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Using randomized controlled trials to evaluate socially complex services: problems, challenges and recommendations.

BACKGROUND: Following the lead of evidence-based medicine, practice based on effectiveness research has become the new gold standard of contemporary public policy. Studies of this sort are increasingly demanded to evaluate services provided by mental health, social services and criminal justice systems. AIMS: The paper questions whether the simple randomized controlled trial (RCT) paradigm as applied in clinical trials can be used "off the rack" to evaluate socially complex service (SCS) interventions. These are services that are characterized by complex, diverse and non-standardized staffing arrangements; ambiguous protocols; hard-to-define study samples and unevenly motivated subjects and dependence on broader social environments. The difficulty of ensuring precise protocols, equivalent groups (tied to a meaningful target population) and neutral and equivalent trial environments under real world conditions are explored, as are the implications of not achieving standardization and equivalence. METHODS: Limitations of effectiveness research as a research tool and information source are examined by comparing the assumptions underpinning the simple RCT to the characteristics of SCS interventions, as illustrated by programs targeted to mentally disordered offenders in Britain. RESULTS: SCSs violate the assumptions underpinning the simple RCT model in ways that draw into sharp question the validity, reliability and generalizability of inferences of SCS trials. DISCUSSION: The RCT is not a panacea. Effectiveness research of SCS interventions that is based on the RCT model is unlikely to yield valid, reliable and generalizable inferences without becoming more complex in design and more sensitive to issues of selection bias, unmeasured variables and endogeneity. Ten recommendations are offered for stylizing the RCT design to the characteristics of socially complex services. IMPLICATIONS: It remains an empirical issue whether RCT-based services effectiveness research can inform mental health policy. Without major design innovations, it is more likely that the information generated by this research will have limited practical use, especially if the RCT model is unable to control for the effect of social complexity and the interaction between social complexity and dynamic systemic change. Scientific evaluations of services make clinical and economic sense so long as they are designed to meet the challenges of the services of which they promise greater knowledge.

Journal Article↗

Relative role of ambulatory and residential rehabilitation.

Cardiac rehabilitation, derived from the concept of early mobilization after an acute cardiac event, seems destined to assume an important role in the approach to patients affected by chronic heart disease (ischaemic heart disease, valvular and congenital diseases, heart transplant, chronic heart failure, etc.). To respond to individual clinical needs, rehabilitative intervention should be organized either at an outpatient level or by combining outpatient and inpatient activities. Three different levels of intervention, of increasing complexity and specialization, are foreseen. First-level interventions are to be performed exclusively at outpatient level and directed mainly towards long-term care of stable chronic patients in order to keep them at the highest level of autosufficiency possible and to prevent acute events. Second-level interventions include the combination of outpatient and inpatient rehabilitative activity, based on an accurate prognostic stratification intended to reduce the consequences of the handicaps which the individual reports after an acute event. Third-level interventions include services provided in highly specialized centres; they should function at both inpatient and outpatient levels, and should be instituted in close collaboration with cardiosurgical departments that are particularly oriented towards transplant activity.

Ambulatory Care↗

The APSAC interventional mortality study (AIMS) trial: mortality data.

The anistreplase (anisoylated plasminogen streptokinase activator complex or APSAC) intervention mortality study was designed as a double-blind, placebo-controlled study to test the effectiveness of anistreplase, 30 U administered intravenously within the first 6 hours of acute myocardial infarction. The primary endpoint of the study was mortality of all causes at 30 days and 1 year. Within 30 days, there were 77 deaths with placebo (17.8%) and 40 deaths (6.5%) with anistreplase, an odds reduction of 50.5% (p = 0.0006). By the end of one year, there had been a total of 113 deaths (17.8%) with placebo and 69 deaths (11.1%) with anistreplase, an odds reduction of 42.7% (p = 0.0007).

Acute Disease↗

Interventional therapies in the management of complex regional pain syndrome.

Invasive procedures have long held a place in the therapeutic armamentarium for the management of complex regional pain syndrome (CRPS). However, this has evolved considerably, particularly as research into the mechanisms of CRPS has called into question long-held presumptions about the key role of sympathetic dysfunction in the syndrome. This review summarizes some of the key information currently available about interventional treatments, including nerve blocks, spinal cord and peripheral nerve stimulation, chemical and surgical sympathectomies, and deep brain stimulation. The potential roles for these procedures in facilitating functional rehabilitation goals that are primary to the treatment of CRPS are emphasized.

Complex Regional Pain Syndromes↗

Combined radiologic and retrograde endoscopic and biliary interventions.

Methods of treating complex biliary duct problems by a team composed of an endoscopist and interventional radiologist are described. These procedures are of two types: Those in which all manipulations are performed through the endoscope and those in which an antegrade transhepatic and a retrograde endoscopic approach are combined.

Bile Duct Diseases↗

Interventional modalities in the treatment of complex regional pain syndrome.

