Effects of feedback of information on clinical practice: a review.

OBJECTIVE--To establish what is known about the role of feedback of statistical information in changing clinical practice. DESIGN--Review of 36 studies of interventions entailing the use of statistical information for audit or practice review, which used a formal research design. SUBJECTS--Papers identified from computer searches of medical and health service management publications, of which 36 describing studies of interventions designed to influence clinical care and including information feedback from clinical or administrative data systems were reviewed. MAIN OUTCOME MEASURES--Evidence for effect of information feedback on change in clinical practice. RESULTS--Information feedback was most likely to influence clinical practice if it was part of strategy to target decision makers who had already agreed to review their practice. A more direct effect was discernable if the information was presented close to the time of decision making. The questions of the optimum layout and quantity of information were not addressed; the 36 papers were insufficient for defining good formats for information to be used for audit or quality assurance. CONCLUSIONS--Given the cost of information processing and the current emphasis on closing the audit loop in the health services, it is important that the use of information in the audit process should be critically evaluated.     

Should all casualty radiographs be reviewed?

The effect on the management of patients of routine reporting of casualty radiographs by radiologists was reviewed. The overall prevalence of error by casualty doctors was 6.2%. Many of these errors, however, were trivial and did not alter treatment. In only 1.1% of the cases reviewed did the report of x ray films appreciably alter the management of the patient. A severity score was introduced to highlight those anatomical areas in which important lesions were overlooked most often. Radiologists'' reports on radiographs of the chest, face, skull, and wrist had the greatest effect on management of patients, while reports on radiographs of fingers, hands, shoulders, long bones, and toes seldom altered treatment.     

Hospital discharge reports: content and design.

The information required by family doctors on initial and final discharge reports from hospitals was specified and 546 such reports from hospitals in Aylesbury, Amersham, Banbury, Oxford, and High Wycombe were reviewed for the availability and accessibility of important information. Several items could have been recorded better, including the name of the hospital, the specialty (or department) concerned, and the name of the consultant in charge of the case. Drug reactions seemed to be under-reported in the initial discharge reports and information about treatment on discharge was inadequate. The recording of the prognosis and information given to the patient was deficient and communication on follow-up needs to be improved. The use of obscure abbreviations was widespread. There is room for improvement in the ease of access to important information, especially the diagnostic assessment, and the time taken for final reports to reach the general practitioner.     

Using information from asthma patients: a trial of information feedback in primary care.

OBJECTIVE--To test the effects of feedback of information about patients'' asthma to primary care teams. DESIGN--Patients'' reports of morbidity, use of health services, and drug use on questionnaire was given to primary care teams. Randomised controlled trial with general practices as the subject of the intervention was used to test effectiveness of supplying information. SETTING--Primary care in district health authority, London. SUBJECTS--23 general practices, each of which notified at least 20 asthmatic patients aged 15-60 years for each principal. Practices were randomly allocated to an invention group (receiving feedback of information on control of asthma) or a control group (no feedback). INTERVENTION--Information on cards inserted in patients'' medical records; booklet copies of information for team members; formal presentation to primary care teams; poster displays of data on patients in each practice. MAIN OUTCOME MEASURES--Type and frequency of asthma symptoms, use of health services, use of asthma drugs. RESULTS--Reported morbidity at entry to the study was substantial: 45% (818) patients reported breathlessness at least once a week. Less than half these patients were using inhaled steroids regularly. Intervention and control groups did not differ in practice or patient characteristics on entry to the study. In spite of the potential for improvement no differences were observed between the two practice groups at the end of the study--for example, breathlessness at least once a week in last six months was experienced by 36% in intervention group v 35% in control group (t = -0.27, P < 0.79); surgery attendance in last six months by 48% v 48% (t = -0.05, P < 0.96); regular use of inhaled steroids by 60% v 58% (t = 0.51, P < 0.62). CONCLUSION--Feedback to general practitioners of information about patients'' asthma does not on its own lead to change in the outcome of clinical care.     

