A quality assurance audit: phase III trial of maximal androgen deprivation in prostate cancer (TROG 96.01)

In 1997 the Trans-Tasman Radiation Oncology Group (TROG) performed a quality assurance (QA) audit of its phase III randomized clinical trial investigating the effectiveness of different durations of maximal androgen deprivation prior to and during definitive radiation therapy for locally advanced carcinoma of the prostate (TROG 96.01). The audit reviewed a total of 60 cases from 15 centres across Australia and New Zealand. In addition to verification of technical adherence to the protocol, the audit also incorporated a survey of centre planning techniques and a QA time/cost analysis. The present report builds on TROG's first technical audit conducted in 1996 for the phase III accelerated head and neck trial (TROG 91.01) and highlights the significant progress TROG has made in the interim period. The audit provides a strong validation of the results of the 96.01 trial, as well as valuable budgeting and treatment planning information for future trials. Overall improvements were detected in data quality and quantity, and in protocol compliance, with a reduction in the rate of unacceptable protocol violations from 10 to 4%. Audit design, staff education and increased data management resources were identified as the main contributing factors to these improvements. In addition, a budget estimate of $100 per patient has been proposed for conducting similar technical audits. The next major QA project to be undertaken by TROG during the period 1998-1999 is an intercentre dosimetry study. Trial funding and staff education have been targeted as the key major issues essential to the continued success and expansion of TROG's QA programme.     

Quality assurance audit in an Australasian phase III trial of accelerated radiotherapy for head and neck cancer (TROG 91.01). Trans-Tasman Radiation Oncology Group

The Trans-Tasman Radiation Oncology Group (TROG) initiated a randomized trial, testing accelerated (twice daily) radiotherapy against conventional radiotherapy for stage III and stage IV squamous cell carcinoma of the head and neck in 1991. In 1996, the Trial Management Committee arranged for a technical audit of 76 cases from 11 institutions, conducted by investigators from interstate institutions. A 10% unacceptable protocol violation rate was detected, which compares favourably with initial Radiation Therapy Oncology Group (RTOG) experience in the late 1970s. Infrastructural deficits with poor quality of documentation, incomplete retrieval of films and document return have been demonstrated in some cases. The Trans-Tasman Radiation Oncology Group is actively pursuing procedural and resourcing issues in order to redress this and is actively expanding its Quality Assurance (QA) Programme with an intercentre dosimetry study. Ultimately, comprehensive clinical and technical QA site visits are planned.     

Is pre-trial quality assurance necessary? Experiences of the CONVERT Phase III randomized trial for good performance status patients with limited-stage small-cell lung cancer

Objective:

This study is an analysis of the pre-trial quality assurance (QA) exercises submitted by clinicians from radiotherapy (RT) centres across Europe and Canada to qualify for participation in the CONVERT trial.

Methods:

QA exercises submitted by 64 clinicians at 64 RT centres were included in this analysis. The exercises included the completion of a trial-specific questionnaire and submission of a treatment plan, for both trial arms, for a patient fitting the eligibility criteria of the trial. This article describes the QA programme set up for the CONVERT trial and identifies deviations from the trial protocol. Patient eligibility, disease and critical structure outlining and treatment planning technique were assessed.

Results:

Results from QA trial-specific questionnaires received between February 2008 and September 2011, returned as part of the QA exercise, indicated that the majority of centres (70.3%) were using 6-MV photons and type B treatment planning system algorithms (57.8%). 90.6% of clinicians assessed submitted data for patients who fitted the eligibility criteria for the trial. There were inconsistencies in outlining of gross tumour volume (GTV) and organs at risk, mainly heart and oesophagus, and in the use of margins around the GTV.

Conclusion:

Such a QA programme helps to ensure that centres conform to trial protocol and should reduce inconsistencies in RT planning that may confound the results of the CONVERT trial.

