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PubMedDate not supplied

Simple and effective technique of guided biopsy in a closed MRI system.

BACKGROUND: Magnetic resonance (MR)-guided biopsies are generally regarded as complex interventions. We implemented interventional MR (IMR) with the resources available in and for practical application in a large (1100 beds) central hospital. METHODS: This simple and straightforward IMR technique uses a step-by-step approach for localization, access route planning, biopsy, verification in at least two planes, and postoperative control. The technique has been used and evaluated unchanged for more than 400 punctures and interventions. RESULTS: Contrast, signal, matrix options, and visibility of needle track and tip permit uncomplicated orientation. The mean duration of a biopsy is 19 min. The technique can be applied to all radiologic puncture settings without any technical or medical complications. CONCLUSION: The crucial step in implementing IMR is not to contemplate its application but to simply start applying the procedure.

Aged↗

PubMed1993

Complications associated with percutaneous placement and use of intraaortic balloon counterpulsation.

In-hospital and late complications related to percutaneous placement of 240 intraaortic balloon pump catheters in 231 consecutive patients from March 1985 through June 1990 were reviewed. Mean age was 64 +/- 11 years and 34% were women. Average duration of counterpulsation was 44.2 hours. Indications for counterpulsation included complications of myocardial infarction (34.6%), prophylactic placement before high-risk coronary angioplasty (20.0%) or open heart surgery (12.9%), complicated coronary angioplasty (18.3%), end-stage cardiomyopathy (5.4%) and miscellaneous (8.8%). Early major complications occurred in 11 cases (4.6%) and included limb ischemia requiring surgery (n = 9), bleeding requiring arterial repair (n = 1) and septicemia (n = 1). Other complications included hematoma requiring transfusion (n = 7), limb ischemia resolving with balloon catheter removal (n = 12), and superficial wound infection (n = 1). Overall in-hospital complication rate was 13% (31 of 240). Peripheral vascular disease and diabetes were found to be significant predictors of limb ischemia (p = 0.01 and p = 0.02, respectively). Follow-up information was obtained in 97% of patients with a mean duration of 19 months: 2 patients (1.1%) required vascular surgery for femoral false aneurysms and 1 patient experienced new onset of claudication. In conclusion, compared with previous experience, contemporary intraaortic balloon counterpulsation with percutaneous placement of smaller size (8.5Fr to 10.5Fr) catheters is associated with improved complication profile. This will further enhance the current trend for an expanding role of intraaortic balloon counterpulsation in complex interventional procedures.

Adult↗

PubMed1991

Value and limitations of transesophageal echocardiographic monitoring during percutaneous balloon mitral valvotomy.

To determine the utility of transesophageal echocardiographic monitoring during percutaneous balloon mitral valvotomy, we analyzed data from 40 consecutive patients who had been randomly assigned to undergo balloon mitral valvotomy under transesophageal echocardiographic guidance or without echo. All procedures were carried out under general anaesthesia. The completion rate (100% vs 73%), the procedure time (108 +/- 28 min vs 65 +/- 18 min), the X-ray exposure time (62 +/- 13 vs 33 +/- 12 min), resulted significantly (P less than 0.001) more favorable in the echo-monitored patients. Moreover, a lower rate of major complications (cardiac tamponade, large residual atrial shunting, and severe mitral regurgitation) was noted in the echo-monitored patients. The achieved final area of the mitral valve did not differ significantly between the two groups. From an evaluation of results as a whole, 96% of the echo-monitored procedures were successful, whereas only 40% of the procedures conducted without echocardiographic control achieved a satisfactory final result in absence of major complications. We conclude that transesophageal echocardiography is a safe, effective, and valuable tool to monitor each step of balloon mitral valvotomy in order to shorten the time of the procedure, and to improve the results of this complex interventional catheterization technique.

Adult↗

PubMed1993

A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty.

