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1.
BMJ ; 373: n379, 2021 04 12.
Artigo em Inglês | MEDLINE | ID: mdl-33846159

RESUMO

Atrial fibrillation is a common chronic disease seen in primary care offices, emergency departments, inpatient hospital services, and many subspecialty practices. Atrial fibrillation care is complicated and multifaceted, and, at various points, clinicians may see it as a consequence and cause of multi-morbidity, as a silent driver of stroke risk, as a bellwether of an acute medical illness, or as a primary rhythm disturbance that requires targeted treatment. Primary care physicians in particular must navigate these priorities, perspectives, and resources to meet the needs of individual patients. This includes judicious use of diagnostic testing, thoughtful use of novel therapeutic agents and procedures, and providing access to subspecialty expertise. This review explores the epidemiology, screening, and risk assessment of atrial fibrillation, as well as management of its symptoms (rate and various rhythm control options) and stroke risk (anticoagulation and other treatments), and offers a model for the integration of the components of atrial fibrillation care.


Assuntos
Fibrilação Atrial/diagnóstico , Programas de Rastreamento/normas , Guias de Prática Clínica como Assunto , Atenção Primária à Saúde/normas , Acidente Vascular Cerebral/prevenção & controle , Antiarrítmicos/administração & dosagem , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/terapia , Cateterismo Cardíaco , Eletrocardiografia , Carga Global da Doença , Estilo de Vida Saudável , Frequência Cardíaca/efeitos dos fármacos , Frequência Cardíaca/fisiologia , Humanos , Incidência , Programas de Rastreamento/métodos , Prevalência , Atenção Primária à Saúde/métodos , Medição de Risco/métodos , Fatores de Risco , Acidente Vascular Cerebral/etiologia
2.
Med Decis Making ; : 272989X211005655, 2021 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-33896270

RESUMO

OBJECTIVE: Shared decision making (SDM) tools can help implement guideline recommendations for patients with atrial fibrillation (AF) considering stroke prevention strategies. We sought to characterize all available SDM tools for this purpose and examine their quality and clinical impact. METHODS: We searched through multiple bibliographic databases, social media, and an SDM tool repository from inception to May 2020 and contacted authors of identified SDM tools. Eligible tools had to offer information about warfarin and ≥1 direct oral anticoagulant. We extracted tool characteristics, assessed their adherence to the International Patient Decision Aids Standards, and obtained information about their efficacy in promoting SDM. RESULTS: We found 14 SDM tools. Most tools provided up-to-date information about the options, but very few included practical considerations (e.g., out-of-pocket cost). Five of these SDM tools, all used by patients prior to the encounter, were tested in trials at high risk of bias and were found to produce small improvements in patient knowledge and reductions in decisional conflict. CONCLUSION: Several SDM tools for stroke prevention in AF are available, but whether they promote high-quality SDM is yet to be known. The implementation of guidelines for SDM in this context requires user-centered development and evaluation of SDM tools that can effectively promote high-quality SDM and improve stroke prevention in patients with AF.

