Adaptive clinical trials in surgery: A scoping review of methodological and reporting quality.

IMPORTANCE: Adaptive surgical trials are scarce, but adopting these methods may help elevate the quality of surgical research when large-scale RCTs are impractical. OBJECTIVE: Randomized-controlled trials (RCTs) are the gold standard for evidence-based healthcare. Despite an increase in the number of RCTs, the number of surgical trials remains unchanged. Adaptive clinical trials can streamline trial design and time to trial reporting. The advantages identified for ACTs may help to improve the quality of future surgical trials. We present a scoping review of the methodological and reporting quality of adaptive surgical trials. EVIDENCE REVIEW: We performed a search of Ovid, Web of Science, and Cochrane Collaboration for all adaptive surgical RCTs performed from database inception to October 12, 2023. We included any published trials that had at least one surgical arm. All review and abstraction were performed in duplicate. Risk of bias (RoB) was assessed using the RoB 2.0 instrument and reporting quality was evaluated using CONSORT ACE 2020. All results were analyzed using descriptive methods. FINDINGS: Of the 1338 studies identified, six trials met inclusion criteria. Trials were performed in cardiothoracic, oral, orthopedic, and urological surgery. The most common type of adaptive trial was group sequential design with pre-specified interim analyses planned for efficacy, futility, and/or sample size re-estimation. Two trials did use statistical simulations. Our risk of bias evaluation identified a high risk of bias in 50% of included trials. Reporting quality was heterogeneous regarding trial design and outcome assessment and details in relation to randomization and blinding concealment. CONCLUSION AND RELEVANCE: Surgical trialists should consider implementing adaptive components to help improve patient recruitment and reduce trial duration. Reporting of future adaptive trials must adhere to existing CONSORT ACE 2020 guidelines. Future research is needed to optimize standardization of adaptive methods across medicine and surgery.

A prospective cohort study of chronic postsurgical pain after ambulatory surgeries.

Objective: The incidence and factors associated with chronic postsurgical pain (CPSP) after ambulatory surgeries have not been well studied. Our primary objective was to determine the incidence of CPSP, and secondary objectives included assessment of intensity of CPSP, incidence of moderate-to-severe CPSP, and exploration of factors associated with CPSP.Methods: This is a prospective cohort study of ambulatory surgery patients having procedures with a potential to cause moderate-to-severe postoperative pain. All patients had participated in a randomized controlled trial (RCT) showing no difference in achieving satisfactory analgesia in recovery unit with either morphine or hydromorphone. CPSP was defined as chronic pain that developed or increased in intensity after the surgical procedure and is localized to the surgical field or within the innervation territory of a nerve in the surgical field, and has persisted for 3 months post-surgery, with the exclusion of other causes of pain. Incidences of CPSP were reported as rate (%) with 95%CI, and intensity using a 0-10 numerical rating scale (95%CI). We used logistic regression to explore factors associated with CPSP adjusting for baseline catastrophizing and depression.Results: Among 402 RCT patients, 208 provided data for the three-month outcome. Incidence of CPSP was 18.8% (39/208), 95%CI 13.7%-24.7% and 78% (28/39) of them had moderate-to-severe CPSP. Average CPSP intensity was 5.5, 95%CI 4.7-6.4. Every unit increase in pain over the first 24 hours was significantly associated with increased odds of moderate-to-severe CPSP at three months; odds ratio, 1.28, 95%CI 1.04-1.58.Conclusions: Nearly one in five patients develop CPSP after ambulatory surgeries with majority of them having moderate to severe pain. Considering that acute pain after discharge is associated with CPSP and that there are no formal care pathways to address this need, studies need to focus on evaluating feasible strategies to provide continuing care.

PReoperative very low-Energy diets for obese PAtients undergoing non-bariatric surgery Randomized Evaluation (PREPARE): a protocol for a pilot randomized controlled trial.