OBJECTIVES: A new percutaneous collagen hemostasis device was compared with conventional compression techniques after diagnostic catheterization and angioplasty. BACKGROUND: Peripheral vascular complications after diagnostic catheterization or more complex interventional procedures, as well as the discomfort of manual compression and prolonged bed rest, represent significant morbidity for invasive cardiac procedures. METHODS: A prospective, multicenter, randomized trial was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving a vascular hemostasis device with those undergoing conventional compression techniques. RESULTS: After diagnostic catheterization, hemostasis time was significantly less with the vascular hemostasis device than with conventional manual compression (4.1 +/- 2.8 min [n = 90 patients] vs. 17.6 +/- 9.2 min [n = 75], p < 0.0001). This difference was greater in patients undergoing angioplasty and was unrelated to the anticoagulation status (4.3 +/- 3.7 min [n = 71 not receiving heparin], 7.6 +/- 11.6 min [n = 85 receiving heparin], 33.6 +/- 24.2 min [n = 134 control patients not receiving heparin], p < 0.0001 vs. control patients). The time from the start of the procedure to ambulation was slightly less after diagnostic catheterization in patients treated with the device (13.3 +/- 12.1 h vs. 19.2 +/- 17.8 h, p < 0.05). It was also less in patients who underwent angioplasty when the device was used after discontinuation of anticoagulation (23.0 +/- 11.1 h, without heparin), as compared with control compression techniques (32.7 +/- 18.8 h, p < 0.0001). Time to ambulation was even shorter (16.1 +/- 11.1 h, p < 0.0001) in patients in whom the device was placed immediately after angioplasty while they were still fully anticoagulated with a prolonged activated clotting time (336 +/- 85 s). There were no major complications (surgery or transfusion) after diagnostic catheterization and a low incidence of major complications in patients who underwent angioplasty (0.7% in control patients, 1.4% with the device without heparin, 1.2% with the device and heparin, p = NS). After angioplasty, there was a trend toward fewer hematomas when the device was used in the absence of heparin (4.2% vs. 9.7% in control patients, p = 0.14). CONCLUSIONS: A new vascular hemostasis device can significantly reduce the puncture site hemostasis time and the time to ambulation without significantly increasing the risk of peripheral vascular complications. The role of this technology in reducing complications, length of hospital stay and cost remains to be determined.

Aged↗

PubMed2006

Forced exercise does not improve recovery after hemorrhagic stroke in rats.

Exercise can improve recovery following ischemia and intracerebral hemorrhage (ICH) in rodents. We tested whether forced exercise (EX; running wheel) prior to and/or following ICH in rats would reduce lesion volume and improve functional outcome (walking, skilled reaching, spontaneous paw usage) at 7 weeks post-ICH. A striatal hemorrhage was produced by infusing collagenase. First, we compared animals that received EX (2 weeks; 1 h/day) ending two days prior to ICH and/or starting two weeks following ICH. EX did not improve functional recovery or affect lesion size. Doubling the amount of EX given per day (two 1-h sessions) both prior to and following ICH did not alter lesion volume, but worsened recovery. We then determined if EX (1 h/day) prior to and following ICH would affect outcome after a somewhat milder insult. There were no differences between the groups in lesion volume or recovery. Finally, we used a hemoglobin assay at 12 h following ICH to determine if pre-stroke EX (2 weeks; 1 h/day) aggravated bleeding. It did not. These observations suggest that EX does not improve outcome when given prior to and/or when delayed following ICH. Effective rehabilitation for ICH will likely require more complex interventions than forced running.

Analysis of Variance↗

PubMed2006

Efficacy of psychoeducational approaches on bipolar disorders: a review of the literature.