Advances in knowledge:

Few studies reporting pre-trial QA have been published to date. This article outlines the importance of such a QA programme in the context of multicentre Phase III studies.Approximately 40 000 new cases of lung cancer are diagnosed annually in the UK. Of these cases, 15% will present with small-cell lung cancer (SCLC) and the 5-year survival is <10%. At the time of diagnosis, about 30–40% of patients with SCLC will have limited-stage (LS) disease and almost all long-term disease-free survivors come from this group. Despite improvements in the treatment of LS-SCLC with the optimization of chemo-radiotherapy (CTRT) combinations and treatment delivery, long-term survival remains low (20–25% at 5 years) and local control is poor.^1–3 Concurrent CTRT is the standard of care for good performance status patients with LS-SCLC.⁴ One strategy to improve local control and survival is to increase the dose of radiation delivered concurrently with chemotherapy. An international Cancer Research UK (London, UK)-funded randomized controlled Phase III trial, CONVERT (concurrent once-daily versus twice-daily radiotherapy⁵) recruited good performance status patients with LS-SCLC with an aim of establishing a standard CTRT regime within this cohort (ClinicalTrials.gov identifier: {"type":"clinical-trial","attrs":{"text":"NCT00433563","term_id":"NCT00433563"}}NCT00433563). At least 532 patients were to be randomized to once-daily (OD) vs twice-daily (BD) radiotherapy (RT) given concurrently with cisplatin–etoposide. The CONVERT trial closed in November 2013, after 547 patients had been accrued.A quality assurance (QA) programme was established at the onset of the trial.Perez et al⁶ stressed the importance of QA in RT clinical trials and suggested that the use of such a programme increases the evaluability rate in a protocol by 10%, leading to a significant decrease in the cost of the study per evaluable patient. In 1995, an update on the European Organisation for Research and Treatment of Cancer (EORTC) master protocol for Phase III RT studies described developments in RT planning, delivery, treatment verification and QA and the implementation of QA procedures in RT studies.⁷Inconsistencies in patient selection, treatment planning and delivery between participating clinicians and centres and deviations from trial protocol may affect the results of a trial. For example, Donaldson et al⁸ assessed the effect of deviations in target volume delineation and dose distribution on local control in a Phase III trial for newly diagnosed patients with Ewing''s sarcoma. Patients with a major deviation from protocol had a 5-year local control rate of 16%, those with a minor deviation had a local control rate of 48% and those who had no deviations had an 80% local control rate.It is therefore important to establish a robust QA programme that assesses the entire RT process, from patient selection, disease and critical structure delineation to treatment planning and delivery. Pre-trial QA feedback to centres increases the likelihood that trial patients are treated according to protocol.A QA programme led by the Mount Vernon Hospital, in conjunction with the Manchester Lung Cancer Group, was established to assess individual clinicians and RT centres wishing to enter patients into the trial. The QA programme aimed to assess adherence to the trial protocol regarding patient selection and RT delivery across all participating centres, and to provide an advice forum for clinicians and physicists at centres where participation in the trial may mean a change in working practice. This programme was supported by the National Cancer Research Institute Radiotherapy Clinical Trials QA (RTTQA) group (www.rttrialsqa.org.uk), a consortium including members from Mount Vernon Hospital, Northwood, UK; Royal Marsden Hospital, London, UK; Clatterbridge Centre for Oncology, Bebington, UK; and Velindre Hospital, Cardiff, UK. The aim of the group is to unify, simplify and streamline the RT clinical trial QA process. In a recent review, the RTTQA group discussed methods of reducing interobserver variation in outlining and the use of a pre-trial benchmark case to assess the outlining quality.⁹     

