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Data Extraction (data + extraction)
Terms modified by Data Extraction Selected AbstractsRole of the Clinical Breast Examination in Breast Cancer ScreeningJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 7 2001Does This Patient Have Breast Cancer? QUESTION: The authors, in an article for the JAMA section on the rational clinical examination, consider the evidence on whether and how to use clinical breast examination as a cancer screening technique. BACKGROUND: Breast cancer is a common disease, particularly in older women. The authors note that by age 70 the annual incidence of breast cancer is one in 200 women. Breast cancer survival is strongly influenced by the stage of the disease at the time of diagnosis. As a result, it is important to consider how best to screen for this disease. In recent years there has been considerable attention in the clinical literature and in the popular media paid to the screening strategies of breast self-examination and of screening mammography, but somewhat less to the potential role of the breast examination by the healthcare provider. In actual clinical practice, the same woman may be the recipient of any, none, or all of these screening modalities. The best way to combine these screening strategies, particularly in the case of the older woman, remains a subject of some uncertainty and controversy. DATA SOURCES: Data were obtained from a MEDLINE search of the English-language literature for 1966 through 1997 and additional articles as identified by the authors. STUDY SELECTION CRITERIA: In their evaluation of the effectiveness of clinical breast examination, the authors included both controlled trials and case-controlled studies in which clinical breast examination was used as a component of the screening. Study of breast examination technique considered both clinical studies and studies using silicone breast models. DATA EXTRACTION: The combined data from the trials included information on approximately 200,000 women who received a breast cancer screening intervention (mammography and/or clinical breast examination). However, none of the studies made the direct comparison of a group receiving clinical breast examination as a sole intervention with a control group that did not receive any screening. Data on the utility of clinical breast examination were partially derived from studies where that screening modality was used in combination with mammography. MAIN RESULTS: A number of trials of cancer screening have demonstrated a reduction in mortality from the use of mammography and clinical breast examination as combined screening strategies compared with no screening, with the inference that the reduction in mortality comes from the earlier detection of breast cancer. The percentage of the detected cancers that are detected in the trials by clinical breast examination despite having been missed on mammography varies across the trials from a low of 3% of the detected cancers to a high of 45%. It is speculative whether the marginal contribution of clinical breast examination to the mortality reduction in these screening trials corresponds to the percentage of cancers detected by clinical breast examination alone. In most of the clinical trials, the technique of breast examination reportedly was not well described. It is unclear therefore how much the technique of breast examination used varied within and among the clinical trials. Data from studies using examinations of breast models made of silicone demonstrated that test performance accuracy correlated with a lengthier breast examination, better breast examination technique, and perhaps with examiner experience. The report includes data from six comparator studies and from two demonstration projects. Of the six comparator studies, four compared a screened population with an unscreened population and two compared different intensities of screening strategies. None of the eight clinical trials was directed to a geriatric population and in fact older women were excluded by upper age entry criteria from the six comparator studies. (The upper age limit for study entry in the six comparator studies varied from 49 to 64.) CONCLUSION: The authors drew on the pooled results of these eight studies to conclude that clinical breast examination has a sensitivity of 54% (95% confidence interval, 48.3,59.8) and a specificity of 94% (95% confidence interval, 90.2,96.9). The authors conclude that screening clinical breast examination should be done for women age older than 40. [source] The Role of Benzodiazepines in the Treatment of InsomniaJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 2001Meta-Analysis of Benzodiazepine Use in the Treatment of Insomnia PURPOSE: To obtain a precise estimate of the efficacy and common adverse effects of