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Foetal bypass: concepts and controversies.

One of the most controversial and challenging surgical undertakings of the next century promises to be foetal cardiac surgery. Animal studies have been underway for several years to gain an understanding of the physiological mechanisms required to achieve this undertaking. Not since the days of crosscirculation has there been a maternal risk associated with open-heart surgery. The diagnosis of congenital heart defects with foetal ultrasound can now be made as early as 12 weeks gestation. Simple cardiac abnormalities, such as valvular stenosis or atresia, alter intracardiac flow patterns and affect normal cardiac chamber development. Without early intervention, these complex lesions often require major surgical reconstruction, beginning in the neonatal period. Foetal cardiac bypass techniques have evolved from the use of roller pumps and bubble oxygenators primed with maternal blood to the use of an axial flow pump incorporated in a right atrial to pulmonary artery or aortic shunt. Because the blood entering the right atrium is oxygenated by the placenta, an oxygenator in the bypass circuit is probably not needed. The low prime axial flow pump system avoids the dilution of the foetus with the maternal adult haemoglobin and improves the outcome. A major focus of research has concentrated on maintenance of placental blood flow with the use of vasodilators and cyclooxygenase inhibitors. Investigation with primates will be necessary to confirm the placental physiology before human operations can be performed. As the foetal bypass challenges are overcome, there is the potential for a reduction in the number of complex cardiac lesions requiring early surgical intervention in the twenty-first century.

Cardiac Surgical Procedures↗

Specialist outreach clinics in primary care and rural hospital settings.

BACKGROUND: Specialist medical practitioners have conducted clinics in primary care and rural hospital settings for a variety of reasons in many different countries. Such clinics have been regarded as an important policy option for increasing the accessibility and effectiveness of specialist services and their integration with primary care services. OBJECTIVES: To undertake a descriptive overview of studies of specialist outreach clinics and to assess the effectiveness of specialist outreach clinics on access, quality, health outcomes, patient satisfaction, use of services, and costs. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care (EPOC) specialised register (March 2002), the Cochrane Controlled Trials Register (CCTR) (Cochrane Library Issue 1, 2002), MEDLINE (including HealthStar) (1966 to May 2002), EMBASE (1988 to March 2002), CINAHL (1982 to March 2002), the Primary-Secondary Care Database previously maintained by the Centre for Primary Care Research in the Department of General Practice at the University of Manchester, a collection of studies from the UK collated in "Specialist Outreach Clinics in General Practice" (Roland 1998), and the reference lists of all retrieved articles. SELECTION CRITERIA: Randomised trials, controlled before and after studies and interrupted time series analyses of visiting specialist outreach clinics in primary care or rural hospital settings, either providing simple consultations or as part of complex multifaceted interventions. The participants were patients, specialists, and primary care providers. The outcomes included objective measures of access, quality, health outcomes, satisfaction, service use, and cost. DATA COLLECTION AND ANALYSIS: Four reviewers working in pairs independently extracted data and assessed study quality. MAIN RESULTS: 73 outreach interventions were identified covering many specialties, countries and settings. Nine studies met the inclusion criteria. Most comparative studies came from urban non-disadvantaged populations in developed countries. Simple 'shifted outpatients' styles of specialist outreach were shown to improve access, but there was no evidence of impact on health outcomes. Specialist outreach as part of more complex multifaceted interventions involving collaboration with primary care, education or other services was associated with improved health outcomes, more efficient and guideline-consistent care, and less use of inpatient services. The additional costs of outreach may be balanced by improved health outcomes. REVIEWER'S CONCLUSIONS: This review supports the hypothesis that specialist outreach can improve access, outcomes and service use, especially when delivered as part of a multifaceted intervention. The benefits of simple outreach models in urban non-disadvantaged settings seem small. There is a need for good comparative studies of outreach in rural and disadvantaged settings where outreach may confer most benefit to access and health outcomes.