Best Practice Recommendations for Anesthetic Perioperative Care and Pain Management in Weight Loss Surgery

Objective: To develop evidence‐based recommendations that optimize the safety and efficacy of perioperative anesthetic care and pain management in weight loss surgery (WLS) patients. Research Methods and Procedures: This Task Group examined the scientific literature on anesthetic perioperative care and pain management published in MEDLINE from January 1994 to March 2004. We also reviewed additional data from other sources (e.g., book chapters). The search yielded 195 abstracts, of which 35 references were reviewed in detail. Task Group consensus was used to provide recommendations when evidence in the literature was insufficient. Results: We developed anesthesia practice and patient safety advisory recommendations for preoperative evaluation, intraoperative management, and postoperative care and pain management of WLS patients. We also provided suggestions related to medical error reduction and systems improvements, credentialing, and future research. Discussion: Obesity‐related comorbidities including obstructive sleep apnea place WLS patients at increased risk for complications perioperatively. Regarding perioperative safety and outcomes, conclusive evidence beyond the accepted standard of care in the reviewed literature is limited. Few reports specifically address the perioperative needs of severely obese patients. In this advisory, we synthesize current knowledge and make best practice recommendations for perioperative care and pain management in WLS patients. These recommendations require periodic review as further medical knowledge and evidence evolve.     

Electronic communication between providers of primary and secondary care.

OBJECTIVE--To study the effects of the introduction of electronic data interchange between primary and secondary care providers on speed of communication, efficiency of data handling, and satisfaction of general practitioners with communication. DESIGN--Comparison of traditional paper based communication for laboratory reports and admission-discharge reports between hospital and general practitioners and electronic data interchange. SETTING--Twenty-seven general practitioners whose offices were equipped with a practice information system and two general hospitals. OUTCOME MEASURES--Paper based communication was evaluated by questionnaire responses from and interviews with care providers; electronic communication was evaluated by measuring time intervals between generation and delivery of messages and by assessing doctors'' satisfaction with electronic data interchange by questionnaire. RESULTS--Via paper mail admission-discharge reports took a median of 2-4 days, and laboratory reports 2 days, to reach general practitioners. With electronic data interchange almost all admission-discharge reports were available to general practitioners within one hour of generation. When samples were analysed on the day of collection (as was the case for 174/542 samples in one hospital and 443/854 in the other) the laboratory reports were also available to the general practitioner the same day via electronic data interchange. Fifteen general practitioners (of the 24 who returned the questionnaire) reported that the use of electronic admission-discharge reports provided more accurate and complete information about the care delivered to their patients. Ten general practitioners reported that electronic laboratory reports lessened the work of processing the data. CONCLUSION--Electronic communication between primary and secondary care providers is a feasible option for improving communication.     

Discontinuation rates in clinical trials in musculoskeletal pain: meta-analysis from etoricoxib clinical trial reports

Introduction

Patient adherence to therapy in clinical practice is often low, and the difference between efficacy measured in clinical trials and effectiveness in clinical practice is probably a function of discontinuation of therapy because of lack of efficacy or because of unmanageable or intolerable adverse events. Discontinuation is frequently measured in clinical trials but is not usually described in detail in published reports, often because of limitations in the size of publications. By contrast, company clinical trial reports include much more detail.

Methods

We examined company clinical trial reports of trials involving etoricoxib in four musculoskeletal conditions: osteoarthritis, rheumatoid arthritis, chronic low back pain and ankylosing spondylitis. Information was available from 18 randomized trials (10,143 patients) lasting 4 to 12 weeks (one 4 weeks, three 6 weeks, one 8 weeks and seven 12 weeks) and from three trials with a mean duration of about 80 weeks (34,695 patients). These clinical trial reports contain over 73,000 pages of information.

Results

Over 12 weeks, lack of efficacy and adverse event discontinuations were similar between osteoarthritis, rheumatoid arthritis and back pain, with lack of efficacy discontinuation rates some three times higher than for adverse events. All-cause and lack of efficacy discontinuations were lower with etoricoxib (all doses combined) and traditional nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) than with placebo, although NSAIDs produced higher rates of clinical adverse events and gastrointestinal discontinuations than did placebo. Etoricoxib had fewer discontinuations than NSAIDs for lack of efficacy, clinical adverse events, and laboratory and gastrointestinal adverse events, but with more discontinuations because of hypertension and oedema. Comparison with two similar meta-analyses of other cyclo-oxygenase-2 selective inhibitors (more than 80,000 patients in total) revealed consistency between analyses.

Conclusion

Examining discontinuation data from clinical trials, even when the numbers of patients are very large, does not necessarily predict what will happen in the real world, where clinical effectiveness may differ from clinical efficacy assessed in trials. Data from these analyses appears to agree with findings from real world practice.     

