Gastric bypass surgery vs intensive lifestyle and medical intervention for type 2 diabetes: the CROSSROADS randomised controlled trial.

AIMS/HYPOTHESIS: Mounting evidence indicates that Roux-en-Y gastric bypass (RYGB) ameliorates type 2 diabetes, but randomised trials comparing surgical vs nonsurgical care are needed. With a parallel-group randomised controlled trial (RCT), we compared RYGB vs an intensive lifestyle and medical intervention (ILMI) for type 2 diabetes, including among patients with a BMI <35 kg/m(2). METHODS: By use of a shared decision-making recruitment strategy targeting the entire at-risk population within an integrated community healthcare system, we screened 1,808 adults meeting inclusion criteria (age 25-64, with type 2 diabetes and a BMI 30-45 kg/m(2)). Of these, 43 were allocated via concealed, computer-generated random assignment in a 1:1 ratio to RYGB or ILMI. The latter involved ≥45 min of aerobic exercise 5 days per week, a dietitian-directed weight- and glucose-lowering diet, and optimal diabetes medical treatment for 1 year. Although treatment allocation could not be blinded, outcomes were determined by a blinded adjudicator. The primary outcome was diabetes remission at 1 year (HbA1c <6.0% [<42.1 mmol/mol], off all diabetes medicines). RESULTS: Twenty-three volunteers were assigned to RYGB and 20 to ILMI. Of these, 11 withdrew before receiving any intervention. Hence 15 in the RYGB group and 17 in the IMLI group were analysed throughout 1 year. The groups were equivalent regarding all baseline characteristics, except that the RYGB cohort had a longer diabetes duration (11.4 ± 4.8 vs 6.8 ± 5.2 years, p = 0.009). Weight loss at 1 year was 25.8 ± 14.5% vs 6.4 ± 5.8% after RYGB vs ILMI, respectively (p < 0.001). The ILMI exercise programme yielded a 22 ± 11% increase in [Formula: see text] (p<0.0001), whereas [Formula: see text] after RYGB was unchanged. Diabetes remission at 1 year was 60.0% with RYGB vs 5.9% with ILMI (p = 0.002). The HbA1c decline over 1 year was only modestly more after RYGB than ILMI: from 7.7 ± 1.0% (60.7 mmol/mol) to 6.4 ± 1.6% (46.4 mmol/mol) vs 7.3 ± 0.9% (56.3 mmol/mol) to 6.9 ± 1.3% (51.9 mmol/mol), respectively (p = 0.04); however, this drop occurred with significantly fewer or no diabetes medications after RYGB. No life-threatening complications occurred. CONCLUSIONS/INTERPRETATION: Compared with the most rigorous ILMI yet tested against surgery in a randomised trial, RYGB yielded greater type 2 diabetes remission in mild-to-moderately obese patients recruited from a well-informed, population-based sample. TRIAL REGISTRATION: ClinicalTrials.gov NCT01295229.

Learning About Missing Data Mechanisms in Electronic Health Records-based Research: A Survey-based Approach.

BACKGROUND: Bias due to missing data is a major concern in electronic health record (EHR)-based research. As part of an ongoing EHR-based study of weight change among patients treated for depression, we conducted a survey to investigate determinants of missingness in the available weight information and to evaluate the missing-at-random assumption. METHODS: We identified 8,345 individuals enrolled in a large EHR-based health care system who had monotherapy treatment for depression from April 2008 to March 2010. A stratified sample of 1,153 individuals completed a detailed survey. Logistic regression was used to investigate determinants of whether a patient (1) had an opportunity to be weighed at treatment initiation (baseline), and (2) had a weight measurement recorded. Parallel analyses were conducted to investigate missingness during follow-up. Throughout, inverse-probability weighting was used to adjust for the design and survey nonresponse. Analyses were also conducted to investigate potential recall bias. RESULTS: Missingness at baseline and during follow-up was associated with numerous factors not routinely collected in the EHR including whether or not the patient had ever chosen not to be weighed, external weight control activities, and self-reported baseline weight. Patient attitudes about their weight and perceptions regarding the potential impact of their depression treatment on weight were not related to missingness. CONCLUSION: Adopting a comprehensive strategy to investigate missingness early in the research process gives researchers information necessary to evaluate key assumptions. While the survey presented focuses on outcome data, the overarching strategy can be applied to any and all data elements subject to missingness.