5.
JAMA Netw Open ; 4(2): e2035792, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-33523188

RESUMO

Importance: Glucagonlike peptide-1 receptor agonists (GLP-1RA), sodium-glucose cotransporter-2 inhibitors (SGLT2i), and dipeptidyl peptidase-4 inhibitors (DPP-4i) are associated with low rates of hypoglycemia, and postmarketing trials of GLP-1RA and SGLT2i demonstrated that these medications improved cardiovascular and kidney outcomes. Objective: To compare trends in initiation of treatment with GLP-1RA, SGLT2i, and DPP-4i by older adults with type 2 diabetes insured by Medicare Advantage vs commercial health plans. Design, Setting, and Participants: This retrospective cohort study used administrative claims data from a deidentified database of commercially insured and Medicare Advantage beneficiaries. Adults aged 58 to 66 years with type 2 diabetes who filled any medication prescription to lower glucose levels from January 1, 2016, to December 31, 2019, were compared between groups. Exposure: Enrollment in a Medicare Advantage or commercial health insurance plan. Main Outcomes and Measures: The odds of initiating GLP-1RA, SGLT2i, and DPP-4i treatment were examined for Medicare Advantage vs commercial insurance beneficiaries using 3 separate logistic regression models adjusted for year and demographic and clinical factors. These models were used to calculate adjusted annual rates of medication initiation by health plan. Results: A total of 382 574 adults with pharmacologically treated type 2 diabetes (52.9% men; mean [SD] age, 62.4 [2.7] years) were identified, including 172 180 Medicare Advantage and 210 394 commercial beneficiaries. From 2016 to 2019, adjusted rates of initiation of GLP-1RA, SGLT2i, and DPP-4i treatment increased among all beneficiaries, from 2.14% to 20.02% for GLP-1RA among commercial insurance beneficiaries and from 1.50% to 11.44% among Medicare Advantage beneficiaries; from 2.74% to 18.15% for SGLT2i among commercial insurance beneficiaries and from 1.57% to 8.51% among Medicare Advantage beneficiaries; and from 3.30% to 11.71% for DPP-4i among commercial insurance beneficiaries and from 2.44% to 7.68% among Medicare Advantage beneficiaries. Initiation rates for all 3 drug classes were consistently lower among Medicare Advantage than among commercial insurance beneficiaries. Within each calendar year, the odds of initiating GLP-1RA treatment ranged from 0.28 (95% CI, 0.26-0.29) to 0.70 (95% CI, 0.65-0.75) for Medicare Advantage and commercial insurance beneficiaries, respectively; SGLT2i, from 0.21 (95% CI, 0.20-0.22) to 0.57 (95% CI, 0.53-0.61), respectively; and DPP-4i, from 0.37 (95% CI, 0.34-0.39) to 0.73 (95% CI, 0.69-0.78), respectively (P < .001 for all). The odds of starting GLP-1RA and SGLT2i increased with income; for an income of $200 000 and higher vs less than $40 000, the odds ratio for GLP-1RA was 1.23 (95% CI, 1.15-1.32) and for SGLT2i was 1.16 (95% CI, 1.09-1.24). Conclusions and Relevance: These findings suggest that Medicare Advantage beneficiaries may be less likely than commercially insured beneficiaries to be treated with newer medications to lower glucose levels, with greater disparities among lower-income patients. Better understanding of nonclinical factors contributing to treatment decisions and efforts to promote greater equity in diabetes management appear to be needed.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Inibidores da Dipeptidil Peptidase IV/uso terapêutico , Hipoglicemiantes/uso terapêutico , Incretinas/uso terapêutico , Seguro Saúde , Medicare Part C , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Idoso , Feminino , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Disparidades em Assistência à Saúde , Humanos , Renda/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estados Unidos
6.
BMC Health Serv Res ; 21(1): 24, 2021 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-33407451

RESUMO

BACKGROUND: Recent evidence suggests the need to reframe healthcare delivery for patients with chronic conditions, with emphasis on minimizing healthcare footprint/workload on patients, caregivers, clinicians and health systems through the proposed Minimally Disruptive Medicine (MDM) care model named. HIV care models have evolved to further focus on understanding barriers and facilitators to care delivery while improving patient-centered outcomes (e.g., disease progression, adherence, access, quality of life). It is hypothesized that these models may provide an example of MDM care model in clinic practice. Therefore, this study aimed to observe and ascertain MDM-concordant and discordant elements that may exist within a tertiary-setting HIV clinic care model for patients living with HIV or AIDS (PLWHA). We also aimed to identify lessons learned from this setting to inform improving the feasibility and usefulness of MDM care model. METHODS: This qualitative case study occurred in multidisciplinary HIV comprehensive-care clinic within an urban tertiary-medical center. Participants included Adult PLWHA and informal caregivers (e.g. family/friends) attending the clinic for regular appointments were recruited. All clinic staff were eligible for recruitment. Measurements included; semi-guided interviews with patients, caregivers, or both; semi-guided interviews with varied clinicians (individually); and direct observations of clinical encounters (patient-clinicians), as well as staff daily operations in 2015-2017. The qualitative-data synthesis used iterative, mainly inductive thematic coding. RESULTS: Researcher interviews and observations data included 28 patients, 5 caregivers, and 14 care-team members. With few exceptions, the clinic care model elements aligned closely to the MDM model of care through supporting patient capacity/abilities (with some patients receiving minimal social support and limited assistance with reframing their biography) and minimizing workload/demands (with some patients challenged by the clinic hours of operation). CONCLUSIONS: The studied HIV clinic incorporated many of the MDM tenants, contributing to its validation, and informing gaps in knowledge. While these findings may support the design and implementation of care that is both minimally disruptive and maximally supportive, the impact of MDM on patient-important outcomes and different care settings require further studying.


