Wide Range Of Patient Populations Research Articles

P-198 Time to maximum blastocyst expansion (tmBE) may represent a novel metric for assessing embryo competence

Abstract Study question Can the time to achieve maximum blastocyst expansion (tmBE) and the frequency of spontaneous collapses serve as useful indicators of embryo competence? Summary answer Compared to the frequency of spontaneous collapses, tmBE was a better indicator of embryo competence, potentially serving as a valuable metric for embryo selection. What is known already Identifying the most viable blastocyst for transfer is essential for success in assisted reproduction. In scenarios with good prognosis, such as oocyte donation, blastocyst selection may require a more nuanced approach, given the high number of available good quality embryos. Exploring indicators of embryo competence beyond traditional morphology-based criteria may be beneficial, however an in-depth understanding is still lacking. Blastocyst expansion and contraction dynamics have been suggested to play a role in developmental and chromosomal fitness. However, their predictive value has not been investigated across a wide range of patient populations. Study design, size, duration This is a single-center retrospective study of 287 blastocysts transferred in autologous (n = 88) and heterologous (n = 199) cycles, performed between September 2019 and September 2022. Only fresh single embryo transfers were considered. We compared blastocysts across two groups: advanced maternal age (AMA) patients (>35 years old, n = 88) and oocyte donors (<35 years old, n = 199). We evaluated well-established indicators of embryo quality, as well as novel metrics, including tmBE and the frequency of spontaneous collapses. Participants/materials, setting, methods Conventional indicators of embryo quality included blastocyst grade and morphokinetic timings (tPNf, t2, t3, t4, t5, t8, tSB and tB). tMBE was defined as the maximum time (hpi) required for the blastocyst to reach its largest diameter, extending beyond tB. Blastocyst contractions were measured as a decrease and subsequent recovery of the blastocoel area over time. ImageJ was employed for size measurements. p<0.05 was considered statistically significant after Two-tailed Student’s t-test or Chi-square test. Main results and the role of chance We observed a significant difference in live birth rates between oocyte donors and AMA patients (40% vs 18%, p=0.0004). Nevertheless, there were no differences across blastocyst expansion scores between oocyte donors and AMA patients (5= 58% vs 65%; 4= 38% vs 30% and 3= 4% vs 5%, p > 0.05), nor in their morphology score (Excellent= 57% vs 61%; Good= 24% vs 18%; Average= 15% vs 16% and Poor= 4% vs 5%). In terms of morphokinetics, when comparing oocyte donor and AMA embryos, the only significant difference was observed at tPNF (22.0±2.4 vs 22.6±2.3; p= 0.04). No differences were found at t2, t3, t4, t5, t8, tSB and tB. Additionally, the frequency of spontaneous collapses showed no significant differences between the oocyte donor and AMA group (1.4±1.2 vs 1.5±1.0, p=0.66). However, blastocysts from oocyte donors reached tmBE significantly faster than AMA embryos (115.0±4.8 vs 117.2±3.4; p = 0.0003). When these variables were further correlated to clinical outcomes, the frequency of spontaneous collapses did not appear to influence live birth in either group. Notably, however, tmBE was significantly shorter for embryos resulting in a live birth, across both the oocyte donor (113.5 vs 115.4, p = 0.04) and AMA group (115.6 vs 117.6, p = 0.04). Limitations, reasons for caution This is a single center retrospective study with a relatively small sample size, especially in the AMA group. Caution should be made when generalizing results to other patient populations, as confounding were not taken into consideration. No data on the chromosomal status of embryos was available. Wider implications of the findings Our results suggest that tMBE may serve as a reliable indicator of embryo potential, allowing a more nuanced embryo selection, particularly in cases with a high number of good quality embryos. This study opens avenues for further research into novel metrics for assessing embryo competence Trial registration number not applicable

Proprotein convertase subtilisin/kexin type 9-inhibition across different patient populations.

