RESUMO
INTRODUCTION: Over half of Americans and up to 78% of US Veteran population meet criteria for obesity. Perioperatively placed intragastric balloon (IGB) can accelerate weight loss goals for safe surgical candidacy, however weight regain is common after removal. Glucagon-like peptide-1-receptor agonists (GLP1RA) may provide a more sustainable weight loss solution after surgery. We hypothesize that weight regain will be less at 1 year after initiation of GLP1RA than IGB placement in Veterans. METHODS: Retrospective review of prospective databases of perioperatively placed intragastric balloon cohort from 1/2019-1/2023 compared to patients who received initiatory GLP1RA from 6/2021-8/2022 at a VA Medical Center(VAMC). All patients were enrolled in the VAMC MOVE! multidisciplinary weight management program for a minimum of 12 weeks. Outcomes measured were patients' weights at 0, 3, 6, and 12 months and weight change for these intervals. Exclusion criteria included history of bariatric surgery and incomplete weight loss data. RESULTS: Two-hundred-twenty-three patients met inclusion criteria; 110 (49%) patients excluded. Mean age was 54 ± 11 years, the majority (78, 69%) were male, and the mean initial BMI was 37 ± 5.9 kg/m2. Seventeen (15%) patients underwent IGB placement and 96 (85%) patients received semaglutide. Weight (kg) change was measured at intervals: 0-3 months:- 11.8(- 17,- 9.5) IGB vs. - 5.1(- 7.4,- 2.3) semaglutide, p < 0.0001; 0-6 months:- 12.7(- 18.4,- 9.9) vs. - 9.4(- 12.6,- 6.1), p = 0.03; 3-6 months:- 0.5(- 2.3,2.3) vs. - 4.3(- 6.8,- 1.6), p < 0.0001; 6-12 months:3(0,7.3) vs. - 1.9(- 4.7,1), p = 0.0006. CONCLUSION: Weight loss occurs more rapidly in the first 6 months after intragastric balloon placement compared to semaglutide (- 12.7 vs. - 9.4 kg, p = 0.03). Despite ongoing attendance in a comprehensive weight loss program, weight regain is common after IGB removal by an average of 3 kg (23.6%) at 1 year. In contrast, patients on GLP1RA (semaglutide) continue to lose weight during this period. Further studies are needed to determine if optimal long-term outcomes may result from combination therapy with intragastric balloon and semaglutide.
RESUMO
To work with a psychological therapies service to implement a recovery plan, as required by a government body, aimed at improving patient outcomes (effectiveness) and decreasing practitioner variability (equity). A case-study utilizing components of a learning health system, including nationally mandated patient outcome data, comprising three 18-month phases: (1) retrospective baseline; (2) improving patient outcomes (management-led); and (3) reducing practitioner variability (clinician-led). Primary analyses focused on 35 practitioners (NPR = 35) who were constant across the three phases and their patients in each phase (NPA = 930, 1226, 1217, respectively). Reliable improvement rates determined patient outcomes and multilevel modeling yielded practitioner effects. To test generalizability, results were compared to the whole practitioner sample for each phase: (1) NPR = 81, NPA = 1982; (2) NPR = 80, NPA = 2227; (3) NPR = 74, NPA = 2267. Ethical approval was granted by the Health Research Authority. Patient outcomes improved in successive phases for both the core and whole practitioner samples with the largest impact occurring in the management-led intervention. Practitioner variability decreased in successive phases in both the core and whole practitioner samples except in the management-led intervention of the whole sample. Compared with the management-led intervention, the practitioner-led intervention yielded a decrease in practitioner effect exceeding 60% in the core sample and approaching 50% in the whole sample. The implementation of multiple components of a learning health system can lead to improvements in both the effectiveness and equity of a psychological therapy service.
RESUMO
OBJECTIVE: To test the predictive accuracy and generalisability of a personalised advantage index (PAI) model designed to support treatment selection for Post-Traumatic Stress Disorder (PTSD). METHOD: A PAI model developed by Deisenhofer et al. (2018) was used to predict treatment outcomes in a statistically independent dataset including archival records for N = 152 patients with PSTD who accessed either trauma-focussed cognitive behavioural therapy or eye movement desensitisation and reprocessing in routine care. Outcomes were compared between patients who received their PAI-indicated optimal treatment versus those who received their suboptimal treatment. RESULTS: The model did not yield treatment specific predictions and patients who had received their PAI-indicated optimal treatment did not have better treatment outcomes in this external validation sample. CONCLUSION: This PAI model did not generalise to an external validation sample.