Assuntos
Assistência à Saúde , Infecções por HIV , Medicina , Adulto , Feminino , HIV , Infecções por HIV/terapia , Humanos , Masculino , Pesquisa Qualitativa , Qualidade de Vida
7.
JAMA Netw Open ; 4(1): e2033115, 2021 01 04.
Artigo em Inglês | MEDLINE | ID: mdl-33439263

RESUMO

Importance: Patients will decide whether to adopt remote digital monitoring (RDM) for diabetes by weighing its health benefits against the inconvenience it may cause. Objective: To identify the minimum effectiveness patients report they require to adopt 36 different RDM scenarios. Design, Setting, and Participants: This survey study was conducted among adults with type 1 or type 2 diabetes living in 30 countries from February to July 2019. Exposures: Survey participants assessed 3 randomly selected scenarios from a total of 36. Scenarios described different combinations of digital monitoring tools (glucose, physical activity, food monitoring), duration and feedback loops (feedback in consultation vs real-time telefeedback by a health care professional or by artificial intelligence), and data handling modalities (by a public vs private company), reflecting different degrees of RDM intrusiveness in patients' personal lives. Main Outcomes and Measures: Participants assessed the minimum effectiveness for 2 diabetes-related outcomes (reducing hypoglycemic episodes and preventing ophthalmologic complications) for which they would adopt each RDM (from much less effective to much more effective than their current monitoring). Results: Of 1577 individuals who consented to participate, 1010 (64%; 572 [57%] women, median [interquartile range] age, 51 [37-63] years, 524 [52%] with type 1 diabetes) assessed at least 1 vignette. Overall, 2860 vignette assessments were collected. In 1025 vignette assessments (36%), participants would adopt RDM only if it was much more effective at reducing hypoglycemic episodes compared with their current monitoring; in 1835 assessments (65%), participants would adopt RDM if was just as or somewhat more effective. The main factors associated with required effectiveness were food monitoring (ß = 0.32; SE, 0.12; P = .009), real-time telefeedback by a health care professional (ß = 0.49; SE, 0.15; P = .001), and perceived intrusiveness (ß = 0.36; SE, 0.06; P < .001). Minimum required effectiveness varied among participants; 34 of 36 RDM scenarios (94%) were simultaneously required to be just as or less effective by at least 25% of participants and much more effective by at least 25% of participants. Results were similar for participant assessments of scenarios regarding the prevention of ophthalmologic complications. Conclusions and Relevance: The findings of this study suggest that patients require greater health benefits to adopt more intrusive RDM modalities, food monitoring, and real-time feedback by a health care professional. Patient monitoring devices should be designed to be minimally intrusive. The variability in patients' requirements points to a need for shared decision-making.


Assuntos
Diabetes Mellitus/terapia , Monitorização Ambulatorial/métodos , Aceitação pelo Paciente de Cuidados de Saúde , Adulto , Inteligência Artificial , Automonitorização da Glicemia , Dieta , Exercício Físico , Feminino , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários
8.
Mayo Clin Proc ; 2021 Jan 19.
Artigo em Inglês | MEDLINE | ID: mdl-33487438