The Ergotropic Activity Index as an Integral Indicator of the Suprasegmental Autonomic Activity

Thirty healthy males between 19 and 25 years of age were examined to develop a method for estimating the suprasegmental autonomic activity. Analysis of the data obtained revealed the most informative indices along with a factor that had positive correlations with the ergotropic autonomic activity indices and negative correlations with the trophotropic autonomic activity indices. This factor was termed the ergotropic activity index. The information content of this factor was analyzed in a thermal environment and clinically in 40 patients with autonomic crises. The effectiveness of this method was tested, and the method was judged to be sufficiently adequate for clinical practice. The procedure developed for estimating the suprasegmental autonomic activity was demonstrated to be a highly informative method for revealing the predominance of either ergotropic or trophotropic activity in healthy subjects and patients with autonomic dystonia and for forecasting heat tolerance in humans. This method can be used during physiological and neurophysiological observations and in clinical practice     

A role of calcium in altered sodium ion transport of hypertensives?

Research on the etiology of essential hypertension has led to many reports of altered ion transport in cells from hypertensive patients and animal models. Abnormalities in sodium and calcium ion gradients and transport in vascular smooth muscle, neuronal tissue, cardiac muscle as well as erythrocytes have been extensively investigated. It is not clear whether these abnormalities are of primary or secondary nature. The current knowledge of sodium and calcium ion transport in essential hypertension is briefly reviewed here. Furthermore, evidence is presented which suggests a role of calcium in the regulation of sodium transport activity.     

Fine needle aspiration biopsy of gastric duplication cysts with endoscopic ultrasound guidance

OBJECTIVE: To evaluate the ability of endoscopic ultrasound (EUS)-guided fine needle aspiration biopsy (FNAB) to diagnose gastric duplication cysts. STUDY DESIGN: FNAB reports from the Department of Pathology, Saint Louis University Hospital, were retrospectively searched for reports of EUS-guided FNABs of the stomach. These reports were then reviewed to find instances in which gastric duplication cysts were diagnosed. The charts of patients diagnosed with gastric duplication cysts were reviewed. RESULTS: Two patients were identified. The first was a 35-year-old, Caucasian male with an asymptomatic submucosal (versus extrinsic) gastric mass discovered during computed tomography of the abdomen. The second was a 44-year-old, Caucasian male with a history of treated low grade B cell lymphoma of mucosa-associated lymphoid tissue (MALToma) who was found to have an asymptomatic gastric wall abnormality by EUS when undergoing follow-up for the MALToma. Respiratory-type epithelial cells were present in each of these gastric duplication cysts. At this writing, both patients were being followed clinically and with imaging. CONCLUSION: Gastric duplication cysts, particularly those that have respiratory-type epithelium, can be diagnosed by EUS-guided FNAB. The diagnosis of gastric duplication cysts by EUS-guided FNAB can preclude surgery, with its associated morbidity.     

General practitioners' views about the statutory annual practice report.

OBJECTIVE--To ascertain the views of primary care professionals about the current purpose, uses, potential, and workload implications of the statutory general practice annual report. DESIGN--Postal questionnaire survey. SETTING--General practices in the Northern region. SUBJECTS--All practices in the region that were singlehanded, fundholding, non-fundholding and with more than five partners, and a one in three random sample of all non-fundholding practices (n = 318). RESULTS--263 practices responded (83%). The report took a median of 12 hours to produce (95% confidence interval 11 to 15 hours; interquartile range 7-35). The main perceived purpose of the report was to monitor practice activity (165 respondents; 63% (95% confidence interval 57% to 69%)), but 44 respondents (17%; 13% to 22%) produced it only because it was contractually required. Practices included statutory and non-statutory data in these reports and would have liked comparative practice activity information (155 respondents; 59%) and "good ideas" (165 respondents; 63%) fed back to them. Respondents would have liked the annual report used to improve practice development planning (122 respondents; 46% (40% to 52%)), to facilitate audit (115 respondents; 44% (38% to 50%)), and to influence resource allocation (104 respondents; 40% (34% to 46%)). One hundred and eighteen practices (45%; 39% to 51%) would produce an annual report even if not contractually required. Data collected were perceived to be already available elsewhere. CONCLUSIONS--Primary care professionals have concerns about the current annual report. They would prefer to collect relevant, standardised data which could lead to better audit, planning, and resource allocation.     