benzodiazepines for the treatment of insomnia compared with those of placebo and other treatments. BACKGROUND: Insomnia, also referred to as disorder of initiating or maintaining sleep, is a common problem and its prevalence among older people is estimated to be 23% to 34%.1 The total direct cost in the United States for insomnia in 1995 was estimated to be $13.9 billion.2 The complaint of insomnia in older people is associated with chronic medical conditions; psychiatric problems, mainly depression, chronic pain, and poor perceived general condition;1,3,4 and use of sleep medications.5 Thus in most cases, insomnia is due to some other underlying problem and is not just a consequence of aging.6 Accordingly, the management of insomnia should focus on addressing the primary problem and not just short-term treatment of the insomnia. Benzodiazepines belong to the drug class of choice for the symptomatic treatment of primary insomnia.7 This abstract will appraise a meta-analysis that compared the effect of benzodiazepines for short-term treatment of primary insomnia with placebo or other treatment. DATA SOURCES: Data sources included articles listed in Medline from 1966 to December 1998 and the Cochrane Controlled Trials Registry. The medical subject heading (MeSH) search terms used were "benzodiazepine" (exploded) or "benzodiazepine tranquillizers" (exploded) or "clonazepam,""drug therapy,""randomized controlled trial" or "random allocation" or "all random,""human," and "English language." In addition, bibliographies of retrieved articles were scanned for additional articles and manufacturers of brand-name benzodiazepines were asked for reports of early trials not published in the literature. STUDY SELECTION CRITERIA: Reports of randomized controlled trials of benzodiazepine therapy for primary insomnia were considered for the meta-analysis if they compared a benzodiazepine with a placebo or an alternative active drug. DATA EXTRACTION: Data were abstracted from 45 randomized controlled trials representing 2,672 patients, 47% of whom were women. Fifteen studies included patients age 65 and older and four studies involved exclusively older patients. Twenty-five studies were based in the community and nine involved inpatients. The duration of the studies ranged from 1 day to 6 weeks, with a mean of 12.2 days and median of 7.5 days. The primary outcome measures analyzed were sleep latency and total sleep duration after a sleep study, subjects' estimates of sleep latency and sleep duration, and subjects' report of adverse effects. Interrater reliability was checked through duplicate, independent abstraction of the first 21 articles. Overall agreement was between 95% and 98% (kappa value of 0.90 and 0.95 accordingly) for classification of the studies and validity of therapy, and 76% (kappa value of 0.51) for study of harmful effects. A scale of 0 to 5 was used to rate the individual reports, taking into account the quality of randomization, blinding, follow-up, and control for baseline differences between groups. Tests for homogeneity were applied across the individual studies and, when studies were found to be heterogeneous, subgroup analysis according to a predefined group was performed. MAIN RESULTS: The drugs used in the meta-analysis included triazolam in 16 studies; flurazepam in 14 studies; temazepam in 13 studies; midazolam in five studies; nitrazepam in four studies; and estazolam, lorazepam, and diazepam in two studies each. Alternative drug therapies included zopiclone in 13 studies and diphenhydramine, glutethimide, and promethazine in one study each. Only one article reported on a nonpharmacological treatment (behavioral therapy). The mean age of patients was reported in 33 of the 45 studies and ranged between 29 and 82. SLEEP LATENCY: In four studies involving 159 subjects, there was sleep-record latency (time to fall asleep) data for analysis. The pooled difference indicated that the latency to sleep for patients receiving a benzodiazepine was 4.2 minutes (95% CI = (,0.7) (,9.2)) shorter than for those receiving placebo. Patient's estimates of sleep latency examined in eight studies showed a difference of 14.3 minutes (95% CI = 10.6,18.0) in favor of benzodiazepines over placebo. TOTAL SLEEP DURATION: Analysis of two studies involving 35 patients in which total sleep duration using sleep-record results was compared indicated that patients in the benzodiazepine groups slept for an average of 61.8 minutes (95% CI = 37.4,86.2) longer than those in the placebo groups. Patient's estimates of sleep duration from eight studies (566 points) showed total sleep duration to be 48.4 minutes (95% CI = 39.6,57.1) longer for patients taking benzodiazepines than for those on placebo. ADVERSE EFFECTS: Analysis of eight studies (889 subjects) showed that those in the benzodiazepine groups