Monoclonal antibodies (mAb) targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) have been established in cardiovascular risk prevention. The purpose of this review is to summarize the effects of PCSK9 inhibitors across different patient populations. Long-term data on the use of evolocumab and alirocumab shows persisting low- density lipoprotein cholesterol (LDL-C) lowering and good tolerability. PCSK9 inhibitors are effective and safe in both sexes, in pediatric patients as well as in the elderly. Initiation of PCSK9 mAb during acute myocardial infarction is safe and leads to beneficial morphological plaque changes. The PCSK9 inhibitors evolocumab, alirocumab and inclisiran lower LDL-C in patients with heterozygous familial hypercholesterolemia (FH), while the response of patients with homozygous FH is heterogeneous. New areas of application beyond lipid lowering are currently investigated. PCSK9 inhibitors are safe, well tolerated, and effective in primary and secondary prevention in a wide range of patient populations.

Learning CT-free attenuation-corrected total-body PET images through deep learning.

Total-body PET/CT scanners with long axial fields of view have enabled unprecedented image quality and quantitative accuracy. However, the ionizing radiation from CT is a major issue in PET imaging, which is more evident with reduced radiopharmaceutical doses in total-body PET/CT. Therefore, we attempted to generate CT-free attenuation-corrected (CTF-AC) total-body PET images through deep learning. Based on total-body PET data from 122 subjects (29 females and 93 males), a well-established cycle-consistent generative adversarial network (Cycle-GAN) was employed to generate CTF-AC total-body PET images directly while introducing site structures as prior information. Statistical analyses, including Pearson correlation coefficient (PCC) and t-tests, were utilized for the correlation measurements. The generated CTF-AC total-body PET images closely resembled real AC PET images, showing reduced noise and good contrast in different tissue structures. The obtained peak signal-to-noise ratio and structural similarity index measure values were 36.92 ± 5.49 dB (p < 0.01) and 0.980 ± 0.041 (p < 0.01), respectively. Furthermore, the standardized uptake value (SUV) distribution was consistent with that of real AC PET images. Our approach could directly generate CTF-AC total-body PET images, greatly reducing the radiation risk to patients from redundant anatomical examinations. Moreover, the model was validated based on a multidose-level NAC-AC PET dataset, demonstrating the potential of our method for low-dose PET attenuation correction. In future work, we will attempt to validate the proposed method with total-body PET/CT systems in more clinical practices. The ionizing radiation from CT is a major issue in PET imaging, which is more evident with reduced radiopharmaceutical doses in total-body PET/CT. Our CT-free PET attenuation correction method would be beneficial for a wide range of patient populations, especially for pediatric examinations and patients who need multiple scans or who require long-term follow-up. • CT is the main source of radiation in PET/CT imaging, especially for total-body PET/CT devices, and reduced radiopharmaceutical doses make the radiation burden from CT more obvious. • The CT-free PET attenuation correction method would be beneficial for patients who need multiple scans or long-term follow-up by reducing additional radiation from redundant anatomical examinations. • The proposed method could directly generate CT-free attenuation-corrected (CTF-AC) total-body PET images, which is beneficial for PET/MRI or PET-only devices lacking CT image poses.

The association of disability conditions with access to minimally invasive general surgery

BackgroundDespite the high prevalence of disability conditions in the US, their association with access to minimally invasive surgery (MIS) remains under-characterized. ObjectiveTo understand the association of disability conditions with rates of MIS and describe nationwide temporal trends in MIS in patients with disability conditions. MethodsWe conducted a retrospective cohort study using the Nationwide Readmission Database (2016–2019). We included patients ≥18 years undergoing general surgery procedures. Our primary outcome was the impact of disability conditions on the rate of MIS. We performed 1:1 propensity matching, comparing patients with disability conditions with those without and adjusting for patient, procedure, and hospital characteristics. We performed a subgroup analysis among patients<65 years and with patients with each type of disability. We evaluated temporal trends of MIS in patients with disabilities. We identified predictors of undergoing MIS using mixed effects regression analysis. ResultsIn the propensity-matched comparison, a lower proportion of patients with disabilities had MIS. In the sub-group analyses, the rate of MIS was significantly lower in patients below 65 years with disabilities and among patients with motor and intellectual impairments. There was an increasing trend in the proportion of patients with disabilities undergoing MIS (p < 0.005). The regression analysis confirmed that the presence of a disability was associated with decreased odds of undergoing MIS. ConclusionsThis study characterizes the negative association of disability conditions with access to MIS. As the healthcare landscape evolves, considerations on how to equitably share new treatment modalities with a wide range of patient populations are necessary.

