits that do not yet fulfil the criteria of dementia. Delaying the onset of dementia using secondary preventive measures such as physical activity and exercise can be a safe way of reducing the risk of further cognitive decline and maintaining independence and improving quality of life. The aim is to systematically review the literature to assess the effectiveness of physical activity and exercise interventions to improve long-term patient-relevant cognitive and non-cognitive outcomes in people living with MCI, including meta-analyses if applicable., Methods and Analysis: We will systematically search five electronic databases from 1995 onward to identify trials reporting on the effectiveness of physical activity and exercise interventions to improve long-term (12+ months) patient-relevant cognitive and non-cognitive outcomes in adults (50+ years) with MCI. Screening procedures, selection of eligible full-texts, data extraction and risk of bias assessment will be performed in dual-review mode. Additionally, the reporting quality of the exercise interventions will be assessed using the Consensus on Exercise Reporting Template. A quantitative synthesis will only be conducted if studies are homogeneous enough for effect sizes to be pooled. Where quantitative analysis is not applicable, data will be represented in a tabular form and synthesised narratively. People living with MCI will be involved in defining outcome measures most relevant to them in order to assess in how far randomised controlled trials report endpoints that matter to those concerned., Ethics and Dissemination: Results will be disseminated to both scientific and lay audiences by creating a patient-friendly video abstract. This work will inform professionals in primary care about the effectiveness of physical activity and exercise interventions and support them to make evidence-based exercise recommendations for the secondary prevention of dementia in people living with MCI. No ethical approval required., Prospero Registration Number: CRD42021287166., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: There are two general frameworks that conceptualize pain that is more intense or persistent than expected based on measurable pathologic findings: the psychological (unhelpful thoughts and emotions) and the physiological (purported nervous system dysfunction, such as central sensitization). Some clinicians believe people will be more receptive to a physiological conceptualization. Prior quantitative research demonstrated that carefully crafted psychological explanations are rated similarly to crafted physiological explanations, with relatively mixed reactions. This qualitative study was undertaken in parallel with that quantitative study to help develop effective communication and treatment strategies by identifying specific thoughts and feelings (themes) regarding the physiological and psychological conceptualizations of disproportionate pain that make people more or less comfortable considering comprehensive, biopsychosocial treatment approaches., Question/purpose: What themes arise in patient thoughts and feelings regarding physiological and psychological conceptualizations of pain that is more intense or persistent than expected?, Methods: We sought to understand the experience of considering pain as a biopsychosocial experience (phenomenology approach) by studying the thoughts and feelings that arise as people seeking care for arm and back pain engage with physiological and psychological conceptualizations of pain that is more intense or persistent than one would expect based on the pathology. We recruited 29 patients presenting for upper extremity or back pain specialty care at one of two urban offices, intentionally recruiting people of various ages, genders, backgrounds, socioeconomic status, as well as type and duration of pain (purposive sampling). The 29 patients included 18 women and 11 men (16 married, 15 non-White, 20 with arm pain) with a median (interquartile range) age of 62 years (42 to 67). The interviews were conducted by a trained woman orthopaedic surgeon interviewer using a semistructured interview guide soliciting participants' thoughts and feelings about a physiological explanation (nerves in the central nervous system stuck in the on position can make pain more intense) and a psychological explanation (unhelpful thoughts and feelings of distress can make pain more intense) for pain more intense or persistent than expected. The interviews were transcribed and themes were identified as the data were collected. Based on current experimental evidence, including what is known about the physiological effects of thoughts, feelings, and context (placebo/nocebo effects), we assumed an underlying physiological basis for pain that is variably experienced and expressed (mixed postpositive/interpretive approach). Themes were identified in the interview transcripts systematically by two coders and then discussed with the entire research team to arrive at consensus. We stopped enrolling patients when the authors agreed that additional themes did not arise in five consecutive interviews., Results: The following themes and interpretations were derived from the analysis: Neither the physiological nor the psychological explanation for disproportionate pain (1) avoided the stigma associated with mental health, (2) was consistently understood, (3) provided a consistent sense of control, (4) consistently provided hope, and (5) represented the stress and emotion of disproportionate or persistent pain. The physiological explanation also generated mixed reactions regarding whether or not it: (1) was a useful point of conversation, (2) was reassuring or frightening, and (3) supported physiological or psychological treatments. The psychological explanation made some people feel worse., Conclusion: People have mixed reactions to both physiological and psychological explanations of disproportionate pain. As such, without direction on content, communication might be most effective by focusing on relational aspects, such as emotional connection and trust., Clinical Relevance: Although there is room to improve the content of strategies for explaining more pain than expected to patients, our findings extend the discoveries of others in highlighting the need for tailored relational communication strategies that prioritize feeling heard, validated, and accompanied., Competing Interests: Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2022 by the Association of Bone and Joint Surgeons.)