Complex regional pain syndrome (CRPS) applies to a variety of conditions in which symptoms such as allodynia and hyperalgesia predominate along with hyperpathia and vasomotor/sudomotor disturbances. The incidence of CRPS in the chronic pain population varies and is difficult to determine, though it appears to affect women more than men. Treatment is multidisciplinary, and recovery of function and the reduction of pain are the main goals of treatment;this article addresses some of the interventional modalities that are used.

Autonomic Nerve Block↗

Substantiation and early decision points in public child welfare: a conceptual reconsideration.

This article will overview substantiation in the context of early intervention decision points faced in state child welfare. The conceptual complexities underlying these interventions and how substantiation does or does not play a role in these interventions are explored. Specific attention will be given to the voluntary or involuntary nature of services, the availability of evidence, and the past or future orientation of the decision-making process. The conceptual consistency of recent child welfare policies will be explored, and suggestions for policy and research will be put forward.

Child↗

Design principles for the use of simulation as an aid in interventional cardiology training.

Learning complex skills through simulation is a goal for training physicians in specialties such as interventional cardiology, where traditional training puts patients at risk. Intuitively, interactive simulation of anatomy, pathology and therapeutic actions should lead to shortening of the learning curve for novice or inexperienced physicians. An accurate recreation of the interactions among anatomy, pathology and therapeutic actions is a necessary, but not sufficient, condition for the development of a simulation-based training system. In addition to real-time graphic interactivity coupled with haptic response, a successful training tool will require features of a 'learning system' such as: an embedded curriculum, functionality that allows rehearsal and practice, hypertext links to educational information, personal archiving, and instructor review and testing capabilities. We describe how such a system might look for the field of interventional cardiology, and suggest that designing a simulation with both technical and pedagogical fidelity is essential in developing simulation-based training systems in any field of medicine.

Journal Article↗

Early adoption of human immunodeficiency virus quality improvement in Veterans Affairs medical centers: use of organizational surveys to measure readiness to change and adapt interventions to local priorities.

Potential delivery system responsiveness to quality improvement (QI) interventions is rarely assessed before implementation, although it might aid in interventional design. Preparing for a national initiative, we assessed Veterans Affairs (VA) human immunodeficiency virus (HIV) clinic organizational characteristics and attitudes toward QI interventions. Current QI activities and attitudes toward potential effectiveness of several techniques to improve antiretroviral and opportunistic infection prophylaxis therapy were assessed. These included computerized clinical reminders (CRs), group-based QI, expert advice, and facility and provider-level audit/feedback. Organizational characteristics were also examined. Respondents rated CRs and group-based QI (GBQI) interventions most highly. Western and complex facilities viewed CR and GBQI interventions more positively than less complex facilities or those in other regions, even controlling for organizational characteristics and perceived barriers to change. VA clinicians favored CR and GBQI over facility/ provider feedback. The persistence of regional variation should be further explored. Organizational surveys of attitudes toward potential QI interventions can assist in choosing interventions and targeting specific facilities.

Attitude of Health Personnel↗

[Intervention priorities in the acute stage of complex emergencies drafted by nine humanitarian aid agencies].

BACKGROUND: Complex Emergencies are an international Public Health problem currently becoming increasingly more frequent and of growing proportions which lead to major death and disease rates, especially during the acute stage thereof. This study is aimed at identifying and analyzing the top-priority areas of intervention in the acute stage of a complex emergency drafted in the operating manuals of the main aid agencies, as well as the degree of development and structuring of the activities proposed in each area on which priority has been placed. METHODS: The intervention manuals drafted by nine major aid agencies were used as study material. A quantitative analysis was then made of the 16 intervention priorities set out, as well as of the degree to which each priority was defined based on the development of 73 variables of aspects of the proposals set out in the manuals. RESULTS: The ACNUR manual includes 90% of the 73 variables for further expansion upon the priorities, the UN Humanitarian Affaire Coordination Office manual including 35% of the 73 variables. ACNUR better expands upon the non-healthcare variables, followed by MSF and USAID. Doctors without borders shows a 97.3% degree of expansion of the healthcare variables) followed by ACNUR (94.7%), USAID (92.1%). CONCLUSIONS: ACNUR has been found to have the most integral proposal, the UN Humanitarian Affairs Coordination Office having the most discreet. There is a general trend towad further expanding upon and unifying the health indicators, whilst other aspects are not further expanded upon.

Emergency Medical Services↗

[Psychotherapeutic intervention for disturbed emotional regulation in complex post-traumatic stress disorder].

