A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial

ObjectiveThis study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery.DesignRandomized, controlled pilot trial.SettingBeth Israel Deaconess Medical Center, Boston, MA, USA.InterventionsBariatric patients 1–5 years post-surgery (n = 18) were randomized to receive a 10-week MBI or a standard intervention.Main outcome measuresPrimary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted.ResultsAttendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (−4.9 ± 13.7 in mindfulness vs. 6.2 ± 28.4 in standard, p for between-group difference = 0.03) but not weight. We also observed a significant increase in HbA1C (0.34 ± 0.38 vs. −0.06 ± 0.31, p = 0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews.ConclusionsThis novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population.Clinical trial registrationClinicalTrials.gov identifier NCT02603601.     

Project IMPACT: results from a pilot validity study of a new observational database

OBJECTIVE: The objective of this study was to evaluate the accuracy of the information contained in the Project IMPACT database. Project IMPACT is a comprehensive database system developed to measure and describe the care of intensive care patients. This database is being used by a large group of hospitals to help clinicians improve the care of these patients. Data on patient demographics, diagnoses, treatment, and outcomes are entered into the Project IMPACT database by staff at participating hospitals. This pilot study was a first step in assessing the accuracy of these data to determine the usefulness of the Project IMPACT database for measuring intensive care unit (ICU) performance and patient outcomes. DESIGN: The design of the pilot study was the independent abstraction of selected data items from a random sample of ICU patient records from two hospitals participating in Project IMPACT. The abstracted data were compared with the data existing in the Project IMPACT database for agreement. SETTING: Abstraction was performed onsite at the two pilot hospitals by a trained abstractor who was not affiliated with either hospital. PATIENTS: Patients whose records were abstracted included 45 randomly selected ICU patients at each of the two pilot hospitals. MEASUREMENTS AND MAIN RESULTS: Comparison of the Project IMPACT data with the independently abstracted data indicated good agreement (80% or above) on discrete items, such as type of ICU patient. Poorer agreement (under 80%) was seen for continuous items (e.g., 24-hr urine output) and coded items requiring judgment (e.g., reason for ICU admission). CONCLUSIONS: The pilot study showed good internal validity for most of the abstracted variables. High agreement rates were observed, regardless of method of original data capture (electronic download or manual entry), although agreement was higher for some data items that had been electronically downloaded into the Project IMPACT database. The results suggest that Project IMPACT is a valuable resource for ICUs to collect and evaluate information about treatment and patient outcomes.     

A new face-mounted display system: pilot trial of clinical application in therapeutic endoscopy

BACKGROUND AND STUDY AIMS: Since fiber endoscopes evolved into video endoscopes, there has been no remarkable progression in the optical system for endoscopy. The current optical system provided by fixed cathode-ray tube (CRT) display is a monitor-oriented system. In this study, we evaluate the practical usefulness of the face-mounted display (FMD), which provides us with an operator-oriented optical system. PATIENTS AND METHODS: The FMD device, weighing 110 g, is designed for consumer video home use, consisting of two active matrix liquid crystal color panels with 180,000-pixel resolution. With the picture-in-picture capability, FMD provided us with image-navigated endoscopic procedure. Fourteen patients were enrolled in this study; seven patients for endoscopic mucosal resection, two for insertion of an esophageal metallic stent, three for clipping for the bleeding and two for dilatation of anastomotic strictures. RESULTS: The FMD device allowed us to use an ultra large screen as if there has been a 62-inch screen 2 m ahead. During endoscopy, we could concentrate more on the procedures. There were no complications attributable to the use of the device. CONCLUSION: We are convinced of a new evolution in the optical system for therapeutic endoscopy with the FMD device.     

Endoscopic ultrasound-guided interstitial brachytherapy of unresectable pancreatic cancer: results of a pilot trial