Pragmatic Randomized Study of Targeted Text Message Reminders to Reduce Missed Clinic Visits.

INTRODUCTION: Missed clinic appointments ("no-shows") waste health system resources, decrease physician availability, and may worsen patient outcomes. Appointment reminders reduce no-shows, though evidence on the optimal number of reminders is limited and sending multiple reminders for every visit is costly. Risk prediction models can be used to target reminders for visits that are likely to be missed. METHODS: We conducted a randomized quality improvement project at Kaiser Permanente Washington among patients with primary care and mental health visits with a high no-show risk comparing the effect of one text message reminder (sent 2 business days prior to the appointment) with 2 text message reminders (sent 2 and 3 days prior) on no-shows and same-day cancellations. We estimated the relative risk (RR) of an additional reminder using G-computation with logistic regression adjusted for no-show risk. RESULTS: Between February 27, 2019 and September 23, 2019, a total of 125,076 primary care visits and 33,593 mental health visits were randomized to either 1 or 2 text message reminders. For primary care visits, an additional text message reduced the chance of no-show by 7% (RR = 0.93, 95% CI: 0.89-0.96) and same-day cancellations by 6% (RR = 0.94, 95% CI: 0.90-0.98). In mental health visits, an additional text message reduced the chance of no-show by 11% (RR = 0.89, 95% CI: 0.86-0.93) but did not impact same-day cancellations (RR = 1.02, 95% CI: 0.96-1.11). We did not find effect modification among subgroups defined by visit or patient characteristics. CONCLUSION: Study findings indicate that using a prediction model to target reminders may reduce no-shows and spend health care resources more efficiently.

Exploring Provider Reactions to Decision Aid Distribution and Shared Decision Making: Lessons from Two Specialties.

BACKGROUND: A critical component of shared decision making (SDM) is the role played by health care providers in distributing decision aids (DAs) and initiating SDM conversations. Existing literature indicates that decisions about designing and implementing DAs must take provider perspectives into account. However, little is known about how differences in provider attitudes across specialties may impact DA implementation and how provider attitudes may shift after DA implementation. Group Health's Decision Aid Implementation project was carried out in six specialties using 12 video-based DAs for preference-sensitive conditions; this study focused on two of the six specialties. DESIGN: In-depth, qualitative interviews with specialty care providers in two specialties-orthopedics and cardiology-at two time points during DA implementation. Data were analyzed using a thematic analysis approach. RESULTS: We interviewed 19 care providers in orthopedics and cardiology. All respondents believed that providing patients with accurate information on their health conditions and treatment options was important and that most patients wanted an active role in decision making. However, respondents diverged in decision-making styles and views on the practicality and appropriateness of using the DAs and SDM. For example, cardiology specialists were ambivalent about DAs for coronary artery disease because many viewed DAs and SDM as unnecessary or inappropriate for this clinical condition. Provider attitudes towards DAs and SDM were generally stable over two years. LIMITATIONS: Limitations include a lack of patient perspectives, social desirability bias, and possible selection bias. CONCLUSIONS: Successfully implementing DAs in clinical practice to promote SDM requires addressing individual provider attitudes, beliefs, and knowledge of SDM by specialty. During DA development and implementation, providers should be asked for input about the specific conditions and care processes that are most appropriate for SDM.

Long-Term Weight Change after Initiating Second-Generation Antidepressants.