Community-Institutional Relations↗

Patterns of HIV prevalence and HIV risk behaviors among injection drug users prior to and 24 months following implementation of cross-border HIV prevention interventions in northern Vietnam and southern China.

In 2002, we implemented a 4-year HIV prevention intervention for injection drug users (IDUs) in Lang Son Province, Vietnam, and Ning Ming County, Guangxi Province, China, a cross-border region seriously affected by inter-twined epidemics of heroin injection and HIV infection. The interventions involve peer education on HIV risk reduction and provision of new needles/syringes through direct distribution and pharmacy vouchers. We consider this to be a structural intervention in which risk reduction information and sterile injection equipment are diffused through the IDU populations and not limited to those who actually interact with peer educators. The evaluation of structural interventions poses complex methodological challenges. The evaluation of our interventions relies primarily on cross-sectional surveys (interviews and HIV testing) of samples of IDUs selected using a combination of targeted cluster and snowball methods. We consider this to be an appropriate, albeit imperfect, design given the study context. This paper presents analyses of data from the IDU surveys conducted just prior to implementation of the interventions and 24 months thereafter. The cross-border interventions have reached large proportions of the IDUs in the project sites, drug-related HIV risk behaviors have declined in frequency, and HIV prevalence among IDUs has been stable in China and declined in Vietnam over the 24 months since the interventions were implemented. Attribution of these positive trends to the interventions must be qualified in light of possible sampling biases and the absence of control groups. However, we believe that the structural interventions implemented by the cross-border project have played a role in stabilizing HIV prevalence among IDUs two years after they were initiated. Evidence of further diffusion of the interventions among IDUs and continued stability or decline of HIV prevalence would strengthen this case.

Adult↗

Using a new taxonomy to combine the uncombinable: integrating results across diverse interventions.

Researchers have examined numerous psychosocial and behavioral interventions intended to alleviate distress among family caregivers of persons with dementia. Many of these interventions are complex, combining numerous treatment components. Although some multicomponent interventions have been successful in reducing caregiver distress, the impact of specific elements of these interventions on outcomes is not known. The article presents results of an analytic approach that allows researchers to describe the individual elements of multicomponent interventions and to examine the relationships between those components and outcomes. This approach is successfully applied to interventions being evaluated in the Resources for Enhancing Alzheimer's Caregiver Health (REACH) program. The results indicate that actively targeting caregiver behavior is effective in achieving positive outcomes with respect to caregiver depression.

Aged↗

Using complexity theory to build interventions that improve health care delivery in primary care.

Previous observational research confirms abundant variation in primary care practice. While variation is sometimes viewed as problematic, its presence may also be highly informative in uncovering ways to enhance health care delivery when it represents unique adaptations to the values and needs of people within the practice and interactions with the local community and health care system. We describe a theoretical perspective for use in developing interventions to improve care that acknowledges the uniqueness of primary care practices and encourages flexibility in the form of intervention implementation, while maintaining fidelity to its essential functions.

Community Health Services↗

Cost-Effectiveness of Electronic Patient-Reported Outcome Measure Interventions in Cancer: Systematic Review and Parameter Extraction for Economic Modeling.