BACKGROUND: Patients with obesity presenting in need of surgical intervention are at 2-to-sixfold higher risk of prolonged hospitalization, infectious morbidity, venous thromboembolism, and more. To mitigate some of these concerns, prescribed preoperative weight loss via very low-energy diets (VLEDs) has become a standard of care for patients with obesity undergoing bariatric surgery. While VLEDs have become standard prior to bariatric surgery, their application in other surgical settings remains limited. A large, definitive trial is required to resolve the uncertainty surrounding their use in these patients. Prior to a definitive trial to compare the efficacy of VLEDs in patients with obesity undergoing major non-bariatric surgery, we require a pilot trial. We argue a pilot trial will provide the following critical feasibility insights: (1) assessment of recruitment ability, (2) evaluation of adherence to VLED regimens, and (3) assessment of our ability follow patients completely. METHODS: The proposed trial will be a multi-center, surgeon, outcome assessor, and data-analyst blinded, parallel pilot randomized controlled trial (RCT). Patients older than 18 years of age with a body mass index (BMI) of greater than 30 kg/m2 undergoing major elective non-bariatric surgery will be eligible for inclusion. Consecutive patients will be allocated 1:1 according to a computer-generated randomization schedule. Randomization will be stratified by center and will employ randomly permutated blocks. All patients in the intervention group will receive standard patient counseling on weight loss and an active VLED protocol. The preoperative VLED protocol will utilize commercially available weight loss products for three weeks preoperatively. The primary outcomes (randomization percentage, recruitment rate, intervention adherence, follow-up completion, network development) will assess feasibility. Descriptive statistics will be used to characterize the study sample. DISCUSSION: The PREPARE pilot RCT will aim to provide feasibility and safety data that will allow for the successful completion of the definitive PREPARE trial that has the potential to provide practice changing data pertaining to the regular use of VLEDs as a means of pre-habilitation for patients with obesity undergoing major non-bariatric surgery. TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov (reference #NCT05918471) on June 23, 2023.

PREscribing preoperative weight loss prior to major non-bariatric abdominal surgery for patients with Elevated weight: Patient and Provider Survey Protocols (PREPARE surveys).

BACKGROUND: Preoperative very low energy diet (VLED) interventions are used routinely in patients undergoing bariatric surgery, a surgical subspecialty that deals almost exclusively with patients with obesity. Yet, their use and study has been limited in non-bariatric abdominal surgery. To investigate the use of VLEDs in non-bariatric surgery, we plan on conducting a randomized controlled trial (RCT). Prior to proceeding, however, we have designed two surveys as important pre-emptive studies aimed at elucidating patient and provider perspectives regarding these interventions. METHODS: The patient survey is a cross-sectional, single-center survey aimed at assessing the safety, adherence, barriers to adherence, and willingness to participate in preoperative optimization protocols with VLEDs prior to undergoing elective non-bariatric intra-abdominal surgery (S1 File). The population of interest is all adult patients with obesity undergoing elective non-bariatric intra-abdominal surgery at St. Joseph's Healthcare Hamilton who were prescribed a course of preoperative VLED. The primary outcomes will be safety and adherence. The target sample size is 35 survey responses. The provider survey is a cross-sectional national survey of practicing surgeons in Canada who perform major non-bariatric abdominal surgery aimed assessing the willingness and ability to prescribe preoperative weight loss interventions amongst practicing Canadian surgeons who perform major non-bariatric abdominal surgery (S2 File). The population of interest is independent practicing surgeons in Canada who perform major non-bariatric abdominal surgery. The primary outcome will be willingness to prescribe preoperative VLED to patients with obesity undergoing major non-bariatric abdominal surgery for both benign and malignant indications. The target sample size is 61 survey responses. Descriptive statistics will be used to characterize the sample populations. To determine variables associated with primary outcomes in the surveys, regression analyses will be performed. DISCUSSION: These survey data will ultimately inform the design of an RCT evaluating the efficacy of preoperative VLEDs for patients with obesity undergoing major abdominal surgery.

Technical Variations and Considerations around OAGB in IFSO-APC and IFSO-MENAC Chapters, an Expert Survey.