The effect of quality assurance on flight nurse documentation

This study was developed to evaluate if a structured quality assurance program has an effect on nursing documentation. A randomized, retrospective audit of records was conducted from 1985 to 1989, and in November 1987, a structured QA program was initiated for flight nurses. Each chart was audited for completeness of 69 elements from seven categories: administrative information, patient history, physical exam, management plan, vital signs, medications and intravenous access. A comparison of audit results was conducted before and after the QA program was initiated. A total of 224 charts were audited, 123 before the QA program and 101 after. There was statistically significant improvement in 4 of 13 administrative, 5 of 7 history, 21 of 31 physical exam, 2 of 6 management, 2 of 2 vital signs, 0 of 4 medication, and 0 of 6 intravenous access elements. Twenty-five of 35 categories that did not show improvement had initial completion rates greater than 90 percent. The significant improvement in documentation by flight nurses after a formal QA program was initiated lead the authors to conclude that QA benefits air medical programs by providing a mechanism to improve documentation.     

Management of localized low-grade follicular lymphomas

Long-term follow-up data from Stanford and other centres suggest that 40-50% of patients with clinical stages I and II follicular low-grade lymphoma can be cured by radiotherapy (RT). Relapse generally occurs outside radiation fields and most relapsed patients ultimately die from lymphoma. No randomized data exist to support adjuvant chemotherapy but only one trial of low-intensity chemotherapy was sufficiently powerful to address the question. Nevertheless, data from a large phase-II study from MD Anderson suggest that combined chemotherapy and RT can produce progression-free survival results that are far superior to historical series, with survival at 10 years to be approximately 20% superior to radiation alone. These results have encouraged the development of a joint phase III study by the Trans Tasman Radiation Oncology Group (TROG) and the Australasian Leukaemia and Lymphoma Group (ALLG) in which patients with clinical stage I/II follicular lymphoma are randomized to involved field RT with or without six cycles of cytotoxic chemotherapy. In an era of rapid development in immunological and molecular therapies the potential for improved results with new combinations of more established treatment modalities should not be forgotten. This report reviews the literature on the management of localized low-grade lymphoma and discusses the rationale for the TROG/ALLG study, which began recruitment in early 2000.     

Is rural radiation oncology practice quality as good as the big smoke? Results of the Australian radiotherapy single machine unit trial

Radiotherapy utilization rates in rural Australia are suboptimal, with one solution being the building of single machine units (SMUs). One concern raised with such an approach is the quality of care delivered in SMUs. The Australian and Victorian governments have established two SMUs in the state of Victoria, with each SMU operated as a satellite service of a major 'hub' site. We report on the planned evaluation of practice quality. Radiation oncologist (RO) clinical practice was externally audited using the Royal Australian and New Zealand College of Radiologists Peer Review Audit instrument. This tool splits RO clinical practice into documentation/quality assurance (QA) criteria and decision-making criteria. Over the four sites, 130 patients were randomly selected for audit. At hub sites, 79.6% of all criteria audited were adequate, compared with 84.4% of criteria audited at SMUs (P = 0.0002). This difference was largely because of better adherence to documentation/QA criteria at the SMU sites. RO decision-making and protocol adherence were routinely very high and consistent with other clinical practice audits. There were no significant differences between hubs and SMUs for adherence to decision-making criteria; however, the few potential deficiencies in patient care identified occurred only at the hub sites. In at least one of these cases, potential suboptimal management was as a direct result of inadequate documentation. This audit found that SMUs provide as high a standard of radiotherapeutic care as larger hub departments. The findings also emphasize the need for all departments to target clinical documentation.     

Quality Assurance in the EORTC Randomized Trial 22922/10925 Investigating the Role of Irradiation of the Internal Mammary and Medial Supraclavicular Lymph Node Chain Works