RESUMO

OBJECTIVE: To assess the relationship between remote digital monitoring (RDM) modalities for diabetes and intrusiveness in patients' lives. PATIENTS AND METHODS: Online vignette-based survey (February 1 through July 1, 2019). Adults with diabetes (type 1, 2, or subtypes such as latent autoimmune diabetes of adulthood) assessed three randomly selected vignettes among 36 that combined different modalities for monitoring tools (three options: glucose- and physical activity [PA]-monitoring only, or glucose- and PA-monitoring with occasional or regular food monitoring), duration/feedback loops (six options: monitoring for a week before all vs before specific consultations with feedback given in consultation, vs monitoring permanently, with real-time feedback by one's physician vs by anoter caregiver, vs monitoring permanently, with real-time, artificial intelligence-generated treatment feedback vs treatment and lifestyle feedback), and data handling (two options: by the public vs private sector). We compared intrusiveness (assessed on a 5-point scale) across vignettes and used linear mixed models to identify intrusiveness determinants. We collected qualitative data to identify aspects that drove participants' perception of intrusiveness. RESULTS: Overall, 1010 participants from 30 countries provided 2860 vignette-assessments (52% were type 1 diabetes). The monitoring modalities associated with increased intrusiveness were food monitoring compared with glucose- and PA-monitoring alone (ß=0.34; 95% CI, 0.26 to 0.42; P<.001) and permanent monitoring with real-time physician-generated feedback compared with monitoring for a week with feedback in consultation (ß=0.25; 95% CI, 0.16 to 0.34, P<.001). Public-sector data handling was associated with decreased intrusiveness as compared with private-sector (ß=-0.15; 95% CI, -0.22 to -0.09; P<.001). Four drivers of intrusiveness emerged from the qualitative analysis: practical/psychosocial burden (eg, RDM attracting attention in public), control, data safety/misuse, and dehumanization of care. CONCLUSION: RDM is intrusive when it includes food monitoring, real-time human feedback, and private-sector data handling.

9.
BMJ Open ; 10(12): e044395, 2020 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-33268435

RESUMO

OBJECTIVES: Despite increasing focus on individualised diabetes management, current diabetes quality measures are based on meeting generic haemoglobin A1c thresholds and do not reflect considerations of clinical complexity, hypoglycaemic susceptibility or treatment burden. Our team observed a multidisciplinary stakeholder panel tasked with informing an appropriate diabetes therapy indicator (ADTI) and analysed their deliberations, seeking to understand what constitutes appropriate diabetes therapy and how it can be captured using an operational quality indicator. We focused specifically on factors the panel valued in an ideal indicator, how they defined appropriateness and how they thought an indicator of appropriateness could be operationalised. DESIGN: Qualitative study examining Delphi panel deliberations as it iteratively refined the ADTI. PARTICIPANTS AND METHODS: The 12-member panel was comprised of clinicians (endocrinology, primary care, geriatrics), pharmacists, nurses, researchers, and representatives of public and private health plans. It met for four teleconference calls and deliberated asynchronously using semi-structured questionnaires following each call to develop the ADTI. These semistructured questionnaires, as well as the meeting minutes, were then analysed using an inductive thematic approach. RESULTS: We identified three themes in panellist discussions that represented the core value systems underpinning the indicator and its formation: (1) promoting individualised, evidence-based and equitable care; (2) balancing autonomy and prescriptiveness in clinical decision-making; and (3) ensuring an accurate, reliable and practical indicator. These three principles were operationalised into definitions of treatment intensity and clinical complexity, and yielded an indicator that participants judged both fair and effective. CONCLUSIONS: Better understanding of what multidisciplinary stakeholders perceive as appropriate diabetes management can help develop quality indicators that are patient-centred, evidence-based, equitable and pragmatic across a range of clinical settings.

10.
BMJ Open ; 10(12): e040699, 2020 12 15.
Artigo em Inglês | MEDLINE | ID: mdl-33323437

RESUMO

BACKGROUND: There has been limited research on the positive aspects of physician wellness and to our knowledge there have been no validity studies on measures of resilience and grit among internal medicine (IM) residents. OBJECTIVES: To investigate the validity of resilience (10 items Connor-Davidson Resilience Scale (CD-RISC 10)) and grit (Short Grit Scale (GRIT-S)) scores among IM residents at a large academic centre, and assess potential associations with previously validated measures of medical knowledge, clinical performance and professionalism. METHODS: We evaluated CD-RISC 10 and GRIT-S instrument scores among IM residents at the Mayo Clinic Rochester, Minnesota between July 2017 and June 2019. We analysed dimensionality, internal consistency reliability and criterion validity in terms of relationships between resilience and grit, with standardised measures of residents' medical knowledge (in-training examination (ITE)), clinical performance (faculty and peer evaluations and Mini-Clinical Evaluation Examination (mini-CEX)) and professionalism/dutifulness (conference attendance and evaluation completion). RESULTS: A total of 213 out of 253 (84.2%) survey-eligible IM residents provided both CD-RISC 10 and GRIT-S survey responses. Internal consistency reliability (Cronbach alpha) was excellent for CD-RISC 10 (0.93) and GRIT-S (0.82) overall, and for the GRIT subscales of consistency of interest (0.84) and perseverance of effort (0.71). CD-RISC 10 scores were negatively associated with ITE percentile (ß=-3.4, 95% CI -6.2 to -0.5, p=0.02) and mini-CEX (ß=-0.2, 95% CI -0.5 to -0.02, p=0.03). GRIT-S scores were positively associated with evaluation completion percentage (ß=2.51, 95% CI 0.35 to 4.67, p=0.02) and conference attendance (ß=2.70, 95% CI 0.11 to 5.29, p=0.04). CONCLUSIONS: This study revealed favourable validity evidence for CD-RISC 10 and GRIT-S among IM residents. Residents demonstrated resilience within a competitive training environment despite less favourable test performance and grittiness that was manifested by completing tasks. This initial validity study provides a foundation for further research on resilience and grit among physicians in training.