BACKGROUND AND STUDY AIMS: Intraoperative interstitial brachytherapy has been found to be effective when used during laparotomy to improve local control in patients with locally advanced pancreatic cancer. In this study, we report the results of using endoscopic ultrasound- (EUS-)guided interstitial brachytherapy in patients with advanced pancreatic cancer, with respect to tumor response, clinical response, safety, and complications. PATIENTS AND METHODS: Fifteen patients (eight men, seven women; median age 61 years) with unresectable pancreatic adenocarcinoma were enrolled into the study, eight patients with stage III disease and seven patients with stage IV disease. A mean number of 22 radioactive seeds per patient were implanted into the tumors by EUS-guided needle puncture. The mean total implanted activity was 20 mCi, the minimum peripheral dose was 14,000 cGy, and the mean volume of implants was 52 cm3. Patients were followed-up by examination and by imaging tests every 2-3 months: clinical end points included the Karnofsky performance status and pain responses, tumor response (assessed by computed tomography and/or EUS), and survival. RESULTS: During a median follow-up period of 10.6 months, the objective tumor response was classified as "partial" in 27% of patients (with a median duration of partial response of 4.5 months), "minimal" in 20% patients, and indicative of "stable disease" in 33% of patients. Clinical benefit was shown in 30% of patients, mostly due to reduction in pain, but this lasted for a limited time. Local complications (pancreatitis and pseudocyst formation) occurred in three patients; grade III hematologic toxicity occurred in three patients without serious clinical sequelae. CONCLUSIONS: EUS-guided intraoperative interstitial brachytherapy had a moderate local tumor effect and showed some clinical benefit in 30% of the patients in this study. Combination of this form of treatment with external radiation and/or chemotherapy should be tested in future trials.     

Endoluminal full-thickness resection of GI lesions: A new device and technique

Abstract

Full-thickness resection techniques are of growing interest in the field of endoscopic removal of tumors or their precursors in the digestive tract. A new dedicated full-thickness resection device has been developed based on the combination of the OTSC clip, an enlarged resection cap and an integrated snare. The device prototype allows combined resection of all gastrointestinal organ wall layers in one maneuver, up to a size of 3 x 3 cm. The device has been pre-clinically tested to demonstrate feasibility of full-thickness resection in the colon. Two clinical cases have been performed successfully to date.     

Flat-detector computed tomography evaluation in an experimental animal aneurysm model after endovascular treatment: A pilot study

We compared flat-detector computed tomography angiography (FD-CTA) to multislice computed tomography (MS-CTA) and digital subtracted angiography (DSA) for the visualization of experimental aneurysms treated with stents, coils or a combination of both.In 20 rabbits, aneurysms were created using the rabbit elastase aneurysm model. Seven aneurysms were treated with coils, seven with coils and stents, and six with self-expandable stents alone. Imaging was performed by DSA, MS-CTA and FD-CTA immediately after treatment. Multiplanar reconstruction (MPR) was performed and two experienced reviewers compared aneurysm/coil package size, aneurysm occlusion, stent diameters and artifacts for each modality.In aneurysms treated with stents alone, the visualization of the aneurysms was identical in all three imaging modalities. Residual aneurysm perfusion was present in two cases and visible in DSA and FD-CTA but not in MS-CTA. The diameter of coil-packages was overestimated in MS-CT by 56% and only by 16% in FD-CTA compared to DSA (p < 0.05). The diameter of stents was identical for DSA and FD-CTA and was significantly overestimated in MS-CTA (p < 0.05). Beam/metal hardening artifacts impaired image quality more severely in MS-CTA compared to FD-CTA.MS-CTA is impaired by blooming and beam/metal hardening artifacts in the visualization of implanted devices. There was no significant difference between measurements made with noninvasive FD-CTA compared to gold standard of DSA after stenting and after coiling/stent-assisted coiling of aneurysms. FD-CTA may be considered as a non-invasive alternative to the gold standard 2D DSA in selected patients that require follow up imaging after stenting.     

Issues in planning a placebo-controlled trial of manual methods: results of a pilot study

OBJECTIVE: There are fundamental differences between the administration of medications and the application of manual procedures, such as those used by chiropractors. The objective of this study was to gather preliminary information on how to address these differences in the design of a multisite, randomized placebo-controlled trial of chiropractic care for women with chronic pelvic pain (CPP). DESIGN: Pilot study for a multisite, randomized, placebo-controlled clinical trial. SETTING: Three chiropractic research clinics in the midwest United States. SUBJECTS: Thirty-nine (39) women with CPP of at least 6 months' duration, diagnosed by board-certified gynecologists. INTERVENTIONS: The active intervention consisted of the chiropractic technique, lumbar spine flexion-distraction, combined with manual Trigger Point Therapy. The placebo intervention consisted of a sham chiropractic procedure performed with an instrument combined with effleurage (light massage). OUTCOME MEASURES: The primary outcome measure was the change in the Pain Disability Index (PDI) from baseline to the end of treatment (6 weeks), assessed by group and site. If the change score was in the same direction at all sites, the results were to be combined to estimate treatment effect size. RESULTS: Patient characteristics were similar to those of patients with CPP in other studies. Recruitment methods, particularly in respect to the eligibility criteria and screening protocols, would require modification in order to recruit an adequate sample for the planned randomized controlled trial. Clinicians followed standardized procedures with apparently minimal deviation, patients in both groups were satisfied with their care and blinding appeared to be successful. PDI change scores were not consistent across sites and so results were not combined and overall treatment effect sizes were not estimated. CONCLUSIONS: The technical and personnel resources required to achieve adequate standardization of procedures at multiple sites may make a placebo-controlled trial unfeasible, given our current lack of knowledge about the active agent in manual chiropractic procedures.     