BACKGROUND AND PURPOSE: A quality assurance (QA) program in conjunction with the EORTC trial investigating the role of adjuvant internal mammary and medial supraclavicular irradiation in stage I-III breast cancer is presented. The results of a dummy run procedure and of an individual case review are compared to each other. The effects of recommendations based on QA procedures on the protocol compliance are evaluated. MATERIAL AND METHODS: Prior to protocol activation all participating institutes were asked to produce treatment plans according to the guidelines of the protocol based on manual outlines of an average patient. Thereafter, they were asked to provide data on each of their first six randomized patients. RESULTS: The dummy run provided a lot of information on specific treatment techniques. In the individual case review, additional patient- and tumor-related data were collected, showing the use of anatomic information for treatment planning. A comparison between both procedures revealed that the individual case reports concurred more accurately with protocol guidelines than the dummy run. CONCLUSION: It was observed that the number of systematic protocol deviations was substantially decreased in trial patients compared to the dummy run case. Therefore, it is concluded that this extensive QA program had a positive effect on the consistency of all institutes participating in the trial.     

IMRiS phase II study of IMRT in limb sarcomas: Results of the pre-trial QA facility questionnaire and workshop

IntroductionSoft tissue sarcomas of the extremities (STSE) are rare malignancies. We report current UK practice for immobilisation of soft tissue sarcoma of STSE, as part of the initial study set-up within the IMRiS trial, a phase II study of intensity modulated radiotherapy (IMRT) in primary bone and soft tissue sarcoma.MethodsA facility questionnaire (FQ) was circulated to 29 IMRiS centres investigating the variation in immobilisation devices, planning techniques, and imaging protocols. A workshop was held to address concerns raised by centres. It focused on STSE immobilisation and patient set-up. Robustness of patient set-up at each centre was evaluated based on the following criteria: evidence of local set-up audit, calculation of margins based on set-up audit results, imaging frequency, and number of patients treated per centre per annum.ResultsTwenty-seven (93%) questionnaires were returned. 30% (8/27) of responders routinely treated STSE with IMRT. The remaining 70% (19/27) had little or no experience with IMRT for STSE. Vacuum bags were the most frequent immobilisation device (9/27), followed by thermoplastic shells (7/27). Nine centres had audited their local set-up; however, only 4 had calculated margins in response to the results. Ten centres were classified as having high level of robustness.ConclusionsImmobilisation devices and planning techniques for STSE are inconsistent across centres. Robustness of set-up is an important tool to ensure quality of results in a multicentre trial setting with such different levels of experience. The IMRiS trial Quality Assurance programme encourages centres to assess robustness of set-up through local audit and subsequent calculation of treatment margins.Implications for practiceThis is the first study that used robustness criteria to tailor QA support to individual centres.     

A radiologist’s guide to the clinical scales used in the 2015 Endovascular Stroke Trials and the Revised American Heart Association/American Stroke Association Guidelines for Endovascular Stroke Treatment

In 2015, five trials demonstrated the efficacy of endovascular treatment for acute stroke, culminating in the revised American Heart Association/American Stroke Association (AHA/ASA) recommendations for stroke management. The different clinical scales used in these trials may be unfamiliar to emergency and on-call radiologists. The modified Rankin Scale was used to describe patient disability for prestroke assessment in three of the trials and for the 90-day follow up in all five trials. The Barthel index was used in one trial to score prestroke ability to perform activities of daily living. The NIH Stroke Scale was used as part of eligibility criteria in four of the stroke trials to assess pre-existing neurological deficits. Also, the modified Rankin Scale and the NIH Stroke Scale are used in the revised AHA/ASA recommendations. By understanding these scales, emergency and on-call radiologists will better appreciate the stroke patient’s condition and will be able to more actively collaborate in the care of acute stroke patients.     