12.
Thyroid ; 2020 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-33176609

RESUMO

BACKGROUND: The use of prescribed medications during pregnancy is a challenge and an underestimated source of treatment burden. Levothyroxine (LT4) for the treatment of overt and subclinical hypothyroidism is extensively prescribed during pregnancy. To this end, we aimed to explore the patients' perceived benefits and risks, knowledge, beliefs, attitudes, and related burden of LT4 therapy during pregnancy. METHODS: In this cross-sectional study, we surveyed pregnant women who were treated with LT4 during pregnancy from January 1, 2019, to December 31, 2019, in a tertiary academic medical center of the U.S. The anonymous online survey included questions to gather demographic data and multiple-choice questions regarding the benefits and risks, knowledge, beliefs, attitudes, and burden related to LT4 use during pregnancy. RESULTS: Sixty-four pregnant women (mean age 31.5 years) completed the study survey (response rate: 96%): 62% were diagnosed with hypothyroidism more than 12 months before pregnancy, 16% less than or about 12 months before pregnancy, and 22% during pregnancy. We found that one-third of pregnant women using LT4 had a feeling of uneasiness/anxiety due to their hypothyroidism diagnosis. More than half of the respondents (53%) reported that they did not receive an explanation by their clinician regarding the maternofetal risks of uncontrolled hypothyroidism or the benefits of adequate control. Finally, two in three patients expressed various concerns of LT4-related treatment burden. CONCLUSIONS: Our findings support the need for increased, effective communication and tailored counseling to address fears, anxiety, and uncertainties about the benefits and risks of LT4 use in pregnancy. For patients with clear benefits from LT4 treatment in pregnancy, it could help to overcome their concerns, promote adherence, and decrease adverse maternofetal outcomes. For patients with no clear benefits established, clinicians need to be aware of LT4-related treatment burden in pregnancy and implement patient-centered approaches in their clinical practices.

13.
J Clin Epidemiol ; 129: 104-113, 2020 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-33049326

RESUMO

OBJECTIVES: The objective of the study was to develop and test feasibility of a framework of patient-important practical issues. STUDY DESIGN AND SETTING: Guidelines and shared decision-making tools help facilitate discussions about patient-important outcomes of care alternatives, but typically ignore practical issues patients consider when implementing care into their daily routines. Using grounded theory, practical issues in the HealthTalk.org registry and in Option Grids were identified and categorized into a framework. We integrated the framework into the MAGIC authoring and publication platform and digitally structured authoring and publication platform and appraised its use in The BMJ Rapid Recommendations. RESULTS: The framework included the following 15 categories: medication routine, tests and visits, procedure and device, recovery and adaptation, coordination of care, adverse effects, interactions and antidote, physical well-being, emotional well-being, pregnancy and nursing, costs and access, food and drinks, exercise and activities, social life and relationships, work and education, travel and driving. Implementation in 15 BMJ Rapid Recommendations added 283 issues to 35 recommendations. The most frequently used category was procedure and device, and the least frequent was social life and relationship. CONCLUSION: Adding practical issues systematically to evidence summaries is feasible and can inform guidelines and tools for shared decision-making. How this inclusion can improve patient-centered care remains to be determined.