Overview of the Gut Microbiome.

The human gastrointestinal tract is home to trillions of microorganisms-collectively referred to as the gut microbiome-that maintain a symbiotic relationship with their host. This diverse community of microbes grows and changes as we do, with developmental, lifestyle, and environmental factors all shaping microbiome community structure. Increasing evidence suggests this relationship is bidirectional, with the microbiome also influencing host physiological processes. For example, changes in the gut microbiome have been shown to alter neurodevelopment and have lifelong effects on the brain and behavior. Age-related changes in gut microbiome composition have also been linked to inflammatory changes in the brain, perhaps increasing susceptibility to neurological disease. Indeed, associations between gut dysbiosis and many age-related neurological diseases-including Parkinson's disease, Alzheimer's disease, multiple sclerosis, and amyotrophic lateral sclerosis-have been reported. Further, microbiome manipulation in animal models of disease highlights a potential role for the gut microbiome in disease development and progression. Although much remains unknown, these associations open up an exciting new world of therapeutic targets, potentially allowing for improved quality of life for a wide range of patient populations.

Infographics and/or Pictograms and Medication Adherence: A Scoping Review

Introduction: Medication adherence is the act of following medication instructions from a health care provider. Infographics and pictograms are visual science communication tools that have been shown to improve medication adherence. Objective: To synthesize and critically evaluate literature surrounding the use of infographics and pictograms in medication adherence. Methods: We conducted a literature search on PubMed, Ovid MEDLINE, CINAHL, Web of Science, and PsycInfo with the purpose of identifying literature published between the years 2000 and 2022. Primary research articles were included for quantitative analysis if they explored/reported the following topics and/or outcomes: (a) infographics and/or pictograms as the exposure of interest and (b) adherence, comprehension, or health outcomes as the outcome measures. Results: 30 studies were included in the results. Outcome measures assessed included (a) comprehension and understanding of factors surrounding medication adherence, (b) medication adherence, and (c) health outcomes. Our review of the studies showed that 87.5% of studies measuring outcome (a), 78.2% of those measuring outcome (b), and 100% of those measuring outcome (c) found improvements when using infographics or pictograms. Conclusion: Our review supports the use of infographics and pictograms as a means of improving medication adherence among a diverse set of demographics, illnesses, and treatments. Practice Implications: Infographics and pictograms are useful tools to improve medication adherence. When these tools are designed carefully, they increase the accessibility of medication information in a wide range of patient populations.

Bilateral vs. Paretic-Limb-Only Ankle Exoskeleton Assistance for Improving Hemiparetic Gait: A Case Series.

People with lower-limb hemiparesis have impaired function on one side of the body that affects their walking ability. Wearable robotic assistance has been investigated to treat hemiparetic gait by applying assistance to the paretic limb. In this exploratory case series, we sought to compare the effects of bilateral vs. paretic-limb-only ankle exoskeleton assistance on walking performance in a case series of three heterogeneous presentations of lower-limb hemiparesis. A secondary goal was to validate the use of a real-time ankle-moment-adaptive exoskeleton control system for effectively assisting hemiparetic gait; the ankle moment controller accuracy ranged from 72 - 90% across all conditions and participants. Compared to walking without the device, both paretic-limb-only and bilateral assistance resulted in greater average total ankle power (up to 72%), improved treadmill walking efficiency (up to 28%), and increased over-ground walking distance (up to 41%). All participants achieved a more symmetrical, efficient gait pattern with bilateral assistance, indicating that assisting both limbs may be more beneficial than assisting only the paretic side in people with hemiparetic gait. The results of this case series are intended to inform future clinical studies and exoskeleton designs in a wide range of patient populations.