were more likely than those in the placebo groups to complain of daytime drowsiness (odds ratio (OR) 2.4, 95% confidence interval (CI) = 1.8,3.4). Analysis of four studies (326 subjects) also showed that subjects in the benzodiazepine groups were more likely to complain of dizziness or lightheadedness than the placebo groups. (OR 2.6, 95% CI = 0.7,10.3). Despite the increased reported side effects in the benzodiazepine groups, drop-out rates were similar in the benzodiazepine and placebo groups. For patient reported outcome, there was no strong correlation found for sleep latency data, (r = 0.4, 95% CI = (,0.3) (,0.9)) or for sleep duration (r = 0.2, 95% CI = ,0.8,0.4) between benzodiazepine dose and outcome. COMPARISON WITH OTHER DRUGS AND TREATMENTS: In three trials with 96 subjects, meta-analysis of the results comparing benzodiazepines with zopiclone, did not show significant difference in sleep latency in the benzodiazepine and placebo groups, but the benzodiazepine groups had increased total sleep duration (23.1 min. 95% CI = 5.6,40.6). In four trials with 252 subjects, the side effect profile did not show a statistically significant difference (OR 1.5, CI 0.8,2.9). There was only one study comparing the effect of behavioral therapy with triazolam. The result showed that triazolam was more effective than behavioral therapy in decreasing sleep latency, but its efficacy declined by the second week of treatment. Behavioral therapy remained effective throughout the 9-week follow-up period. There were four small trials that involved older patients exclusively, with three of the studies having less than 2 weeks of follow-up. The results were mixed regarding benefits and adverse effects were poorly reported. CONCLUSION: The result of the meta-analysis shows that the use of benzodiazepines results in a decrease in sleep latency and a significant increase in total sleep time as compared with placebo. There was also a report of significantly increased side effects, but this did not result in increased discontinuation rate. There was no dose-response relationship for beneficial effect seen with the use of benzodiazepines, although the data are scant. Zopiclone was the only alternative pharmacological therapy that could be studied with any precision. There was no significant difference in the outcome when benzodiazepines were compared with zopiclone. There was only one study that compared the effect of benzodiazepines with nonpharmacological therapy; thus available data are insufficient to comment. [source] Regular or "Super-Aspirins"?JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 4 2001A Review of Thienopyridines or Aspirin to Prevent Stroke PURPOSE: To review the evidence for the effectiveness and safety of the thienopyridines (ticlopidine and clopidogrel) compared with aspirin for the prevention of vascular events among patients at high risk of vascular disease. BACKGROUND: Atherosclerosis and resultant cardiovascular disease are important causes of morbidity and mortality in older people. In particular, atherosclerosis of the cerebral arteries can lead to transient ischemic attacks (TIAs) and stroke. Stroke ranks as the third-leading cause of death in the United States and in 1997 was responsible for over 150,000 fatalities.1 In addition to the mortality associated with this disease, stroke is also a leading source of long-term disability in survivors. Nearly 4.5 million stroke survivors are alive today,1 highlighting the fact that primary, but also secondary, prevention are extremely important for minimizing the complications of this illness. DATA SOURCES: Specialized trial registers of the Cochrane Stroke Group and the Antithrombotic Trialist's Collaboration, MEDLINE, and Embase were searched. Additional unpublished information and data were sought from Sanofi, the pharmaceutical company that developed and manufactures ticlopidine and clopidogrel, as well as the principal investigators of the Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) trial,7 the largest of the trials identified. STUDY SELECTION CRITERIA: All unconfounded randomized trials comparing either ticlopidine or clopidogrel with aspirin among patients at high risk of vascular disease (those with symptoms of ischemia of the cerebral, coronary, or peripheral circulations) who were followed for at least 1 month for the recurrence of vascular events were included. DATA EXTRACTION: Data were extracted from four completed randomized trials completed in the past 20 years, which included 22,656 patients.7,10 Two authors independently extracted the data from these trials for the following information: the types of patients enrolled; the entry and exclusion criteria; the randomization method; the number of patients originally allocated to the treatment and control groups; the method and duration of