BACKGROUND: Complex digital interventions that integrate electronic patient-reported outcome measures (ePROM) into clinical practice in cancer have the potential to improve quality of life, increase survival, and reduce health resource use and costs. Such systems can help patients with cancer self-manage chemotherapy symptoms, reduce clinicians' workloads through automated decision support, and resolve problems earlier. However, more research on the cost-effectiveness of ePROM monitoring is needed. OBJECTIVE: This paper comprises two complementary components: (1) a systematic literature review summarizing and evaluating the quantitative and qualitative evidence related to the cost-effectiveness of ePROM monitoring and (2) a health economic model parameter extraction. We also conducted supplementary targeted searches and scoping to provide context to our findings. METHODS: We searched Ovid (including MEDLINE and Embase), Scopus, and the International Health Technology Assessment Database for original English-language papers published on or before March 2025 using search strings that combined terms related to ePROMs, health economics, and cancer/oncology. We included papers reporting health economic-related outcomes for ePROM interventions designed for adult cancer populations and excluded screening tools and conference abstracts. RESULTS: We included 34 publications from 27 unique studies and identified and analyzed 26 ePROM-integrated interventions within these. Most (23/26) of the included interventions explicitly described some form of alert handling and automated decision support based on remote ePROM monitoring. Of the 34 publications, 5 presented full cost-effectiveness analysis results, of which 3 were highly uncertain and lacked clear differences in costs and health outcomes between ePROMs and standard care; conversely, 2 presented strong evidence of cost-effectiveness due to quality-of-life improvements, reduced hospitalizations, and potentially more autonomy in health-related travel (eg, ePROM-monitored patients can drive or walk to the hospital instead of using taxis or ambulances). A further 5 publications reported partial health economic results (eg, cost-consequence and budget impact), of which 1 detected no difference in strategies; in contrast, 4 reported lower health resource use and costs of ePROMs, mainly due to hospitalization reductions. Overall, 12 of the 27 studies included a qualitative component but mostly focused on user experience and design-related themes; only 2 of these addressed economic-specific themes (eg, changes in workflow and resource use due to ePROM implementation and integration), indicating some potential for time saving due to ePROM monitoring. CONCLUSIONS: Some ePROM-integrated interventions demonstrated cost-effectiveness in cancer care, but the evidence base remains limited. Where evidence does exist, cost-effectiveness appears driven by reduced hospitalization and improved quality of life. Qualitative research within the included studies rarely addressed economic questions. We provide a detailed parameter extraction for use in future economic modeling and recommend research priorities, including quantitative mapping of ePROM symptom data onto health resource use patterns, and qualitative work exploring how ePROM implementation affects clinical workloads and patient-perspective costs.

Humans↗

[Percutaneous administration of collagen (VasoSeal): an efficacious system of hemostasis after catheterization or interventional procedures using arterial approach].

INTRODUCTION: The widespread use of PTCA and complex percutaneous interventional techniques has significantly increased peripheral vascular complications prompting the development of innovative hemostatic closure devices. METHODS: To evaluate the efficacy and safety of a bovine collagen plug (VasoSeal), we sealed 362 consecutive femoral artery puncture sites in 324 patients (240 males) (mean age 57.9 +/- 11.3 years), who underwent interventional procedures or diagnostic catheterization during acute or chronic anticoagulant treatment. RESULTS: Complete hemostasis was achieved in 2.31 +/- 1.97 minutes in 342 cases (94.4%), with a mean activated clotting time at collagen deployment of 197 +/- 56". In 20 cases, mechanical arterial compression was needed in order to obtain vascular hemostasis (mean time: 44 +/- 13 min). We observed 1 arteriovenous fistula and 1 acute arterial thrombosis (collagen related at surgical inspection) which underwent successful surgical treatment. Minor complications without clinical sequelae were: small hematomas in 13 cases (3.8%), 4 groin abscesses (1.1%) and 4 cases of lymphangitis (1.1%). CONCLUSIONS: Percutaneous collagen application at the femoral artery puncture site allows quick and effective hemostasis with low incidence of peripheral vascular complications following interventional percutaneous procedures or catheterization during anticoagulant treatment.

Administration, Cutaneous↗

Producing useful research about quality improvement.

Many quality improvement interventions such as educational programmes, hospital quality strategies, and quality evaluation systems have not been evaluated. The aim of this paper is to encourage research into these "quality improvement processes" by presenting suitable designs and methods, and by describing research approaches which are less familiar in healthcare. The paper proposes that the choice of research design depends on the level and complexity of the intervention. Theory-building approaches are more suitable than experimental theory testing approaches for evaluating higher-level complex interventions and for understanding critical context factors. Collaborative action evaluation studies can provide useful information for decision makers--an examples is given. "User focused" research can provide knowledge for developing more effective quality intervention processes and for making better decisions about their use and implementation.