The Effects of Mobile-Phone Electromagnetic Fields on Brain Electrical Activity: A Critical Analysis of the Literature

We analyzed the reports in which human brain electrical activity was compared between the presence and absence of radio-frequency and low-frequency electromagnetic fields (EMFs) from mobile phones, or between pre- and post-exposure to the EMFs. Of 55 reports, 37 claimed and 18 denied an EMF-induced effect on either the baseline electro encephalogram (EEG), or on cognitive processing of visual or auditory stimuli as reflected in changes in event-related potentials. The positive reports did not adequately consider the family-wise error rate, the presence of spike artifacts in the EEG, or the confounding role of the two different EMFs. The negative reports contained neither positive controls nor power analyses. Almost all reports were based on the incorrect assumption that the brain was in equilibrium with its surroundings. Overall, the doubt regarding the existence of reproducible mobile-phone EMFs on brain activity created by the reports appeared to legitimate the knowledge claims of the mobile-phone industry. However, it funded, partly or wholly, at least 87% of the reports. From an analysis of their cognitive framework, the common use of disclaimers, the absence of information concerning conflicts of interest, and the industry's donations to the principal EMF journal, we inferred that the doubt was manufactured by the industry. The crucial scientific question of the pathophysiology of mobile-phone EMFs as reflected in mea surements of brain electrical activity remains unanswered, and essentially unaddressed.     

PSYCHOSIS AND SYSTEMIC LUPUS ERYTHEMATOSUS—A Review of the Literature and Case Reports

In a review of the literature of the last 60 years concerning the association between psychosis and systemic lupus erythematosus, reports of 227 cases of this association were found. The average incidence of psychosis in the various series of systemic lupus erythematosus that were reviewed was 22 per cent. In only 25 per cent of the cases in which the information was given was the psychosis associated with steroid therapy.The psychiatric manifestations are variable and may be associated with a neurological disorder. Psychosis may antedate by many years other features of lupus. The psychosis due to lupus may respond to steroid therapy. Since systemic lupus erythematosus sometimes may be an important differential diagnosis of functional psychosis, appropriate diagnostic studies should be carried out in psychotic patients who have an accelerated sedimentation rate or positive serological test for syphilis without apparent reason.     

Surgical correction of the vertically deficient chin

Surgical correction of the vertically deficient chin has received relatively little attention. This paucity of information is most likely related to the failure to diagnose vertical microgenia and the questionable stability of its surgical correction utilizing autogenous bone grafts. This paper reports on eight patients who have undergone vertical augmentation genioplasty utilizing a transverse symphyseal osteotomy and interpositional implantation of porous, block hydroxyapatite. All patients had preoperative measured decreases in lower face height. Mean vertical lengthening of the chin was 5.3 mm. Seven of the eight patients had class II occlusions and underwent simultaneous sagittal advancement of the chin. Follow-up at a mean time of 11.1 months revealed complete stability of the vertically repositioned symphyseal segment. Mean ratio of the vertical soft to hard tissue augmentation was 0.89:1. There were no instances of operative complications. Vertical facial aesthetics and their application in the evaluation and treatment of patients with vertically deficient lower faces and chins are reviewed.     

Cryptococcus Neoformans Meningitis Cases Among China’s HIV-Infected Population may have been Severely Under-Reported

Cryptococcal meningitis (CM) is the leading fungal infection of the central nervous system. Globally, most CM cases have been reported from patients with compromised immunities, especially those infected with HIV. However, reports from China have shown that most CM infections were from HIV-negative, immunocompetent hosts. Here, we reviewed the published reports and found those studies were almost exclusively based on patients from hospitals associated with Chinese universities but not from specialized infectious diseases hospitals where most Chinese HIV-infected patients have been treated. Thus, we believe CM cases among China’s HIV-infected population may have been severely under-reported. Analyses of CM cases in specialized infectious diseases hospitals are needed to identify the true epidemiological pattern of CM in China.

     

Study of information submitted by drug companies to licensing authorities.

Reports of clinical trials included in applications submitted by drug companies to licensing authorities in Finland and Sweden in four different years were studied. Many reports were submitted, but most of the trials were uncontrolled and of poor quality. Many of the reports were unpublished, and thus, as the submissions are secret, were not available to doctors. These unpublished reports were in most respects as valuable as the published reports. Most of the reports included some information about adverse effects; the information was often deficient, but skilled analysis might increase its value. This study provides support for those who want to see public disclosure of the reports of trials submitted in licensing applications.     

Practice patterns of mitochondrial disease physicians in North America. Part 2: treatment,care and management

Mitochondrial medicine is a young subspecialty. Clinicians have limited evidence-based guidelines on which to formulate clinical decisions regarding diagnosis, treatment and management for patients with mitochondrial disorders. Mitochondrial medicine specialists have cobbled together an informal set of rules and paradigms for preventive care and management based in part on anecdotal experience. The Mitochondrial Medicine Society (MMS) assessed the current state of clinical practice including diagnosis, preventive care and treatment, as provided by various mitochondrial disease providers in North America. In this second of two reports, we present data related to clinical practice that highlight the challenges clinicians face in the routine care of patients with established mitochondrial disease. Concerning variability in treatment and preventative care approaches were noted. We hope that sharing this information will be a first step toward formulating a set of consensus criteria and establishing standards of care.     

