The complex interplay between clinical and

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. It is often stated that type 1 diabetes results from a complex interplay between varying degrees of genetic susceptibility and environmental factors.

Studies examining the microecology of the gastrointestinal tract have identified specific microorganisms whose presence appears related either quantitatively or qualitatively to disease; in type 1 diabetes, a role for microflora in the pathogenesis of disease has recently been suggested. Increased intestinal permeability has also been observed in animal models of type 1 diabetes as well as in humans with or at increased-risk for the disease.

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Finally, an altered mucosal immune system has been associated with the disease and is likely a major contributor to the failure to form tolerance, resulting in the autoimmunity that underlies type 1 diabetes. Herein, we discuss the complex interplay between these factors and raise testable hypotheses that form a fertile area for future investigations as to the role of the gut in the pathogenesis and prevention of type 1 diabetes.

In addition to comprising the largest surface area of the body, the intestinal mucosa is constantly exposed to a vast array of microbes, food antigens, and toxins. The intestinal epithelium must discriminate between pathogenic and nonpathogenic organisms as well as food antigens. It is becoming increasingly clear that the nexus of intestinal microbiota composition, the intestinal barrier, and the mucosal immune system plays pivotal roles in the development of a variety of allergic and autoimmune diseases.

If these facets do indeed form important components for the pathogenesis of type 1 diabetes, they also offer potential targets for intervention that would include maintenance of a nondiabetogenic microbiota, tightening of interepithelial junctions, as well as prevention of propagation of inflammation and autoimmunity by nutritional or pharmacologic means. In the following sections, we will review each aspect for its physiological function and provide evidence as to how it may form pathogenic significance in type 1 diabetes.

the complex interplay between clinical and

Intestinal alterations reported in patients with type 1 diabetes or in individuals at risk of type 1 diabetes. The presence of a commensal intestinal microbiota in infancy is critical for numerous physiologic processes including growth, angiogenesis, optimization of nutrition, and stimulation of various arms of the innate and adaptive immune systems 1 — 4.

With this, it is surprising that the effects of intestinal microbiota on the development of type 1 diabetes remain an area subject to somewhat limited investigation. What does seem clear is that rodent models of type 1 diabetes, including NOD mice and related substrains, are more likely to develop disease under specific pathogen-free conditions 56. In terms of using such information to proactively modulate diabetes formation, the provision of antibiotics, such as fucidic acid, Colistin, and Bactrim, in BB rats after weaning 89 lead to diabetes prevention, whereas in our own efforts using the NOD mouse, a decreased frequency of type 1 diabetes was observed with the administration of doxycycline The specific mechanisms of how such therapies modulate disease are unclear, but it is clear that changes in the microbiota affect the development of autoimmune diabetes in both animal models.

Supporting this view, oral probiotic administration to NOD mice was noted to induce interleukin IL i. Interest exists on intestinal microbiota composition, a metric that has previously relied almost exclusively on the quantitative cultures from feces. At this time, we are not aware of any published studies that have demonstrated differences in intestinal microbiota of animals or humans with or at high-risk for the development of type 1 diabetes.

Furthermore, most microbial species in the intestinal microbiota are not amenable to culture. With the knowledge that environment influences the development of type 1 diabetes and that the gastrointestinal tract provides the greatest surface area for interaction of the environment, this is an area that begs further investigation.

Over species of microbes are known to reside in the human gastrointestinal tract 12.

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Their interaction with the mucosal immune system, especially in the first years of life, may have life-long effects. As but one example, differences in the composition of intestinal microflora between healthy and allergic infants in countries with a high and low prevalence of allergies have been noted and precede clinical symptoms Furthermore, probiotics have been successfully used as immunomodulators in the prevention and treatment of allergies in children 1314findings indicating that commensal bacteria are not innocent bystanders in humans but active players in the shaping of the immunological network of the host.

Hence, new approaches for evaluating the interactions between the intestinal microbiota and barrier and innate immunity are needed. Among the most promising molecular techniques that have recently been developed to fill this void are those that enable detection of uncultivatable species and that are amenable to statistical microecologic analyses. Some of these methods target 16Ss RNA gene sequences, as they contain signatures of phylogenetic groups and sometimes even species Other techniques apply PCR with denaturing or temperature gradient gel electrophoresis, fluorescent in situ hybridization and shotgun sequencing DNA 16and whole metagenomic approaches These techniques offer promise for future efforts seeking to establish a causal link between the intestinal microbiota and type 1 diabetes, as well as to the identification of aberrant microbiota that could be targeted for disease prevention strategies.