Introduction: Older patients with multimorbidity, polypharmacy and related complex care needs represent a growing proportion of the population and a challenge for healthcare systems. Particularly in transitional care (hospital admission and hospital discharge), medical errors, inappropriate treatment, patient concerns and lack of confidence in healthcare are major problems that may arise from a lack of information continuity. The aim of this study is to develop an intervention to improve informational continuity of care at the interface between general practice and hospital care., Methods and Analysis: A qualitative approach will be used to develop our participatory intervention. Overall, 32 semistructured interviews with relevant stakeholders will be conducted and analysed. The stakeholders will include healthcare professionals from the outpatient setting (general practitioners, healthcare assistants, ambulatory care nurses) and the inpatient setting (clinical doctors, nurses, pharmacists, clinical information scientists) as well as patients and informal caregivers. At a series of workshops based on the results of the stakeholder analyses, we aim to develop a participatory intervention that will then be implemented in a subsequent pilot study. The same stakeholder groups will be invited for participation in the workshops., Ethics and Dissemination: Ethical approval for this study was waived by the Ethics Committee of Goethe University Frankfurt because of the nature of the proposed study. Written informed consent will be obtained from all study participants prior to participation. Results will be tested in a pilot study and disseminated at (inter)national conferences and via publication in peer-reviewed journals., Trial Registation Number: Clinical Trials Register: registration number DRKS00027649., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Objectives were first to evaluate by education level one-year trajectories of pain, function and general health, as well as hospital resource and medication needs in patients undergoing primary total hip arthroplasty (THA); and second, to evaluate whether outcome differences are related to existing baseline differences in health and disease severity., Methods: We included all primary THAs from a public hospital-based prospective arthroplasty registry, performed in a high-income country 2010 to 2017. Education was classified in three levels: ≤8years of schooling (low), 9-12years (medium), and ≥13years (high). Pain and function prior to and one-year after surgery were assessed with the Western Ontario McMaster Universities score (WOMAC) and general health with the 12-item short-form health survey (SF-12)., Results: Overall 963 patients were included, 340 (35.3%) with low, 306 (31.8%) with medium, and 317 (32.9%) with high education. With increasing educational level preoperative scores for pain, function and SF-12 mental health component increased. One year after surgery improvement was observed in all education categories for WOMAC pain and function, SF-12 mental and physical component. However, absolute postoperative scores remained lower in all four domains for the low education group. After adjustment for baseline characteristics differences were much attenuated and no longer significant. There was also greater resource need in low educated patients., Conclusions: The inferior absolute results one year after surgery in less educated patients were largely due to older age, worse preoperative health and greater symptom severity calling for greater attention to timely and equal management, for more targeted perioperative care and increased support for the lower education group., (© 2022. The Author(s).)

Introduction: Hispanics represent the largest minority group in the United States. In Kansas, the population of Hispanics has been increasing; unfortunately, their infant mortality rate has increased as well. Baby Talk is a prenatal education program promoting maternal and infant health through risk-reduction strategies and healthy decision-making. The aim of this pilot project was to develop and evaluate a Spanish curriculum for Baby Talk., Methods: A collaborative partnership between bilingual community members and health professionals from different origins, nationalities, and Spanish dialects was formed to create a culturally and linguistically appropriate Spanish Baby Talk curriculum. This interventional pilot mixed methods research study employed quantitative and qualitative methods to evaluate participant knowledge, intentions, satisfaction, and perceptions of the new curriculum., Results: Fifteen pregnant women participated in Spanish Baby Talk. Of those, 12 participated in either phone interviews (n = 6) or a focus group (n = 6). All respondents described their experience with the Spanish Baby Talk program as "excellent". Significant increases in knowledge were seen related to topics such as benefits of full-term pregnancy and benefits of breastfeeding. Four themes were identified from the focus group and interviews: 1) lack of accessible community resources; 2) sense of community; 3) Spanish Baby Talk strengths; and 4) areas for improvements., Conclusions: Findings suggested that the Spanish Baby Talk curriculum was linguistically appropriate and resulted in increases in knowledge and intentions related to health and safety behaviors. Areas for improvement were related to marketing the program and referring to resources that provide material supports (i.e., diapers) to continue the move towards a culturally competent program., (© 2022 The University of Kansas Medical Center.)

Introduction: Multimorbidity is the simultaneous occurrence of several (chronic) diseases. Persons living with multimorbidity not only have complex care needs, but the burden of care often has a negative impact on their family lives, leisure time and professional activities. The aim of this project is to systematically review the literature to assess how multimorbidity affects the everyday lives of middle-aged persons, and to find out what abilities and resources help in the development of coping strategies to overcome the challenges of living with it., Methods and Analysis: We will systematically search for studies reporting on the everyday life experiences of middle-aged persons (30-60 years) with multimorbidity (≥2 chronic conditions) in MEDLINE, CINAHL, PsycINFO, Social Sciences Citation Index, Social Sciences Citation Index Expanded, PSYNDEX and The Cochrane Library from inception. We will include all primary studies that use quantitative, qualitative and mixed methodologies, irrespective of publication date/study setting.Two independent reviewers will screen titles/abstracts/full texts, extract data from the selected studies and present evidence in terms of study/population characteristics, data collection method and the phenomenon of interest, that is, everyday life experiences of middle-aged persons with multimorbidity. Risk of bias will be independently assessed by two reviewers using the Mixed Methods Appraisal Tool. We will use a convergent integrated approach on qualitative/quantitative studies, whereby information will be synthesised narratively and, if possible, quantitatively., Ethics and Dissemination: Ethical approval is not required due to the nature of the proposed systematic review. Results from this research will be disseminated at relevant (inter)national conferences and via publication in peer-reviewed journals., Prospero Registration Number: CRD42021226699., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Given the influence of psychosocial factors on musculoskeletal symptoms and limitations, this study assessed if the ability of resilience (an individual's ability to adapt under stress) mediates the association of psychological adaptability with magnitude of physical limitations and pain intensity during recovery from an upper extremity injury., Methods: A total of 107 patients were enrolled in this prospective, longitudinal, observational cohort study. Patients completed the Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF), an 11-point ordinal measure of pain intensity, the Brief Resilience Scale (BRS), and the Psychological Adaptation Scale (PAS). We used structural equation modeling to assess the mediation effect by resiliency and psychological adaptability on patient-reported disability and pain at initial assessment and after three months., Results: PAS and BRS were not independently associated with PROMIS PF or pain intensity at enrollment or after three months, so it was not possible to assess if resiliency mediated the association of psychological adaptability with physical function or pain. There were no factors independently associated with resilience., Conclusion: General measures of psychological adaptability and resiliency do not correlate with symptoms and limitations as well as specific measures of adaptiveness in response to nociception., Competing Interests: No benefits in any form have been received or will be received related directly or indirectly to the subject of this article. The authors report no conflict of interest concerning the materials or methods used in this study or the findings specified in this paper CN, JK, AG, TC, GV, and LR certify that they have no commercial associations (e.g. consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article. DR has or may receive payment or benefits from Skeletal Dynamics, Wright Medical for elbow implants, Deputy Editor for Clinical Orthopaedics and Related Research, Universities and Hospitals, Lawyers outside the submitted work.

