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A randomised controlled trial of occupational therapy for people with early rheumatoid arthritis.

BACKGROUND: Occupational therapy (OT) aims at improving performance of daily living tasks, facilitating successful adjustments in lifestyle, and preventing losses of function. OBJECTIVE: To evaluate the effects of a pragmatic, comprehensive OT programme on self management and health status of people with early rheumatoid arthritis (RA) (<2.5 years). METHODS: A randomised, controlled "assessor blinded" trial was conducted with assessments made at entry, 6, 12, and 24 months. Main outcomes were AIMS2: physical function (PF), pain visual analogue scale (VAS), and Arthritis Self-Efficacy Scale (ASES). RESULTS: Groups had similar disease duration (9 months OT (n = 162) v 10 months control (n = 164)). The OT group received 7.57 (SD 3.04) hours of therapy. Self management significantly increased in the OT group. Otherwise, there were no significant differences in any outcome measures, or between groups, by ACR functional class: AIMS2: PF (F = 0.04; p = 0.96); pain VAS (F = 0.29; p = 0.74); total ASES score (F = 0.93; p = 0.39). CONCLUSIONS: OT improved self management but not health status in early RA. Functional ability remains reasonably good for many in the first five years, so preventive benefits of self management may not yet be apparent and longer follow up is needed. Although many considered the education and therapy useful, insufficient numbers in the OT group used self management sufficiently to make a difference. Behavioural approaches can improve adherence and, potentially, the long term benefits. Future research should evaluate OT as a complex intervention and develop programmes from a theoretical and evidence base.

Adult↗

Three-dimensional CT scanning: a new diagnostic modality in congenital heart disease.

New generation multislice CT technology has changed the approach to non-invasive assessment of congenital heart disease, in both paediatric and adult patients. This is mainly because of rapid advances in spatial and temporal resolution and in post-processing capability. At Hôpital Necker-Enfants Malades, CT with multiplanar and three-dimensional reconstruction has become a routine examination in the evaluation of congenital heart disease planning surgery, complex interventional catheterisations and for follow-up. It has proved to be an invaluable diagnostic and decision-aiding methodology in these situations, as a complement to echocardiography and, increasingly, as a substitute for diagnostic angiography (which is usually associated with higher-dose radiation and longer sedation times, as well as occasional morbidity). This review illustrates the current status of 64-slice CT in congenital heart diseases, including assessment of the aorta, the coronary arteries, the pulmonary arteries, the systemic and pulmonary veins, and other intra- and extracardiac malformations.

Aorta, Thoracic↗

Enhancing the evidence base for health impact assessment.

Health impact assessment differs from other purposes for which evidence is collated in a number of ways, including:the focus on complex interventions or policy and their diverse effects on determinants of health;the need for evidence on the reversibility of adverse factors damaging to health;the diversity of the evidence in terms of relevant disciplines, study designs, quality criteria and sources of information;the broad range of stakeholders involved;the short timescale and limited resources generally available;the pragmatic need to inform decision makers regardless of the quality of the evidence. These have implications for commissioning and conducting reviews. Methods must be developed to: facilitate comprehensive searching across a broad range of disciplines and information sources; collate appropriate quality criteria to assess a range of study designs; synthesise different kinds of evidence; and facilitate timely stakeholder involvement. Good practice standards for reviews are needed to reduce the risk of poor quality recommendations. Advice to decision makers must make explicit limitations resulting from absent, conflicting, or poor quality evidence.

Decision Making↗

Getting teams to talk: development and pilot implementation of a checklist to promote interprofessional communication in the OR.