14.
PLoS One ; 15(10): e0241485, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33125426

RESUMO

BACKGROUND: The burden of treatment can overwhelm people living with type 2 diabetes and lead to poor treatment fidelity and outcomes. Chronic care programs must consider and mitigate the burden of treatment while supporting patients in achieving their goals. OBJECTIVE: To explore what patients with type 2 diabetes and their health providers consider are the workload and the resources they must mobilize, i.e., their capacity, to shoulder it. METHODS: We conducted focus groups comprised of 30 patients and 32 clinicians from three community health centers in Chile implementing the Chronic Care Model to reduce cardiovascular risk in patients with type 2 diabetes. Transcripts were analyzed using thematic content analysis techniques illuminated by the Minimally Disruptive Medicine framework. FINDINGS: Gaining access to and working with their clinicians, implementing complex medication regimens, and changing lifestyles burdened patients. To deal with the distress of the diagnosis, difficulties achieving disease control, and fear of complications, patients drew capacity from their family (mostly men), social environment (mostly women), lay expertise, and spirituality. Clinicians found that administrative tasks, limited formulary, and protocol rigidity hindered their ability to modify care plans to reduce patient workload and support their capacity. CONCLUSIONS: Chronic primary care programs burden patients living with type 2 diabetes while hindering clinicians' ability to reduce treatment workloads or support patient capacity. A collaborative approach toward Minimally Disruptive Medicine may result in treatments that fit the lives and loves of patients and improve outcomes.

15.
Wellcome Open Res ; 5: 23, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32923686

RESUMO

Background: Three previous clinical trials have found that thermometry use reduced diabetic foot ulcers (DFUs) incidence four- to ten-fold among individuals with diabetes at high-risk of developing a DFU. However, these benefits depend on patient adherence to self-assessment. Therefore, novel approaches to improve self-management thermometry adherence are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders intervention arm vs. thermometry-only control arm. Methods: We conducted a randomized trial, enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) groups and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted. Results: A total of 172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group. More patients enrolled in the intervention arm had a history of DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the Hazard Ratio (HR) for DFU was 1.44 (95% CI 0.65, 3.22). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook, with no difference between the intervention and control arms. Conclusions: This trial contributes to the evidence about the value of mHealth in preventing diabetes foot ulcers. Trial registration: ClinicalTrials.gov NCT02373592 (27/02/2015).

16.
Endocrine ; 2020 Sep 21.
Artigo em Inglês | MEDLINE | ID: mdl-32959229

RESUMO

PURPOSE: Currently available randomized trial evidence has shown no reductions in type 2 diabetes (T2D) complications important to patients with tight glycemic control. Yet, economic analyses consistently find tight glycemic control to be cost-effective. To understand this apparent paradox, we systematically identified and appraised economic analyses of tight glycemic control for T2D. METHODS: We searched multiple databases from January 2016 to January 2018 for cost-effectiveness or cost-utility analyses of any glucose-lowering treatments for adults with T2D using simulations with long-40 years to lifetime-time horizons. Reviewers selected and appraised each study independently and in duplicate with good reproducibility. RESULTS: We found 30 analyses, most comparing the glycemic impact of glucose-lowering drugs and applying their impact on HbA1c to model (most commonly IMS CORE or Cardiff T2DM) their impact on the incidence of diabetes-related complication. Models drew from observational evidence of the correlation of HbA1c levels and diabetes-related complication rates; none used estimates of the effect of lowering HbA1c on these outcomes from systematic reviews of randomized trials. Sensitivity analyses, when conducted, demonstrate substantial loss of cost-effectiveness as simulations approach the results seen in these trials. CONCLUSIONS: Reliance on the association between glycemic control and diabetes-related complications evident in observational studies but not apparent in randomized trial bias the estimates of the cost-effectiveness of interventions to improve glycemic control.