ECMO is an extracorporeal cardiorespiratory support system whose use has been increased in the last decade. Respiratory failure, postcardiotomy shock, and lung or heart primary graft failure may require the use of cardiorespiratory mechanical assistance. In this scenario perioperative medical and surgical management is crucial. Despite the evolution of technology in the area of extracorporeal support, morbidity and mortality of these patients continues to be high, and therefore the indication as well as the ECMO removal should be established within a multidisciplinary team with expertise in the area. This consensus document aims to unify medical knowledge and provides recommendations based on both the recent bibliography and the main national ECMO implantation centres experience with the goal of improving comprehensive patient care., (Copyright © 2021 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.)

Introduction: Clinically complex patients often require multiple medications. Polypharmacy is associated with inappropriate prescriptions, which may lead to negative outcomes. Few effective tools are available to help physicians optimise patient medication. This study assesses whether an electronic medication management support system (eMMa) reduces hospitalisation and mortality and improves prescription quality/safety in patients with polypharmacy., Methods and Analysis: Planned design: pragmatic, parallel cluster-randomised controlled trial; general practices as randomisation unit; patients as analysis unit. As practice recruitment was poor, we included additional data to our primary endpoint analysis for practices and quarters from October 2017 to March 2021. Since randomisation was performed in waves, final study design corresponds to a stepped-wedge design with open cohort and step-length of one quarter., Scope: general practices, Westphalia-Lippe (Germany), caring for BARMER health fund-covered patients., Population: patients (≥18 years) with polypharmacy (≥5 prescriptions)., Sample Size: initially, 32 patients from each of 539 practices were required for each study arm (17 200 patients/arm), but only 688 practices were randomised after 2 years of recruitment. Design change ensures that 80% power is nonetheless achieved., Intervention: complex intervention eMMa., Follow-Up: at least five quarters/cluster (practice). recruitment: practices recruited/randomised at different times; after follow-up, control group practices may access eMMa., Outcomes: primary endpoint is all-cause mortality and hospitalisation; secondary endpoints are number of potentially inappropriate medications, cause-specific hospitalisation preceded by high-risk prescribing and medication underuse., Statistical Analysis: primary and secondary outcomes are measured quarterly at patient level. A generalised linear mixed-effect model and repeated patient measurements are used to consider patient clusters within practices. Time and intervention group are considered fixed factors; variation between practices and patients is fitted as random effects. Intention-to-treat principle is used to analyse primary and key secondary endpoints., Ethics and Dissemination: Trial approved by Ethics Commission of North-Rhine Medical Association. Results will be disseminated through workshops, peer-reviewed publications, local and international conferences., Trial Registration: NCT03430336. ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03430336)., Competing Interests: Competing interests: BSM, RK-M, AIG-G, RH, JK-N, PK-M, NT, TB, LD, BS, BF, PI, SS, TSD, AP, IM, UK, HP, WG, FMG, HJT, CM report grants from the German Federal Joint Committee during the conduct of the study. DG reports grants from BARMER during the conduct of the study and family member works for and holds shares of IT company involved in the project. SG works for and holds shares of IT company involved in the project. SH, RP, PG declare that they have no competing interests., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To explore factors that potentially impact external validation performance while developing and validating a prognostic model for hospital admissions (HAs) in complex older general practice patients., Study Design and Setting: Using individual participant data from four cluster-randomised trials conducted in the Netherlands and Germany, we used logistic regression to develop a prognostic model to predict all-cause HAs within a 6-month follow-up period. A stratified intercept was used to account for heterogeneity in baseline risk between the studies. The model was validated both internally and by using internal-external cross-validation (IECV)., Results: Prior HAs, physical components of the health-related quality of life comorbidity index, and medication-related variables were used in the final model. While achieving moderate discriminatory performance, internal bootstrap validation revealed a pronounced risk of overfitting. The results of the IECV, in which calibration was highly variable even after accounting for between-study heterogeneity, agreed with this finding. Heterogeneity was equally reflected in differing baseline risk, predictor effects and absolute risk predictions., Conclusions: Predictor effect heterogeneity and differing baseline risk can explain the limited external performance of HA prediction models. With such drivers known, model adjustments in external validation settings (eg, intercept recalibration, complete updating) can be applied more purposefully., Trial Registration Number: PROSPERO id: CRD42018088129., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The evidence that symptom intensity and magnitude of limitations correlate with thoughts and emotions means that subjective signs, such as pain with physical examination, reflect both physical and mental health. During a 1-month evaluation of a rapidly healing upper extremity fracture with no risk of nonunion, 117 people completed measures of adaptiveness to pain and pain during the physical examination. Greater pain during examination correlated with less adaptive responses to pain and older age. This finding raises questions about using tenderness to assess fracture union. Level of evidence: II.