The intestinal surface barrier is one of the most important components of the innate immune system, separating highly immunogenic agents in the intestinal lumen from a highly immunoreactive submucosa. Before aberrant microbes or other antigens can affect the highly immunoreactive submucosa, they must transduce signals mediated by intestinal epithelial toll-like or similar receptors, traverse the intestinal epithelial barrier by either the transcellular or interepithelial paracellar route, or influence other cells possessing the capacity to traverse this barrier e.

Before describing how this system may relate to type 1 diabetes, we will review a few key components of the system Fig. There are numerous cell types in the small intestine that play a role in barrier function, including the following. Intestinal epithelial cells IECs comprise the lining epithelium of the primitive intestine.Critically ill patients are prescribed sedatives and analgesics to decrease pain and anxiety, improve patient — ventilator dyssynchrony and ensure patient safety.

These medications may themselves lead to delirium and ICU-acquired weakness, which are associated with worse clinical outcomes. This review will focus on the epidemiology of these two disease processes and discuss strategies aimed at reducing these devastating complications of critical illness. Delirium and ICU-acquired weakness are associated with longer hospital stay, increased cost and decreased quality of life after discharge from the ICU. Delirium has also shown to be associated with increased mortality.

Strategies aimed at reducing sedative exposure through protocols and coordination of daily sedation and ventilator cessation trials, avoiding benzodiazepines in favor of alternative sedative regimens and early mobilization of patients have all shown to significantly improve patient outcomes.

the complex interplay between clinical and

Delirium and ICU-acquired weakness are complications of critical illness associated with worse clinical outcomes and functional decline in survivors. An evidence-based approach based on the following tenets; minimization of sedative medication, particularly benzodiazepines, delirium monitoring and management and early mobilization may mitigate these complications.

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Pain, anxiety and delirium are common occurrences in an Intensive Care Unit ICU secondary to existing diseases, surgical procedures, trauma, invasive monitors, endotracheal intubation, and nursing interventions 1 — 3. Inadequately treated pain may lead to increased stress response, with resultant tachycardia, increased oxygen consumption, hypercoagulability, immunosuppression, hypermetabolism, and increased endogenous catecholamine activity 4 — 7.

Insufficient pain relief can also contribute to deficient sleep, disorientation, anxiety, and long-term effects such as post-traumatic stress disorder 8. Analgesia and sedation is therefore used in the ICU to provide comfort and ensure patient safety, especially in those who are mechanically ventilated. Although analgesia and sometimes sedation is necessary in an ICU, when over used without goals and targets, they predispose patients to untoward complications of increased time on mechanical ventilation, longer times in the ICU, more radiological testing for altered mental status, ICU-Acquired Weakness and greater likelihood of delirium 9 This state of the art review will focus on: delirium, representing an acute or newly acquired cognitive dysfunction, and ICU-Acquired Weakness, an ICU associated physical disability, as two areas for intervention, to improve functional outcomes in our critically ill patients.

the complex interplay between clinical and

A detailed description of the epidemiology of delirium in trauma patients with emphasis on its relationship with analgesic and sedative medications will be provided, followed by brief overview of ICU-Acquired Weakness. Finally we will provide an evidence based approach to assist the readers in incorporating best analgesia, sedation and delirium practices, including early ambulation, to improve outcomes in their critically ill patients.

Delirium is a manifestation of acute brain dysfunction, characterized by an acute disturbance of consciousness accompanied by inattention, disorganized thinking, and perceptual disturbances that fluctuates over a short period of time Delirium can be categorized into subtypes according to psychomotor behavior manifested by patients.

Hypoactive delirium patients are characterized by decreased physical and mental activity lethargy and inattention, is frequently overlooked by both physicians and nursing staff and may have higher mortality and morbidity 20 On the other extreme are hyperactive delirium patients who are agitated and combative.

the complex interplay between clinical and

Patients exhibiting both characteristics have mixed delirium. Angels et. Historically, delirium was considered an inconsequential occurrence during critical illness.Log in to view full text.