Copyright as a Barrier to Music Therapy Telehealth Interventions: Qualitative Interview Study.

BackgroundMusic therapy is a multifaceted discipline that harnesses the power of music to treat a wide range of patient populations. A therapist who plays music in a private room for a patient is not subject to copyright restrictions on public performances. However, in the wake of the COVID-19 pandemic, music therapy is no longer strictly confined to the face-to-face setting. This study explores music therapists’ perceptions of copyright law with respect to their ability to provide mediated services to their clients.ObjectiveThe objectives of our study were two-fold. The first was to investigate whether concerns about copyright law are hampering the diffusion of telehealth innovations, and the second was whether these concerns are causing music therapists to avoid therapeutically beneficial telehealth interventions.MethodsSemistructured interviews were conducted with credentialed music therapists (n=18) in the United States between May 2020 and June 2020. With participants’ consent, we used video conference technology to record and transcribe the in-depth interviews. The median interview length was 45 (SD 16.37) minutes. This theoretically informed study employed thematic analysis of the interview data.ResultsThe COVID-19 pandemic accelerated the adoption of telehealth interventions to facilitate therapy outside of private face-to-face environments: environments where music therapy practices are largely shielded from copyright infringement concerns. Five main themes emerged, including therapists’ uncertainty about permissible uses of music and therapists’ erring on the side of caution causing lost opportunities for care. Our interview data suggest music therapists have altered telehealth interventions in suboptimal ways to avoid copyright liability in a physically distanced environment.ConclusionsSome music therapists “drag their feet” on offering therapeutically appropriate telehealth services to clients because of copyright concerns. Our findings suggest innovative mediated therapies were shied away from or abandoned. These findings offer a novel contribution to the public health literature by highlighting copyright law as an unexpected and unwelcome barrier to the diffusion of music therapy practices in technology-mediated settings.

A Critical Analysis of Funding Models: Sustainability of the Nurse Practitioner Role in Canada

Numerous barriers inhibit the integration of full role components of nurse practitioners (NPs) in Canada. Although the number of NPs in Canada has increased substantially over the past decade, the contributions made by NPs to patient care and the health system are undervalued and insufficiently recognized. A critical analysis of the current state of Canadian NP funding models utilizing the Sustainability of Innovation Framework was conducted. Our analysis suggest that Canadian NP funding models need to be flexible, modern, affordable, responsive to the needs of a wide range of patient populations and support the work of health care leaders, funders, and policymakers in sustaining NP practice models across the nation.

Telemental Health Care: A Review of Efficacy and Interventions

Objective: Mental illness continues to rise in the United States, burdening a healthcare system set to dive further into a shortage of mental health practitioners. The effects of this are already being felt in many rural areas, which are all too frequently understaffed to address the mental health concerns of their populations. To further compound this growing crisis, COVID-19 has led to a reduction in access to in-person care. Furthermore, COVID-19 has led to reduced access to in-person care. As a result, Telehealth has become more essential. Knowledge of the strategies and barriers to implement a successful Telehealth program is necessary to deliver a sustainable, accessible, and quality care. Design: In this review, we analyze published research on the efficacy of Telehealth for mental health, discuss how these services have been implemented, and explore how to address barriers to quality care delivery via Telehealth. Results: Telehealth, when the appropriate resources and supports are considered, is effective in a wide range of patient populations and care locations. Multiple modalities, including via video, apps, and telephone were shown to be efficacious. Interventions have been shown to increase the accessibility to care without compromising quality of care. Conclusions: Telehealth constitutes a well-researched, efficacious tool to address the issues in access to care. Telemental health programs should address the barriers to implementation, including training, access to technology, reimbursement and regulations, and adequate program oversight. Telehealth interventions should be strongly considered in areas facing shortages of mental health practitioners and long wait times for patients with mental health disorders, to reduce the burden of mental illness on healthcare.