BACKGROUND: To evaluate the efficacy of psychoeducation in the treatment of bipolar disorder according to specific therapeutic targets such as treatment compliance, patients' and families' knowledge of the illness and its treatments, relapse prevention, symptomatic (depressive or (hypo)manic) phases of the illness or social and occupational functioning. METHODS: A systematic review of the literature published on psychoeducation up to July 2006 was carried out using the main electronic data bases (Medline, PubMed). The key words employed included bipolar disorder, psychoeducation, depression, mania, relapse prevention and treatment compliance. RESULTS: Although the methodological shortcomings of the early studies must be taken into account, most data accumulated to date suggest that psychoeducation, used alone or as a component of more complex interventions, makes it possible to improve the course of the illness, notably by increasing the patients' and their families' knowledge of the disorder and of treatment options, by decreasing the risk of (hypo)manic or depressive relapse and of hospitalization and by improving treatment compliance. LIMITATIONS: More studies based solely on psychoeducation, rather than psychoeducation as part of a multicomponent approach, are needed to confirm the efficacy of PE reported to date. CONCLUSIONS: Given the results published to date, psychoeducation should be part of the integrated treatment of bipolar disorder. As a complement to pharmacotherapy, psychoeducation delivered individually or in a group setting constitutes a first-line psychological intervention. Applicable to a majority of patients and their families, it can be delivered by a wide range of health professionals trained in this approach.

Bipolar Disorder↗

PubMedDate not supplied

Safe motherhood program evaluation: theory and practice.

Debate on the evaluation of safe motherhood programs has mainly focused on the outcome or process measure to be used. Less attention is paid to the application of different approaches to evaluation. This article reviews current theories of evaluation and provides examples of the extent to which these theories have been applied in the actual practice of evaluation. Most evaluations use multiple methods and approaches, but the rationale and intention behind these choices are often not made explicit. Factors are identified that need to be taken into consideration when planning and conducting safe motherhood program evaluations. Safe motherhood programs are complex interventions, requiring evaluation by different theoretical approaches and multiple methods. Awareness of these approaches will allow health professionals to plan for evaluation and to use evaluation findings more effectively. If cognizant of the different approaches to evaluation, evaluation frameworks can be developed to improve assessment of the effectiveness of these programs.

Female↗

PubMed2026

Perspectives of participating neurologists and study nurses - Mixed-methods process evaluation of a web-based program for relapse management in multiple sclerosis (POWER@M2).

BACKGROUND: Relapsing-remitting multiple sclerosis is a chronic inflammatory disease of the central nervous system and the leading cause of disability in young adults. In Germany, 90% of relapses are treated with high-dose intravenous glucocorticoids, despite limited evidence for long-term benefit and international preference for oral administration. Time constraints often hinder informed decision-making. The multicentre Randomized Controlled Trial (RCT) POWER@MS2 (N = 160, 2020-2023), conducted at 18 German MS-centres, aimed to promote self-determined relapse management through a complex intervention (dialogue-based decision aid, nurse-led webinar, online-chat). OBJECTIVE: While RCTs demonstrate effectiveness, process evaluations are essential to understand implementation, mechanisms of impact and contextual factors. This study explored healthcare professionals' experiences and attitudes toward implementing relapse self-management and self-medication in clinical practice. METHODS: A mixed-methods process evaluation followed the UK Medical Research Council- framework. Quantitative data were collected via validated questionnaires at up to three time points and analysed descriptively. Interview guides were developed based on these results. Qualitative data from neurologist and study nurse interviews were thematically analysed. Results were triangulated using a joint display. RESULTS: Data were collected from 55 neurologists and 17 study nurses (quantitative) and from 7 neurologists and 4 nurses (qualitative) (2020-2024). Most neurologists opposed routine steroid use, reserving it for severe relapses. Some voiced concerns about self-management, but informed patients were generally viewed as capable of safe self-medication. Study nurses gave mixed feedback on the intervention, citing overload and improved guidance. CONCLUSION: Clinicians showed openness toward implementing the intervention. Enhancing accessibility and addressing specific concerns may support broader adoption.

Humans↗

PubMed2005

Evidence-based patient information about treatment of multiple sclerosis--a phase one study on comprehension and emotional responses.