If you're not a subscriber, you can:. Colleague's E-mail is Invalid. Your message has been successfully sent to your colleague. Save my selection. Reprints: Juan M. This study aimed to analyze the associations among depressive and anxiety and pain symptoms in patients diagnosed with chronic pain.

Four hundred fifty-four inpatients who were consecutively admitted in a multimodal 3-week treatment in a tertiary, psychosomatic university clinic completed 25 items from the Brief Pain Inventory and the Hospital Anxiety and Depression Scale at baseline and after treatment termination.

Associations among symptoms were explored by network analyses using the graphical least absolute shrinkage and selection operator to estimate their partial correlations, whereas Extended Bayesian Information Criterion was used to select the best network solution for the data. Besides expected associations within depressive and anxiety and pain symptoms, the estimated network showed several local associations between depressive and pain interference symptoms.

The lacks of being cheerful and of laughing are 2 of the depressive symptoms that showed the greatest associations with pain interference and a strong centrality within the network. Sleep problems were associated with both anxiety and depressive symptoms and pain intensity symptoms. Although at posttreatment most of the symptoms showed a significant decrease, the strength of the associations between the symptoms within the network was significantly higher than at baseline.

The results support focusing psychosocial interventions in chronic pain treatment not only on reducing pain, anxietyand sleep symptoms but also on enhancing positive affect. Future research is needed to replicate these findings using repeated within-person measures designs.

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In the latter case, please turn on Javascript support in your web browser and reload this page. Free to read. Psychotherapy is a Western method of treating mental illness. Culturally adapting psychotherapy to better meet the needs of ethnic minorities is an important endeavor. Hall et al. They also point out that some therapies can be naturally syntonic with Asian American cultural values and belief systems.

This is especially important given cultural differences between the East and West. Below, I provide an overview of the complexities involved in adapting treatments for diverse clients. I also discuss the importance of deconstructing stereotypes and understanding the complex interplay between clinical and cultural issues.

Individualization of treatment for diverse clients can be achieved through culturally formed practice. The importance of culturally modifying and adapting psychotherapy to meet the needs of ethnic minorities is an important new "hot topic. It is known that ethnic minorities are less likely to receive quality health and mental health services, and that overall they evidence worse treatment outcomes than European Americans IOM, ; USDHHS, Although there is debate about whether an "as is" approach to implementing evidence-based treatments EBTs is sufficient in treating ethnic minorities, it would be difficult to argue that culturally modifying and individualizing treatments for minority clients would not improve therapeutic outcomes.

This cultural adaptation and individualization of treatments already occurs for Europeans and European Americans, which therapy was designed for. Specifically, the paradigm of psychotherapy was developed in the West, and psychotherapy is heavily laden with Western cultural values and beliefs.

The real question is whether targeted cultural adaptations can further improve treatment outcomes, increase client engagement, and reduce premature treatment failure.

Many clinical scholars who focus on reducing international and domestic mental health disparities believe that this is an important endeavor. Clinical researchers have already begun culturally adapting Western psychotherapy to better meet the needs of diverse communities.

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In addition, there is also some evidence that culturally adapted treatments, and even simplistic cultural adaptations to mental health interventions, such as language and ethnic match, can benefit minority clients see meta-analysis by Griner and Smith, Resnicow discusses two types of cultural sensitivity that can help improve treatment for ethnic minorities.

In contrast, deep structure involves incorporating the ideas, beliefs, and values into the treatment. Although there has been a lot of research conducted on surface structure adaptations e. Few comprehensive frameworks for implementing deep structure adaptations, which require more intensive changing greater thoughtfulness, are available. Bernal, Bonilla, and Bellido came up with one of the first frameworks, focusing on 8 different dimensions including language, persons, metaphors, content, file concepts, goals, methods, and context when adapting therapy for culturally diverse clientele.

Hwang ; developed two integrative frameworks for adapting therapy. The FMAP approach consists of five phases: a generating knowledge and collaborating with stakeholders b integrating generated information with theory and empirical and clinical knowledge, c reviewing the initial culturally adapted clinical intervention with stakeholders and revising the culturally adapted intervention, d testing the culturally adapted intervention, and e finalizing the culturally adapted intervention.