Rofecoxib in the prevention of perimenstrual migraine: an open-label pilot trial

OBJECTIVE: To investigate the effectiveness of rofecoxib in the prevention of perimenstrual migraine. BACKGROUND: Nonsteroidal anti-inflammatory drugs have demonstrated benefit in reducing the frequency and intensity of menstrual migraine when administered perimenstrually. Anti-inflammatory drugs, however, may not be well tolerated and can produce gastrointestinal irritation. Rofecoxib, a selective cyclooxygenase-2 inhibitor, has anti-inflammatory and analgesic properties, and a significantly improved gastrointestinal tolerability profile. METHODS: A pilot study was conducted in which patients with a history of menstrually associated migraine and experiencing at least one migraine monthly during the perimenstrual period were enrolled. Patients who completed a baseline diary for the first month were randomized to receive either rofecoxib 25 mg or 50 mg daily for 10 days, starting 5 days before menstrual flow. Headaches experienced during this 10-day period were recorded in the patient's diary. Patients continued rofecoxib for 2 consecutive menstrual cycles. Mean migraine frequency, intensity, and duration as well as patient's level of functioning during the 2 cycles were compared with baseline. RESULTS: Fourteen patients completed baseline and rofecoxib dosing for 2 menstrual cycles. Mean migraine frequency decreased from 5.6 to 2.6 migraines per menstrual cycle (P=.005). Eight (57%) of 14 patients had a > or = 50% reduction in headache frequency. No significant improvement in headache intensity, duration, and functional impairment were observed. Both doses of rofecoxib were well tolerated with no statistical difference in patient response between the doses. CONCLUSION: Rofecoxib at a perimenstrual daily dose of 25 or 50 mg demonstrated a significant reduction in frequency of perimenstrual migraine. A double-blind, placebo-controlled trial of rofecoxib in the prevention of perimenstrual migraine is warranted.     

Clinical trial implementation and recruitment: lessons learned from the early closure of a randomized clinical trial

BackgroundThe NHLBI-sponsored Sickle Cell Disease Clinical Research Network (SCDCRN) conducted a multi-center, acute intervention randomized clinical trial of two methods of Patient Controlled Analgesia for acute pain. This trial was terminated early due to low enrollment. We analyzed the perceived barriers and recruitment difficulties as reported by the coordinators and principal investigators.MethodsParticipating sites completed a missed eligibility log of subjects admitted in pain crisis throughout the study and a survey at the end of the trial. The survey covered site-specific factors, policies, and procedures in study implementation, recruitment strategies, and eligibility factors. The New England Research Institutes (NERI) collected de-identified surveys from 31 respondents at 29 of 31 participating sites.ResultsFrom December 2009 to June 2010, 1116 patient encounters for SCD and pain occurred at participating institutions: 38 subjects were enrolled (14 pediatric and 24 adults) and 34 completed the trial, below the projected 278 subjects. Fourteen sites enrolled subjects and seventeen did not. Recruitment barriers included insufficient staff, subject ineligibility or in too much pain to consent, competing protocols, and concerns regarding pain control. Recruitment methods were referrals from urgent care, SCD clinics and in house databases. No use of media or outside physicians was reported.ConclusionWe identified multiple barriers to patient accrual including short duration of enrollment period, protocol design, complex dosing schedule, requirement for staff availability during week-end and after hours, multiple departments' involvement, protocol acceptance, eligibility criteria, competing protocols, and limited staff. Each of these areas should be targeted for intervention in order to plan and conduct successful future clinical trials.     

Transapical access and closure devices: rationale and current status

In the past years transcatheter aortic valve implantation became a highly standardized option for the treatment of high-risk patients suffering from severe aortic stenosis. The number of transcatheter aortic valve implantation procedures is increasing exponentially worldwide. In this context the transapical approach should be considered as a safe and reproducible alternative access to the left ventricle with some specific advantages compared with transfemoral, transaortic and transsubclavian approach due to its antegrade nature. To further ease the transapical access first apical closure devices have been developed and entered first clinical trials.     