Effect of supervised physiotherapy versus home exercise program in patients with subacromial impingement syndrome: A systematic review and meta-analysis

ObjectiveTo determine whether supervised physiotherapy is more effective for functional improvement and pain relief than a home exercise program in subjects with subacromial impingement syndrome.DesignSystematic review and meta-analysis of randomized clinical trials.MethodsAn electronic search was performed in Medline, Central, Embase, PEDro, Lilacs, Cinahl, SPORTDiscus, and Web of Science databases. The eligibility criteria for selecting studies included randomized clinical trials that compared supervised physiotherapy versus home exercise program, in the shoulder function, pain, and range of motion in subjects older than 18 years of age with a medical diagnosis of subacromial impingement syndrome treated conservatively.ResultsSeven clinical trials met the eligibility criteria, and for the quantitative synthesis, four studies were included. The standardized mean difference for shoulder function was −0.14 points (95% CI: −1.04 to 0.76; p = 0.760), mean difference 0.21 cm (95% CI: −1.36 to 1.78; p = 0.790) for pain, and mean difference 0.62° (95% CI: −7.15 to 8.38; p = 0.880) for range of motion of flexion.ConclusionSupervised physical therapy and home-based progressive shoulder strengthening and stretching exercises for the rotator cuff and scapular muscles are equally effective in patients with subacromial impingement syndrome treated conservatively.Trial registration numberCRD42018086348.     

氮卓斯汀片治疗变应性鼻炎的疗效和安全性观察

目的　观察氮卓斯汀片治疗变应性鼻炎的疗效和安全性。　方法　采用多中心、随机、双盲、双模拟、阳性药 (氯雷他定片 )平行对照的方法进行Ⅱ期临床观察。　结果　本中心按要求入组 2 4对 4 8例 ,试验组和对照组各完成 2 4例。两组受试者的一般资料、治疗前后临床表现得分比较 ,差异无显著性 (P >0 .0 5 ) ;试验组有效率为 95 .83% ,对照组有效率为 87.5 0 % ,两组疗效比较差异无显著性 (P >0 .0 5 ) ,不良反应主要有嗜睡等 (试验组n =2 ,对照组n =4 ,P >0 .0 5 ) ,且两药对心肝肾和甲状腺等功能无明显影响。　结论　氮卓斯汀片是治疗变应性鼻炎安全而有效的药物。     

Radiation oncology and medical physicists quality assurance in British Columbia Cancer Agency Provincial Prostate Brachytherapy Program

PurposeTo describe in detail British Columbia (BC) Cancer Agency (BCCA) Provincial Prostate Brachytherapy (PB) Quality Assurance (QA) Program.Methods and MaterialsThe BCCA PB Program was established in 1997. It operates as one system, unified and supported by electronic and information systems, making it a single PB treatment provider for province of BC and Yukon. To date, >4000 patients have received PB (450 implants in 2011), making it the largest program in Canada. The Program maintains a large provincial prospective electronic database with records on all patients, including disease characteristics, risk stratification, pathology, preplan and postimplant dosimetric data, follow-up of prostate-specific antigen, and toxicity outcomes.ResultsQA was an integral part of the program since its inception. A formal QA Program was established in 2002, with key components that include: unified eligibility criteria and planning system, comprehensive database, physics and oncologist training and mentorship programs, peer review process, individual performance outcomes and feedback process, structured continuing education and routine assessment of the program's dosimetry, toxicity and prostate-specific antigen outcomes, administration and program leadership that promotes a strong culture of patient safety. The emphasis on creating a robust, broad-based network of skilled providers has been achieved by the program's requirements for training, education, and the QA process.ConclusionsThe formal QA process is considered a key factor for the success of cancer control outcomes achieved at BCCA. Although this QA model may not be wholly transferable to all PB programs, some of its key components may be applicable to other programs to ensure quality in PB and patient safety.     

What is the optimum breast plan: a study based on the START trial plans

Each year thousands of women within the UK are treated with radiotherapy for breast cancer. The majority of these women are treated using a medial and lateral tangential field. This study evaluates the plans submitted to the quality assurance (QA) team of the START trial and investigates some of the differences between departments. Throughout the START trial, hardcopies of the radiotherapy dose distribution on the central slice for one in three women were submitted to the QA team for analysis. The QA team measured physical parameters including breast size and lung depth as well as noting parameters used for the radiotherapy delivery including beam energy, field size and wedge angle. Over 1400 plans from 36 centres were analysed. The mean patient separation was 19.7 cm (SD 2.7 cm) with a mean lung depth of 1.5 cm (SD 0.7 cm). The modal beam energy was 6 MV and the mean wedge angle was 23 degrees . Significant differences in the choice of wedge angle between departments were noted; however, in 90% of cases the resultant plan complied with the maximum dose gradient of 10% on the central axis specified by the trial protocol. Less than 3% (37 plans) had dose gradients of greater than 12%. This resulted in a mean dose gradient for all patients on the central axis of 5.7% (SD 2.9%).     