BACKGROUND: Pilot studies of complex interventions such as a team checklist are an essential precursor to evaluating how these interventions affect quality and safety of care. We conducted a pilot implementation of a preoperative team communication checklist. The objectives of the study were to assess the feasibility of the checklist (that is, team members' willingness and ability to incorporate it into their work processes); to describe how the checklist tool was used by operating room (OR) teams; and to describe perceived functions of the checklist discussions. METHODS: A checklist prototype was developed and OR team members were asked to implement it before 18 surgical procedures. A research assistant was present to prompt the participants, if necessary, to initiate each checklist discussion. Trained observers recorded ethnographic field notes and 11 brief feedback interviews were conducted. Observation and interview data were analyzed for trends. RESULTS: The checklist was implemented by the OR team in all 18 study cases. The rate of team participation was 100% (33 vascular surgery team members). The checklist discussions lasted 1-6 minutes (mean 3.5) and most commonly took place in the OR before the patient's arrival. Perceived functions of the checklist discussions included provision of detailed case related information, confirmation of details, articulation of concerns or ambiguities, team building, education, and decision making. Participants consistently valued the checklist discussions. The most significant barrier to undertaking the team checklist was variability in team members' preoperative workflow patterns, which sometimes presented a challenge to bringing the entire team together. CONCLUSIONS: The preoperative team checklist shows promise as a feasible and efficient tool that promotes information exchange and team cohesion. Further research is needed to determine the sustainability and generalizability of the checklist intervention, to fully integrate the checklist routine into workflow patterns, and to measure its impact on patient safety.

Communication↗

Evaluation of recurrent pyogenic cholangitis with CT: analysis of 50 patients.

The use of computed tomography (CT) was investigated in 50 patients with recurrent pyogenic cholangitis, 22 of whom had undergone prior choledochoenterostomy or sphincteroplasty. A spectrum of pathologic features was noted, including intrahepatic ductal dilatation (n = 50), common duct dilatation (n = 34), strictures (n = 11), intrahepatic calculi (n = 37), common duct calculi (n = 15), pneumobilia (n = 26), segmental atrophy (n = 18), and splenomegaly (n = 7). Unilobar disease existed in 14 patients. The left lateral segment was predominantly affected, with ductal dilatation (n = 23) and segmental atrophy (n = 13). During acute exacerbation, additional manifestations were observed: ductal wall enhancement (n = 4), segmental parenchymal enhancement (n = 9), hepatic abscess (n = 9), and biloma (n = 2). CT enables sensitive, complete evaluation of this disorder. It is valuable when results of ultrasonography are non-diagnostic and for planning hepatic resection, evaluating associated mass lesions, and guiding complex interventional procedures.

Adult↗

The evidence for prosthodontic treatment planning for older, partially dentate patients.

This paper provides a review of the available evidence for traditional prosthodontic need determination and management strategies for older, partially dentate individuals, and compares it to the documented functional benefits of a more limited yet targeted approach to alleviating morphological shortfalls for this group of people, at the population level. The reasons for which the traditional total replacement strategy is not universally applicable or viable are discussed, and research is presented which tests many of the assertions made for the mandatory replacement of posterior teeth. Evidence is presented of the growing prosthodontic challenge posed by an increasing number of middle-aged and older partially dentate individuals in society: many of their remaining teeth are in poor condition, yet few such patients are willing to accept the prospect of becoming edentulous. The shortened dental arch concept is discussed and proposed as an appropriate strategy when complex intervention is to be avoided, inadvisable, or not possible. At the population level, current evidence suggests that prosthodontic strategies aimed at the restoration and/or replacement of all lost molars may be inappropriate in older, partially dentate individuals. A more limited yet targeted strategy is both more effective and more efficient, and should not be seen as compromised care.

Adaptation, Physiological↗

Medical students' and tutors' experiences of directed and self-directed learning programs in evidence-based medicine: a qualitative evaluation accompanying a randomized controlled trial.

This qualitative study aims to interpret the results of a randomized controlled trial comparing two educational programs (directed learning and self-directed learning) in evidence-based medicine (EBM) for medical students at the University of Oslo from 2002 to 2003. There is currently very little comparative educational research in this field. In the trial, no statistically significant differences between the study groups were shown for any outcomes considered (EBM knowledge, skills, and attitudes). Further analysis suggests that main reason for the negative trial results was that the majority of students learned equally effectively, whichever program they received, although implementation of the educational programs was not complete because of varying attendance. This study illustrates a stepwise evaluation model that might be useful in evaluating other socially complex interventions.

Education, Medical, Undergraduate↗

Zero effects in substance abuse programs. Avoiding false positives and false negatives in the evaluation of community-based programs.