RESUMO
BACKGROUND: Comparisons between bona fide psychological therapies generally report no effects or small effects favoring cognitive behavioral therapy (CBT), suggesting that differences between therapy modalities are of little importance. METHODS: An observational, cohort study of patients (N = 11,116), drawn from the English Talking Therapies program. Patients presented with depression and were treated by CBT or person-centered experiential therapy (PCET), 67 % were female and the age range was 15-94. Multilevel modeling was used to identify variables associated with outcomes and CBT and PCET outcomes were compared dependent on the number of sessions patients attended and the severity of their depression at intake. RESULTS: Although overall a small effect size of 0.14 (0.10, 0.18) favored CBT, we found differing effect sizes depending on patient severity and the number of sessions they had attended at outcome. For non-clinical and moderately depressed patients no significant differences between therapies were found. For moderately-severe and severe patients there was a crossover in effectiveness with PCET more effective up to 5 or 6 sessions and CBT more effective thereafter. However, small effects in favour of PCET were unreliable. The largest effects were found for CBT for patients who were moderately-severe and had >10 sessions (d = 0.30, 0.12, 0.48) or were severe and had >12 sessions (d = 0.26 (0.02, 0.49). LIMITATIONS: No data was available on therapy allocation decisions or therapists and the results may not be generalizable to non-NHS Talking Therapies services. CONCLUSIONS: Small effects can mask important contextual differences between therapies and their study can inform allocation decisions.
Assuntos
Terapia Cognitivo-Comportamental , Humanos , Feminino , Masculino , Adulto , Pessoa de Meia-Idade , Adolescente , Idoso , Adulto Jovem , Resultado do Tratamento , Índice de Gravidade de Doença , Estudos de Coortes , Idoso de 80 Anos ou mais , Psicoterapia Centrada na Pessoa/métodos , Inglaterra , Transtorno Depressivo/terapiaRESUMO
The paralaminar nucleus of the amygdala (PL) comprises neurons that exhibit delayed maturation. PL neurons are born during gestation but mature during adolescent ages, differentiating into excitatory neurons. These late-maturing PL neurons contribute to the increase in size and cell number of the amygdala between birth and adulthood. However, the function of the PL upon maturation is unknown, as the region has only recently begun to be characterized in detail. In this study, we investigated key defining features of the adult mouse PL; the intrinsic morpho-electric properties of its neurons, and its input and output circuit connectivity. We identify two subtypes of excitatory neurons in the PL based on unsupervised clustering of electrophysiological properties. These subtypes are defined by differential action potential firing properties and dendritic architecture, suggesting divergent functional roles. We further uncover major axonal inputs to the adult PL from the main olfactory network and basolateral amygdala. We also find that axonal outputs from the PL project reciprocally to these inputs and to diverse targets including the amygdala, frontal cortex, hippocampus, hypothalamus, and brainstem. Thus, the adult mouse PL is centrally placed to play a major role in the integration of olfactory sensory information, to coordinate affective and autonomic behavioral responses to salient odor stimuli.
