Endoscopic therapies for patients with obesity: a systematic review and meta-analysis.

BACKGROUND: Obesity is a major threat to public health and traditional bariatric surgery continues to have low utilization. Endoscopic treatments for obesity have emerged that offer less risk, but questions remain regarding efficacy, durability, and safety. We compared the efficacy of endoscopic bariatric procedures as compared to other existing treatments. METHODS: A literature search of Embase, Cochrane Central, and Pubmed was conducted from January 1, 2014 to December 7, 2021, including endoscopic bariatric therapies that were FDA or CE approved at the time of search to non-endoscopic treatments. Thirty-seven studies involving 15,639 patients were included. Primary outcomes included % total body weight loss (%TBWL), % excess body weight loss (%EBWL), and adverse events. Secondary outcomes included quality of life data and differences in hemoglobin A1C levels. Strength of clinical trial and observational data were graded according to the Cochrane methods. RESULTS: Intragastric balloons achieved greater %TBWL with a range of 7.6-14.1% compared to 3.3-6.7% with lifestyle modification at 6 months, and 7.5-14.0% compared to 3.1-7.9%, respectively, at 12 months. When endoscopic sleeve gastroplasty (ESG) was compared to laparoscopic sleeve gastrectomy (LSG), ESG had less %TBWL at 4.7-14.4% compared to 18.8-26.5% after LSG at 6 months, and 4.5-18.6% as compared to 28.4-29.3%, respectively, at 12 months. For the AspireAssist, there was greater %TBWL with aspiration therapy compared to lifestyle modification at 12 months, 12.1-18.3% TBWL versus 3.5-5.9% TBWL, respectively. All endoscopic interventions had higher adverse events rates compared to lifestyle modification. CONCLUSION: This review is the first to evaluate various endoscopic bariatric therapies using only RCTs and observational studies for evaluation of weight loss compared with conservative management, lifestyle modification, and bariatric surgery. Endoscopic therapies result in greater weight loss compared to lifestyle modification, but not as much as bariatric surgery. Endoscopic therapies may be beneficial as an alternative to bariatric surgery.

Patient and researcher stakeholder preferences for use of electronic health record data: a qualitative study to guide the design and development of a platform to honor patient preferences.

OBJECTIVE: This qualitative study aimed to understand patient and researcher perspectives regarding consent and data-sharing preferences for research and a patient-centered system to manage consent and data-sharing preferences. MATERIALS AND METHODS: We conducted focus groups with patient and researcher participants recruited from three academic health centers via snowball sampling. Discussions focused on perspectives on the use of electronic health record (EHR) data for research. Themes were identified through consensus coding, starting from an exploratory framework. RESULTS: We held two focus groups with patients (n = 12 patients) and two with researchers (n = 8 researchers). We identified two patient themes (1-2), one theme common to patients and researchers (3), and two researcher themes (4-5). Themes included (1) motivations for sharing EHR data, (2) perspectives on the importance of data-sharing transparency, (3) individual control of personal EHR data sharing, (4) how EHR data benefits research, and (5) challenges researchers face using EHR data. DISCUSSION: Patients expressed a tension between the benefits of their data being used in studies to benefit themselves/others and avoiding risk by limiting data access. Patients resolved this tension by acknowledging they would often share their data but wanted greater transparency on its use. Researchers expressed concern about incorporating bias into datasets if patients opted out. CONCLUSIONS: A research consent and data-sharing platform must consider two competing goals: empowering patients to have more control over their data and maintaining the integrity of secondary data sources. Health systems and researchers should increase trust-building efforts with patients to engender trust in data access and use.

Use of Acupuncture for Adult Health Conditions, 2013 to 2021: A Systematic Review.