(1) OBJECTIVE: To examine the relationship between the choice of second-generation antidepressant drug treatment and long-term weight change; (2) METHODS: We conducted a retrospective cohort study to investigate the relationship between choice of antidepressant medication and weight change at two years among adult patients with a new antidepressant treatment episode between January, 2006 and October, 2009 in a large health system in Washington State. Medication use, encounters, diagnoses, height, and weight were collected from electronic databases. We modeled change in weight and BMI at two years after initiation of treatment using inverse probability weighted linear regression models that adjusted for potential confounders. Fluoxetine was the reference treatment; (3) RESULTS: In intent-to-treat analyses, non-smokers who initiated bupropion treatment on average lost 7.1 lbs compared to fluoxetine users who were non-smokers (95% CI: -11.3, -2.8; p-value < 0.01); smokers who initiated bupropion treatment gained on average 2.2 lbs compared to fluoxetine users who were smokers (95% CI: -2.3, 6.8; p-value = 0.33). Changes in weight associated with all other antidepressant medications were not significantly different than fluoxetine, except for sertraline users, who gained an average of 5.9 lbs compared to fluoxetine users (95% CI: 0.8, 10.9; p-value = 0.02); (4) CONCLUSION: Antidepressant drug therapy is significantly associated with long-term weight change at two years. Bupropion may be considered as the first-line drug of choice for overweight and obese patients unless there are other existing contraindications.

Antipsychotic medications and extreme weight gain in two health systems.

OBJECTIVE: We conducted this study to investigate the rate of clinically important, extreme weight gain (EWG; ≥7% body weight gain) among all second generation antipsychotic (SGA) users in two large health care systems in the United States. STUDY DESIGN: Retrospective observational cohort study. METHODS: We used electronic medical record databases of two health systems to identify adults aged 18-79 years who from 1 January 2004 to 31 December 2011 had initiated a SGA medication. All patients had to have a minimum of two weight measures in the medical record: (1) one or more weights in the 180-day pre-treatment (baseline) period; and (2) one or more weights in the first year after initiating SGA treatment. RESULTS: We found that EWG occurred in 7.7-17.0% of SGA users. At one year, the average weight gain was nearly 10kg among SGA users who experienced EWG. Olanzapine was the SGA most commonly associated with EWG with a rate of 17.0 per 100 users [95% confidence interval (CI): 14.2-20.5], while ziprasidone was least commonly associated with EWG (7.7 per 100 users; 95% CI: 4.6-13.0). CONCLUSIONS: We found that clinically-important weight gain was common after the initiation of SGA treatment, and the EWG phenotype was easily identifiable within electronic medical records. There was significant heterogeneity in the rate of EWG across SGA medications. Weight gains of this magnitude are likely to have adverse health consequences and there is a significant unmet opportunity for physicians to identify these events and mitigate the harms of SGA use.

Improvements in glycemic control after gastric bypass occur despite persistent adipose tissue inflammation.

OBJECTIVE: Type 2 diabetes commonly goes into remission following Roux-en-Y gastric bypass (RYGB). As the mechanisms remain incompletely understood, a reduction in adipose tissue inflammation may contribute to these metabolic improvements. Therefore, whether RYGB reduces adipose tissue inflammation compared with equivalent weight loss from an intensive lifestyle intervention was investigated. METHODS: Sixteen people with obesity and type 2 diabetes were randomized to RYGB or lifestyle intervention. Fasting blood and subcutaneous abdominal adipose tissue were obtained before and after the loss of ∼7% of baseline weight. Adipose tissue inflammation was assessed by whole-tissue gene expression and flow cytometry-based quantification of tissue leukocytes. RESULTS: At 7% weight loss, insulin and metformin use were reduced among the RYGB but not the Lifestyle cohort, while fasting glucose and insulin declined in both. Adipose tissue inflammation increased modestly after RYGB and to a similar extent following nonsurgical weight loss. In both groups, the number of neutrophils increased severalfold (P < 0.001), mRNA levels of the proinflammatory cytokine interleukin-1ß increased (P = 0.037), and mRNA expression of the anti-inflammatory and insulin-sensitizing adipokine adiponectin decreased (P = 0.010). CONCLUSIONS: A reduction in adipose tissue inflammation is not one of the acute weight loss-independent mechanisms through which RYGB exerts its antidiabetes effects.

Decision aids for benign prostatic hyperplasia and prostate cancer.