Comparative evaluation of autologous chondrocyte implantation and mosaicplasty: a multicentered randomized clinical trial.

OBJECTIVE: To compare the respective performance and effectiveness of autologous chondrocyte implantation (ACI) and mosaicplasty at resurfacing local full-thickness chondral defects of the knee. DESIGN: Randomized clinical trial. SETTING: Multicenter trial at orthopedic clinics and university hospitals conducted from 1997 to 2000. PATIENTS: A population of patients selected according to eligibility criteria of age, traumatic origin of the defect, its localization, size, and gravity, and above all, no previous surgical treatment of the lesion. Forty-seven patients were randomly assigned to ACI or mosaicplasty and subjected to arthroscopic debridement of the lesion at the time of enrollment. They were called for surgery 6 months after the initial debridement. MAIN OUTCOME: Improved knee functionality as assessed by repeated clinical evaluation based on the International Knee Documentation Committee Scale and the Lysholm Knee Scoring Scale. RESULTS: Fourteen patients (31.8%) experienced substantial improvement following the initial debridement and, being clinically cured, received no further treatment. Seven patients (15.9%) were lost to follow-up. Among the 23 patients (52.3%) who could effectively be evaluated, a complete recovery (ie, Lysholm Knee Scoring Scale score, 90-100) was observed upon clinical examination in 88% of the mosaicplasty-treated patients and in 68% of the ACI-treated ones (P = 0.093). CONCLUSIONS: Although the low power of our study prevents definitive conclusions, ACI and mosaicplasty are cartilage repair techniques that are clinically equivalent and similar in performance. The high percentage of spontaneous improvement ((1/3) of the patients) observed after simple debridement calls into question the need for prompt surgical treatment of patients with lesions similar to those included in this clinical trial. Moreover, this finding warrants further investigation, ideally through randomized clinical trials in which patients subjected to debridement alone are compared with patients undergoing reconstructive surgery.     

Adjuvant post-operative radiotherapy in rectal cancer: results from the ANZ Bowel Cancer Trial (Protocol 8202)

In July 1982 the Gastrointestinal Section of The Clinical Oncological Society of Australia began a multicentre randomized trial to assess the value of post-operative pelvic radiotherapy in the local control of stage B and C carcinoma of the rectum. Patients who had undergone a potentially curative resection were randomized either to no further treatment (NO RT) or to pelvic radiotherapy (RT), 45 Gy in 25 fractions (plus a perineal boost of 5 Gy in 2 fractions after abdomino-perineal resection). The trial was prematurely terminated in December 1985 owing to slow accrual after 70 patients had been randomized: 36 patients to RT and 34 patients to NO RT. Two patients in each group were found to be ineligible after randomization and, for a variety of reasons, thirteen patients who were randomized to RT did not receive that treatment. The incidence of post-operative complications were comparable in both groups, indicating that radiotherapy produced no additional problems. Radiotherapy-related morbidity comprised mainly diarrhoea (grade 1 = 2/21; grade 2 = 5/21; grade 3 = 0/21; grade 4 = 1/21). There were no deaths due to radiotherapy and only one patient, with grade 4 diarrhoea, failed to complete the prescribed course of radiotherapy. After an average follow-up period of 52 months there were 15 local recurrences, 8 in the RT group and 7 in the NO RT group, giving an actuarial 2 year local recurrence rate of 16%. There was no difference in the time to local recurrence, either by randomization group (p = 0.50) or by actual treatment received (p = 0.91).(ABSTRACT TRUNCATED AT 250 WORDS)     