Assuntos
Tonsila do Cerebelo , Neurônios , Animais , Camundongos , Tonsila do Cerebelo/fisiologia , Tonsila do Cerebelo/citologia , Neurônios/fisiologia , Masculino , Camundongos Endogâmicos C57BL , Potenciais de Ação/fisiologia , Feminino , Vias Neurais/fisiologia , Camundongos Transgênicos , Dendritos/fisiologiaRESUMO
BACKGROUND: Severe hypertriglyceridemia (sHTG) is associated with an increased risk of acute pancreatitis. Prompt recognition and treatment of sHTG is key for prevention of acute pancreatitis and its associated life-threatening complications. LOCAL PROBLEM: Patients with sHTG at a primary care clinic within the Veterans Affairs Eastern Colorado Health Care System were receiving suboptimal treatment that did not align with evidence-based guidelines. METHODS: We initiated a quality improvement (QI) project to improve the management of sHTG in an outpatient primary care clinic. Veterans with a triglyceride level between 500 and 1,500 mg/dl were included in the project. INTERVENTIONS: Project interventions included provider education, patient education, and targeted electronic consultations (e-consults) with treatment recommendations. The primary outcome was to decrease the percentage of patients with triglycerides ≥500 mg/dl by 25%. The secondary outcome was to decrease the mean triglyceride level of the patient population by 15%. RESULTS: Education on evaluation and treatment of sHTG was given to 100% (n = 21) of primary care clinicians. Overall, 72.8% (95% CI [62.6-81.6%]) of patients (n = 67) received appropriate written education materials, and 72.8% (95% CI [62.6-81.6%]) of patients (n = 67) received a targeted e-consult. The percentage of patients with sHTG decreased by 47%. Average triglyceride level decreased from 651 to 483 mg/dl (25.8% decrease). CONCLUSION: A multipronged QI project consisting of provider education, patient education, and targeted e-consults resulted in decreased triglyceride levels and improved access to specialist expertise. Clinical implications include decreased prevalence of sHTG and risk of acute pancreatitis among patients in the project.
RESUMO
Context: Despite a high prevalence of obesity in the veteran population, antiobesity medications (AOMs) have been underused in the Veterans Health Administration. Real-world reports on outcomes when AOMs have been used in veterans is limited. Objective: To analyze weight loss outcomes from a local Veterans Health Administration pharmacotherapy-based weight management clinic (WMC). Methods: This was a retrospective cohort study of veterans enrolled in a local WMC for 15 months from August 2016 through September 2018 and followed through November 2019. Patients were offered 1 of 5 available AOMs based on their comorbidities. Factors associated with weight loss (5% or more weight loss) were assessed. Key results: A total of 159 patients were seen in a WMC, 149 (93.7%) veterans were prescribed an AOM, and 129 returned for follow-up. Overall, 61/129 (47%) patients achieved 5% or greater weight loss and 28/129 (22%) achieved 10% or greater weight loss within 15 months. Clinically significant weight loss (%) over the first 15 months was achieved with phentermine/topiramate ER (-6.3%) and liraglutide (-7.5%), but not with orlistat (-3.9%) and lorcaserin (-3.6%). Comorbid obstructive sleep apnea was negatively associated with achieving ≥5% weight loss. Conclusion: Phentermine/topiramate ER and liraglutide were found to be effective AOMs among veterans. Further work is needed to mitigate barriers to AOM initiation given the continued rise in obesity.
RESUMO
The aims of this practice-based evidence study were to (a) examine clients' trajectories of psychological and spiritual distress over the course of spiritually integrated psychotherapies (SIPs) and (b) explore the role of varying types of spiritual interventions in these outcomes. In total, 164 practitioners of SIPs from 37 settings in a practice-research network administered the Clinically Adaptive Multidimensional Outcome Survey (Sanders et al., 2018) at each session with 1,227 clients and reported their use of theoretical orientations and spiritual interventions on an after-session summary checklist. Focusing on sessions over an initial 12-week period, latent growth curve modeling analyses revealed that clients, on average, experienced significant reduction of psychological distress during their engagement in SIPs with improvements occurring most sharply in the first month. Further, other findings revealed a salient reciprocal interplay with spiritual distress throughout treatment, such that clients who were struggling with their religious faith and/or spirituality were more psychologically distressed and displayed a more attenuated and gradual pattern of symptom reduction. In such cases, clinicians frequently utilized spiritual interventions involving basic skills (e.g., spiritual assessment), virtues (e.g., discuss self-control), and religious attachment (e.g., encourage acceptance of divine love) that were uniquely associated with clients' rate and duration of decline in psychological and spiritual distress. The present findings affirm the routine effectiveness of SIPs along with highlighting the potential value of certain spiritual interventions in supporting holistic recovery among clients who want clinicians to be culturally responsive to their spiritual and/or religious identities. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