Importance: Acupuncture is a popular treatment that has been advocated for dozens of adult health conditions and has a vast evidence base. Objective: To map the systematic reviews, conclusions, and certainty or quality of evidence for outcomes of acupuncture as a treatment for adult health conditions. Evidence Review: Computerized search of PubMed and 4 other databases from 2013 to 2021. Systematic reviews of acupuncture (whole body, auricular, or electroacupuncture) for adult health conditions that formally rated the certainty, quality, or strength of evidence for conclusions. Studies of acupressure, fire acupuncture, laser acupuncture, or traditional Chinese medicine without mention of acupuncture were excluded. Health condition, number of included studies, type of acupuncture, type of comparison group, conclusions, and certainty or quality of evidence. Reviews with at least 1 conclusion rated as high-certainty evidence, reviews with at least 1 conclusion rated as moderate-certainty evidence, and reviews with all conclusions rated as low- or very low-certainty evidence; full list of all conclusions and certainty of evidence. Findings: A total of 434 systematic reviews of acupuncture for adult health conditions were found; of these, 127 reviews used a formal method to rate certainty or quality of evidence of their conclusions, and 82 reviews were mapped, covering 56 health conditions. Across these, there were 4 conclusions that were rated as high-certainty evidence, and 31 conclusions that were rated as moderate-certainty evidence. All remaining conclusions (>60) were rated as low- or very low-certainty evidence. Approximately 10% of conclusions rated as high or moderate-certainty were that acupuncture was no better than the comparator treatment, and approximately 75% of high- or moderate-certainty evidence conclusions were about acupuncture compared with a sham or no treatment. Conclusions and Relevance: Despite a vast number of randomized trials, systematic reviews of acupuncture for adult health conditions have rated only a minority of conclusions as high- or moderate-certainty evidence, and most of these were about comparisons with sham treatment or had conclusions of no benefit of acupuncture. Conclusions with moderate or high-certainty evidence that acupuncture is superior to other active therapies were rare.

Pilot RCT Testing A Mailing About Sleeping Pills and Cognitive Behavioral Therapy for Insomnia: Impact on Benzodiazepines and Z-Drugs.

OBJECTIVES: The aim is to pilot a low-touch program for reducing benzodiazepine receptor agonist (BZRA; benzodiazepines, z-drugs) prescriptions among older veterans. METHODS: Pilot randomized controlled trial consists of 2,009 veterans aged ≥ 65 years who received BZRA prescriptions from a Veterans Health Administration pharmacy (Colorado or Montana) during the prior 18 months. Active: Arm 1 was a mailed brochure about BZRA risks that also included information about a free, online cognitive behavioral therapy for the insomnia (CBTI) program. Arm 2 was a mailed brochure (same as arm 1) and telephone reinforcement call. Control: Arm 3 was a mailed brochure without insomnia treatment information. Active BZRA prescriptions at follow-up (6 and 12 months) were measured. RESULTS: In logistic regression analyses, the odds of BZRA prescription at 6- and 12-month follow-ups were not significantly different for arm 1 or 2 (active) versus arm 3 (control), including models adjusted for demographics and prescription characteristics (p-values >0.36). CONCLUSIONS: Although we observed no differences in active BZRA prescriptions, this pilot study provides guidance for conducting a future study, indicating a need for a more potent intervention. A full-scale trial testing an optimized program would provide conclusive results. CLINICAL IMPLICATIONS: Mailing information about BZRA risks and CBTI did not affect BZRA prescriptions.

Clinical outcomes and cost of robotic ventral hernia repair: systematic review.

BACKGROUND: Robotic ventral hernia repair (VHR) has seen rapid adoption, but with limited data assessing clinical outcome or cost. This systematic review compared robotic VHR with laparoscopic and open approaches. METHODS: This systematic review was undertaken in accordance with PRISMA guidelines. PubMed, MEDLINE, Embase, and Cochrane databases were searched for articles with terms relating to 'robot-assisted', 'cost effectiveness', and 'ventral hernia' or 'incisional hernia' from 1 January 2010 to 10 November 2020. Intraoperative and postoperative outcomes, pain, recurrence, and cost data were extracted for narrative analysis. RESULTS: Of 25 studies that met the inclusion criteria, three were RCTs and 22 observational studies. Robotic VHR was associated with a longer duration of operation than open and laparoscopic repairs, but with fewer transfusions, shorter hospital stay, and lower complication rates than open repair. Robotic VHR was more expensive than laparoscopic repair, but not significantly different from open surgery in terms of cost. There were no significant differences in rates of intraoperative complication, conversion to open surgery, surgical-site infection, readmission, mortality, pain, or recurrence between the three approaches. CONCLUSION: Robotic VHR was associated with a longer duration of operation, fewer transfusions, a shorter hospital stay, and fewer complications compared with open surgery. Robotic VHR had higher costs and a longer operating time than laparoscopic repair. Randomized or matched data with standardized reporting, long-term outcomes, and cost-effectiveness analyses are still required to weigh the clinical benefits against the cost of robotic VHR.