follow-up; the number of patients in each group lost to follow-up; information on compliance with the treatment allocated; the definitions of outcome events; the number of outcome events in each treatment group; and any method used for blinding patients, treating clinicians, and outcome assessors to treatment allocation. MAIN RESULTS: Four completed trials involving a total of 22,656 patients were identified. Aspirin was compared with ticlopidine in three trials (3,471 patients)8,10 and with clopidogrel in one trial (19,185 patients).7 A recent TIA or ischemic stroke was the qualifying event in 9,840 patients, a recent myocardial infarction in 6,302 patients, and symptomatic peripheral arterial disease in 6,514 patients. The average age of the patients was approximately 63, with approximately two-thirds of the patients being male and white. The duration of follow-up ranged from 12 to 40 months. CONCLUSIONS: This systematic review demonstrates that, compared with aspirin, thienopyridines are only modestly more effective in preventing serious vascular events in high-risk patients. For patients who are intolerant of, or allergic to aspirin, the available safety and efficacy data suggest that clopidogrel is an appropriate, but more-expensive, alternative antiplatelet drug. It appears safer than ticlopidine and as safe as aspirin but it should not replace aspirin as the first-choice antiplatelet agent for all patients. Further studies are necessary to determine which, if any, particular types of patients would benefit most and least from clopidogrel instead of aspirin. [source] Sensitivity of superficial cultures in lower extremity wounds,JOURNAL OF HOSPITAL MEDICINE, Issue 7 2010Chayan Chakraborti MD Abstract BACKGROUND: Superficial wound cultures are routinely used to guide therapy, despite a lack of clear supporting evidence. PURPOSE: To conduct a systematic review of the correlation between superficial wound cultures and the etiology of skin and soft tissue infections. DATA SOURCES: Medline, EMBASE, CINAHL, Scopus. STUDY SELECTION: Articles published between January 1960 and August 2009 involving superficial wound cultures and deeper comparison cultures. DATA EXTRACTION: Two reviewers independently searched for abstracted information pertaining to the microbiology of lower extremity wounds sufficient to calculate the sensitivity and specificity of superficial wound cultures versus comparison cultures. DATA SYNTHESIS: Data pooled using a random-effects meta-analysis model. RESULTS: Of 9032 unique citations, 8 studies met all inclusion criteria. Inter-rater reliability was substantial (Kappa = 0.78). Pooled test sensitivity for superficial wound swabs was 49% (95% confidence interval [CI], 37-61%], and specificity was 62% (95% CI, 51-74%). The pooled positive and negative likelihood ratios (LRs) were 1.1 (95% CI, 0.71-1.5) and 0.67 (95% CI, 0.52-0.82). The median number of isolates for surface cultures (2.7, interquartile range [IQR] 1.8-3.2) was not significantly different than that for comparison cultures, (2.2, IQR 1.7-2.9) (P = 0.75). CONCLUSION: Few studies show a strong relationship between superficial wound swabs and deep tissue cultures, and the current data demonstrate poor overall sensitivity and specificity. The positive and negative LRs were found to provide minimal utility in influencing pretest probabilities. Results of this analysis show that wound cultures should not be used in lieu of local antibiograms to guide initial antibiotic therapies. Journal of Hospital Medicine 2010;5:415,420. © 2010 Society of Hospital Medicine. [source] Effect of hospitalist attending physicians on trainee educational experiences: A systematic review,JOURNAL OF HOSPITAL MEDICINE, Issue 8 2009Pradeep Natarajan MD Abstract BACKGROUND: Trainees receive much of their inpatient education from hospitalists. PURPOSE: To characterize the effects of hospitalists on trainee education. DATA SOURCES: MEDLINE, Database of Reviews of Effectiveness (DARE), National Health Service (NHS) Economic Evaluation Database (EED), Health Technology Assessment (HTA), and the Cochrane Collaboration Database (last searched October 2008) databases using the term "hospitalist", and meeting abstracts from the Society of Hospital Medicine (SHM) (2002-2007), Society of General Internal Medicine (SGIM) (2001-2007), and Pediatric Academic Societies (PAS) (2000-2007). STUDY SELECTION: Original English language research studies meeting all of the following: involvement of hospitalists; comparison to nonhospitalist attendings; evaluation of trainee knowledge, skills, or attitudes. 