The evaluation of community-based programs poses special design and analysis problems. The present article focuses on two major types of errors that can occur in such evaluations: false positive--incorrectly declaring a program to be effective--and false negatives--incorrectly declaring a program to be ineffective. The evaluation of a national demonstration of community-based programs to reduce substance abuse, Fighting Back, is used to illustrate several approaches to reduce the probability of errors. Both those errors that are affected by the design and those by analytic approaches are considered. Ways to assess multiple outcomes and to match the complexity of the program with design and analytic strategies are proposed. Community trials are complex interventions, and, although they can provide very useful information, their outcomes have to be understood in terms of the constructs they test and the contexts within which they are carried out.

Adolescent↗

Current issues in treating the hypertensive patient with diabetes: focus on diabetic nephropathy.

OBJECTIVE: To review the pathophysiology of hypertension and complications in patients with diabetes mellitus, specifically focusing on diabetic nephropathy; to evaluate the current clinical literature regarding the appropriate management of hypertension in this patient group; and to offer treatment recommendations. DATA SOURCES: A MEDLINE search of applicable English-language clinical studies, abstracts, and review articles pertaining to hypertension, diabetes, and diabetic nephropathy. STUDY SELECTION: Relevant studies on humans, examining hypertension, diabetes, and diabetic nephropathy, and the effects of drug therapy on these interrelated disease states. DATA SYNTHESIS: Pathophysiology of hypertension in the patient with diabetes mellitus and the pathophysiology of diabetic nephropathy are discussed. Studies evaluating the therapeutic effect of certain antihypertensive agents, their effect on glucose control and insulin sensitivity, and the progression of diabetic nephropathy are reviewed. Recommendations on the treatment of the patient with diabetes and hypertension are given. CONCLUSIONS: The treatment of the patient with diabetes mellitus and hypertension remains complex. Interventions in this patient population should not only decrease blood pressure, but also reduce the risk of both vascular and nonvascular complications. Data support the theory that by controlling a patient's hypertension, the incidence of albuminuria and the progression of diabetic nephropathy are slowed. Additionally, data are available to support the use of pharmacologic interventions in nonhypertensive patients with diabetes and proteinuria. Drug therapies that have produced reductions in proteinuria in this patient population include angiotension-converting enzyme inhibitors and nondihydropyridine calcium-channel antagonists. Additional information is needed to better differentiate the individual agents within each of the antihypertensive drug classes regarding their individual effects on the patient with diabetes and hypertension, specifically effects on diabetic nephropathy and its progression to endstage renal disease.

Adrenergic alpha-Antagonists↗

Treatment of patients with spontaneous pneumothorax during videothoracoscopy.

Thoracoscopy for spontaneous pneumothorax has been performed over the years by many pulmonologists. The aim of the procedure was merely diagnostic: the detection of blebs and bullae. Therapeutic modalities were restricted to chemical pleurodesis. The development of videothoracoscopy has made more complex interventions, such as bullectomy possible. A protocol for videothoracoscopic treatment of spontaneous pneumothorax, with all treatment modalities in one session, has been developed. All patients with spontaneous pneumothorax underwent videothoracoscopy under general anaesthesia with double lumen tube intubation. If no abnormalities were found on the visceral pleura, talc pleurodesis was performed. Small lesions, blebs or bullae < 2 cm, were coagulated prior to pleurodesis. In case of blebs or bullae > 2 cm, thoracoscopic resection with an EndoGIA stapling device was performed, followed by scarification, i.e. electrocoagulation, of the parietal pleura. In 43 patients, 44 procedures were performed. In 15 cases (34%) no blebs or bullae were found. In 6 cases (14%) only blebs < 2 cm were found. In 23 cases (52%) blebs and bullae > 2 cm were found. In 21 out of 44 cases (48%), talc pleurodesis was performed, and in 23 cases (52%) bullectomy was performed. No major complication occurred. The average hospital stay was 5.7 days after talc pleurodesis and 6.0 days after bullectomy. There were 2 recurrences (5%) after a follow-up of at least 18 months. In conclusion, the use of videothoracoscopy in spontaneous pneumothorax makes it possible to continue a diagnostic procedure as a therapeutic session.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Research ethics committees: agents of research policy?