Comparison of Clinical Outcomes of Robot-Assisted, Video-Assisted, and Open Esophagectomy for Esophageal Cancer: A Systematic Review and Meta-analysis.

Importance: The utilization of robot-assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer is increasing, despite limited data comparing RAMIE with other surgical approaches. Objective: To evaluate the literature for clinical outcomes of RAMIE compared with video-assisted minimally invasive esophagectomy (VAMIE) and open esophagectomy (OE). Data Sources: A systematic search of PubMed, Cochrane, Ovid Medline, and Embase databases from January 1, 2013, to May 6, 2020, was performed. Study Selection: Studies that compared RAMIE with VAMIE and/or OE for cancer were included. Data Extraction and Synthesis: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline, data were extracted by independent reviewers. A random-effects meta-analysis of 9 propensity-matched studies was performed for the RAMIE vs VAMIE comparison only. A narrative synthesis of RAMIE vs VAMIE and OE was performed. Main Outcomes and Measures: The outcomes of interest were intraoperative outcomes (ie, estimated blood loss [EBL], operative time, lymph node [LN] harvest), short-term outcomes (anastomotic leak, recurrent laryngeal nerve [RLN] palsy, pulmonary and total complications, and 90-day mortality), and long-term oncologic outcomes. Results: Overall, 21 studies (2 randomized clinical trials, 11 propensity-matched studies, and 8 unmatched studies) with 9355 patients were included. A meta-analysis was performed with 9 propensity-matched studies comparing RAMIE with VAMIE. The random-effects pooled estimate found an adjusted risk difference (RD) of -0.06 (95% CI, -0.11 to -0.01) favoring fewer pulmonary complications with RAMIE. There was no evidence of differences between RAMIE and VAMIE in LN harvest (mean difference [MD], -1.1 LN; 95% CI, -2.45 to 0.25 LNs), anastomotic leak (RD, 0.0; 95% CI, -0.03 to 0.03), EBL (MD, -6.25 mL; 95% CI, -18.26 to 5.77 mL), RLN palsy (RD, 0.01; 95% CI, -0.08 to 0.10), total complications (RD, 0.05; 95% CI, -0.01 to 0.11), or 90-day mortality (RD, -0.01; 95% CI, -0.02 to 0.0). There was low certainty of evidence that RAMIE was associated with a longer disease-free survival compared with VAMIE. For OE comparisons (data not pooled), RAMIE was associated with a longer operative time, decreased EBL, and less pulmonary and total complications. Conclusions and Relevance: In this study, RAMIE had similar outcomes as VAMIE but was associated with fewer pulmonary complications compared with VAMIE and OE. Studies on long-term functional and cancer outcomes are needed.

Intraoperative and postoperative outcomes of robot-assisted cholecystectomy: a systematic review.