OBJECTIVE: This study aimed to evaluate the technical variations of one-anastomosis gastric bypass (OAGB) among IFSO-APC and MENAC experts. BACKGROUND: The multitude of technical variations and patient selection challenges among metabolic and bariatric surgeons worldwide necessitates a heightened awareness of these issues. Understanding different perspectives and viewpoints can empower surgeons performing OAGB to adapt their techniques, leading to improved outcomes and reduced complications. METHODS: The scientific team of IFSO-APC, consisting of skilled bariatric and metabolic surgeons specializing in OAGB, conducted a confidential online survey. The survey aimed to assess technical variations and considerations related to OAGB within the IFSO-APC and IFSO-MENAC chapters. A total of 85 OAGB experts participated in the survey, providing their responses through a 35-question online format. The survey took place from January 1, 2024, to February 15, 2024. RESULTS: Most experts do not perform OAGB for children and adolescents younger than 18 years. Most experts create the gastric pouch over a 36-40-F bougie and prefer to create a gastrojejunostomy, at the posterior wall of the gastric pouch. An anti-reflux suture during OAGB is performed in all patients by 51.8% of experts. Most experts set a common limb length of > 4 m in revisional and conversional OAGBs to prevent nutritional complications. CONCLUSION: The ongoing debate among metabolic and bariatric surgeons regarding the technical variations and patient selection in OAGB remains a significant point of discussion. This survey demonstrated the variations in technical aspects and patient selection for OAGB among MBS surgeons in the IFSO-APC and IFSO-MENAC chapters. Standardizing the OAGB technique is crucial to ensure optimal safety and efficacy in this procedure.

REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol.

INTRODUCTION: The aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials. Moreover, we aim to assess for the presence of spin reporting and inconsistency between abstract and main text reporting in surgical pilot and feasibility randomised trials. METHODS AND ANALYSIS: A comprehensive, electronic search strategy will be used to identify studies indexed in Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Studies will be included if they are pilot or feasibility randomised trials of surgical interventions. The primary outcome will be overall CONSORT statement extension to randomised pilot and feasibility trials checklist completeness. This will be defined as trials reporting each of the 40 items in the CONSORT statement extension to randomised pilot and feasibility trials checklist. Secondary outcomes will include the reporting of individual studies as per the CONSORT extension to randomised pilot and feasibility trials, the use of spin reporting strategies, trial factors associated with reporting quality and spin strategy use, and consistency between abstract and main text reporting. Poisson and logistic regressions will be performed to explore the association between trial factors and completeness of reporting as measured by the number of reported CONSORT items. ETHICS AND DISSEMINATION: This is a methodological survey that has been registered a priori on the International Prospective Register for Systematic Reviews (PROSPERO) (CRD42023475512). Local ethics approval is not required. We plan to disseminate study results through peer-reviewed publication and conference presentations.

Arthroscopic stabilization surgery for first-time anterior shoulder dislocations: a systematic review and meta-analysis.