Assuntos
Angústia Psicológica , Psicoterapia , Espiritualidade , Humanos , Feminino , Masculino , Adulto , Psicoterapia/métodos , Pessoa de Meia-Idade , Prática Clínica Baseada em Evidências , Terapias Espirituais/métodosRESUMO
The paralaminar nucleus of the amygdala (PL) is comprised of neurons which exhibit delayed maturation. PL neurons are born during gestation but mature during adolescent ages, differentiating into excitatory neurons. The PL is prominent in the adult amygdala, contributing to its increased neuron number and relative size compared to childhood. However, the function of the PL is unknown, as the region has only recently begun to be characterized in detail. In this study, we investigated key defining features of the adult PL; the intrinsic morpho-electric properties of its neurons, and its input and output connectivity. We identify two subtypes of excitatory neurons in the PL based on unsupervised clustering of electrophysiological properties. These subtypes are defined by differential action potential firing properties and dendritic architecture, suggesting divergent functional roles. We further uncover major axonal inputs to the adult PL from the main olfactory network and basolateral amygdala. We also find that axonal outputs from the PL project reciprocally to major inputs, and to diverse targets including the amygdala, frontal cortex, hippocampus, hypothalamus, and brainstem. Thus, the adult PL is centrally placed to play a major role in the integration of olfactory sensory information, likely coordinating affective and autonomic behavioral responses to salient odor stimuli. Significance Statement: Mammalian amygdala development includes a growth period from childhood to adulthood, believed to support emotional and social learning. This amygdala growth is partly due to the maturation of neurons during adolescence in the paralaminar amygdala. However, the functional properties of these neurons are unknown. In our recent studies, we characterized the paralaminar amygdala in the mouse. Here, we investigate the properties of the adult PL in the mouse, revealing the existence of two neuronal subtypes that may play distinct functional roles in the adult brain. We further reveal the brain-wide input and output connectivity of the PL, indicating that the PL combines olfactory cues for emotional processing and delivers information to regions associated with reward and autonomic states.
RESUMO
OBJECTIVE: This study investigated if patients' experience of an initial assessment may be associated with outcome expectations, and with subsequent treatment attendance. METHOD: The sample comprised n = 6051 patients with depression/anxiety disorders, nested within k = 148 assessing therapists. Multilevel modelling (MLM) was used to examine therapist effects on treatment initiation and subsequent dropout, adjusting for patient-level characteristics. We tested associations between early outcome expectancy measured at an initial assessment with attendance at a first therapy session, and with dropout after initiation. Variability in mean expectancy ratings in the caseloads of assessing therapists was examined using the intracluster correlation coefficient (ICC). RESULTS: Therapist effects partly explained the variance in treatment initiation and dropout. Pre-treatment outcome expectations significantly predicted treatment initiation but not dropout for the subgroup of patients who started treatment. Approximately 16% of variability in mean expectancy ratings was explained by therapist effects (ICC = 0.159) after controlling for patient-level covariates. CONCLUSIONS: Patients assessed by some therapists are more likely to have higher outcome expectations, which influences their decision to initiate treatment thereafter. Once patients start therapy, early expectancy measured at assessment no longer influences their attendance, but the "first impression" from an initial assessment does influence their subsequent likelihood of dropout.
RESUMO
The human amygdala paralaminar nucleus (PL) contains many immature excitatory neurons that undergo prolonged maturation from birth to adulthood. We describe a previously unidentified homologous PL region in mice that contains immature excitatory neurons and has previously been considered part of the amygdala intercalated cell clusters or ventral endopiriform cortex. Mouse PL neurons are born embryonically, not from postnatal neurogenesis, despite a subset retaining immature molecular and morphological features in adults. During juvenile-adolescent ages (P21-P35), the majority of PL neurons undergo molecular, structural, and physiological maturation, and a subset of excitatory PL neurons migrate into the adjacent endopiriform cortex. Alongside these changes, PL neurons develop responses to aversive and appetitive olfactory stimuli. The presence of this homologous region in both humans and mice points to the significance of this conserved mechanism of neuronal maturation and migration during adolescence, a key time period for amygdala circuit maturation and related behavioral changes.