Multi-Biomarker Prediction Models for Multiple Infection Episodes Following Blunt Trauma.

SummarySevere trauma predisposes patients to multiple independent infection episodes (MIIEs), leading to augmented morbidity and mortality. We developed a method to identify increased MIIE risk before clinical signs appear, which is fundamentally different from existing approaches entailing infections' detection after their establishment. Applying machine learning algorithms to genome-wide transcriptome data from 128 adult blunt trauma patients' (42 MIIE cases and 85 non-cases) leukocytes collected ≤48 hr of injury and ≥3 days before any infection, we constructed a 15-transcript and a 26-transcript multi-biomarker panel model with the least absolute shrinkage and selection operator (LASSO) and Elastic Net, respectively, which accurately predicted MIIE (Area Under Receiver Operating Characteristics Curve [AUROC] [95% confidence intervals, CI]: 0.90 [0.84–0.96] and 0.92 [0.86–0.96]) and significantly outperformed clinical models. Gene Ontology and network analyses found various pathways to be relevant. External validation found our model to be generalizable. Our unique precision medicine approach can be applied to a wide range of patient populations and outcomes.

Virtual reality hand therapy: A new tool for nonopioid analgesia for acute procedural pain, hand rehabilitation, and VR embodiment therapy for phantom limb pain

IntroductionAffordable virtual reality (VR) technology is now widely available. Billions of dollars are currently being invested into improving and mass producing VR and augmented reality products. Purpose of the StudyThe purpose of the present study is to explore the potential of immersive VR to make physical therapy/occupational therapy less painful, more fun, and to help motivate patients to cooperate with their hand therapist. DiscussionThe following topics are covered: a) psychological influences on pain perception, b) the logic of how VR analgesia works, c) evidence for reduction of acute procedural pain during hand therapy, d) recent major advances in VR technology, and e) future directions—immersive VR embodiment therapy for phantom limb (chronic) pain. ConclusionVR hand therapy has potential for a wide range of patient populations needing hand therapy, including acute pain and potentially chronic pain patients. Being in VR helps reduce the patients’ pain, making it less painful for patients to move their hand/fingers during hand therapy, and gamified VR can help motivate the patient to perform therapeutic hand exercises, and make hand therapy more fun. In addition, VR camera–based hand tracking technology may be used to help therapists monitor how well patients are doing their hand therapy exercises, and to quantify whether adherence to treatment increases long-term functionality. Additional research and development into using VR as a tool for hand therapist is recommended for both acute pain and persistent pain patient populations.

Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators

BackgroundUnderstanding why people take part in health research is critical to improve research efficiency and generalisability. The aim of this overview of systematic reviews was to identify psychosocial determinants of research participation and map them to psychological theory and empirical recruitment research, to identify effective strategies to increase research participation.MethodsQualitative and quantitative systematic reviews were systematically identified. No date or language limits were applied. Two reviewers independently selected reviews. Methodological quality was rated using AMSTAR, and poor-quality reviews (scoring 0–3) were excluded. Barriers and facilitators were coded to psychological theory (Theoretical Domains Framework) and empirical recruitment research (recruitment interventions that had been subjected to randomised controlled trial evaluation).ResultsWe included 26 systematic reviews (429 unique primary studies), covering a wide range of patient populations and health settings. We identified five groups of facilitators, of which three were dominant (potential for personal benefit, altruism, trust) and appear to be relevant across research setting and design. We identified nine groups of barriers, which were more dependent on the particular study (context, population, design). Two determinants (participant information, social influences) were found to be both barriers and facilitators. Barriers and facilitators could be coded to the Motivation and Opportunity components of the Theoretical Domains Framework; only one was coded to a Capability component. There was some overlap between psychosocial determinants and empirical recruitment research, but some barriers and facilitators had not been tested at all.ConclusionsIdentifying effective recruitment strategies could increase the efficiency and generalisability of primary research. We identified a number of barriers and facilitators that could be addressed by researchers. There is a need for more research to identify effective recruitment strategies that draw on the psychosocial facilitators and barriers identified in this overview.