711 articles were reviewed, 32 retrieved, and 6 included; 7,062 meeting abstracts were reviewed, 9 retrieved, and 2 included. DATA EXTRACTION: Two authors reviewed articles to determine study eligibility. Three authors independently reviewed included articles to abstract data elements and classify study quality. DATA SYNTHESIS: Seven studies were quasirandomized one was a noncontemporaneous comparison. All citations only measured trainee attitudes. In all studies comparing hospitalists to nonhospitalists, trainees were more satisfied with hospitalists overall, and with other aspects of their teaching, but ratings were high for both groups. One of 2 studies that distinguished nonhospitalist general internists from specialists showed that trainees preferred hospitalists, but the other did not demonstrate a hospitalist advantage over general internists. CONCLUSIONS: Trainees are more satisfied with inpatient education from hospitalists. Whether the increased satisfaction translates to improved learning is unclear. Journal of Hospital Medicine 2009;4:490,498. © 2009 Society of Hospital Medicine. [source] Effects of rapid response systems on clinical outcomes: Systematic review and meta-analysisJOURNAL OF HOSPITAL MEDICINE, Issue 6 2007Sumant R. Ranji MD Abstract BACKGROUND A rapid response system (RRS) consists of providers who immediately assess and treat unstable hospitalized patients. Examples include medical emergency teams and rapid response teams. Early reports of major improvements in patient outcomes led to widespread utilization of RRSs, despite the negative results of a subsequent cluster-randomized trial. PURPOSE To evaluate the effects of RRSs on clinical outcomes through a systematic literature review. DATA SOURCES MEDLINE, BIOSIS, and CINAHL searches through August 2006, review of conference proceedings and article bibliographies. STUDY SELECTION Randomized and nonrandomized controlled trials, interrupted time series, and before-after studies reporting effects of an RRS on inpatient mortality, cardiopulmonary arrests, or unscheduled ICU admissions. DATA EXTRACTION Two authors independently determined study eligibility, abstracted data, and classified study quality. DATA SYNTHESIS Thirteen studies met inclusion criteria: 1 cluster-randomized controlled trial (RCT), 1 interrupted time series, and 11 before-after studies. The RCT showed no effects on any clinical outcome. Before-after studies showed reductions in inpatient mortality (RR = 0.82, 95% CI: 0.74-0.91) and cardiac arrest (RR = 0.73, 95% CI: 0.65-0.83). However, these studies were of poor methodological quality, and control hospitals in the RCT reported reductions in mortality and cardiac arrest rates comparable to those in the before-after studies. CONCLUSIONS Published studies of RRSs have not found consistent improvement in clinical outcomes and have been of poor methodological quality. The positive results of before-after trials likely reflects secular trends and biased outcome ascertainment, as the improved outcomes they reported were of similar magnitude to those of the control group in the RCT. The effectiveness of the RRS concept remains unproven. Journal of Hospital Medicine 2007;2:422,432. © 2007 Society of Hospital Medicine. [source] Access to Health Care Services for the Disabled ElderlyHEALTH SERVICES RESEARCH, Issue 3p1 2006Donald H. Taylor Jr. Objective. To determine whether difficulty walking and the strategies persons use to compensate for this deficit influenced downstream Medicare expenditures. Data Source. Secondary data analysis of Medicare claims data (1999,2000) for age-eligible Medicare beneficiaries (N=4,997) responding to the community portion of the 1999 National Long Term Care Survey (NLTCS). Study Design. Longitudinal cohort study. Walking difficulty and compensatory strategy were measured at the 1999 NLTCS, and used to predict health care use as measured in Medicare claims data from the survey date through year-end 2000. Data Extraction. Respondents to the 1999 community NLTCS with complete information on key explanatory variables (walking difficulty and compensatory strategy) were linked with Medicare claims to define outcome variables (health care use and cost). Principal Findings. Persons who reported it was very difficult to walk had more downstream home health visits (1.1/month, p<.001), but fewer outpatient physician visits (,0.16/month, p<.001) after controlling for overall disease burden. Those using a compensatory strategy for walking also had increased home health visits/month (0.55 for equipment, 1.0 for personal assistance, p<.001 for both) but did not have significantly reduced outpatient visits. Persons reporting difficulty walking had increased downstream Medicare costs ranging from $163 to $222/month (p<.001) depending upon how difficult walking was. Less than half of the persons who used equipment to adapt to walking difficulty had their difficulty fully compensated by the use of equipment. Persons using equipment that fully compensated their difficulty used around $300/month less in Medicare-financed