Predictors of exercise compliance in individuals with Gulf War veterans illnesses: Department of Veterans Affairs Cooperative Study 470

Although the health benefits of exercise for individuals with Persian Gulf War veterans illnesses (GWVI) are documented, many of these individuals do not exercise regularly enough to obtain benefits. The purpose of this study was to investigate factors predicting exercise compliance among individuals with GWVI in a multicenter, randomized, clinical trial. Participants were 1,092 veterans who reported at least two of the following cardinal symptoms of GWVI: (1) fatigue, (2) musculoskeletal pain, and (3) cognitive problems. Participants received exercise alone or exercise and cognitive-behavioral therapy. The overall level of compliance was relatively low during the exercise treatment phase (46.2%) and decreased by one-half during the follow-up period (23.0%). Predictors of compliance during treatment included less pain and greater age, motivation, and body mass index. Predictors of compliance during the follow-up period included less pain and greater age. The results highlight factors that affect adoption and maintenance of physical activity in a population with GWVI.     

The effects of exercise upon symptoms and quality of life in patients diagnosed with irritable bowel syndrome: a randomised controlled trial

While it seems intuitively appealing to promote participation in regular exercise in the management of irritable bowel syndrome, limited randomised controlled trial evidence exists to support this recommendation. We examined the feasibility and effects of an exercise intervention upon quality of life and irritable bowel symptoms using a randomised controlled trial methodology. Patients with a clinically confirmed diagnosis of irritable bowel syndrome according to Rome II criteria were randomised to either an exercise consultation intervention or usual care for 12 weeks. Outcomes included irritable bowel specific quality of life, symptoms (total symptoms, constipation, diarrhoea and pain) and exercise participation. The recruitment rate of eligible patients identified from hospital records was 18.3 % (56/305). Analyses revealed no differences in quality life scores between groups at 12-week follow-up. The exercise group reported significantly improved symptoms of constipation (mean difference = 10.9, 95 % CI = - 20.1, - 1.6) compared to usual care at follow-up. The intervention group participated in significantly more exercise than usual care at follow-up (mean difference = 21.6, 95 % CI = 9.4, 33.8). Recruitment of eligible patients into this study was possible but rates were low. Findings highlight the possibility that exercise may be an effective intervention for symptom management in patients with irritable bowel syndrome; this may be particularly the case for constipation predominant patients.     

Effectiveness of intra-arterial anesthesia for uterine fibroid embolization using dilute lidocaine

A modified protocol of uterine fibroid embolization (UFE) is proposed for alleviating the postinterventional pain. This randomized and double-blinded clinical trial is to evaluate the effectiveness of intra-arterial infusion of dilute lidocaine for postinterventional pain relief in UFE. Forty-six patients who underwent UFE were randomly grouped equally. In the test group, after the poly(vinyl alcohol) embolization was complete, a dilute lidocaine solution with 40 mg in 6.0 ml, 3.0 ml for each side or 4.0 and 2.0 ml for two sides, was given through the catheter. In the control group, the patients received 6.0 ml of saline solution as a placebo. A simple pain degree classification method for patient self-evaluation was developed. A questionnaire was completed by each patient to record the degree of pain during five periods; these were during the procedure, the first 12 h, the second 12 h, between 24 and 48 h, and between 48 and 72 h. The numbers of patients with the same degree of pain in the five time segments from the two groups were statistically compared. Compared with the control group, the patients in the test group experienced less pain within 48 h after the procedure (p<0.01). The results suggest that this improved UFE protocol is a simple approach to prevent the acute postinterventional pain of UFE.     