Efficiency, Organizational↗

Antibiotic prophylaxis in interventional radiology.

Despite several decades of advances in both minimally invasive techniques and antibiotic therapy, infection remains one of the more common complications of invasive procedures. Interventional radiology (IR) has traditionally been believed to be associated with lower infection rates than surgery. However, new interventional techniques, as well as more aggressive therapeutic interventions, have presented new challenges in relation to pharmacological management of postprocedural infection and pain. The risk of infection associated with IR procedures can never be completely eliminated, and the reasons for this are manifold, including more virulent organisms, ongoing and newly emerging antibiotic resistance, increased numbers of immunocompromised patients, and the adoption into everyday interventional practice of more aggressive interventional techniques such as chemoembolization, uterine fibroid embolization, and complex biliary intervention. Despite the widespread use of prophylactic antibiotics in IR, and the widely held belief that they are beneficial and are the standard of care, randomized controlled clinical trials have never validated the use of antibiotics in this setting. As such, an argument could be made not to use antibiotics at all for prophylaxis in IR. The purpose of this article is to discuss some of the issues relating to the use of prophylactic antibiotics, and what choice of antibiotics physicians make when they decide to use prophylaxis for IR procedures.

Antibiotic Prophylaxis↗

Cyclic perimenstrual pain and discomfort: the scientific basis for practice.

OBJECTIVE: To review and organize the science related to cyclic perimenstrual pain and discomfort for the fifth research-based practice project of the Association of Women's Health, Obstetric and Neonatal Nurses. DATA SOURCES: Computerized searches in CINAHL, MEDLINE, and the Cochrane Library, as well as hand searches of cited references. Keywords included cyclic pelvic pain, comfort, pain guidelines, and dysmenorrhea. DATA EXTRACTION: All relevant articles prior to 1999 were considered. Thirty-three research-based articles (1992-1999) were reviewed for relevance by the science team as part of the fifth research-based practice project of the Association of Women's Health, Obstetric and Neonatal Nurses. DATA SYNTHESIS: The literature review and synthesis resulted in a cogent description of cyclic perimenstrual pain and discomfort and the development of three nursing diagnoses: perimenstrual cyclic pelvic pain, perimenstrual discomfort, and perimenstrual negative affect. Cyclic pelvic pain is a new concept, developed by the science team during the project. Perimenstrual cyclic pelvic pain is an acute, subjective experience defined by pelvic pain that presents in a repeating time frame associated with the menstrual cycle. It is usually clustered with other discomforts and appreciably affects a woman's quality of life. Because the science about interventions is complex and extensive, data synthesis led to organization of the interventions within seven categories. CONCLUSIONS: Translation of research into practice is essential. Cyclic perimenstrual pain and discomfort is an important clinical issue, yet the science had not previously been comprehensively reviewed with the mission to translate it for nursing practice. Translation of this complex literature was accomplished though an innovative clinical practice guideline and subsequently evaluated in nursing practice through the research-based practice project.

Dysmenorrhea↗

Increased survival after APSAC: 30-day and 12-month mortality data from the APSAC Intervention Mortality Study.

Preliminary analysis of mortality data from the anisoylated plasminogen streptokinase activator complex (APSAC) Intervention Mortality Study (AIMS) showed a 47% reduction in 30-day mortality (with a 95% confidence interval of 21 to 65%) for patients treated with APSAC within 6 hours of onset of acute myocardial infarction. After follow-up of 1,004 patients for 30 days after randomization in the double-blind, placebo-controlled, clinical trial, researchers found that 61 patients (12.2%) in the placebo group had died compared with 32 patients (6.4%) in the APSAC group (p = 0.0016). Incomplete follow-up of these patients for 1 year provided an estimated mortality of 19.4% in the placebo group and 10.8% in the APSAC group (log-rank test for survival to year p = 0.0006). Benefit was seen irrespective of age, site of infarction and time from onset of symptoms up to 6 hours.