BACKGROUND: The optimal management of first-time anterior shoulder dislocations (FTASDs) remains controversial. Therefore, the purpose of this study was to assess the efficacy of arthroscopic stabilization surgery for FTASDs through a systematic review and meta-analysis of existing literature. METHODS: MEDLINE, Embase, and Web of Science were searched from inception to December 18, 2022, for single-arm or comparative studies assessing FTASDs managed with arthroscopic stabilization surgery following first-time dislocation. Eligible comparative studies included studies assessing outcomes following immobilization for an FTASD, or arthroscopic stabilization following recurrent dislocations. Eligible levels of evidence were I to IV. Primary outcomes included rates of shoulder redislocations, cumulative shoulder instability, and subsequent shoulder stabilization surgery. RESULTS: Thirty-four studies with 2222 shoulder dislocations were included. Of these, 5 studies (n = 408 shoulders) were randomized trials comparing immobilization to arthroscopic Bankart repair (ABR) after a first dislocation. Another 16 studies were nonrandomized comparative studies assessing arthroscopic Bankart repair following first-time dislocation (ABR-F) to either immobilization (studies = 8, n = 399 shoulders) or arthroscopic Bankart repair following recurrent dislocations (ABR-R) (studies = 8, n = 943 shoulder). Mean follow-up was 59.4 ± 39.2 months across all studies. Cumulative loss to follow-up was 4.7% (range, 0%-32.7%). A composite rate of pooled redislocation, cumulative instability, and reoperations across ABR-F studies was 6.8%, 11.2%, and 6.1%, respectively. Meta-analysis found statistically significant reductions in rates of redislocation (odds ratio [OR] 0.09, 95% confidence interval [CI] 0.04-0.3, P < .001), cumulative instability (OR 0.05, 95% CI 0.03-0.08, P < .001), and subsequent surgery (OR 0.08, 95% CI 0.04-0.15, P < .001) when comparing ABR-F to immobilization. Rates of cumulative instability (OR 0.32, 95% CI 0.22-0.47, P < .001) and subsequent surgery rates (OR 0.27, 95% CI 0.09-0.76, P = .01) were significantly reduced with ABR-F relative to ABR-R, with point estimate of effect favoring ABR-F for shoulder redislocation rates (OR 0.59, 95% CI 0.19-1.83, P = .36). Return to sport rates to preoperative levels or higher were 3.87 times higher following ABR-F compared to immobilization (95% CI 1.57-9.52, P < .001), with limited ABR-R studies reporting this outcome. The median fragility index of the 5 included randomized controlled trials (RCTs) was 2, meaning reversing only 2 outcome events rendered the trials' findings no longer statistically significant. CONCLUSION: Arthroscopic stabilization surgery for FTASDs leads to lower rates of redislocations, cumulative instability, and subsequent stabilization surgery relative to immobilization or arthroscopic stabilization surgery following recurrence. Although a limited number of RCTs have been published on the subject matter to date, the strength of their conclusions is limited by a small sample size and statistically fragile results.

Investigation of divergent thinking among surgeons and surgeon trainees in Canada (IDEAS): a mixed-methods study.

OBJECTIVE: To assess the creative potential of surgeons and surgeon trainees, as measured by divergent thinking. The secondary objectives were to identify factors associated with divergent thinking, assess confidence in creative problem-solving and the perceived effect of surgical training on creative potential, and explore the value of creativity in surgery. DESIGN: We used a mixed-methods design, conducting a survey of divergent thinking ability using a validated questionnaire followed by two semi-structured interviews with top-scoring participants. PARTICIPANTS & SETTING: Surgeons and surgeon trainees in the Department of Surgery at McMaster University. OUTCOMES: The primary outcome was divergent thinking, assessed with the Abbreviated Torrance Test for Adults. Participants also self-assessed their confidence in creative problem-solving and the effect of surgical training on their creative potential. We performed descriptive analyses and multivariable linear regression to identify factors associated with divergent thinking. We conducted a thematic analysis of the interview responses. RESULTS: 82 surgeons and surgeon trainees were surveyed; 43 were junior trainees and 28 were senior trainees. General surgery, orthopaedic surgery and plastic surgery represented 71.9% of the participants. The median participant age was 28 years (range 24-73), 51.2% of whom were female. Participants demonstrated levels of divergent thinking that were higher but not meaningfully different from the adult norm (62.39 (95% CI 61.25, 63.53), p<0.001). While participants scored significantly higher than the average adult on fluency (the ability to produce quantities of ideas) and flexibility (the ability to process information in different ways) (p<0.001 for both), they scored below average on originality (the ability to produce uncommon, new or unique ideas) (p<0.001). Regression analysis identified higher divergent thinking scores among females (estimated ß=-3.58 (95% CI -6.25 to -0.90), p=0.010). CONCLUSIONS: The divergent thinking ability among surgeons and surgeon trainees was not meaningfully different from the adult normative score; however, their ability to generate original ideas was below average.

Pilot and feasibility trials in surgery are incompletely reported according to the CONSORT checklist: a meta-research study.