OBJECTIVE: This study analysis the comprehension and emotional responses of people suffering from multiple sclerosis when provided with an evidence-based information module. It is a core module of a comprehensive decision aid about immunotherapy. The core module is designed to enable patients to process scientific uncertainty without adverse effects. It considers existing standards for risk communication and presentation of data. METHODS: Using a mailing approach we investigated 169 patients with differing courses of disease in a before-after design. Items addressed the competence in processing relative and absolute risk information and patients' emotional response to the tool, comprising grade of familiarity with the information, understanding, relevance, emotional arousal, and certainty. RESULTS: Overall, numeracy improved (p < 0.001), although 99 of 169 patients did not complete the numeracy task correctly. Understanding depended on the relevance related to the course of disease. A moderate level of uncertainty was induced. No adverse emotional responses could be shown, neither in those who did comprehend the information, nor in those who did not develop numeracy skills. CONCLUSION: In conclusion, the tool supports people suffering from multiple sclerosis to process evidence-based medical information and scientific uncertainty without burdening them emotionally. PRACTICE IMPLICATIONS: This study is an example for the documentation of an important step in the development process of a complex intervention.

Adult↗

PubMed2005

Doctor-patient interaction in a randomised controlled trial of decision-support tools.

In this paper, we draw on the analytic perspectives of ethnomethodology to explore doctor-patient encounters in an experimental trial of a complex intervention: an efficacy randomised controlled trial (RCT) of decision-support tools in the UK. We show how the experimental context in which these encounters take place pervades the interactions within them. We argue that two interactional orders were at work in the encounters that we observed: (i) the ceremonial order of the consultation and (ii) the assemblage of the decision-support tool trial. We demonstrate how doctors in the trial oscillate between positions as authoritative clinician and neutralistic decision-support tool-implementer, and patients move between positions as passive recipients of clinical knowledge and as active subjects required to render their experience as calculable in terms of the demands of the decision-support tools and the broader trial they are embedded in. We demonstrate how the RCT coordinates the world of the clinical environment and the world of experimental evidence.

Decision Support Systems, Clinical↗

PubMed1998

A solution to the problem of undictated operative reports by residents.

PURPOSE: The objective of this study was to reduce the number of operative reports assigned to the surgical residents but not dictated within 48 hours by 80% within 6 months. METHODS: A before-after trial was conducted in a teaching hospital (part of a major academic medical center) in an urban setting, of a complex intervention based on a theoretical framework for behavioral change. Data were collected for more than 6 months before the intervention, and then in three separate time periods during the next 18 months. The intervention, lasting 41 weeks, and directed specifically at undictated operative reports, comprised the following: educational sessions, posting of residents' names with delinquency rates, attending/resident interactions, telephone reminders, rewards, and punishments. The population studied comprised every resident who rotated through the general surgery service over a 2-year period 1995 to 1997. RESULTS: The mean (+/-SD) number of undictated operative reports declined progressively from 72 (+/-8.3) to 6 (+/-2.6). This 92% reduction was statistically significant (P <0.00005). The mean number of undictated discharge summaries declined progressively from 54 (+/-11.2) to 13 (+/-8.1). This 76% reduction was also statistically significant (P <0.00005). There was a close correlation between the operative reports and the discharge summaries (r = 0.82). CONCLUSIONS: The performance of residents on the surgical service in respect to operative report dictation can be profoundly influenced by a carefully targeted set of interventions based on behavioral theory. The improved performance can be maintained with simple reminders and the halo effect of the intervention extends to the dictation of discharge summaries.

Behavior Therapy↗

PubMed2005

The impact of a hands-on ERCP workshop on clinical practice.