Mindfulness Based Therapies for Autoimmune Diseases and Related Symptoms

Systemic lupus erythematosus (SLE) is an autoimmune disease that is characterized by symptoms including chronic fatigue, joint pain, swelling, skin rashes, pain, and anemia. Symptoms can flare or be in remission unpredictably, often affect multiple organ systems, and can be life-threatening. SLE is more prevalent in females and persons of color, but is not a widely prevalent disease. Perhaps because of this fact, there have been minimal advances in effective new behavioral or psychotherapeutic interventions for people living with SLE in the past two decades. Contextual psychotherapies, such as Mindfulness Based Stress Reduction, have demonstrated effectiveness in a wide range of patient populations, including patients with cancer and those suffering from autoimmune disorders. There have also been preliminary positive findings in patients with SLE. In this manuscript, we review current literature regarding the use and efficacy of contemplative based interventions for patients living with SLE and discuss how such information could inform an intervention to positively impact psychological symptoms, physiological symptoms, and disease markers in patients with SLE. We propose the need for future research and suggest areas of specific research development and implementation.

Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes.

Continuous Glucose Monitoring (CGM) has been demonstrated to be clinically valuable, reducing risks of hypoglycemia and hyperglycemia, glycemic variability (GV), and improving patient quality of life for a wide range of patient populations and clinical indications. Use of CGM can help reduce HbA1c and mean glucose. One CGM device, with accuracy (%MARD) of approximately 10%, has recently been approved for self-adjustment of insulin dosages (nonadjuvant use) and approved for reimbursement for therapeutic use in the United States. CGM had previously been used off-label for that purpose. CGM has been demonstrated to be clinically useful in both type 1 and type 2 diabetes for patients receiving a wide variety of treatment regimens. CGM is beneficial for people using either multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). CGM is used both in retrospective (professional, masked) and real-time (personal, unmasked) modes: both approaches can be beneficial. When CGM is used to suspend insulin infusion when hypoglycemia is detected until glucose returns to a safe level (low-glucose suspend), there are benefits beyond sensor-augmented pump (SAP), with greater reduction in the risk of hypoglycemia. Predictive low-glucose suspend provides greater benefits in this regard. Closed-loop control with insulin provides further improvement in quality of glycemic control. A hybrid closed-loop system has recently been approved by the U.S. FDA. Closed-loop control using both insulin and glucagon can reduce risk of hypoglycemia even more. CGM facilitates rigorous evaluation of new forms of therapy, characterizing pharmacodynamics, assessing frequency and severity of hypo- and hyperglycemia, and characterizing several aspects of GV.

Paritaprevir/ritonavir-ombitasvir and dasabuvir, the 3D regimen for the treatment of chronic hepatitis C virus infection: a concise review

The treatment for chronic hepatitis C has been revolutionized with the development of direct-acting antiviral agents. Several regimens have been approved and are currently used in clinical practice, treating a wide range of patient populations infected with hepatitis C. The interferon-free combination of paritaprevir/ritonavir-ombitasvir and dasabuvir (PrOD or the three-drug [3D] regimen) with or without ribavirin is indicated for the treatment of chronic hepatitis C in both treatment-naïve and experienced patients infected with genotype 1, including those coinfected with HIV and patients post-liver transplantation. More recently, paritaprevir/ritonavir-ombitasvir (PrO, or 2D regimen) has been approved in hepatitis C virus patients infected with genotype 4. This review will summarize pharmacokinetic and clinical efficacy data for the 3D regimen in an attempt to help the clinicians delineate its place in the ever-increasing direct-acting antiviral armamentarium for the treatment of chronic hepatitis C.

Utilization of a mental health collaborative care model among patients who require interpreter services.