costs compared with those with residual difficulty. Conclusions. Difficulty walking and use of compensatory strategies are correlated with the use of Medicare-financed services. The potential impact on the Medicare program is large, given how common such limitations are among the elderly. [source] Predicting Patterns of Mammography Use: A Geographic Perspective on National Needs for Intervention ResearchHEALTH SERVICES RESEARCH, Issue 4 2002Julie Legler Objective. To introduce a methodology for planning preventive health service research that takes into account geographic context. Data Sources. National Health Interview Survey (NHIS) self-reports of mammography within the past two years, 1987, and 1993,94. Area Resource File (ARF), 1990. Database of mammography intervention research studies conducted from 1984 to 1994. Design. Bayesian hierarchical modeling describes mammography as a function of county-level socioeconomic data and explicitly estimates the geographic variation unexplained by the county-level data. This model produces county use estimates (both NHIS-sampled and unsampled), which are aggregated for entire states. The locations of intervention research studies are examined in light of the statewide mammography utilization estimates. Data Extraction. Individual level NHIS data were merged with county-level data from the ARF. Principal Findings. State maps reveal the estimated distribution of mammography utilization and intervention research. Eighteen states with low mammography use reported no intervention research activity. County-level occupation and education were important predictors for younger women in 1993,94. In 1987, they were not predictive for any demographic group. Conclusions. Opportunities exist to improve the planning of future intervention research by considering geographic context. Modeling results suggest that the choice of predictors be tailored to both the population and the time period under study when planning interventions. [source] The Relationship of Post-acute Home Care Use to Medicaid Utilization and ExpendituresHEALTH SERVICES RESEARCH, Issue 3 2002Susan M. C. Payne Research Objectives: To describe the use of post-acute home care (PAHC) and total Medicaid expenditures among hospitalized nonelderly adult Medicaid eligibles and to test whether health services utilization rates or total Medicaid expenditures were lower among Medicaid eligibles who used PAHC compared to those who did not. Study Population: 5,299 Medicaid patients aged 18,64 discharged in 1992,1996 from 29 hospitals in the Cleveland Health Quality Choice (CHQC) project. Data Sources: Linked Ohio Medicaid claims and CHQC medical record abstract data. Data Extraction: One stay per patient was randomly selected. Design: Observational study. To control for treatment selection bias, we developed a model predicting the probability (propensity) a patient would be referred to PAHC, as a proxy for the patient's need for PAHC. We matched 430 patients who used Medicaid-covered PAHC ("USE") to patients who did not ("NO USE") by their propensity scores. Study outcomes were inpatient re-admission rates and days of stay (DOS), nursing home admission rates and DOS, and mean total Medicaid expenditures 90 and 180 days after discharge. Principal Findings: Of 3,788 medical patients, 12.1 percent were referred to PAHC; 64 percent of those referred used PAHC. Of 1,511 surgical patients, 10.9 percent were referred; 99 percent of those referred used PAHC. In 430 pairs of patients matched by propensity score, mean total Medicaid expenditures within 90 days after discharge were $7,649 in the USE group and $5,761 in the NO USE group. Total Medicaid expenditures were significantly higher in the USE group compared to the NO USE group for medical patients after 180 days (p<.05) and surgical patients after 90 and 180 days (p<.001). There were no significant differences for any other outcome. Sensitivity analysis indicates the results may be influenced by unmeasured variables, most likely functional status and/or care-giver support. Conclusions: Thirty-six percent of the medical patients referred to PAHC did not receive Medicaid-covered services. This suggests potential underuse among medical patients. The high post-discharge expenditures suggest opportunities for reducing costs through coordinating utilization or diverting it to lower-cost settings. Controlling for patients' need for services, PAHC utilization was not associated with lower utilization rates or lower total Medicaid expenditures. Medicaid programs are advised to proceed cautiously before expanding PAHC utilization and to monitor its use carefully. Further study, incorporating non-economic outcomes and additional factors influencing PAHC use, is warranted. [source] What is the Slowest-Yet-Normal Cervical Dilation Rate Among Nulliparous Women