17.
JAMA Intern Med ; 180(9): 1215-1224, 2020 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-32897386

RESUMO

Importance: Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear. Objective: To assess the extent to which the use of an SDM tool affects the quality of SDM and anticoagulant treatment decisions in at-risk patients with AF. Design, Setting, and Participants: This encounter-randomized trial recruited patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019. Encounters were randomized to either the standard care arm or care that included the use of an SDM tool (intervention arm). Data were analyzed from August 1 to November 30, 2019. Interventions: Standard care or care using the Anticoagulation Choice Shared Decision Making tool (which presents individualized risk estimates and compares anticoagulant treatment options across issues of importance to patients) during the clinical encounter. Main Outcomes and Measures: Quality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process. Results: The clinical trial enrolled 922 patients (559 men [60.6%]; mean [SD] age, 71 [11] years) and 244 clinicians. A total of 463 patients were randomized to the intervention arm and 459 patients to the standard care arm. Participants in both arms reported high communication quality, high knowledge, and low decisional conflict, demonstrated low accuracy in their risk perception, and would similarly recommend the approach used in their encounter. Clinicians were significantly more satisfied after intervention encounters (400 of 453 encounters [88.3%] vs 277 of 448 encounters [61.8%]; adjusted relative risk, 1.49; 95% CI, 1.42-1.53). A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication. Patient involvement in decision-making (as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale) scores were significantly higher in the intervention arm (mean [SD] score, 33.0 [10.8] points vs 29.1 [13.1] points, respectively; adjusted mean difference, 4.2 points; 95% CI, 2.8-5.6 points). No significant between-arm difference was found in encounter duration (mean [SD] duration, 32 [16] minutes in the intervention arm vs 31 [17] minutes in the standard care arm; adjusted mean between-arm difference, 1.1; 95% CI, -0.3 to 2.5 minutes). Conclusion and Relevance: The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration. These results help to calibrate expectations about the value of implementing SDM tools in the care of patients with AF. Trial Registration: ClinicalTrials.gov Identifier: NCT02905032.

18.
Mayo Clin Proc Innov Qual Outcomes ; 4(4): 416-423, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32793869

RESUMO

Objective: To determine how shared decision-making (SDM) tools used during clinical encounters that raise cost as an issue impact the incidence of cost conversations between patients and clinicians. Patients and Methods: A randomly selected set of 220 video recordings of clinical encounters were analyzed. Videos were obtained from eight practice-based randomized clinical trials and one quasi-randomized clinical trial (pre- and post-) comparing care with and without SDM tools. The secondary analysis took place in 2018 from trials ran between 2007 and 2015. Results: Most patient participants were white (85%), educated (38% completed college), middle-aged (mean age 56 years), and female (61%). There were 105 encounters with and 115 without the SDM tool. Encounters with SDM tools were more likely to include both general cost conversations (62% vs 36%, odds ratio [OR]: 9.6; 95% CI: 4 to 26) as well as conversations on medication costs specifically (89% vs 51%, P=.01). However, clinicians using SDM tools were less likely to address cost issues during the encounter (37% vs 51%, P=.04). Encounters with patients with less than a college degree were also associated with a higher incidence of cost conversations. Conclusion: Using SDM tools that raise cost as an issue increased the occurrence of cost conversations but was less likely to address cost issues or offer potential solutions to patients' cost concerns. This result suggests that SDM tools used during the consultation can trigger cost conversations but are insufficient to support them.

19.
Ann Intern Med ; 173(4): JC18, 2020 08 18.
Artigo em Inglês | MEDLINE | ID: mdl-32805173

RESUMO

SOURCE CITATION: Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382:1507-19. 32187462.

20.
Patient Educ Couns ; 103(10): 2192-2199, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32636085

RESUMO

OBJECTIVE: Generalized shared decision making (SDM) describes the involvement of patients in choosing options. However, there are many situations in which patients and clinicians make decisions together that don't focus on choosing between options, e.g. problem-solving dialysis and insulin use while traveling. Poor uptake associated with clinicians' perception that SDM doesn't apply to clinical situations they face may reflect the lack of adaptation of generalized SDM approaches to patients' problems. The Purposeful SDM schema published in 2019 identifies problems for which different kinds of SDM are appropriate. METHODS: The U.S. Agency for Healthcare Research and Quality developed SHARE as a generalized SDM approach. We sought to adapt SHARE to the different problems that patients face using a matrix to relate SHARE steps and Purposeful SDM modes and describe changes in generalized concepts and practices of SDM across these modes. RESULTS: Many SHARE communicative behaviors applied across modes, although the meaning of SDM terms and practices, e.g. patients involved as problem solvers versus experts, varied substantially. CONCLUSION: Aspects of SHARE require adaptation to different patient problems. PRACTICE IMPLICATIONS: SDM in education, practice, and tools may be supported by adapting generalized SDM approaches to patients' problems.

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