BACKGROUND: Rapid adoption of robotic-assisted general surgery procedures, particularly for cholecystectomy, continues while questions remain about its benefits and utility. The objective of this study was to compare the clinical effectiveness of robot-assisted cholecystectomy for benign gallbladder disease as compared with the laparoscopic approach. METHODS: A literature search was performed from January 2010 to March 2020, and a narrative analysis was performed as studies were heterogeneous. RESULTS: Of 887 articles screened, 44 met the inclusion criteria (range 20-735,537 patients). Four were randomized controlled trials, and four used propensity-matching. There were variable comparisons between operative techniques with only 19 out of 44 studies comparing techniques using the same number of ports. Operating room time was longer for the robot-assisted technique in the majority of studies (range 11-55 min for 22 studies, p < 0.05; 15 studies showed no difference; two studies showed shorter laparoscopic times), while conversion rates and intraoperative complications were not different. No differences were detected for the length of stay, surgical site infection, or readmissions. Across studies comparing single-port robot-assisted to multi-port laparoscopic cholecystectomy, there was a higher rate of incisional hernia; however, no differences were noted when comparing single-port robot-assisted to single-port laparoscopic cholecystectomy. CONCLUSIONS: Clinical outcomes were similar for benign, elective gallbladder disease for robot-assisted compared with laparoscopic cholecystectomy. Overall, the rates of complications were low. More high-quality studies are needed as the robot-assisted technique expands to more complex gallbladder disease, where its utility may prove increasingly beneficial. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020156945.

Perioperative and Long-Term Outcomes of Robot-Assisted Partial Nephrectomy: A Systematic Review.

BACKGROUND: Adoption of the robotic surgical platform for small renal cancers has rapidly expanded, but its utility compared to other approaches has not been established. The objective of this review is to assess perioperative and long-term oncologic and functional outcomes of robot-assisted partial nephrectomy (RAPN) compared to laparoscopic partial nephrectomy (LPN) and open partial nephrectomy (OPN). METHODS: A search in PubMed, Embase, and Cochrane (2010-2019) was conducted. Of 3877 articles screened, 7 observational studies were included. RESULTS: RAPN was associated with 24-50 mL less intraoperative blood loss compared to LPN and 39-84 mL less than OPN. RAPN also demonstrated trends of other postoperative benefits, such as shorter length of stay and fewer major complications. Several studies reported better long-term functional kidney outcomes, but these findings were inconsistent. Recurrence and cancer-specific survival (CSS) were similar across groups. While RAPN had a 5-year CSS of 90.1%-97.9%, LPN and OPN had survival rates of 85.9%-86.9% and 88.5-96.3% respectively. CONCLUSIONS: RAPN may be associated with a lower estimated blood loss and comparable long-term outcomes when compared to other surgical approaches. However, additional randomized or propensity matched studies are warranted to fully assess long-term functional kidney and oncologic outcomes.

Clinical Effectiveness and Resource Utilization of Surgery versus Endovascular Therapy for Chronic Limb-Threatening Ischemia.

BACKGROUND: The clinical effectiveness of surgical versus endovascular therapy for chronic limb-threatening ischemia (CLTI) continues to be debated, and the resources required for each therapy are unclear. METHODS: Systematic review of randomized controlled trials (RCTs) and observational studies comparing surgery with endovascular therapy for CLTI, which reported clinical effectiveness and resource utilization. Short-term and long-term clinical outcomes were examined. RESULTS: The search yielded 4,231 titles, of which 17 publications met our inclusion criteria. Five publications were all from 1 RCT, and 12 publications were observational studies. In the RCT, the surgical approach had greater resource use in the first year (total hospital days across all admissions for surgery versus angioplasty: 46.14 ± 53.87 vs. 36.35 ± 51.39; P < 0.001; also true for days in high-dependency and intensive therapy units), but differences were not statistically significant in subsequent years. All-cause mortality presented a nonsignificant difference favoring angioplasty in the first 2 years (adjusted hazard ratio [aHR], 1.27; 95% confidence interval [95% CI], 0.75-2.15), but after 2 years, it favored surgical treatment (aHR, 0.34; 95% CI, 0.17-0.71). The observational studies reported short-term effectiveness and resource utilization favoring endovascular therapy, but most differences were not statistically significant. Long-term outcomes were more mixed; in particular, mortality outcomes generally favored surgery, although concluding that cause and effect is not possible as endovascularly treated patients tended to be older and may have had a shorter life expectancy regardless of therapy. CONCLUSIONS: The clinical effectiveness and resource utilization of surgery compared with endovascular therapy for CLTI is not known with certainty and will not be known until ongoing trials report results. It is likely that findings will vary by the time horizon, where initial outcomes and utilization tend to favor endovascular interventions, but long-term outcomes favor surgical revascularization.