BACKGROUND: Hands-on endoscopy workshops are increasingly common venues for procedure training. However, the effect of this type of training on the practices of participants is unknown. The goal of this study was to examine the changes in individual clinical practices subsequent to participation in an ERCP hands-on course. METHODS: Forty-eight practicing pancreatobiliary endoscopists participating in a 2-day hands-on advanced ERCP course were asked to complete a 24-item survey evaluating their endoscopic practices both before and 3 months after workshop participation. The surveys evaluated monthly volume and self-confidence in performing the following procedures: diagnostic ERCP, standard sphincterotomy, needle-knife pre-cut sphincterotomy, biliary stone extraction, mechanical lithotripsy, plastic stent placement, metal stent placement, and biliary brushing for cytologic specimens. RESULTS: Thirty-one of the 48 participants (65%) who completed both pre- and postcourse surveys form the study cohort. After the workshop, there was a significant increase in use of needle-knife pre-cut sphincterotomy in clinical practices. In addition, the post-workshop survey indicated a significant increase in confidence for procedures such standard sphincterotomy, needle-knife pre-cut sphincterotomy, stone extraction, mechanical lithotripsy, placement of metal stents, and cytology brushing. Confidence in basic diagnostic ERCP and plastic stent placement did not increase because of high initial confidence levels. CONCLUSIONS: Participation in a hands-on course appears to increase the confidence of endoscopists in the performance of more complex interventions. However, this was only associated with increased clinical application for one technique.

Adult↗

PubMed2002

Uterine compression sutures: surgical management of postpartum hemorrhage.

BACKGROUND: It has been estimated that worldwide, over 125,000 women die of postpartum hemorrhage each year. The traditional management of this condition includes the use of oxytocics, such as oxytocin, ergometrine, and prostaglandins, before proceeding to ligation of the internal iliac arteries and even hysterectomy. The B-Lynch technique is a surgical procedure that may be used to arrest postpartum hemorrhage resulting from uterine atony. CASES: This paper describes simple modifications of this technique that make this procedure less complex to perform. Three clinical case scenarios illustrate the context in which the sutures may be used. CONCLUSION: Compression sutures placed into the postpartum uterus may provide a simple first surgical step to control bleeding when routine oxytocic measures have failed. We suggest that the technique we have described is a simple procedure and should be tried before more complex interventions are used.

Adult↗

PubMed1999

The menopause.

Menopause is diagnosed after 12 months of amenorrhoea resulting from the permanent cessation of ovarian function. The mean age at menopause is 51 years. The perimenopause, a time of changing ovarian function, precedes the final menses by several years. The physiology and clinical manifestations of this transition to menopause are not well understood; however, some symptoms, such as hot flashes, certainly begin in the perimenopause. Causal associations between menopause and several symptoms and diseases are proposed. The evidence for these associations varies and is reviewed. Hormone replacement therapy can be directed at symptom relief or at prevention or treatment of chronic diseases. Doses and routes of hormone replacement therapy vary by indication. Complications of hormone replacement therapy depend on the regimen used. Knowing the expected vaginal bleeding pattern for each hormone replacement therapy regimen is important, since unexpected bleeding may signal endometrial hyperplasia. Postmenopausal hormone therapy is a complex intervention that produces positive and negative specific health effects. Overall, based on observational studies, postmenopausal women who use hormones have a 30-50% lower all-cause mortality rate than those who do not use hormones. It is important to recognise that the value that individual women place on various health outcomes associated with hormone replacement therapy may differ. Thus, the decision to use hormone replacement therapy should be made jointly by each woman and her health-care provider, after careful consideration of possible benefits, risks, and her personal preferences.

Coronary Disease↗

PubMed2003

Selective occlusion of subfoveal choroidal neovascularization in angioid streaks by using a new technique of ingrowth site treatment.