Assuntos
Complexo Nuclear Basolateral da Amígdala , Células-Tronco Neurais , Adolescente , Humanos , Adulto , Animais , Camundongos , Neurônios , Tonsila do Cerebelo , AfetoRESUMO
Purpose: Extension for Community Health Outcomes (ECHO) is a model of continuing medical education meant to connect academic medical center-based specialists with community providers to increase capacity in managing complex health conditions. The purpose of this study was to evaluate the effectiveness of a shortened "bootcamp" ECHO model in increasing participant competence with topics related to transgender and gender diverse (TGD) health care and the impact of "bootcamp" participation on enrollment in an ongoing ECHO series. Methods: An ongoing monthly ECHO series was instituted on topics of TGD health. After 2 years, the team implemented a four-session "bootcamp" for four consecutive weeks during March 2022 to introduce foundational topics for new participants who had joined or were considering joining the ongoing series. Qualitative and quantitative results were collected from self-reported pre-/post-surveys as well as from in-session quizzes. Results: There were 71 participants in the "bootcamp" including health care providers and support staff. Attendees reported a 10.3% increase (p = 0.02) in self-reported comfort providing care to transgender patients. Pre-/post-knowledge improved in areas of health inequities (50% vs. 74% correct pre/post), surgical requirements (33% vs. 74%), and effects of masculinizing (55% vs. 70%) and feminizing (64% vs. 89%) hormone therapy. Prescribing providers reported a significant change across four areas of practice competency. Among 71 "bootcamp" participants, 15 registered for the ongoing program. Conclusion: Use of a "bootcamp" highlights ways to increase participant comfort and knowledge in providing TGD health care in a shortened timeframe and recruit new participants to an ongoing ECHO curriculum.
Assuntos
Minorias Sexuais e de Gênero , Pessoas Transgênero , Humanos , Currículo , Inquéritos e Questionários , AutorrelatoRESUMO
OBJECTIVE: To develop two prediction algorithms recommending person-centered experiential therapy (PCET) or cognitive-behavioral therapy (CBT) for patients with depression: (1) a full data model using multiple trial-based and routine variables, and (2) a routine data model using only variables available in the English NHS Talking Therapies program. METHOD: Data was used from the PRaCTICED trial comparing PCET vs. CBT for 255 patients meeting a diagnosis of moderate or severe depression. Separate full and routine data models were derived and the latter tested in an external data sample. RESULTS: The full data model provided the better prediction, yielding a significant difference in outcome between patients receiving their optimal vs. non-optimal treatment at 6- (Cohen's d = .65 [.40, .91]) and 12 months (d = .85 [.59, 1.10]) post-randomization. The routine data model performed similarly in the training and test samples with non-significant effect sizes, d = .19 [-.05, .44] and d = .21 [-.00, .43], respectively. For patients with the strongest treatment matching (d ≥ 0.3), the resulting effect size was significant, d = .38 [.11, 64]. CONCLUSION: A treatment selection algorithm might be used to recommend PCET or CBT. Although the overall effects were small, targeted matching yielded somewhat larger effects.
RESUMO
BACKGROUND: There is debate about how best to increase access to psychological therapy and deliver mental healthcare effectively and efficiently at a national level. One trend is the increased use of the telephone to deliver therapy. However, there is the potential to disadvantage certain patient groups and/or impact on uptake of help. This study aims to answer three questions: (i) Which factors are associated with being offered an assessment by telephone? (ii) Which factors are associated with attendance at assessment? and (iii) What is the impact of an assessment by telephone on subsequent treatment appointment? METHODS: Routine outcome data was provided by seven UK Improving Access to Psychological Therapy services. The analysis sample comprised 49,923 patients who referred to 615 general practices in 2017. Multilevel modelling, including service and GP practice as random factors, was used to answer the three research questions. RESULTS: The offer of an initial assessment by telephone was strongly associated with local service configuration. Patient self-referral, a shorter wait, greater age and lower deprivation were associated with attendance at assessment and subsequent treatment session. Telephone mode assessment had no impact on the uptake of the assessment but may influence the uptake of further treatment if this was also by telephone. The practitioner carrying out the assessment had a significant effect on subsequent treatment uptake. CONCLUSION: Offering telephone assessments does not have a negative impact on uptake of assessment and services may benefit by facilitating and integrating telephone assessments into their systems. The COVID-19 pandemic has accelerated the use of telephone and other remote means of delivery, and results from this study can inform services to consider how best to re-configure post-pandemic.