Background: Musculoskeletal specialists who attempt to discuss the connection between mental health (thoughts and emotions) and physical health (symptom intensity and activity tolerance) with patients, may fear that they risk offending those patients. In a search for language that creates comfort with difficult conversations, some specialists favor a biomedical framework, such as central sensitization, which posits abnormal central neuron activity. Without addressing the relative accuracy of mind- or brain-based conceptualizations, we addressed crafted and practiced communication strategies as conversation starters that allow specialists to operate within a biopsychosocial framework without harming the relationship with the patient., Questions/purposes: We measured (1) patient resonance with various explanations of the mind-body connection, including examples of both mind- and brain-based communication strategies, and (2) factors associated with resonance and emotional reactions to the explanations., Methods: In this cross-sectional study, all adult new and returning patients who were literate in English and who attended several musculoskeletal specialty offices were invited to complete questionnaires addressing reactions to one of seven explanations of the mind-body connection assigned using a random number generator. Acknowledging that the relative accuracy of mind-based and nerve- or brain-based strategies are speculative, we developed the following conversation starters: two explanations that were cognitively framed ("the mind is a great story teller"; one positively framed and one negatively framed), two emotionally framed explanations ("stressed or down"; one positively framed and one negatively framed), one mentioning thoughts and emotions in more neutral terms ("mind and body work together … thoughts and emotions affect the way your body experiences pain"), and two biomedical neurophysiology-based explanations ("nerves get stuck in an over-excited state" and "overstimulated nerves"), all crafted with the assistance of a communication scholar. It was unusual for people to decline (although the exact number of those who did was not tracked) and 304 of 308 patients who started the questionnaires completed them and were analyzed. In this sample, 51% (155 of 304) were men, and the mean ± SD age was 49 ± 17 years. Reactions were measured as resonance (a 1 to 5 Likert scale regarding the degree to which the stated concept aligns with their understanding of health and by inference is a comfortable topic of discussion) and self-assessment manikins using circled figurines to measure feelings of happiness (frowning to smiling figures), stimulation/excitement (a relaxed sleepy figure to an energized wide-eyed figure), and security/control (small to large figures). These are commonly used to quantify the appeal and emotive content of a given message. Patients also completed surveys of demographics and mental health. Multilevel multivariable linear regression models were constructed to assess factors associated with resonance, happiness, excitement, and control., Results: Controlling for potential confounding variables such as demographics and mental health measures, a relatively neutral biopsychosocial explanation ("mind and body work together") had the greatest mean resonance (4.2 ± 0.8 versus 3.8 ± 0.9 for the other explanations; p < 0.01) and the largest regression coefficient for resonance (0.78 [95% confidence interval 0.41 to 1.15]). The next-most-resonant explanations were biomedical ("excitable nerves", "over-excited state"). Biopsychosocial explanations that mention stress, distress, or cognitive bias ("mind is a great storyteller") had lower resonance. People with greater unhealthy cognitive bias regarding pain (more catastrophic thinking) were less comfortable with all the explanations (lower resonance, regression coefficient -0.03 [95% CI -0.06 to -0.01]). Emotional reactions were relatively comparable with the exception that people felt less control and security with specific explanations such as "excitable nerves" and "mind is a great storyteller.", Conclusion: Crafted communication strategies allow musculoskeletal specialists to address health within the biopsychosocial paradigm without harming their relationship with the patient., Clinical Relevance: Musculoskeletal specialists may be the first clinicians to notice mental health opportunities. It may be helpful for them to develop and practice effective communication strategies that make mental health a comfortable topic of discussion., Competing Interests: Each author certifies that neither he nor she, nor any member of his or her immediate family, has funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2021 by the Association of Bone and Joint Surgeons.)

Spatial coherence is an impactful source parameter in many applications ranging from atomic and molecular physics to metrology or imaging. In lensless imaging, for example, it can strongly affect the image formation, especially when the source exhibits shot-to-shot variations. Single-shot characterization of the spatial coherence length of a source is thus crucial. However, current techniques require either parallel intensity measurements or the use of several masks. Based on the method proposed by González et al. [J. Opt. Soc. Am. A28, 1107 (2011)JOAOD60740-323210.1364/JOSAA.28.001107], we designed a specific arrangement of a two-dimensional non-redundant array of apertures, which allows, through its far field interference pattern, for a single-shot measurement of the spatial coherence, while being robust against beam-pointing instabilities. The strategic configuration of the pinholes allows us to disentangle the degree of spatial coherence from the intensity distribution, thus removing the need for parallel measurement of the beam intensity. An experimental validation is performed using a high-harmonic source. A statistical study in different regimes shows the robustness of the method.