The domains include: a dynamic issues and cultural complexities, b orienting clients to psychotherapy and increasing mental health awareness, c understanding cultural beliefs about mental illness, its causes, and what constitutes appropriate treatment, d improving the client-therapist relationship, e understanding cultural differences in the expression and communication of distress, and f addressing cultural issues specific to the population.

Although many randomized controlled trials RCTs testing different types of therapy have been conducted with European Americans, no well conducted RCTs testing different types of therapies have been done with ethnic minority groups. Treatments that are more culturally syntonic are likely to be more culturally acceptable, improve outcomes, increase adherence, and decrease treatment failure. It is quite possible that some treatments are more evidence-based for some populations than others.Metrics details.

New approaches to cope with clinical and psychosocial aspects of type 2 diabetes T2DM are needed; gender influences the complex interplay between clinical and non-clinical factors. Clinical quality of care indicators relative to control of HbA1c, lipid profile, blood pressure, and BMI were derived from electronic medical records.

Overall, 26 diabetes clinics enrolled 2, people men: Women had statistically significant poorer scores for physical functioning, psychological well-being, self-care activities dedicated to physical activities, empowerment, diabetes-related distress, satisfaction with treatment, barriers to medication taking, satisfaction with access to chronic care and healthcare communication, and perceived social support than men; In T2DM, women show poorer clinical and person-centered outcomes indicators than men.

Diabetes-related distress plays a role as a correlate of metabolic control in women but not in men. The study provides new information about the interplay between clinical and person-centered indicators in men and women which may guide further improvements in diabetes education and support programs. The considerable pressure on health care systems to provide high-quality care while controlling costs has led several public and private health care organizations to promote initiatives to measure and improve the quality of care for people with diabetes [ 12 ].

In Italy, the Associazione Medici Diabetologi AMD scientific society has implemented since a continuous improvement effort involving a large network of diabetes clinics throughout the country AMD-Annals [ 3 ]. The periodic dissemination of Annals has been effective in improving several process and intermediate outcome indicators clinical indicators over a few years [ 4 ].

The model has also been proven to be cost-effective [ 5 ]. Data from AMD-Annals have been recently used to evaluate gender differences in pharmacological and non-pharmacological treatment of diabetes [ 6 ]. These findings suggested that a complex interplay among biological, clinical and behavioral differences can underlie these differences and call for diversifying the care and specializing the support provided to men and women.

In parallel, the increasing recognition of patient-centered care as the best model to ensure a care respectful of, and responsive to patient preferences, needs, and values [ 7 ] call for the need to include psychosocial aspects in the quality model of diabetes care, as clearly emphasized by the international Diabetes Attitudes, Wishes, and Needs DAWN-2 Program [ 8 ].

The DAWN-2 study well documented that people with diabetes have major psychosocial issues; in particular, Due to this body of evidence, individualized interventions based on patient needs, concerns, and capabilities have been promoted while taking gender into account.

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The first important step of the BENCH- study was to describe the person-centered indicators in type 2 population and to explore the relationship among different quality of care and quality of life dimensions. As described in two previous papers [ 1213 ], BENCH-D documented that: high levels of diabetes distress are common among people with type 2 diabetes T2DMaffecting almost two-thirds of patients; high diabetes distress is associated with worse clinical and psychosocial outcomes; higher empowerment is on the other hand associated with better glycemic control, psychosocial functioning and perceived access to person-centered chronic illness care.

In the present secondary analysis of the BENCH-D data, database has been used to assess gender-differences in T2DM in terms of diabetes-related distress, physical and psychological well-being, empowerment, perceived social support and other measures of satisfaction with treatment and care.

We wanted to test the hypothesis that systematic differences exist in the two genders in the interplay between clinical and person-centered indicators, especially on the likelihood on poor metabolic control i. A deeper comprehension of these differences may inform individualized, gender-specific educational approaches. A detailed description of the BENCH-D study protocol and of the questionnaires utilized as person-centered indicators was published elsewhere [ 11 ].