Aged↗

Canine bone blood flow measurements using serial microsphere injections.

The objective of this study was to determine the reproducibility of serial bone blood flow (BBF) quantitation using multiple microsphere injections. Three consecutive estimates of BBF were obtained, using 15-mu radionuclide-labeled microspheres from 21 anesthetized adult dogs. A dose of 3 million spheres/kg was used in seven dogs (Cohort 1); a dose of 0.5 million spheres/kg was used in the remaining 14 dogs (Cohorts 2 and 3). Estimates of BBF were made at an average of 129, 153, and 175 minutes after the animals had been anesthetized in the first two cohorts and 179, 203, and 225 minutes in Cohort 3. The dogs in Cohort 1 had no surgical intervention; the dogs in Cohorts 2 and 3 had increasingly complex surgical interventions. Despite stabilization of cardiovascular status, BBF was found to vary by 33.4% in Cohort 1, 25.7% in Cohort 2, and 42.5% in Cohort 3 over the three injections. Cortical BBF fell by 13.9%, 12.1%, and 12.4% between the first and second, and by 31.0%, 11.2%, and 29.9% between the second and third estimates for Cohorts 1, 2, and 3, respectively. Variation in right to left blood flow was used as an overall measure of error caused by technique and did not consistently increase between the first, second, or third BBF estimates in any cohort. Cortical BBF data were found to be significantly more reliable than cancellous data (p < 0.01); error caused by technique was least in the midshaft femoral or midshaft humeral cortical samples. Increasing the dose of spheres administered from 0.5 to 3 million/kg for three serial microsphere injections increased the number of reliable samples and did not lead to increased technical error or shunting. This study demonstrates that there is a significant decrease in BBF over time in the anesthetized dog; therefore, serial estimates of BBF can only be interpreted if the results are normalized or if a control group of animals is included.

Animals↗

The safety of anistreplase from the placebo-controlled AIMS study (anistreplase Intervention Mortality Study). The AIMS Study Group.

In the anistreplase, or anisoylated plasminogen streptokinase activator complex (APSAC) Intervention Mortality Study (AIMS), 1,258 patients with acute myocardial infarction were randomized in a parallel, double-blind, placebo-controlled mortality study in which they received either anistreplase or placebo, followed by anticoagulation therapy. Data on all adverse clinical events were recorded, regardless of their clinical significance or possible relation to therapy. There was a similar frequency of such events in both groups (anistreplase 80.4%, placebo 76.0%, difference not significant). Cardiovascular events included more reports of bradycardia, idioventricular rhythm, and hypotension in the anistreplase group, and a higher incidence of cardiac arrest, ventricular fibrillation, complete heart block, and pericarditis in the placebo group. Hemorrhagic events occurred in 13.8% of patients in the anistreplase group compared with 4.1% of patients in the placebo group. Most of these events consisted of bleeding or bruising around the puncture sites. There was a low incidence of allergic events after administration of both anistreplase and placebo. Thirteen cerebrovascular events (8 strokes and 5 transient ischemic episodes) were reported in the anistreplase group, compared with 5 in the placebo group (5 and 0, respectively). The mean systolic and diastolic pressures were significantly lower (by 5-10 mmHg) in patients in the anistreplase group during the first 24 hours after dosing. There were no significant differences in temperature and pulse rate between the two groups. The incidence of chest pain during the first 4- to 24-h period was lower in the anistreplase-treated patients than in the placebo group. The frequency of in-hospital reinfarction was higher in anistreplase-treated patients compared with patients given placebo.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗

A simulation study of the effects of cardiac anatomy in ventricular fibrillation.