This study assessed the correlation of 9 questions addressing communication effectiveness (the Communication Effectiveness Questionnaire [CEQ]) with other patient-reported experience measures (PREMs; satisfaction, perceived empathy) as well as patient-reported outcome measures (PROMs; pain intensity, activity tolerance) in patients with musculoskeletal illness or injury. In a cross-sectional study, 210 patients visiting an orthopedic surgeon completed the CEQ and measures of satisfaction with the visit, perceived empathy, pain intensity, and activity tolerance. We evaluated correlations between CEQ and other PREMs and CEQ and PROMs. We measured ceiling effects of the PREMs. Communication effectiveness correlated moderately with other PREMs such as satisfaction (ρ = 0.54; P < .001) and perceived empathy (ρ = 0.54; P < .001). Communication effectiveness did not correlate with PROMs: pain intensity (ρ = -0.01; P = .93) and activity tolerance (ρ = -0.05; P = .44). All of the experience measures have high ceiling effects: perceived empathy 37%, satisfaction 80%, and CEQ 46%. The observation of notable correlations of various PREMs, combined with their high ceiling effects, direct us to identify a likely common statistical construct (which we hypothesize as "relationship") accounting for variation in PREMs, and then develop a PREM which measures that construct in a manner that results in a Gaussian distribution of scores. At least within the limitations of current experience measures, there seems to be no association between illness (PROMs) and experience (PREMs)., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: No benefits in any form have been received or will be received related directly or indirectly to the subject of this article. YV, ML, LEB, AIG, and JTPK certify that they have no commercial associations (eg consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article. DR has or may receive payment or benefits from Skeletal Dynamics, Wright Medical for elbow implants, Deputy Editor for Clinical Orthopaedics and Related Research, Universities and Hospitals, Lawyers outside the submitted work., (© The Author(s) 2021.)

Background: Misperception that an established, gradual-onset disease such as osteoarthritis started when the symptoms were first noticed might lead to testing and treatment choices that are inconsistent with what matters most to a patient. In the present study, the primary null hypothesis was that there are no factors associated with patient-reported symptom duration (in months). The secondary null hypotheses were that there are no factors independently associated with (1) a sudden versus gradual perception of disease onset, (2) an event or injury-related versus age-related perceived cause of disease onset, and (3) the magnitude of physical limitations., Methods: In this cross-sectional study, 121 patients with an atraumatic, established, gradual-onset condition of the upper extremity completed a demographic questionnaire, measures of mental health (symptoms of depression and anxiety, worst-case thinking, and self-efficacy [the ability to adapt and continue with daily activity] when in pain), measurement of the magnitude of upper extremity-specific limitations, and questions about the perceived course and cause of the disease., Results: The median patient-reported symptom duration was 12 months (interquartile range, 3 to 36 months). Twenty-two patients (18%) perceived their disease as new, and 29 patients (24%) believed that the condition was related to ≥1 event (injury) rather than being time and age-related. In multivariable analysis, patients with Medicare insurance were independently associated with longer reported symptom duration (in months). Greater self-efficacy was associated with longer symptom duration in bivariate, but not multivariable, analysis. No factors were independently associated with a sudden versus gradual onset of symptoms. Hispanic ethnicity and federal, county, or no insurance were independently associated with the perception that the problem was caused by an injury or event., Conclusions: Approximately 1 in 5 patients misperceived new symptoms as representing a new disease, often as a type of injury. Misperception of the pathology as new had a limited association with unhealthy thoughts and is likely generally responsive to reorientation. We speculate that gentle, strategic reorientation of misperception can protect patients from choices inconsistent with their values., Competing Interests: Disclosure: The authors indicated that no external funding was received for any aspect of this work. On the Disclosure of Potential Conflicts of Interest forms, which are provided with the online version of the article, one or more of the authors checked “yes” to indicate that the author had a relevant financial relationship in the biomedical arena outside the submitted work (http://links.lww.com/JBJS/G144)., (Copyright © 2020 by The Journal of Bone and Joint Surgery, Incorporated.)

Background: Measures of patient satisfaction are increasingly used to measure patient experience. Most satisfaction measures have notable ceiling effects, which limits our ability to learn from variation among relatively satisfied patients. This study tested a variety of single-question satisfaction measures for their mean overall score, ceiling and floor effect, and data distribution. In addition, we assessed the correlation between satisfaction and psychological factors and assessed how the various methods for measuring satisfaction affected net promoter scores (NPSs)., Methodology: A total of 212 patients visiting orthopedic offices were enrolled in this randomized controlled trial. Patients were randomized to 1 of 5 newly designed, single-question satisfaction scales: (a) a helpfulness 11-point ordinal scale from 0 to 10, (b) a helpfulness ordinal 11-point scale from 0 to 5 (ie, with 1.5, 2.5, etc), (c) a helpfulness 100-point slider, (d) a satisfaction 11-point ordinal scale from 0 to 10, and (e) a willingness to recommend 11-point ordinal scale from 0 to 10. Additionally, patients completed the 2-item Pain Self-Efficacy Questionnaire (PSEQ-2), 5-item Short Health Anxiety Inventory (SHAI-5) Scale, and Patient-Reported Outcomes Measurement Information System (PROMIS) Depression. We assessed mean and median score, ceiling and floor effect, and skewness and kurtosis for each scale. Spearman's correlation tests were used to test correlations between satisfaction and psychological status. Finally, we assessed the NPS for the various scales., Results: Ceiling effects ranged from 29% to 68%. The 11-point ordinal helpfulness scale from 0 to 10 had the least ceiling effect (29%). All of the scales were asymmetrically distributed, with the 11-point ordinal scale from 0 to 5 having the most Gaussian distribution (skew = 0.64 and kurtosis = 2.3). Satisfaction scores did not correlate with psychological factors: PSEQ-2 ( r = 0.04; P = .57), SHAI-5 ( r = 0.01; P = .93), and PROMIS Depression ( r = -0.04; P = .61). Net promoter scores varied substantially by scale design, with higher scores corresponding with greater ceiling effects., Conclusions: Variations in scale types, text anchors, and lead-in statements do not eliminate the ceiling effect of single-question measures of satisfaction with a visit to an orthopedic specialist. Further studies might test other scale designs and labels., Level of Evidence: Diagnostic; Level II., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2020.)