OBJECTIVES: Given the key role that pilot and feasibility (PAF) trials play in addressing the challenges of surgical trials, adequate reporting completeness is essential. Our aim was to assess completeness of reporting and evaluate if the items of the Consolidated Standards of Reporting Trials (CONSORT) extension for PAF trials have been reported in surgical PAF trials. STUDY DESIGN: This is a metaresearch study reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies were included if they were pilot or feasibility randomized trials evaluating a surgical intervention. The primary outcome was overall adherence to the CONSORT statement extension to randomized PAF trials checklist. A Poisson regression was performed to explore the association between research factors and reporting completeness. SETTING: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched from January 1-December 31, 2011 and 2021. RESULTS: After screening 1991 citations, 38 studies from 2011 to 34 studies from 2021 were included. The mean CONSORT reporting score across all included studies was 21.5 (standard deviation 6.3). After excluding items that were not applicable to all studies, a mean of 20.1 (standard deviation 6.1) of 34 items (0.59) were reported. Studies published in 2021 (vs 2011) did not have a greater number of CONSORT items reported (incidence rate ratio [IRR] 1.01, 95% confidence interval [CI] 0.89-1.15). Studies registered in a clinical trial registry (IRR 1.29, 95% CI 1.12-1.48) and randomizing more than 50 patients (IRR 1.16, 95% CI 1.04-1.30) were associated with more CONSORT items reported. CONCLUSION: The reporting completeness of surgical PAF trials is poor and has not improved after the publication of the CONSORT extension.

Opioid reduction and enhanced recovery in orthopaedic surgery (OREOS): a protocol for a feasibility randomised controlled trial in patients undergoing total knee arthroplasty.

BACKGROUND: Knee arthritis is a leading cause of limited function and long-term disability in older adults. Despite a technically successful total knee arthroplasty (TKA), around 20% of patients continue to have persisting pain with reduced function, and low quality of life. Many of them continue using opioids for pain control, which puts them at risk for potential long-term adverse effects such as dependence, overdose and risk of falls. Although persisting pain and opioid use after TKA have been recognised to be important issues, individual strategies to decrease their burden have limitations and multi-component interventions, despite their potential, have not been well studied. In this study, we propose a multi-component pathway including personalized pain management, facilitated by a pain management coordinator. The objectives of this pilot trial are to evaluate feasibility (recruitment, retention, and adherence), along with opioid-free pain control at 8 weeks after TKA. METHODS: This is a protocol for a multicentre pilot randomised controlled trial using a 2-arm parallel group design. Adult participants undergoing unilateral total knee arthroplasty will be considered for inclusion and randomised to control and intervention groups. Participants in the intervention group will receive support from a pain management coordinator who will facilitate a multicomponent pain management pathway including (1) preoperative education on pain and opioid use, (2) preoperative risk identification and mitigation, (3) personalized post-discharge analgesic prescriptions and (4) continued support for pain control and recovery up to 8 weeks post-op. Participants in the control group will undergo usual care. The primary outcomes of this pilot trial are to assess the feasibility of participant recruitment, retention, and adherence to the interventions, and key secondary outcomes are persisting pain and opioid use. DISCUSSION: The results of this trial will determine the feasibility of conducting a definitive trial for the implementation of a multicomponent pain pathway to improve pain control and reduce harms using a coordinated approach, while keeping an emphasis on patient centred care and shared decision making. TRIAL REGISTRATION: Prospectively registered in Clinicaltrials.gov (NCT04968132).

The GRADE Working Group and CINeMA approaches provided inconsistent certainty of evidence ratings for a network meta-analysis of opioids for chronic noncancer pain.