With Spontaneous Labor Onset?JOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 4 2010Jeremy L. Neal ABSTRACT Objective: To integrate research literature that has provided insights into the cervical dilation rate that may best describe the slowest-yet-normal dilation rate among nulliparous women when beginning with criteria commonly associated with active labor onset. Data Sources: A literature search from 1950 through 2008 was conducted using the Medline electronic database, reference lists from identified articles, and other key references. Study Selection: Research reports written in English with a focus on the cervical dilation and/or labor duration of low-risk, nulliparous women with spontaneous labor onset. Data Extraction: Classic and contemporary research literature was reviewed and organized under the following subheadings: Friedman Studies, Partograph Studies, Active Management of Labor Studies, Additional Studies. Data Synthesis: An integrative review of the literature approximated the slowest-yet-normal cervical dilation rate for nulliparous women when beginning with criteria commonly associated with active labor. Conclusions: The slowest-yet-normal linear dilation rate approximates 0.5 cm/hour for low-risk, nulliparous women with spontaneous labor onset when starting at dilatations traditionally associated with active labor onset. However, this linear rate must be evaluated judiciously in light of the physiological acceleration of dilation that occurs during typical labor. Given this, cervical dilation for this population is likely slower than 0.5 cm/hour in earlier active labor and faster in more advanced active labor. Faster dilation expectations (e.g., 1 cm/hour) likely contribute to an overdiagnosis of dystocia ("slow, abnormal progression of labor") in contemporary practice and, subsequently, to an overuse of interventions aimed at accelerating labor progress. [source] A Systematic Review of the Effectiveness of Breastfeeding Intervention Delivery MethodsJOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 6 2009Barbara Pate ABSTRACT Objective: To analyze breastfeeding intervention delivery methods to determine the likelihood of successful breastfeeding outcomes of e-based interventions compared to provider-based interventions. Data Sources: Eligible studies were identified by searching MEDLINE, CINAHL, Academic Search Elite, Health Source: Nursing/Academic Edition, SOC INDEX, and PsycINFO. Study Selection: Studies were included if they were conducted in a developed country, published between the years 2004 and 2008, included a concurrent control group, and reported frequency data on breastfeeding initiation or duration. The suitability of design and quality of execution were evaluated using the Centers for Disease Control procedure for systematic reviews. Twenty-one articles met the criteria for inclusion. Data Extraction: Study design, demographics, intervention/control conditions, settings, sampling strategies, potential threats to validity, and breastfeeding outcomes were abstracted and entered into a database for analysis and synthesis. Data Synthesis: Odds ratios were calculated for each individual study, and studies were stratified into 2 groups by intervention delivery type. The pooled results indicated that studies using e-based interventions had a moderate effect on breastfeeding (odds ratio=2.2 [1.9-2.7], d=0.5); whereas provider-based interventions had very little to no effect (odds ratio=1.1 [1.0-1.2], d=0.03). Conclusions: Results indicate that breastfeeding promotion programs delivered via the Internet may be an appealing alternative to time-consuming and expensive provider-based breastfeeding education and support. [source] A Review of the Health Beliefs and Lifestyle Behaviors of Women with Previous Gestational DiabetesJOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 5 2009Emily J. Jones ABSTRACT Objective: To critically review and synthesize original research designed to examine the health beliefs, including risk perceptions and health behaviors related to diet and physical activity of women with previous gestational diabetes mellitus. Data Sources: PubMed and CINAHL databases were searched for studies published in the last decade (1998-2008) that examined variables related to the health beliefs and behaviors of women with previous gestational diabetes mellitus. Keyword searches included health beliefs, health behaviors, perceived risk, gestational diabetes, type 2 diabetes, diet, physical activity, and postpartum. Study Selection: Eight articles, representing 6 studies, were selected that met the inclusion criteria of original research, dependent variable of health beliefs and behaviors of women with previous gestational diabetes mellitus, and measurement after pregnancy. Data Extraction: Articles were reviewed and