Patient experience measures such as satisfaction are increasingly tracked and incentivized. Satisfaction questionnaires have notable ceiling effects that may limit learning and improvement. This study tested a Guttman-type (iterative) Satisfaction Scale (GSS) after a musculoskeletal specialty care visit in the hope that it might reduce the ceiling effect. We measured floor effects, ceiling effects, skewness, and kurtosis of GSS. We also assessed factors independently associated with GSS and the top 2 possible scores. In this cross-sectional study, 164 patients seeing an orthopedic surgeon completed questionnaires measuring (1) a demographics, (2) symptoms of depression, (3) catastrophic thinking in response to nociception, (4) heightened illness concerns, and (5) satisfaction with the visit (GSS). Bivariate and multivariable analyses sought associations of the explanatory variable with total GSS and top 2 scores of GSS. Accounting for potential confounding using multivariable analysis, lower satisfaction was independently associated with greater symptoms of depression (β: -0.03; 95% CI: -0.05 to -0.00; P = .047). The top 2 scores of the GSS were independently associated with women (compared to men: odds ratio [OR]: 2.12, 99% CI: 1.01-4.45, P = .046) and lower level of education (masters' degree compared to high school; OR: 0.16, 95% CI: 004-0.61, P = .007). The GSS had no floor effect, a ceiling effect of 38%, a skewness of -0.08, and a kurtosis of 1.3. The 38% ceiling effect of the iterative (Guttman-style) satisfaction measure is lower than ordinal satisfaction scales, but still undesirably high. Alternative approaches for reducing the ceiling effect of patient experience measures are needed., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: No benefits in any form have been received or will be received related directly or indirectly to the subject of this article. YV, LEB, MR, AIG, and MDD certify that they have no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article. DR has or may receive payment or benefits from Skeletal Dynamics, Wright Medical for elbow implants, Deputy Editor for Clinical Orthopedics and Related Research, Universities and Hospitals, Lawyers outside the submitted work., (© The Author(s) 2020.)

Background: Shoulder injury from vaccination was approved for automatic compensation from the Vaccine Injury Compensation Program (VICP)-a federal government program started in 1988 to shield the manufacturers of childhood vaccines from liability. The approval was made on the basis of case reports rather than experimental evidence. This, combined with the addition of influenza vaccination to the VICP in 2005 (which broadened coverage to include adults) and other social factors, was associated with a rapid rise in the number of claims of shoulder injury from vaccination over the last decade, which now account for more than half of all claims to the VICP. Given the high prevalence of newly symptomatic sources of shoulder pain such as rotator cuff tendinopathy, combined with the high prevalence of annual influenza vaccinations, there is a substantial risk of overlap leading to the post hoc ergo propter hoc fallacy ("after this, therefore because of this") contributing to misdiagnosis and inappropriate management of patients that perceive injury from vaccination. Records of medical care after a large number of vaccinations have a good chance of detecting serious shoulder pathology, even it is uncommon, which would result in an increased prevalence of visits for shoulder problems and specific types of shoulder pathology., Questions/purposes: Is there a difference in the proportion of visits for shoulder pain within 3 months before and after vaccination among students and faculty receiving an influenza vaccination in the shoulder?, Methods: We studied people who were vaccinated for influenza between 2009 and 2018 at a university health service. During the study period, a comprehensive billing database identified 24,206 influenza vaccinations administered to 12,870 people (median age 20 years, range 16-77; 57% women). We had 80% power to detect a 0.1% increase in the proportion of shoulder problems after vaccination compared with before vaccination. Visits with coded ICD-9 shoulder diagnoses were identified from the electronic medical record. We compared the proportion of shoulder evaluations within 3 months before and 3 months after vaccination., Results: With the numbers available, the proportion of visits for shoulder problems were not different before (1.1% [52 of 4801]) and after vaccination (1% [40 of 3977], risk ratio 1.1 [95% CI 0.8 to 1.5]; p = 0.72). Among all vaccinations, 49% (11,834 of 24,206) were preceded or followed by an appointment within 3 months before (20% [4801 of 24,206]), after (16% [3977]), or both before and after (13% [3056]) vaccine administration, and 1.4% (170) of these visits were related to a shoulder issue. The most common reason for shoulder-related appointments was atraumatic shoulder pain (79% [134 of 170])., Conclusions: Shoulder symptoms sufficient to seek care are notably common, even among relatively young adults, and are not more common after vaccination. Although this does not rule out an important rare pathology specific to vaccination, it seems important to consider the potential harms of assuming, based largely on chronology, that persistent shoulder pain after vaccination-something expected to be common based merely on the anticipated frequency of overlap of vaccination and common shoulder problems-represents harm from vaccine., Level of Evidence: Level III, therapeutic study.