Safety of air travel following acute myocardial infarction

BACKGROUND: A randomized, single-blind, controlled trial was carried out to: 1) examine the safety of patients flying on commercial airlines 2 wk after a myocardial infarction; 2) determine whether or not the use of supplemental oxygen was associated with a reduced risk of in-flight adverse events; and 3) determine the need for a medical escort. METHODS: There were 38 patients who were prospectively and randomly assigned supplemental continuous oxygen therapy (2 L x min(-1) via nasal prongs; n = 19) or no oxygen (n = 19) during the flight. Prior to flying, an escorting doctor completed a medical questionnaire for each patient. Both groups underwent Holter monitoring throughout the flight. The major end-point was the development of inflight myocardial ischemia, as detected by Holter monitoring. Minor end-points included patients complaining of chest pain or dyspnea; the detection of bigeminy or trigeminy by Holter monitoring; or oxygen desaturation to less than 90%, as measured by pulse oximetry. RESULTS: Of the 38 patients enrolled, there was only 1 major end-point. This patient had a brief, self-limiting, asymptomatic episode of myocardial ischemia diagnosed by Holter monitoring. Minor end-points occurred in 13 (34%) patients. One patient had asymptomatic evidence of S-T depression on a transport monitor, but not on the Holter. Five patients had transient low (<90%) oxygen saturations, two complained of chest pain, and five had complex ventricular ectopic beats or periods of transient ventricular tachycardia. None of the minor end-points were associated with Holter evidence of myocardial ischemia. Of the 30 patients with completed questionnaires and Holter results, there was no difference in the incidence of minor end-points between the oxygen (5/13) and no oxygen groups (6/15) (p = 0.93). Intervention by the medical escort consisted of commencing oxygen therapy on those patients with low oxygen saturations and those with chest pain. Use of an already dispensed glyceryl trinitrate spray was initiated in one patient with chest pain that turned out to be non-ischemic when the Holter traces were later analyzed. CONCLUSIONS: This study suggests that, provided that care is taken during the immediate preflight and postflight phases not to overexert the patients, neither supplemental oxygen nor medical escorts are needed in the transportation of patients who fly 2 wk after acute myocardial infarction.     

Safety and Efficacy of Segmental Yttrium-90 Radioembolization for Hepatocellular Carcinoma after Transjugular Intrahepatic Portosystemic Shunt Creation

PurposeTo evaluate safety and efficacy of segmental yttrium-90 (Y90) radioembolization for hepatocellular carcinoma (HCC) after transjugular intrahepatic portosystemic shunt (TIPS) placement. The hypothesis was liver sparing segmental Y90 for HCC after TIPS would provide high antitumor response with a tolerable safety profile.Materials and MethodsThis single-arm retrospective study included 39 patients (16 women, 23 men) with ages 49–81 years old who were treated with Y90. Child-Pugh A/B liver dysfunction was present in 72% (28/39) with a median Model for End-stage Liver Disease score of 18 (95% confidence interval, 16.4–19.4). Primary outcomes were clinical and biochemical toxicities and antitumor imaging response by World Health Organization (WHO) and European Association for the Study of the Liver (EASL) criteria. Secondary outcomes were orthotopic liver transplantation (OLT), time to progression (TTP), and overall survival (OS) estimates by the Kaplan-Meier method.ResultsThe 30-day mortality was 0%. Grade 3+ clinical adverse events and grade 3+ hyperbilirubinemia occurred in 5% (2/39) and 0% (0/39), respectively. Imaging response was achieved in 58% (22/38, WHO criteria) and 74% (28/38, EASL criteria), respectively. Median TTP was 16.1 months for any cause and 27.5 months for primary index lesions. OLT was completed in 88% (21/24) of listed patients at a median time of 6.1 months (range, 0.9–11.7 months). Median OS was 31.6 months and 62.9 months censored and uncensored to OLT, respectively.ConclusionsSegmental Y90 for HCC appears safe and efficacious in patients after TIPS. Preserved transplant eligibility suggests that Y90 is a useful tool for bridging these patients to liver transplantation.