Assuntos
COVID-19 , Medicina Geral , Humanos , Pandemias , Encaminhamento e Consulta , TelefoneRESUMO
Despite professional society guidelines recommending that obesity be treated as a chronic disease by emphasizing the use of lifestyle modification in conjunction with pharmacotherapy, antiobesity medications are uncommonly prescribed in most clinical practices. The recent Food and Drug Administration approval of semaglutide 2.4â mg weekly to treat obesity-as well as other forthcoming advancements in diabetes and antiobesity medications-highlights the potential of pharmacotherapy to significantly augment weight loss efforts. In this Expert Endocrine Consult, we review the evolving role of antiobesity pharmacotherapy in clinical practice and suggest a framework for the use of these medications.
RESUMO
OBJECTIVE(S): To examine the psychometric properties of the idiographic Goal-Based Outcome (GBO) tool for young people: test-retest stability, convergent validity, and sensitivity to an intervention. METHODS: This measure validation study used data from a randomized controlled trial of school-based humanistic counseling. We used multilevel analyses to assess test-retest stability, convergent validity of the GBO tool against nomothetic measures of mental wellbeing, and sensitivity to an intervention. RESULTS: The GBO tool showed acceptable stability over a 6-24 week period; moderate convergent validity with nomothetic measures of mental well-being, self-esteem, and depression; and greater sensitivity to an intervention than a measure of psychological distress. CONCLUSIONS: The GBO tool shows evidence of having acceptable psychometric properties and is suitable for monitoring change on individual goals. It may also have the capacity to function as a population-level indicator of outcomes in conjunction with the use of other measures of mental health and wellbeing.
Assuntos
Aconselhamento , Objetivos , Humanos , Adolescente , Saúde Mental , Psicometria , Bem-Estar Psicológico , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
Currently, no reports exist on the phenomenon of early response in humanistic-experiential therapies. This study investigated the prognostic value of early response on posttreatment outcomes in person-centered experiential therapy (PCET) for depression within the English Improving Access to Psychological Therapies program. The design of the study was a retrospective observational cohort study. Routine clinical data were drawn from N = 3,321 patients with depression symptoms. The primary outcome was reliable and clinically significant improvement (RCSI) on the Patient Health Questionnaire-9 (PHQ-9) self-report depression measure at the end of treatment. Early response was operationalized as reliable improvement, defined as a PHQ-9 change score ≥ 6 from baseline to Session 4. Early response was examined as a predictor of RCSI using logistic regression controlling for baseline depression severity. In sensitivity analyses, therapist effects were controlled using multilevel modeling. A total of 38.7% of patients met the criterion for early response. Patients who experienced an early response to treatment were six times more likely to recover at the end of treatment compared to patients who did not have an early response. The early response effect was still evident after accounting for individual variability between therapists. However, a quarter of patients displayed a pattern of eventual response, reaching recovery at end of treatment despite not experiencing an initial improvement early in therapy. Early response to PCET is a reliable predictor of treatment outcome. Different response patterns evidenced in this study indicate that identifying subgroups of patients associated with early and eventual response could support clinical decision-making. (PsycInfo Database Record (c) 2022 APA, all rights reserved).