Introduction: End-of-life care is an essential task performed by most healthcare providers and often involves decision-making about how and where patients want to receive care. To provide decision support to healthcare professionals and patients in this difficult situation, we will systematically review a knowledge cluster of the end-of-life care preferences of older patients with multimorbidity that we previously identified using an evidence map., Methods and Analysis: We will systematically search for studies reporting end-of-life care preferences of older patients (mean age ≥60) with multimorbidity (≥2 chronic conditions) in MEDLINE, CINAHL, PsycINFO, Social Sciences Citation Index, Social Sciences Citation Index Expanded, PSYNDEX and The Cochrane Library from inception to September 2019. We will include all primary studies that use quantitative, qualitative and mixed methodologies, irrespective of publication date and language.Two independent reviewers will assess eligibility, extract data and describe evidence in terms of study/population characteristics, preference assessment method and end-of-life care elements that matter to patients (eg, life-sustaining treatments). Risk of bias/applicability of results will be independently assessed by two reviewers using the Mixed-Methods Appraisal Tool. Using a convergent integrated approach on qualitative/quantitative studies, we will synthesise information narratively and, wherever possible, quantitatively., Ethics and Dissemination: Due to the nature of the proposed systematic review, ethics approval is not required. Results from our research will be disseminated at relevant (inter-)national conferences and via publication in peer-reviewed journals. Synthesising evidence on end-of-life care preferences of older patients with multimorbidity will improve shared decision-making and satisfaction in this final period of life., Prospero Registration Number: CRD42020151862., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Unwanted anticholinergic effects are both underestimated and frequently overlooked. Failure to identify adverse drug reactions (ADRs) can lead to prescribing cascades and the unnecessary use of over-the-counter products. The objective of this systematic review and meta-analysis is to explore and quantify the frequency and severity of ADRs associated with amitriptyline vs. placebo in randomized controlled trials (RCTs) involving adults with any indication, as well as healthy individuals., Methods: A systematic search in six electronic databases, forward/backward searches, manual searches, and searches for Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval studies, will be performed. Placebo-controlled RCTs evaluating amitriptyline in any dosage, regardless of indication and without restrictions on the time and language of publication, will be included, as will healthy individuals. Studies of topical amitriptyline, combination therapies, or including < 100 participants, will be excluded. Two investigators will screen the studies independently, assess methodological quality, and extract data on design, population, intervention, and outcomes ((non-)anticholinergic ADRs, e.g., symptoms, test results, and adverse drug events (ADEs) such as falls). The primary outcome will be the frequency of anticholinergic ADRs as a binary outcome (absolute number of patients with/without anticholinergic ADRs) in amitriptyline vs. placebo groups. Anticholinergic ADRs will be defined by an experienced clinical pharmacologist, based on literature and data from Martindale: The Complete Drug Reference. Secondary outcomes will be frequency and severity of (non-)anticholinergic ADRs and ADEs. The information will be synthesized in meta-analyses and narratives. We intend to assess heterogeneity using meta-regression (for indication, outcome, and time points) and I 2 statistics. Binary outcomes will be expressed as odds ratios, and continuous outcomes as standardized mean differences. Effect measures will be provided using 95% confidence intervals. We plan sensitivity analyses to assess methodological quality, outcome reporting etc., and subgroup analyses on age, dosage, and duration of treatment., Discussion: We will quantify the frequency of anticholinergic and other ADRs/ADEs in adults taking amitriptyline for any indication by comparing rates for amitriptyline vs. placebo, hence, preventing bias from disease symptoms and nocebo effects. As no standardized instrument exists to measure it, our overall estimate of anticholinergic ADRs may have limitations., Systematic Review Registration: Submitted to PROSPERO; assignment is in progress.

Background: The purpose of this study was to evaluate the association between epidemiological, clinical and radiographic factors of patients with tibial shaft fractures and the occurrence of acute compartment syndrome., Methods: 270 consecutive adult patients sustaining 273 tibial shaft fractures between January 2005 and December 2009 were included in this retrospective cohort study. The outcome measure was acute compartment syndrome. Patient-related (age, sex), fracture-related (high- vs. low-energy injury, isolated trauma vs. polytrauma, closed vs. open fracture) and radiological parameters (AO/OTA classification, presence or absence of a noncontiguous tibial plateau or pilon fracture, distance from the centre of the tibial fracture to the talar dome, distance between tibial and fibular fracture if associated, and angulation, translation and over-riding of main tibial fragments) were evaluated regarding their potential association with acute compartment syndrome. Univariate analysis was performed and each covariate was adjusted for age and sex. Finally, a multivariable logistic regression model was built, and odds ratios and 95% confidence intervals were obtained. Statistical significance was defined as p < 0.05., Results: Acute compartment syndrome developed in 31 (11.4%) cases. In the multivariable regression model, four covariates remained statistically significantly associated with acute compartment syndrome: polytrauma, closed fracture, associated tibial plateau or pilon fracture and distance from the centre of the tibial fracture to the talar dome ≥15 cm., Conclusions: One radiological parameter related to the occurrence of acute compartment syndrome has been highlighted in this study, namely a longer distance from the centre of the tibial fracture to the talar dome, meaning a more proximal fracture. This observation may be useful when clinical findings are difficult to assess (doubtful clinical signs, obtunded, sedated or intubated patients). However, larger studies are mandatory to confirm and refine the prediction of acute compartment syndrome occurrence. Radiographic signs of significant displacement were not found to be correlated to acute compartment syndrome development. Finally, the higher rate of acute compartment syndrome occurring in tibial shaft fractures associated to other musculoskeletal, thoraco-abdominal or cranio-cerebral injuries must raise the level of suspicion of any surgeon managing multiply injured patients.