Following the AMD-Annals methodology [ 3 — 6 ], clinical data were extracted from electronic databases of diabetes clinics, including information on body mass index BMIdiabetes duration, HbA1c, blood pressure and lipid profile values, glucose-lowering, antihypertensive and lipid-lowering treatments, diabetic complications i. AMD-Annals intermediate outcome measures were evaluated on the BENCH-D sample; these indicators include the proportion of patients with satisfactory values as well as the percentage of those with unacceptably high values.

The scores of these instruments represented the person-centered outcomes. In line with the methodology applied in the DAWN2 study [ 8 ], the instruments were chosen to evaluate the impact of diabetes and its management on physical and psychological well-being and satisfaction. In addition, perceived barriers, diabetes distress, and social support were included as mediators of the relationship between self-care activities, quality of life, and diabetes outcomes.

All the instruments were validated and showed satisfactory psychometric properties [ 9 ]. All the scores i. The only exception is the SDSCA6 scale [ 27 ] that provides a single score for each item, ranging from 0 to 7 to indicate the average number of days in the previous week respondent had performed each self-care activity.In particular, it omits some core issues, deferring to national data protection authorities instead.

As a result, disparities are likely to remain and should be taken into account when implementing a clinical trial across various EU jurisdictions e. As noted in our previous alertthe EDPB intends to opine further on the issue of secondary use, and this may be an opportunity to advocate for further consistency for other issues. Also, please note that our attorneys do not seek to practice law in any jurisdiction in which they are not properly authorized to do so.

Client Alert. Keep up with the latest legal and industry insights, news, and events from MoFo Sign Up. In parallel, EU clinical trial rules generally require that clinical trial participants provide their informed consent to participate in a clinical trial. This is the case in particular, given the potential imbalance of power between participants and clinical trial investigators so that consent would not be freely given and because if a participant withdraws consent, personal data collected prior to the withdrawal may have to be deleted, which can lead to a host of issues, and threaten the quality and credibility of the clinical trial.

As we identified in our previous alert, while clarifying the absence of the need for consent under the GDPR is helpful, it can also cause tension where local privacy laws prescribe consent for reliance on scientific research [1]as in Ireland [2] or the Netherlands [3]. Those objectives are then built into clinical trial documentation that is provided to the participants.

That said, clinical trials may last several years and discoveries may prompt the need for research beyond the protocol. Under clinical trial rules, such prolonged use is allowed CTR Art. The EDPB confirms that it is possible to rely on the initial justification for the scientific research also for the prolonged use. It should be noted, however, that secondary use is a complex issue under the GDPR, and that the EDPB already announced, in its opinion, that it will devote further attention and guidance to it in the future.

There will, therefore, be additional considerations to look out for in the future.

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In other words, there is no automatic withdrawal of both consents. It is therefore useful to clearly split out the requests for privacy and clinical trial consent in participant documentation e. For example, it is known that there are local disparities amongst EU Member States as to what the qualifications of the investigator and the sponsor should be e. Likewise, it is not clear how the territorial criteria of the GDPR apply to foreign-sponsored trials e.

This interpretation seems to depart from guidance provided by the Article 29 Working Party and endorsed by the EDPB regarding consent that suggested that controllers may, as a one-off situation, be able to make the transition to another GDPR-compliant legal basis. Ronan Tigner Associate. Alex van der Wolk Partner. First Name. Last Name.Medicine Matters Diabetes. Back to the search result list.

The complex interplay between clinical and person-centered diabetes outcomes in the two genders

Table of Contents. Background New approaches to cope with clinical and psychosocial aspects of type 2 diabetes T2DM are needed; gender influences the complex interplay between clinical and non-clinical factors. Methods Clinical quality of care indicators relative to control of HbA1c, lipid profile, blood pressure, and BMI were derived from electronic medical records. Results Overall, 26 diabetes clinics enrolled 2, people men: Women had statistically significant poorer scores for physical functioning, psychological well-being, self-care activities dedicated to physical activities, empowerment, diabetes-related distress, satisfaction with treatment, barriers to medication taking, satisfaction with access to chronic care and healthcare communication, and perceived social support than men; Conclusions In T2DM, women show poorer clinical and person-centered outcomes indicators than men.

Diabetes-related distress plays a role as a correlate of metabolic control in women but not in men. The study provides new information about the interplay between clinical and person-centered indicators in men and women which may guide further improvements in diabetes education and support programs. Please log in to get access to this content Log in Register for free.

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