BackgroundImmigrants and refugees to the United States have a higher prevalence of depression compared to the general population and are less likely to receive adequate mental health services and treatment. Those with limited English proficiency (LEP) are at an even higher risk of inadequate mental health care. Collaborative care management (CCM) models for depression are effective in achieving treatment goals among a wide range of patient populations, including patients with LEP. The purpose of this study was to assess the utilization of a statewide initiative that uses CCM for depression management, among patients with LEP in a large primary care practice.MethodsThis was a retrospective cohort study of patients with depression in a large primary care practice in Minnesota. Patients who met criteria for enrollment into the CCM [with a provider-generated diagnosis of depression or dysthymia in the electronic medical records, and a Patient Health Questionnaire-9 (PHQ-9) score ≥10]. Patient-identified need for interpreter services was used as a proxy for LEP. Rates of enrollment into the DIAMOND (Depression Improvement Across Minnesota, Offering A New Direction) program, a statewide initiative that uses CCM for depression management were measured. These rates were compared between eligible patients who require interpreter services versus patients who do not.ResultsOf the 7561 patients who met criteria for enrollment into the DIAMOND program during the study interval, 3511 were enrolled. Only 18.2 % of the eligible patients with LEP were enrolled into DIAMOND compared with the 47.2 % of the eligible English proficient patients. This finding persisted after adjustment for differences in age, gender and depression severity scores (adjusted OR [95 % confidence interval] = 0.43 [0.23, 0.81]).ConclusionsWithin primary care practices, tailored interventions are needed, including those that address cultural competence and language navigation, to improve the utilization of this effective model among patients with LEP.

Measurement Properties of the Lower Extremity Functional Scale: A Systematic Review.

Systematic review of measurement properties. Many primary studies have examined the measurement properties, such as reliability, validity, and sensitivity to change, of the Lower Extremity Functional Scale (LEFS) in different clinical populations. A systematic review summarizing these properties for the LEFS may provide an important resource. To locate and synthesize evidence on the measurement properties of the LEFS and to discuss the clinical implications of the evidence. A literature search was conducted in 4 databases (PubMed, MEDLINE, Embase, and CINAHL), using predefined search terms. Two reviewers performed a critical appraisal of the included studies using a standardized assessment form. A total of 27 studies were included in the review, of which 18 achieved a very good to excellent methodological quality level. The LEFS scores demonstrated excellent test-retest reliability (intraclass correlation coefficients ranging between 0.85 and 0.99) and demonstrated the expected relationships with measures assessing similar constructs (Pearson correlation coefficient values of greater than 0.7). The responsiveness of the LEFS scores was excellent, as suggested by consistently high effect sizes (greater than 0.8) in patients with different lower extremity conditions. Minimal detectable change at the 90% confidence level (MDC90) for the LEFS scores varied between 8.1 and 15.3 across different reassessment intervals in a wide range of patient populations. The pooled estimate of the MDC90 was 6 points and the minimal clinically important difference was 9 points in patients with lower extremity musculoskeletal conditions, which are indicative of true change and clinically meaningful change, respectively. The results of this review support the reliability, validity, and responsiveness of the LEFS scores for assessing functional impairment in a wide array of patient groups with lower extremity musculoskeletal conditions.

Academic health centers and the growth of integrative medicine.