PURPOSE: To evaluate the visual and angiographic effects, as well as optical coherence tomography (OCT) findings, after a new treatment-neovascular ingrowth-site photothrombosis-in patients with subfoveal choroidal neovascularization (CNV) secondary to angioid streaks. DESIGN: Prospective noncomparative small case series. PARTICIPANTS: Five eyes of 5 patients with angioid streaks in whom fluorescein and conventional indocyanine green (ICG) angiography clearly demonstrated distinct CNV vessels supplying the subfoveal neovascular complex. INTERVENTION: All five eyes were submitted to ICG-mediated photothrombosis of the neovascular ingrowth site. This novel, laser/dye-mediated technique uses large-spot, lower-intensity 810-nm light for continuous application of laser energy to ICG concentrated in vascular lesions. MAIN OUTCOME MEASURES: Visual outcome and the results of fluorescein angiography, ICG angiography, and OCT evaluation. RESULTS: Fluorescein and conventional ICG angiography were sufficient to identify the CNV ingrowth site, which was juxtafoveal in 2 and extrafoveal in 3 of the 5 eyes in this series. Obliteration of the entire neovascular lesion was achieved in all patients within the first hour after ICG-mediated photothrombosis of the CNV ingrowth site. At 1 week, the mean change in best-corrected visual acuity from baseline was +3.2 (+/-1.4) lines. Twelve months after treatment, visual acuity improved by 3 or more lines in all patients, and decreased leakage of fluorescein from the CNV, as well as OCT evidence of reduced or resolved retinal edema, was seen at the last follow-up visit. Major complications, such as immediate severe visual loss and retinal vessel occlusion in the early posttreatment period, were not identified in the 5 patients submitted to the procedure. CONCLUSIONS: Photothrombosis of the CNV ingrowth site by using lower-intensity light to direct laser energy continuously after IV ICG infusion is a safe and effective technique for rapid induction of CNV hypoperfusion in selected patients and is associated with considerable improvement in visual acuity and partial restoration of the retinal architecture up to 12 months after treatment.

Aged↗

PubMed2001

Troubleshooting techniques for abdominal aortic aneurysm endograft placement: when things go wrong.

Since the Food and Drug Administration approved the Ancure (Guidant Corp, Menlo Park, CA) and AneuRx (Medtronic Corp, Minneapolis, MN) abdominal aortic aneurysm stent-grafts, there has been a tremendous increase in the number of stent-graft implantations, both in the United States and worldwide. Successful stent-graft deployment requires complex interventional skills and accurate preprocedure planning. Even the most skilled operator may experience intraoperative difficulties during graft deployment. There are intraprocedural complications that are common to all stent-grafts, as well as specific complications that are unique to the particular stent-graft being implanted. The first step to managing an intraprocedural complication is to be able to quickly recognize that a deployment difficulty has occurred. The interventionalist must then be ready to use common troubleshooting techniques to rectify or avoid complications of stent-graft delivery.

Aortic Dissection↗

PubMed2004

Tackling Rugby injury: lessons learned from the implementation of a five-year sports injury prevention program.

Rugby Union football is a very popular sport in New Zealand but of all the major sports played in that country, it has the highest reported incidence of injury. In 1995, a national rugby injury prevention program was instigated to address this problem. Known as Tackling Rugby Injury, this multifaceted program was implemented over a five-year period. The program was based on the results of a prospective cohort study of rugby injury, known as the Rugby Injury and Performance Project (RIPP), and was organised around seven themes, five relating to the prevention of injury: coaching, fitness, injury management, tackling, and foul play, and two relating to the implementation and evaluation of the program. The purpose of this paper is to describe the lessons learned from the implementation of Tackling Rugby Injury. Qualitative research methods were used to describe the process of implementation, including informant interviews, participant observation, and the scrutiny of written, visual and archival material. Among the lessons learned were the importance of basing injury prevention strategies on scientific evidence rather than popular belief, the difficulty in implementing complex interventions, the advantages of a formal agreement between partners in the implementation of a program, the central role played by coaches in promoting injury prevention strategies, and the value of describing the process of implementation as well as monitoring injury outcomes and changes in knowledge, attitudes and behaviour. It is hoped that other sports wishing to develop injury prevention programs can learn from this experience.

Athletic Injuries↗

PubMed1997

Design of cost-effective packages of care for non-insulin-dependent diabetes mellitus. Defining the information needs.

This review concludes that: a) the global burden of disease from non-insulin-dependent diabetes mellitus (NIDDM) cannot be completely estimated at present; b) evidence for the efficacy of key elements of a package of care is still needed; c) generalizing the results of evaluations of costs or effectiveness across different populations is not straightforward; and d) for this complex intervention, the costs and effectiveness of intervention may be highly dependent on methods of organizing care. Addressing this information deficit represents an important task for researchers and health decision makers.

Case Management↗