OBJECTIVES: Assessment of the certainty of evidence (CoE) from network meta-analysis is critical to convey the strength of inferences for clinical decision-making. Both the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group (GWG) and the Confidence in Network Meta-Analysis (CINeMA) framework have been designed to assess the CoE of treatment effects informed by network meta-analysis; however, the concordance of results is uncertain. STUDY DESIGN AND SETTING: We assessed the CoE for treatment effects of individual opioids on pain relief and physical functioning from a network meta-analysis for chronic noncancer pain using the GWG approach and the CINeMA framework. Both approaches evaluate the CoE as high, moderate, low or very low. We quantified the number of discrepant CoE ratings between approaches and the magnitude of the difference (ie, one level, two levels, or three levels). RESULTS: Across 105 comparisons among individual opioids for pain relief, the GWG and CINeMA approaches provided different CoE ratings in 34% of cases (36 of 105). Across 66 comparisons for physical functioning, there was discordance in 17% of cases (11 of 66). All discrepancies were separated by one level. The CINeMA framework typically provided lower CoE ratings compared to the GWG approach, predominantly because of differences in the assessment of transitivity and heterogeneity. CONCLUSION: Our findings suggest there are differences between the CoE ratings provided by the GWG and CINeMA approaches when applied to network meta-analyses. Further research is needed to replicate or refute our findings in other network meta-analyses and assess the implications for clinical decision-making.

Metabolic and Bariatric Surgery in Patients with Obesity Class V (BMI > 60 kg/m2): a Modified Delphi Study.

BACKGROUND: Metabolic and bariatric surgery (MBS) is the preferred method to achieve significant weight loss in patients with Obesity Class V (BMI > 60 kg/m2). However, there is no consensus regarding the best procedure(s) for this population. Additionally, these patients will likely have a higher risk of complications and mortality. The aim of this study was to achieve a consensus among a global panel of expert bariatric surgeons using a modified Delphi methodology. METHODS: A total of 36 recognized opinion-makers and highly experienced metabolic and bariatric surgeons participated in the present Delphi consensus. 81 statements on preoperative management, selection of the procedure, perioperative management, weight loss parameters, follow-up, and metabolic outcomes were voted on in two rounds. A consensus was considered reached when an agreement of ≥ 70% of experts' votes was achieved. RESULTS: A total of 54 out of 81 statements reached consensus. Remarkably, more than 90% of the experts agreed that patients should be notified of the greater risk of complications, the possibility of modifications to the surgical procedure, and the early start of chemical thromboprophylaxis. Regarding the choice of the procedure, SADI-S, RYGB, and OAGB were the top 3 preferred operations. However, no consensus was reached on the limb length in these operations. CONCLUSION: This study represents the first attempt to reach consensus on the choice of procedures as well as perioperative management in patients with obesity class V. Although overall consensus was reached in different areas, more research is needed to better serve this high-risk population.

Perceptions in orthopedic surgery on the use of cannabis in treating pain: a survey of patients with spine pain (POSIT Spine).

BACKGROUND: Back pain is the leading cause of disability worldwide. Despite guidelines discouraging opioids as first-line treatment, opioids remain the most prescribed drugs for back pain. There is renewed interest in exploring the potential medical applications of cannabis, and with the recent changes in national legislation there is a unique opportunity to investigate the analgesic properties of cannabis. METHODS: This was a multi-center survey-based study examining patient perceptions regarding cannabis for spine pain. We included patients presenting with back or neck pain to one of three Orthopedic clinics in Ontario. Our primary outcome was perceived effect of cannabis on back pain, while secondary outcomes were perceptions regarding potential applications and barriers to cannabis use. RESULTS: 259 patients participated in this study, 35.3% (90/255) stating they used cannabis medically. Average pain severity was 6.5/10 ± 0.3 (95% CI 6.2-6.8). Nearly three-quarters were prescribed opioids (73.6%, 148/201), with oxycodone/oxycontin (45.9% 68/148) being the most common, and almost half of (49.3%, 73/148) had used an opioid in the last week. Patients estimated cannabis could treat 54.3% ± 4.0 (95% CI 50.3-58.3%) of their spine pain and replace 46.2% ± 6. 6 (95% CI 39.6-52.8%) of their current analgesics. Age (ß = - 0.3, CI - 0.6-0.0), higher pain severity (ß = 0.4, CI 0.1-0.6) and previous cannabis use (ß = 14.7, CI 5.1-24.4) were associated with a higher perceived effect of cannabis. Patients thought cannabis would be beneficial to treat pain (129/146, 88.4%), and reduce (116/146, 79.5%) or eliminate opioids (102/146, 69.9%). Not considering using cannabis for medical purposes (65/150, 43.3%) was the number one reported barrier. CONCLUSIONS: Patients estimated medical cannabis could treat more than half of their spine pain, with one in three patients already using medical cannabis. 79% of patients also believe cannabis could reduce opioid usage. This data will help support more research into cannabis for musculoskeletal pain.