Review of Oral Cholecystographic Agents for the Management of Hyperthyroidism

ObjectiveAlthough the use of oral cholecystographic agents (OCAs) had declined due to limited availability, there is literature to suggest it is an effective medication for thyrotoxicosis in appropriate clinical situations.MethodsThe authors performed a PubMed search and systematically reviewed all the English written case reports, original studies and reviews from 1953 to 2012. Additional information was supplemented from available online pharmacologic databases.ResultsThe off-label use of OCAs was reviewed for the management of neonatal and adult Graves’ disease, subacute thyroiditis, amiodarone-induced thyroiditis (AIT), exogenous hyperthyroidism, toxic multinodular goiter (TMNG), thyrotropinoma, thyrotoxicosis during pregnancy, rapid pre-operative control of hyperthyroidism, and thyroid storm. Adverse effects were also reviewed.ConclusionOCAs generally are effective agents in treating thyrotoxicosis in the etiologies reviewed. OCAs are clinically relevant in patients who require rapid control, such as in the pre-operative state or patient who cannot tolerate a thyrotoxicosis state. OCA may also be beneficial in situations where other anti-thyroidal medication would be hazardous or ineffective, such as thionamide allergy or exogenous thyrotoxicosis. Given concern for long-term relapse, OCAs should be considered a short-term bridge to definitive therapy. OCAs are limited in TMNG and should be second line after glucocorticoids in AIT II. OCAs do not preclude the use of radioactive iodine, which can be performed one week after OCA therapy. (Endocr Pract. 2014;20:1084-1092)     

Re-Examination of 30-Day Survival and Relapse Rates in Patients with Thrombotic Thrombocytopenic Purpura-Hemolytic Uremic Syndrome

ResultsFifty-nine patients were analyzed and all were initially treated with TPE and corticosteroids. Eleven patients were classified as not having TTP-HUS due to testing or clinical reassessment which ruled in other etiologies, and 18/59 patients had ADAMTS13 activity <10%. Of remaining patients, 36/48 (75%) were diagnosed as idiopathic and 12/48 (25%) as secondary TTP-HUS. Patients received a mean of 12 TPEs (range 1-42); 42/48 (87.5%) patients had ADAMTS13 activity measured; complete response obtained in 39/48 (81.2%) patients (platelet count >100 x 10⁹/L); partial response in 4/48 (8%); and 5/48 (10.4%) did not have increases in platelet counts (2/5 of these patients died within the study period). Forty percent of patients obtained platelet counts >150 x 10⁹/L. Overall 30-day mortality for our patient cohort was 6.7% (4/59). Comparison of our mortality rate to combined data of five published studies of 16% (92/571) showed a significant difference, p = 0.04. Our relapse rate was 18.6% (11/59) similar to previous reports.ConclusionsWide differences in mortality may be due to grouping of two distinct pathologic entities under TTP-HUS; and presence of confounding factors in the patient populations under study such as co-morbidities, promptness of TPE initiation, delay in diagnosis and therapeutic practice.     

Isavuconazole in a Successful Combination Treatment of Disseminated Mucormycosis in a Child with Acute Lymphoblastic Leukaemia and Generalized Haemochromatosis: A Case Report and Review of the Literature

Invasive mucormycosis in immunocompromised children is a life-threatening fungal infection. We report a case of a 7-year-old girl treated for acute lymphoblastic leukaemia complicated by disseminated mucormycosis during induction therapy. Microscopic examination of surgically removed lung tissue revealed wide, pauci-septate hyphae suggesting a Mucorales infection. This diagnosis was confirmed immunohistochemically and by PCR analysis followed by a final identification of Cunninghamella sp. The patient was treated successfully with surgical debridement and antifungal combination therapy with amphotericin B, caspofungin and isavuconazole. The use of isavuconazole in a child was not previously reported. Additionally, case reports concerning pulmonary mucormycoses in paediatric population published after 2010 were reviewed. Nineteen out of 26 identified patients suffered from haematological diseases. Reported mortality reached 38.5%. By the fact of rising morbidity, unsatisfactory results of treatment and remaining high mortality of mucormycoses in immunocompromised patients, new therapeutic options are warrant. Isavuconazole, with its broad-spectrum activity, good safety profile and favourable pharmacokinetics, is a promising drug. However, further studies are necessary to confirm positive impact of isavuconazole on mucormycosis treatment in children.