In ventricular fibrillation (VF), the principal cause of sudden cardiac death, waves of electrical excitation break up into turbulent and incoherent fragments. The causes of this breakup have been intensely debated. Breakup can be caused by fixed anatomical properties of the tissue, such as the biventricular geometry and the inherent anisotropy of cardiac conduction. However, wavebreak can also be caused purely by instabilities in wave conduction that arise from ion channel dynamics, which represent potential targets for drug action. To study the interaction between these two wave-breaking mechanisms, we used a physiologically based mathematical model of the ventricular cell, together with a realistic three-dimensional computer model of cardiac anatomy, including the distribution of fiber angles throughout the myocardium. We find that dynamical instabilities remain a major cause of the wavebreak that drives VF, even in an anatomically realistic heart. With cell physiology in its usual operating regime, dynamics and anatomical features interact to promote wavebreak and VF. However, if dynamical instability is reduced, for example by modeling of certain pharmacologic interventions, electrical waves do not break up into fibrillation, despite anatomical complexity. Thus, interventions that promote dynamical wave stability show promise as an antifibrillatory strategy in this more realistic setting.

Animals↗

Health related virtual communities and electronic support groups: systematic review of the effects of online peer to peer interactions.

OBJECTIVE: To compile and evaluate the evidence on the effects on health and social outcomes of computer based peer to peer communities and electronic self support groups, used by people to discuss health related issues remotely. DESIGN AND DATA SOURCES: Analysis of studies identified from Medline, Embase, CINAHL, PsycINFO, Evidence Based Medicine Reviews, Electronics and Communications Abstracts, Computer and Information Systems Abstracts, ERIC, LISA, ProQuest Digital Dissertations, Web of Science. SELECTION OF STUDIES: We searched for before and after studies, interrupted time series, cohort studies, or studies with control groups; evaluating health or social outcomes of virtual peer to peer communities, either as stand alone interventions or in the context of more complex systems with peer to peer components. MAIN OUTCOME MEASURES: Peer to peer interventions and co-interventions studied, general characteristics of studies, outcome measures used, and study results. RESULTS: 45 publications describing 38 distinct studies met our inclusion criteria: 20 randomised trials, three meta-analyses of n of 1 trials, three non-randomised controlled trials, one cohort study, and 11 before and after studies. Only six of these evaluated "pure" peer to peer communities, and one had a factorial design with a "peer to peer only" arm, whereas 31 studies evaluated complex interventions, which often included psychoeducational programmes or one to one communication with healthcare professionals, making it impossible to attribute intervention effects to the peer to peer community component. The outcomes measured most often were depression and social support measures; most studies did not show an effect. We found no evidence to support concerns over virtual communities harming people. CONCLUSIONS: No robust evidence exists of consumer led peer to peer communities, partly because most peer to peer communities have been evaluated only in conjunction with more complex interventions or involvement with health professionals. Given the abundance of unmoderated peer to peer groups on the internet, research is required to evaluate under which conditions and for whom electronic support groups are effective and how effectiveness in delivering social support electronically can be maximised.

Clinical Trials as Topic↗

Realizing the potential of empowerment: the impact of a feedback intervention on the performance of complex technology.

An empowerment initiative involving enhanced fault-management responsibility for operators of complex technology had not led to expected increases in performance, and investigations suggested that this was due to a lack of appropriate feedback. Thus, a feedback intervention was designed to provide specific, timely feedback on operator-correctable faults. It was hypothesized that the intervention would increase operator self-reliance in operating complex technology and promote system performance. Moreover, given the feedback was continuous from the point of intervention, it was predicted that gains would increase over time. Time series analysis of data on engineer call-outs (self-reliance) and machine utilization (performance) showed clear positive effects of the feedback intervention, with call-outs also showing progressive improvement. Self-report data showed no change over time in motivation, but an increase in knowledge dissemination and a reduction in the likelihood of making expensive mistakes. There were no detrimental effects on operator well being. Implications for theory and practice in the management of complex technology are discussed.

Data Collection↗