OBJECTIVES: To examine the relationships among implementing decision aids (DAs) for benign prostatic hyperplasia (BPH) and prostate cancer (PRCA), and treatment rates and costs. STUDY DESIGN: A pre-post observational evaluation of a quality improvement initiative in a healthcare system in Washington state. METHODS: Men with BPH seen in urology clinics and all men diagnosed with localized PRCA were identified for an intervention period, in which urologists were instructed to order a DA for every patient with those conditions, and a historical control period. Outcomes were 6-month rates of surgery for BPH, any active treatment (hormone therapy, radiation, or surgery) for PRCA, and total healthcare costs. Results During the intervention, DAs were delivered to 22% of men with recent BPH drug treatment, 24% of men with untreated BPH, and 56% of men with PRCA. DA implementation was associated with a 32% lower rate of surgery among men with treated BPH (rate ratio [RR], 0.68; 95% CI, 0.49-0.94) and a nonsignificant 22% lower rate of surgery among men with previously untreated BPH (RR, 0.78; 95% CI, 0.50-1.22). For PRCA, DA implementation was associated with a 27% lower rate of active treatment (RR, 0.73; 95% CI, 0.57-0.93). We found no significant associations between DA implementation and costs of care for either condition. CONCLUSIONS: Implementing patient DAs was associated with lower rates of elective surgery for previously treated BPH and active treatment for localized PRCA; however, implementation of these DAs was not associated with lower costs of care.

Weight control practices of severely obese patients who are not seeking bariatric surgery.

OBJECTIVE: We sought to better understand why so few severely obese patients undergo bariatric surgery in the United States. DESIGN AND METHODS: We conducted a telephone survey to assess the weight control practices of severely obese patients who were not actively seeking bariatric surgery in Group Health, a health system in Washington State. RESULTS: Among 295 severely obese participants surveyed (63% response rate), most reported actively working on weight loss (58%), although current use of commercial weight loss programs (10%) and obesity pharmacotherapy (0.1%) was low. Household income and white race were strongly associated with lifetime use of commercial programs, suggesting a possible disparity in use of effective treatment for obesity. Many were interested in learning more about bariatric surgery (49%) and pharmacotherapy (53%), but few had ever discussed surgery (26%) or pharmacotherapy (33%) with their physician. Finally, although only 29% had coverage for bariatric surgery, those with coverage were not more likely to have discussed bariatric surgery with their physician. CONCLUSIONS: Overall, our survey of severely obese patients who are not currently seeking bariatric surgery suggests that interest in obesity treatments is high, coverage and receipt of treatment is low, and that there is a potential socioeconomic disparity related to the use of commercial programs.

Incorporating patient decision aids into standard clinical practice in an integrated delivery system.

BACKGROUND: Randomized controlled trials show that patient decision aids (DAs) can promote shared decision making and improve decision quality. Despite this evidence, integration of DAs into routine clinical practice has proceeded slowly. OBJECTIVE: To identify factors that promote or impede integrating DAs into clinical practice in a large health care delivery system. DESIGN: Mixed-methods case study. SETTING AND PATIENTS: Group Health, an integrated health plan and care delivery system in Washington state. Intervention. The project was carried out in 6 specialty service lines using 12 video-based DAs for preference-sensitive conditions related to elective surgical procedures. MEASUREMENTS: Process data, site visits, meeting observations, and in-depth interviews conducted with clinical staff, project staff, and health plan leaders in 2009 and 2010. RESULTS: The project established systemwide and clinic-specific processes that facilitated the distribution of approximately 10,000 DAs over 2 years. Several factors were identified as important for success in this implementation, including strong support from senior leaders, establishing a system for previsit ordering and providing timely feedback to teams about distribution rates, engaging providers and staff in development of the implementation process, and finding ways to address concerns about conditions that were perceived as life-threatening and/or time sensitive. LIMITATIONS: Limitations included lack of data on patient perspectives, an implementation setting with salaried providers, and frontline provider interviews conducted in only selected service lines. CONCLUSIONS: With strong leadership, financial support, and a well-defined implementation strategy, 12 video-based DAs in 6 specialty service lines were integrated into routine practice over 2 years. Findings from this demonstration may advance the ability of other organizations to use DAs effectively and promote widespread adoption of shared decision making in routine patient care.