Objectives: To systematically identify knowledge clusters and research gaps in the health-related preferences of older patients with multimorbidity by mapping current evidence., Design: Evidence map (systematic review variant)., Data Sources: MEDLINE, EMBASE, PsycINFO, PSYNDEX, CINAHL and Science Citation Index/Social Science Citation Index/-Expanded from inception to April 2018., Study Selection: Studies reporting primary research on health-related preferences of older patients (mean age ≥60 years) with multimorbidity (≥2 chronic/acute conditions)., Data Extraction: Two independent reviewers assessed studies for eligibility, extracted data and clustered the studies using MAXQDA-18 content analysis software., Results: The 152 included studies (62% from North America, 28% from Europe) comprised 57 093 patients overall (range 9-9105). All used an observational design except for one interventional study: 63 (41%) were qualitative (59 cross-sectional, 4 longitudinal), 85 (57%) quantitative (63 cross-sectional, 22 longitudinal) and 3 (2%) used mixed methods. The setting was specialised care in 85 (56%) and primary care in 54 (36%) studies. We identified seven clusters of studies on preferences: end-of-life care (n=51, 34%), self-management (n=34, 22%), treatment (n=32, 21%), involvement in shared decision making (n=25, 17%), health outcome prioritisation/goal setting (n=19, 13%), healthcare service (n=12, 8%) and screening/diagnostic testing (n=1, 1%). Terminology (eg, preferences, views and perspectives) and concepts (eg, trade-offs, decision regret, goal setting) used to describe health-related preferences varied substantially between studies., Conclusion: Our study provides the first evidence map on the preferences of older patients with multimorbidity. Included studies were mostly conducted in developed countries and covered a broad range of issues. Evidence on patient preferences concerning decision-making on screening and diagnostic testing was scarce. Differences in employed terminology, decision-making components and concepts, as well as the sparsity of intervention studies, are challenges for future research into evidence-based decision support seeking to elicit the preferences of older patients with multimorbidity and help them construct preferences., Trial Registration Number: Open Science Framework (OSF): DOI 10.17605/OSF.IO/MCRWQ., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The complexity and heterogeneity of patients with multimorbidity and polypharmacy renders traditional disease-oriented guidelines often inadequate and complicates clinical decision making. To address this challenge, guidelines have been developed on multimorbidity or polypharmacy. To systematically analyse their recommendations, we conducted a systematic guideline review using the Ariadne principles for managing multimorbidity as analytical framework. The information synthesis included a multistep consensus process involving 18 multidisciplinary experts from seven countries. We included eight guidelines (four each on multimorbidity and polypharmacy) and extracted about 250 recommendations. The guideline addressed (i) the identification of the target population (risk factors); (ii) the assessment of interacting conditions and treatments: medical history, clinical and psychosocial assessment including physiological status and frailty, reviews of medication and encounters with healthcare providers highlighting informational continuity; (iii) the need to incorporate patient preferences and goal setting: eliciting preferences and expectations, the process of shared decision making in relation to treatment options and the level of involvement of patients and carers; (iv) individualized management: guiding principles on optimization of treatment benefits over possible harms, treatment communication and the information content of medication/care plans; (v) monitoring and follow-up: strategies in care planning, self-management and medication-related aspects, communication with patients including safety instructions and adherence, coordination of care regarding referral and discharge management, medication appropriateness and safety concerns. The spectrum of clinical and self-management issues varied from guiding principles to specific recommendations and tools providing actionable support. The limited availability of reliable risk prediction models, feasible interventions of proven effectiveness and decision aids, and limited consensus on appropriate outcomes of care highlight major research deficits. An integrated approach to both multimorbidity and polypharmacy should be considered in future guidelines., (© 2018 The Association for the Publication of the Journal of Internal Medicine.)

Flavonoids are recognized to regulate animals' food digestion processes trough interaction with digestive enzymes. The binding capacity of hesperetin (HES), luteolin (LUT), quercetin (QUE), catechin (CAT) and rutin (RUT) with pancreatic α-amylase were evaluated, using UV-Vis spectroscopy, fluorescence and molecular docking. Using p-nitrophenyl-α-d-maltopentoside (pNPG5) as substrate analog, LUT showed the best inhibitory capacity, even better than that of the positive control, acarbose (ACA). A mixed-type inhibition was observed for HES, LUT and QUE, a competitive-type for ACA, while no inhibition was observed with CAT and RUT. In agreement with kinetic results, α-amylase presented a higher affinity for LUT, when analyzed by fluorescence quenching. The binding of flavonoids to amylase followed a static mechanism, where the binding of one flavonoid per enzyme molecule was observed. Docking analysis showed that flavonoids bound near to enzyme active site, while ACA bound in another site behind the catalytic triad. Extrinsic fluorescence analysis, together with docking analysis pointed out that hydrophobic interactions regulated the flavonoid-α-amylase interactions. The present study provides evidence to understand the relationship of flavonoids structure with their inhibition mechanism., (Copyright © 2018 Elsevier B.V. All rights reserved.)