As evidenced by this issue of JNCI Monographs, integrative medicine is rapidly gaining ground as part of the practice of oncology in the United States. The Consortium of Academic Health Centers for Integrative Medicine—an organization comprised of 57 academic health centers and health systems in North America—defines inte grative medicine as follows: Integrative Medicine is the practice of medicine that reaffirms the importance of the relationship between practitioner and patient, focuses on the whole person, is informed by evidence, and makes use of all appropriate therapeutic approaches, healthcare professionals and disciplines to achieve optimal health and healing. As this definition implies, although an openness to using therapies such as acupuncture or massage is a component of the integrative approach, integrative medicine goes far beyond simply combining the therapies previously described as “complementary/alternative medicine” with conventional care. It describes a change in philosophy, which expands our role beyond that of treating disease to reaffirm the commitment to treating the whole person. Almost more than anywhere else in medicine, the practice of oncology and the work of caring for a patient with cancer and their family clearly call for this approach and for a commitment to whole-person care. Lifestyle counseling, behavioral medicine interventions, and spiritual support all play critical roles in this integrative approach, alongside the use of other therapeutic strategies rooted in a rigorous evidence-based approach to the best conventional care. This is integrative medicine for cancer. The mission of the Consortium of Academic Health Centers for Integrative Medicine (the Consortium) is to advance the principles and practices of integrative health care within academic institutions. Having grown significantly since its founding in 2002 with only 13 member institutions, the Consortium’s mission is accomplished through supporting and mentoring academic leaders, faculty, and students to advance integrative health-care curricula, research, and clinical care; disseminating information on rigorous scientific research, educational curricula in integrative health, and sustainable models of clinical care; and working to inform health-care policy. This issue is a perfect example of how the Consortium’s support for collaboration between researchers and institutions is critical in the emergence of this new field and in the effort to make healthcare practitioners aware of its potential for our patients. The idea emerged from our Research Working Group, chaired at the time by Dr Jun Mao, coeditor of this supplement. Dr Mao felt strongly that we had reached a critical mass of high-quality research on the role of integrative medicine in cancer survivorship and that there was a pressing need to provide an outlet to make this new knowledge available to the larger worlds of oncology and medicine. With support from his colleagues on the Research Working Group and with funding from their six member institutions, the Consortium at large, and the Society for Integrative Oncology, Dr Mao and Dr Cohen were successful in making this idea a reality. None of this would have been possible without the environment of supportive collaboration, which is the foundation of our organization. As we know, living through the treatment of a cancer and surviving in its aftermath pose daunting challenges for many of our patients. The recent advances in the treatment of many cancers notwithstanding, the impact on patients’ quality of life of both the treatment process and the fear of recurrence is staggering. This is an area where integrative medicine can play a very important role in cancer care. In this issue, authors present their findings on a wide variety of integrative approaches to different dimensions of this survivor experience, including the potential impact of mind–body therapies such as meditation and tai chi in addressing the common problems of insomnia and anxiety; the role of diet change and exercise in survivorship; and the impact of patients’ expectations and preferences on the effectiveness of integrative approaches to managing symptoms. The articles also demonstrate the wide range of patient populations and clinical settings in which integrative

The use of statins in people at risk of developing diabetes mellitus: Evidence and guidance for clinical practice

Reducing low-density lipoprotein cholesterol (LDL-C) levels using statins is associated with significant reductions in cardiovascular (CV) events in a wide range of patient populations. Although statins are generally considered to be safe, recent studies suggest they are associated with an increased risk of developing Type 2 diabetes (T2D). This led the US Food and Drug Administration (FDA) to change their labelling requirements for statins to include a warning about the possibility of increased blood sugar and HbA1c levels and the European Medicines Agency (EMA) to issue guidance on a small increased risk of T2D with the statin class. This review examines the evidence leading to these claims and provides practical guidance for primary care physicians on the use of statins in people with or at risk of developing T2D. Overall, evidence suggests that the benefits of statins for the reduction of CV risk far outweigh the risk of developing T2D, especially in individuals with higher CV risk. To reduce the risk of developing T2D, physicians should assess all patients for T2D risk prior to starting statin therapy, educate patients about their risks, and encourage risk-reduction through lifestyle changes. Whether some statins are more diabetogenic than others requires further study. Statin-treated patients at high risk of developing T2D should regularly be monitored for changes in blood glucose or HbA1c levels, and the risk of conversion from pre-diabetes to T2D should be reduced by intensifying lifestyle changes. Should a patient develop T2D during statin treatment, physicians should continue with statin therapy and manage T2D in accordance with relevant national guidelines.