A population-based, shared decision-making approach to recruit for a randomized trial of bariatric surgery versus lifestyle for type 2 diabetes.

BACKGROUND: Randomized trials of bariatric surgery versus lifestyle treatment likely enroll highly motivated patients, which may limit the interpretation and generalizability of study findings. The objective of this study was to assess the feasibility of a population-based shared decision-making (SDM) approach to recruitment for a trial comparing laparoscopic Roux-en-Y gastric bypass surgery with intensive lifestyle intervention among adults with mild to moderate obesity and type 2 diabetes. METHODS: Adult members with a body mass index (BMI) between 30 and 45 kg/m(2) taking diabetes medications were identified in electronic databases and underwent a multiphase screening process. Candidates were given a telephone survey, education about treatment options for obesity and diabetes using decision aids, and an SDM phone call with a nurse practitioner, in addition to standard office-based consent. RESULTS: We identified 1808 members, and 828 (45.7%) had a BMI of 30-34.9 kg/m(2). Among these, 1063 (59%) agreed to the telephone survey, 416 (23%) expressed interest in education about treatment options, and 277 (15%) completed the SDM process. The preferred treatment options were surgery (21 [8%]), diet and exercise (149 [53.8%]), pharmacotherapy (5 [2%]), none of the above (8 [3%]), and unsure (94 [34%]). Ultimately, 43 participants were randomly assigned to the trial. Significant differences, mainly related to sex, disease severity, and hypoglycemic medication use, were observed among people who did and did not agree to participate in our trial. CONCLUSION: This population-based, SDM-based recruitment strategy successfully identified, enrolled, and randomly assigned patients who had balanced views of surgery and lifestyle management. Even with this approach, selection biases may remain, highlighting the need for careful characterization of nonparticipants in all future studies.

Relationship between obesity, depression, and disability in middle-aged women.

BACKGROUND: Obesity and depression are closely linked, and each has been associated with disability. However, few studies have assessed inter-relationships between these conditions. DESIGN AND METHODS: In this study, 4641 women aged 40-65 completed a structured telephone interview including self-reported height and weight, the Patient Health Questionnaire (PHQ) assessment of depression, and the World Health Organization Disability Assessment Schedule II (WHODAS II). The survey response rate was 62%. We used multivariable regression models to assess relationships between obesity, depression, and disability. RESULTS: The mean age was 52 years; 82% were White; and 80% were currently employed. One percent were underweight, 39% normal weight, 27% overweight, and 34% obese. Mild depressive symptoms were present in 23% and moderate-to-severe symptoms were present in 13%. After multivariable adjustment, depression was a strong independent predictor of worse disability in all 7 domains (cognition, mobility, self-care, social interaction, role functioning, household, and work), but obesity was only a significant predictor of greater mobility, role-functioning, household, and work limitations (P < 0.05) (overweight was not significantly associated with any disability domain). Overall, the effect on disability was stronger and more pervasive for depression than obesity, and there was no significant interaction between the two conditions (P > 0.05). Overweight and obesity were associated with 5760 days of absenteeism per 1000 person-years, and depression was associated with 18,240 days of absenteeism per 1000 person-years. CONCLUSIONS: The strong relationships between depression, obesity and disability suggest that these conditions should be routinely screened and treated among middle-aged women.

Relationship between Obesity, Depression, and Disability in Middle-Aged Women.