Assuntos
Depressão , Humanos , Depressão/terapia , Prognóstico , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: Therapeutic inertia threatens the potential long-term benefits of achieving early glycemic control after type 2 diabetes diagnosis. We evaluated temporal trends in second-line diabetes medication initiation among individuals initially treated with metformin. RESEARCH DESIGN AND METHODS: We included data from 199,042 adults with type 2 diabetes in the U.S. Department of Veterans Affairs health care system initially treated with metformin monotherapy from 2005 to 2013. We used multivariable Cox proportional hazards and linear regression to estimate associations of year of metformin monotherapy initiation with time to second-line diabetes treatment over 5 years of follow-up (primary outcome) and with hemoglobin A1c (HbA1c) at the time of second-line diabetes treatment initiation (secondary outcome). RESULTS: The cumulative 5-year incidence of second-line medication initiation declined from 47% among metformin initiators in 2005 to 36% in 2013 counterparts (P < 0.0001) despite a gradual increase in mean HbA1c at the end of follow-up (from 6.94 ± 1.28% to 7.09 ± 1.42%, Ptrend < 0.0001). In comparisons with metformin monotherapy initiators in 2005, adjusted hazard ratios for 5-year initiation of second-line diabetes treatment ranged from 0.90 (95% CI 0.87, 0.92) for 2006 metformin initiators to 0.68 (0.66, 0.70) for 2013 counterparts. Among those receiving second-line treatment within 5 years of metformin initiation, HbA1c at second-line medication initiation increased from 7.74 ± 1.66% in 2005 metformin initiators to 8.55 ± 1.92% in 2013 counterparts (Ptrend < 0.0001). CONCLUSIONS: We observed progressive delays in diabetes treatment intensification consistent with therapeutic inertia. Process-of-care interventions early in the diabetes disease course may be needed to reverse adverse temporal trends in diabetes care.
Assuntos
Diabetes Mellitus Tipo 2 , Metformina , Adulto , Glicemia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemiantes/uso terapêutico , Metformina/uso terapêutico , Estudos RetrospectivosRESUMO
BACKGROUND: Rural patients with type 2 diabetes (T2D) may experience poor glycemic control due to limited access to T2D specialty care and self-management support. Telehealth can facilitate delivery of comprehensive T2D care to rural patients, but implementation in clinical practice is challenging. OBJECTIVE: To examine the implementation of Advanced Comprehensive Diabetes Care (ACDC), an evidence-based, comprehensive telehealth intervention for clinic-refractory, uncontrolled T2D. ACDC leverages existing Veterans Health Administration (VHA) Home Telehealth (HT) infrastructure, making delivery practical in rural areas. DESIGN: Mixed-methods implementation study. PARTICIPANTS: 230 patients with clinic-refractory, uncontrolled T2D. INTERVENTION: ACDC bundles telemonitoring, self-management support, and specialist-guided medication management, and is delivered over 6 months using existing VHA HT clinical staffing/equipment. Patients may continue in a maintenance protocol after the initial 6-month intervention period. MAIN MEASURES: Implementation was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The primary effectiveness outcome was hemoglobin A1c (HbA1c). KEY RESULTS: From 2017 to 2020, ACDC was delivered to 230 patients across seven geographically diverse VHA sites; on average, patients were 59 years of age, 95% male, 80% white, and 14% Hispanic/Latinx. Patients completed an average of 10.1 of 12 scheduled encounters during the 6-month intervention period. Model-estimated mean baseline HbA1c was 9.56% and improved to 8.14% at 6 months (- 1.43%, 95% CI: - 1.64, - 1.21; P < .001). Benefits persisted at 12 (- 1.26%, 95% CI: - 1.48, - 1.05; P < .001) and 18 months (- 1.08%, 95% CI - 1.35, - 0.81; P < .001). Patients reported increased engagement in self-management and awareness of glycemic control, while clinicians and HT nurses reported a moderate workload increase. As of this submission, some sites have maintained delivery of ACDC for up to 4 years. CONCLUSIONS: When strategically designed to leverage existing infrastructure, comprehensive telehealth interventions can be implemented successfully, even in rural areas. ACDC produced sustained improvements in glycemic control in a previously refractory population.