Pervasive disturbances in emotional regulation are a frequent problem for patients with complex trauma disorders. Emotional instability is a core diagnostic criterion of borderline personality disorder, in which a high prevalence of physical and sexual childhood abuse has been found. Self-injury, substance abuse, and binge-eating are strategies for coping with unbearable traumatic emotions. Therapeutic strategies for improving emotion regulation include pharmacological and psychological approaches. For the former, serotonin reuptake inhibitors have been shown to improve emotion regulation. The latter, psychotherapeutic techniques are: refocusing attention on positive emotions, imaginative distancing, resource activation, cognitive methods for improving affect differentiation, and fostering confidence in relationships and emotional attachment through the experience of a positive therapeutic relationship.

Adaptation, Psychological↗

Investigating the three systems approach to complex childhood nocturnal enuresis--medical treatment interventions.

OBJECTIVE: Nocturnal enuresis is a heterogeneous condition with various treatment options of both pharmacological and psychological origin. The three systems model previously proposed by us suggests a framework to facilitate understanding, identify a child's needs and specify the appropriate treatment option. In this study we sought to investigate the model in clinical practice in a group of children with severe nocturnal enuresis, with particular reference to pharmacological treatment. MATERIAL AND METHODS: A total of 66 children were assessed using a schedule for identifying mono- and non-monosymptomatic nocturnal enuresis, and were administered either desmopressin (0.4 mg) or anticholinergic medication (5-10 mg), respectively. Children were assessed at 4 weeks, with those failing to meet the success criterion being offered combination treatment for a further 4 weeks. RESULTS: Success rates for monotherapy were 49% and 33% for desmopressin and anticholinergic medication, respectively, with an overall success rate of 74.5%, including those who went on to combination treatment. Good clinical signs were identified for those successfully treated with anticholinergic medication. CONCLUSIONS: This study endorses the three systems approach in clinical practice.

Adolescent↗

The beta-adrenergic receptor-adenylate cyclase complex as a target for therapeutic intervention in heart failure.

In the human heart the beta-adrenergic pathways are the primary means of increasing cardiac performance in response to acute or chronic stress. Control of beta pathway function is achieved by changes in the receptors themselves, and to a lesser degree by adjustments in the inhibitory G protein (Gi). In heart failure myocardial beta-receptor function is substantially reduced, but the beta-receptor pathways are so powerful that they remain capable of supporting inotropic function. Certain therapeutic interventions that improve exercise performance in heart failure can partially restore beta-receptor pathway function to normal; these interventions include beta-blocker therapy and treatment with angiotensin converting enzyme inhibitors. Other types of therapy, such as chronic administration of beta-adrenergic agonists, may produce undesirable effects by increasing beta-receptor subsensitivity; however, the effects of beta-agonists on beta-receptor function are somewhat unpredictable and certain beta-agonists do not appear to produce much desensitization. Finally, the failing human heart is in effect partially denervated due to depletion of neuronal norepinephrine, and consequently in advanced heart failure beta-agonists that possess an indirect component of action will be less effective than exclusively direct-acting agents. These observations indicate that the baseline status and the intervention-associated behaviour of the human myocardial beta-adrenergic receptor systems need to be considered in developing therapeutic strategies in congestive heart failure.

Adenylyl Cyclases↗

[Problem-posing as a nutritional education strategy with obese teenagers].

Obesity is a public health issue with relevant social determinants in its etiology and where interventions with teenagers encounter complex biopsychological conditions. This study evaluated intervention in nutritional education through a problem-posing approach with 22 obese teenagers, treated collectively and individually for eight months. Speech acts were collected through the use of word cards, observer recording, and tape-recording. The study adopted a qualitative methodology, and the approach involved content analysis. Problem-posing facilitated changes in eating behavior, triggering reflections on nutritional practices, family circumstances, social stigma, interaction with health professionals, and religion. Teenagers under individual care posed problems more effectively in relation to eating, while those under collective care posed problems in relation to family and psychological issues, with effective qualitative eating changes in both groups. The intervention helped teenagers understand their life history and determinants of eating behaviors, spontaneously implementing eating changes and making them aware of possibilities for maintaining the new practices and autonomously exercising their role as protagonists in their own health care.

Adolescent↗

[Comparative efficacy of low molecular heparin (fraxiparine), non-fractionized heparin and anti-aggregate therapy in the prophylaxis complex for thromboembolic complications after surgical interventions performed for oncological disease].

Thromboembolism is one of the most frequent postoperative complications, which lead to exitus letalis in many of the patients. The thromboembolism occurrence is the most frequent in oncological diseases. Anticoagulants of direct action the nonfractionized heparin and low molecular weight heparins are applied for prophylaxis of thromboembolic complications. Their usage in combination with antiaggregative preparations is undesirable because of the bleeding occurrence threat. Comparative studying of prophylactic action and the haemorrhagic complications frequency under the usage of heparin, fraxiparin and antiaggregative preparations was performed in 462 patients. Maximal activity of low molecular weight heparins vs such of nonfractionized heparin and antiaggregative preparations was proved. The trustworthy enhancement of the bleeding frequency and of the blood coagulating system was not noted in the combined application of fraxiparin and antiaggregative preparations.

Adult↗