UNLABELLED: The purpose of this commentary is to describe the unintended effects ethics committees may have on research and to analyse the regulatory and administrative problems of clinical trials. DISCUSSION: The Finnish law makes an arbitrary distinction between medical research and other health research, and the European Union's directive for good clinical trials further differentiates drug trials. The starting point of current rules is that clinical trials are lesser in the interest of patients and society than routine health care. However, commercial interests are not considered unethical. The contrasting procedures in research and normal health care may tempt physicians to continue introducing innovations into practice by relying on unsystematic and uncontrolled observations. Tedious and bureaucratic rules may lead to the disappearance of trials initiated by researchers. Trying to accommodate the special legislative requirements for new drug trials into more complex interventions may result in poor designs with unreliable results and increased costs. Meanwhile, current legal requirements may undermine the morale of ethics committee members. CONCLUSION: The aims and the quality of the work of ethics committees should be evaluated, and a reformulation of the EU directive on good clinical trials is needed. Ethical judgement should consider the specific circumstance of each trial, and ethics committees should not foster poor research for legal reasons.

Journal Article↗

Gene therapy for carcinoma of the breast: Pro-apoptotic gene therapy.

The dysregulation of apoptosis contributes in a variety of ways to the malignant phenotype. It is increasingly recognized that the alteration of pro-apoptotic and anti-apoptotic molecules determines not only escape from mechanisms that control cell cycle and DNA damage, but also endows the cancer cells with the capacity to survive in the presence of a metabolically adverse milieu, to resist the attack of the immune system, to locally invade and survive despite a lack of tissue anchorage, and to evade the otherwise lethal insults induced by drugs and radiotherapy. A multitude of apoptosis mediators has been identified in the past decade, and the roles of several of them in breast cancer have been delineated by studying the clinical correlates of pathologically documented abnormalities. Using this information, attempts are being made to correct the fundamental anomalies at the genetic level. Fundamental to this end are the design of more efficient and selective gene transfer systems, and the employment of complex interventions that are tailored to breast cancer and that are aimed concomitantly towards different components of the redundant regulatory pathways. The combination of such genetic modifications is most likely to be effective when combined with conventional treatments, thus robustly activating several pro-apoptotic pathways.

Animals↗

Gait pattern of severely disabled hemiparetic subjects on a new controlled gait trainer as compared to assisted treadmill walking with partial body weight support.

OBJECTIVES: To investigate to what extent and with how much therapeutic effort nonambulatory stroke patients could train a gait-like movement on a newly developed, machine-supported gait trainer. DESIGN: Open study comparing the movement on the gait trainer with assisted walking on the treadmill. SETTING: Motion analysis laboratory of a rehabilitation centre. SUBJECTS: Fourteen chronic, nonambulatory hemiparetic patients. INTERVENTION: Complex gait analysis while training on the gait trainer and while walking on the treadmill. MAIN OUTCOME MEASURES: Gait kinematics, kinesiological EMG of several lower limb muscles and the required assistance. RESULTS: Patients could train a gait-like movement on the gait trainer, characterized kinematically by a perfect symmetry, larger hip extension during stance, less knee flexion and less ankle plantar flexion during swing as compared to treadmill walking (p <0.01). The pattern and amount of activation of relevant weight-bearing muscles was comparable with an even larger activation of the M. biceps femoris on the gait trainer (p <0.01). The tibialis anterior muscle of the nonaffected side, however, was less activated during swing (p <0.01). Two therapists assisted walking on the treadmill while only one therapist was necessary to help with weight shifting on the new device. CONCLUSION: The newly developed gait trainer offered severely disabled hemiparetic subjects the possibility of training a gait-like, highly symmetrical movement with a favourable facilitation of relevant anti-gravity muscles. At the same time, the effort required of the therapists was reduced.

Adult↗

Estimating treatment effects from randomized clinical trials with noncompliance and loss to follow-up: the role of instrumental variable methods.

Perfectly implemented randomized clinical trials, particularly of complex interventions, are extremely rare. Almost always they are characterized by imperfect adherence to the randomly allocated treatment and variable amounts of missing outcome data. Here we start by describing a wide variety of examples and then introduce instrumental variable methods for the analysis of such trials. We concentrate mainly on situations in which compliance is all or nothing (either the patient receives the allocated treatment or they do not--in the latter case they may receive no treatment or a treatment other than the one allocated). The main purpose of the review is to illustrate the use of latent class (finite mixture) models, using maximum likelihood, for complier-average causal effect estimation under varying assumptions concerning the mechanism of the missing outcome data.