Assuntos
Diabetes Mellitus Tipo 2 , Telemedicina , Instituições de Assistência Ambulatorial , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Hemoglobinas Glicadas , Humanos , Masculino , População Rural , Telemedicina/métodosRESUMO
BACKGROUND: The UK Government's implementation in 2008 of the Improving Access to Psychological Therapies (IAPT) initiative in England has hugely increased the availability of cognitive behavioural therapy (CBT) for the treatment of depression and anxiety in primary care. Counselling for depression-a form of person-centred experiential therapy (PCET)-has since been included as an IAPT-approved therapy, but there is no evidence of its efficacy from randomised controlled trials (RCTs), as required for recommendations by the National Institute for Health and Care Excellence. Therefore, we aimed to examine whether PCET is cost effective and non-inferior to CBT in the treatment of moderate and severe depression within the IAPT service. METHODS: This pragmatic, randomised, non-inferiority trial was done in the Sheffield IAPT service in England and recruited participants aged 18 years or older with moderate or severe depression on the Clinical Interview Schedule-Revised. We excluded participants presenting with an organic condition, a previous diagnosis of personality disorder, bipolar disorder, or schizophrenia, drug or alcohol dependency, an elevated clinical risk of suicide, or a long-term physical condition. Eligible participants were randomly assigned (1:1), independently of the research team, and stratified by site with permuted block sizes of two, four, or six, to receive either PCET or CBT by use of a remote, web-based system that revealed therapy after patient details were entered. Those assessing outcomes were masked to treatment allocation. Participants were seen by appropriately trained PCET counsellors and CBT therapists in accordance with the IAPT service delivery model. Depression severity and symptomatology measured by the Patient Health Questionnaire-9 (PHQ-9) at 6 months post-randomisation was the primary outcome, with the PHQ-9 score at 12 months post-randomisation being a key secondary outcome. These outcomes were analysed in the modified intention-to-treat population, which comprised all randomly assigned patients with complete data, and the per-protocol population, which comprised all participants who did not switch from their randomised treatment and received between four and 20 sessions. Safety was analysed in all randomly assigned patients. The non-inferiority margin was set a priori at 2 PHQ-9 points. Patient safety was monitored throughout the course of therapy, adhering to service risk procedures for monitoring serious adverse events. This trial is registered at the ISRCTN Registry, ISRCTN06461651, and is complete. FINDINGS: From Nov 11, 2014, to Aug 3, 2018, 9898 patients were referred to step three treatments in the Sheffield IAPT service for common mental health problems, of whom 761 (7·7%) were referred to the trial. Of these, we recruited and randomly assigned 510 participants to receive either PCET (n=254) or CBT (n=256). In the PCET group, 138 (54%) participants were female and 116 (46%) were male, and 225 (89%) were White, 16 (6%) were non-White, and 13 (5%) had missing ethnicity data. In the CBT group, 155 (61%) participants were female and 101 (39%) were male, and 226 (88%) were White, 17 (7%) were non-White, and 13 (5%) had missing ethnicity data. The 6-month modified intention-to-treat analysis comprised 401 (79%) of the enrolled participants (201 in the PCET group; 200 in the CBT group) and the 12-month modified intention-to-treat analysis comprised 319 participants (167 in the PCET group; 152 in the CBT group). The 6-month per-protocol analysis comprised 298 participants (154 in the PCET group; 144 in the CBT group). At 6 months post-randomisation, PCET was non-inferior to CBT in the intention-to-treat population (mean PHQ-9 score 12·74 [SD 6·54] in the PCET group and 13·25 [6·35] in the CBT group; adjusted mean difference -0·35 [95% CI -1·53 to 0·84]) and in the per-protocol population (12·73 [SD 6·57] in the PCET group and 12·71 [6·33] in the CBT group; 0·27 [95% CI -1·08 to 1·62]). At 12 months post-randomisation, there was a significant adjusted between-group difference in mean PHQ-9 score in favour of CBT (1·73 [95% CI 0·26-3·19]), with a 95% CI exceeding the 2-point non-inferiority margin. There were two deaths, one death by suicide in the PCET group and one due to chronic obstructive pulmonary disease in the CBT group. Both were assessed by the responsible clinician to be unrelated to the trial. In terms of using emergency departments for depression-related events, four people (three in the PCET group; one in the CBT group) made more than a single use and six people (three in the PCET group; three in the CBT group) made a single use. One patient in the PCET group had inpatient treatment for a depression-related event. INTERPRETATION: This trial is the first to examine the two most frequently administered psychological therapies in the IAPT service. The finding of non-inferiority of PCET to CBT at 6 months supports the results from large, routine, non-randomised datasets from the IAPT programme. Given the high demand for psychological therapies and the need for patient choice, our findings suggest the need for continued investment in the training and delivery of PCET for improving short-term outcomes, but suggest that PCET might be inferior to CBT at 12 months. FUNDING: British Association for Counselling and Psychotherapy Research Foundation.