BACKGROUND: Obesity and depression are closely linked, and each has been associated with disability. However, few studies have assessed inter-relationships between these conditions. DESIGN AND METHODS: In this study, 4 641 women aged 40-65 completed a structured telephone interview including self-reported height and weight, the Patient Health Questionnaire (PHQ) assessment of depression, and the World Health Organization Disability Assessment Schedule II (WHODAS II). The survey response rate was 62%. We used multivariable regression models to assess relationships between obesity, depression, and disability. RESULTS: The mean age was 52 years; 82% were white; and 80% were currently employed. One percent were underweight, 39% normal weight, 27% overweight, and 34% obese. Mild depressive symptoms were present in 23% and moderate-to-severe symptoms were present in 13%. After multivariable adjustment, depression was a strong independent predictor of worse disability in all 7 domains (cognition, mobility, self-care, social interaction, role functioning, household, and work), but obesity was only a significant predictor of greater mobility, role-functioning, household, and work limitations (P<0.05) (overweight was not significantly associated with any disability domain). Overall, the effect on disability was stronger and more pervasive for depression than obesity, and there was no significant interaction between the two conditions (P>0.05). Overweight and obesity were associated with 5 760 days of absenteeism per 1 000 person-years, and depression was associated with 18 240 days of absenteeism per 1 000 person-years. CONCLUSIONS: The strong relationships between depression, obesity and disability suggest that these conditions should be routinely screened and treated among middle-aged women.

Randomized trial of a video-based patient decision aid for bariatric surgery.

The decision to have bariatric surgery should be based on accurate information on possible risks and benefits of all treatment options. The goal of this study was to determine whether a video-based bariatric decision aid intervention results in superior decision quality compared to an educational booklet. We conducted a prospective, randomized controlled trial among adult patients in a single health plan who met standard criteria for bariatric surgery. Patients were randomly assigned to review either a video-based decision aid (intervention) or an educational booklet on bariatric surgery (control). Changes in patient decision quality were assessed using bariatric-specific measures of knowledge, values, and treatment preference after 3 months. Of 152 eligible participants, 75 were randomly assigned to the intervention and 77 to the control. The 3-month follow-up rate was 95%. Among all participants, significant improvements were observed in knowledge (P < 0.001), values concordance (P = 0.009), decisional conflict (P < 0.001), decisional self-efficacy (P < 0.001), and in the proportion who were "unsure" of their treatment choice (P < 0.001). The intervention group had larger improvements in knowledge (P = 0.03), decisional conflict (P = 0.03), and outcome expectancies (P = 0.001). The proportion of participants choosing bariatric surgery did not differ significantly between groups, although there was a trend toward decreased surgical choice in the intervention group (59% booklet vs. 42% video at 3 months; P = 0.16). The use of bariatric surgery decision aids was followed by improved decision quality and reduced uncertainty about treatment at 3 months. The video-based decision aid appeared to have a greater impact than the educational booklet on patient knowledge, decisional conflict, and outcome expectancies.

Insurance coverage and incentives for weight loss among adults with metabolic syndrome.

OBJECTIVE: To describe how insured adults with metabolic syndrome respond to various options for insurance coverage and financial incentives for weight management. METHODS AND PROCEDURES: Insured adults meeting the criteria for the metabolic syndrome were randomly identified through automated medical records and invited to participate in a telephone-based survey of the acceptability of various weight management programs-with different financial incentives and insurance coverage options-in a health maintenance organization. Multivariable logistic regression models were used to test the relationship between participant characteristics and the odds of being motivated by incentives. RESULTS: One hundred and fifty-three adults with the metabolic syndrome completed the survey (i.e., 79% of telephone contacts). A hypothetical increase in insurance coverage from 10 to 100% led to a threefold increase among women and a sevenfold increase among men in the proportion reporting they were "very interested" in enrolling in a weight management program within the next 30 days. Most participants (76% of women and 57% of men) supported a health plan-sponsored financial incentive program tied to weight loss, and 41% believed such a program would motivate them to lose weight. The mean financial incentive proposed for a 15-pound weight loss was $591 (median: $125). DISCUSSION: Although weight loss is an effective treatment for metabolic syndrome, standard health insurance rarely covers intensive behavioral treatment. The results of this study suggest that providing full insurance coverage and financial incentives for weight management increases the interest in participating in obesity treatment programs. Further research should determine how full coverage and incentives affect participation rates, long-term body weight changes, and costs.