Depression↗

Assessing the value of assertive outreach. Qualitative study of process and outcome generation in the UK700 trial.

BACKGROUND: It is unclear why intensive case management (ICM) failed to reduce hospitalisation in the UK700 trial. AIMS: To investigate outcome generation in the UK700 trial. METHOD: A qualitative investigation was undertaken in one UK700 centre. RESULTS: Both intensive and standard case management practised individual casework, employed assertive outreach with comparable frequency, and performed similarly in the out-patient management of emergencies and in-patient discharge. However, ICM was advantaged in managing some non-compliance and undertaking casework that prevented psychiatric emergencies. Absence of team-based management and bureaucratised access to social care limited the impact of these differences on outcomes and the effective practice of assertive outreach, although this was relevant to only a sub-population of patients. CONCLUSIONS: The impact of ICM was undermined by organisational factors. Sensitive anticipatory casework, which prevents psychiatric emergencies, may make ICM more effective than an exclusive focus on assertive outreach. Our findings demonstrate the value of qualitative research in evaluating complex interventions.

Adolescent↗

Developing services for first-episode psychosis and the critical period.

BACKGROUND: Providing specialised services to individuals experiencing first-episode psychosis (FEP) is a relatively new endeavour. AIMS: To overview developing services for newly diagnosed cases of FEP and the context in which they develop. METHOD: This paper describes five model multi-element FEP programmes, outlines recent evaluation studies of FEP services, discusses current evidence gaps relating to the evaluation of complex interventions and specific interventions for FEP and illustrates attempts to examine aspects of clinical work practised at the Early Psychosis Prevention and Intervention Centre (EPPIC) in Melbourne, Australia. RESULTS: Considerable progress has been made in terms of influencing practice in the assessment and treatment of early psychosis. CONCLUSIONS: There is need for quality clinical and research efforts to inform and accelerate progress in this burgeoning field.

Delivery of Health Care↗

Risk profile of female sex workers who participate in a routine penicillin prophylaxis programme in Surabaya, Indonesia.

We conducted a sexually transmitted disease (STD) prevalence survey of 1867 female sex workers in Surabaya, Indonesia, some of whom reported participation in a routine penicillin prophylaxis programme. In Surabaya, 34% of female sex workers had received a prophylactic penicillin injection programme from the government within 28 days. Sex workers who had received routine prophylaxis injection were more likely to be less educated, to work in brothel complexes, and to have more customers per week than other sex workers. The prevalence rates of syphilis, gonorrhoea, chlamydia, and trichomoniasis were higher among sex workers who received the routine penicillin treatment than among those who had not received antibiotic treatment in the last 28 days. However, after adjustment for age, education, fee per sex act, number of customers, and condom use in the previous 7 days, only trichomoniasis was still significantly different (adjusted odds ratio of 3.2). High-risk women were more likely to participate in the routine penicillin prophylaxis programme. The lack of a demonstrable individual-level protection from this prophylaxis treatment programme in this cross-sectional study appears due to differential uptake of penicillin prophylaxis by women at higher presumptive risk for STD. Randomized clinical trials and mathematical modelling, together with observational data such as presented here, all can contribute to optimal understanding of a complex intervention like mass chemoprophylaxis for STD among female sex workers.

Adult↗

How the philosophies, styles, and methods of family medicine affect the research agenda.

Family physicians provide person-centered, continuous, comprehensive care that is accessible and available at the time of need. Although this core philosophy is shared around the world, its translation into actual practice can vary greatly with time and from place to place as family physicians adapt to local constraints and conditions. Factors driving these local variations include entrenched habits and patterns of care, funding systems, patient expectations, public policy, and the availability and quality of other critical health system components. This diversity provides both an opportunity and a challenge for family medicine research. The potential for fruitful comparisons and contrasts arising from natural experiments may require investigators to use multiple research methods capable of evaluating complex interventions and comparisons. Family medicine has the capacity to be an excellent laboratory in which research in representative populations can offer the pragmatic answers needed by practicing physicians. The nature of the research questions and interventions require the involvement of clinicians in the formulation of research questions and evaluation of the applicability of research results. The variations in implementation of the family medicine philosophy can be a potential asset because of the research opportunities they provide.

Biomedical Research↗