Economic Evaluations Comparing Deep Brain Stimulation to Best Medical Therapy for Movement Disorders: A Meta-Analysis.

BACKGROUND: Movement disorders (Parkinson's disease, essential tremor, primary dystonia) are a debilitating group of conditions that are progressive in nature. The mainstay of treatment is best medical therapy; however, a number of surgical therapies are available, including deep brain stimulation. Economic evaluations are an important aspect of evidence to inform decision makers regarding funding allocated to these therapies. OBJECTIVE: This systematic review and meta-analysis evaluated the cost effectiveness of including deep brain stimulation compared with best medical therapy for movement disorder indications in the adult population. METHODS: Ovid Medical Literature Analysis and Retrieval System Online, Embase, and Cochrane Central Register of Controlled Trials were queried. Only economic evaluations reporting incremental cost-effectiveness ratios for including deep brain stimulation versus best medical therapy for movement disorders were included. Studies were reviewed in duplicate for inclusion and data abstraction. Data were harmonized using the Consumer Price Index and Purchasing Power Parity to standardize values to 2022 US dollars. For inclusion in meta-analyses, studies were required to have sufficient data available to calculate an estimate of the incremental net benefit. Meta-analyses of pooled incremental net benefit based on the time horizon were performed. The study was registered at PROSPERO (CRD42022335436). RESULTS: There were 2190 studies reviewed, with 14 economic evaluations included following a title/abstract and full-text review. Only studies considering Parkinson's disease were available for the meta-analysis. Quality of the identified studies was low, with moderate transferability to the American Healthcare System, and certainty of evidence was low. However, studies with a longer time horizon (15 years to lifetime) were found to have significant positive incremental net benefit (indicating cost effectiveness) for including deep brain stimulation with a mean difference of US$40,504.81 (95% confidence interval 2422.42-78,587.19). CONCLUSIONS: Deep brain stimulation was cost effective for Parkinson's disease when considered over the course of the patient's remaining life after implantation. TRIAL REGISTRATION: Clinical Trial Registration: PROSPERO (CRD42022335436).

Effect of Swallow Balloon Therapy with the Combination of Semaglutide Oral Formulation: a Randomised Double-Blind Single-Centre Study.

BACKGROUND: Obesity is a significant public health issue; new therapies and pharmaceutical approaches to weight management are needed. OBJECTIVE: This study assesses weight reduction efficacy in the novel swallow balloon procedure and semaglutide, both promising non-surgical and pharmaceutical options, addressing obesity's critical public health challenge. METHODS: This was a computer-generated, blocked randomisation, double-blind, single-centre study. Fifty-seven participants were assigned to swallow balloon therapy group I (with semaglutide), and 58 were assigned to swallow balloon therapy group II (without semaglutide). All treatment doses were orally administered once daily (3 mg for the 1st month, 7 mg for the 2nd month, and 14 mg for the 3rd and 4th months after the placement of the swallow balloon). All the data were statistically analysed. RESULTS: The groups were highly well-matched. The %TWL in group I was 7.9%, 12.5%, 15.2%, and 17.6% and in group II was 6.1%, 10.5%, 12.8%, and 13.7% at 1, 2, 3, and 4 months, respectively. The most common adverse events (AEs) were nausea and vomiting, observed within the week. The resolution of T2DM, HTN, and OSA was 64.7% vs 55.5%, 64.3% vs 58.8%, and 72.0 vs 57.8% in groups I vs II, respectively. QoL significantly improved 4 months postoperatively in both groups. No major late complications occurred in either of the groups. CONCLUSION: The study supports the efficacy of swallow balloon therapy combined with semaglutide oral formulation in promoting weight loss and improving comorbid conditions. The findings highlight the potential of this combined approach in managing obesity and its associated health issues.