Improved healing rates for chronic venous leg ulcers: pilot study results from a randomized controlled trial of a community nursing intervention

Venous leg ulcers are a frequent source of chronic ill-health and a considerable cost to health-care systems. This paper reports pilot study results from a randomized controlled trial to determine the effectiveness of a community-based 'Leg Club' environment on improving healing rates of venous leg ulcers. Leg Clubs offer a setting where people with similar problems can socialize in a supportive, information-sharing environment. A sample of 33 clients with a below-knee venous leg ulcer were randomized to treatment, either in their own homes or in a community Leg Club. Treatment was provided to all participants, whether in the control group or intervention group, by a team of trained wound-care nurses following evidence-based assessment and treatment guidelines. Data were collected on admission to the study and at 12 weeks from admission. Results showed a significant improvement in healing in the intervention group compared to the control group, as measured by ulcer area size and Pressure Ulcer Scale for Healing scores. These results suggest that a community Leg Club environment provides benefits additional to wound care expertise and evidence-based care. Knowledge gained from this study provides evidence to guide service delivery and improve client outcomes.     

Depression in cardiological practice: pilot results from a multicenter clinico-epidemiological trial in hypertensive patients with ischemic heart disease (koordinata)

AIM: To study effects of depression on the course and prognosis of arterial hypertension (AH) and coronary heart disease (CHD), potentialities of the combined treatment in a prospective multicenter trial. MATERIAL AND METHODS: A total of 376 patients with AH and/or CHD having depression (10 scores and higher by HADS scale) were assigned to two groups: 189 (50.3%) patients received somatotropic therapy+coaxil (the study group), 187 (49.7%) patients received somatotropic therapy alone (the comparison group). Coaxil was given for 6 weeks in a dose of 37.5 mg/day, to patients over 70 years--25 mg/day. The effects were assessed by changes in HADS, CGI scale, blood pressure, heart rate; by tolerance and side effects (objective effects); complaints, well- being, stress, tolerance (subjective effects). RESULTS: The addition of coaxil to somatotropic therapy of patients with AH and/or CHD associated with depression led to improvement of the psychological status (a 36% decrease by HADS depression scale from 13.1 +/- 2.75 to 8.43 +/- 3.64, -delta4.76, p < 0.0001; by HADS anxiety scale--by 35.6% from 12.08 +/- 3.90 to 7.78 +/- 3.63, -delta4.31, p < 0.0001; by response to psychoemotional stress--by 23% from 6.65 +/- 1.94 to 4.77 +/- 1.85, -delta1.88, p < 0.05). Control patients also showed a positive trend in the above indices (a decrease in the above indices from 13.15 +/- 2.65 to 11.79 +/- 3.31, from 11.50 +/- 3.66 to 10.12 +/- 3.95, from 6.63 +/- 1.99 to 6.03 +/- 2.07, p < 0.05, respectively) but positive changes were much weaker than in the coaxil group (p < 0.001). To the end of the treatment, patients of the study group had less number of complaints, more patients achieved the target level of arterial pressure under 140/90 mm Hz (43.9 versus 29.9% in the control group; p < 0.005). CONCLUSION: Standard somatotropic treatment of AH patients with CHD and depression is not sufficiently effective. Combination of such treatment with antidepressive therapy (coaxil) significantly improves psychological status, and efficacy of therapy of basic cardiological diseases.     

A new technique of endoscopic full-thickness resection using a flexible stapler

There is a significant need for a safe and easy technique for endoluminal endoscopic resection of gastrointestinal lesions, but such procedures are usually restricted to resection of the mucosal layer in order to preserve the integrity of the wall of the gastrointestinal tract. We present two patients, one with early cancer and one with a carcinoid tumor, who were treated by endoscopic full-thickness resection. We used a stapling device, consisting of a flexible shaft, which was positioned intraluminally, and a remote control. After pilot investigations in pigs and in human anatomical preparations, we performed a full-thickness resection of the gastric wall in these patients, using the flexible stapling device under gastroscopic control. Gastric wall specimens up to 4 cm x 4 cm in size were resected with the use of two to three stapler magazines. Both procedures followed an uneventful course and the patients made an uncomplicated recovery. Further studies are necessary to test the applicability of the technique in the management of other gastric neoplastic lesions.