discussed according to the concepts of risk perception and health beliefs, health behaviors related to diet and physical activity, and psychosocial factors related to women's health beliefs and behaviors. Data Synthesis: Data revealed common health beliefs and behaviors of women with previous gestational diabetes mellitus, including low risk perceptions for future type 2 diabetes mellitus and suboptimal levels of physical activity and fruit and vegetable intake. The majority of studies revealed a distinct knowledge-behavior gap among women with previous gestational diabetes mellitus, whereas others revealed a lack of knowledge regarding necessary lifestyle modifications. Conclusions: Findings from this review may assist women's health researchers and clinicians in developing appropriate interventions for increasing risk awareness, promoting self-efficacy for weight loss and physical activity behaviors, and decreasing rates of diabetes and cardiovascular disease among women with previous gestational diabetes mellitus. Further research is necessary to identify factors that influence the health beliefs and behaviors of women with previous gestational diabetes mellitus. Future research should focus on populations of greater racial, ethnic, and socioeconomic diversity, as the majority of studies have been conducted with non-Hispanic White, socioeconomically advantaged women. [source] Are Maternal Cortisol Levels Related to Preterm Birth?JOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 4 2009Carmen Giurgescu ABSTRACT Objective: To examine the evidence related to the relationship between maternal cortisol levels and preterm birth. Data Sources: A search of Medline, PubMed, and Cumulative Index of Nursing and Allied Health Literature was conducted using the keywords preterm birth, preterm delivery, premature birth, and cortisol. Study Selection: Fifteen studies published in English were selected based on the inclusion criteria. There were no limitations on the dates of publication. Data Extraction: The data extracted were related to the gestational age at collection of biological samples, time of day at collection, and differences in cortisol levels between preterm and full-term groups. Data Synthesis: The majority of the studies suggested that maternal cortisol levels are related to preterm birth. Women with higher levels of cortisol had higher risk of having a preterm birth. Conclusions: Researchers can use the findings of this review to develop future studies that examine the relationship between cortisol levels and preterm birth. Health care providers need to assess pregnant women's stress levels more closely and provide appropriate referrals and treatment to ensure that any actions that may possibly lower stress are being taken to reduce the likelihood of preterm birth. [source] A Selective Review of Maternal Sleep Characteristics in the Postpartum PeriodJOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 1 2009Lauren P. Hunter ABSTRACT Objective: To determine the current knowledge of postpartum womens' sleep patterns, sleep disturbances, consequences of sleep disturbances, and known strategies for prevention in order to provide best practice recommendations for health care providers. Data Sources: A literature search from 1969 through February 2008 was conducted using the CINHL, Index of Allied Health Literature, Ovid, PsycINFO, and PubMed electronic databases in addition to reference lists from selected articles and other key references. Search terms included sleep, postpartum, sleep deprivation, and sleep disturbance. Study Selection: A critical review of all relevant articles from the data sources was conducted with attention to the needs of postpartum womens' sleep and implications for health care providers. Data Extraction: Literature was reviewed and organized into groups with similar characteristics. Data Synthesis: An integrative review of the literature summarized the current state of research related to sleep alterations in postpartum women. Conclusions: Postpartum women experience altered sleep patterns that may lead to sleep disturbances. The most common reasons for sleep disturbances are related to newborn sleep and feeding patterns. Although present, the relationships among sleep disturbance, fatigue, and depression in postpartum women lack clarity due to their ambiguous definitions and the variety of the studies conducted. Providers should encourage prenatal education that assists the couple in developing strategies for decreasing postpartum sleep deprivation. Alterations of in-hospital care and home care should be incorporated to improve the new family's sleep patterns. [source] Interventions for Weight Management in Postpartum WomenJOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 1 2008Colleen Keller ABSTRACT Objective:, To report the results of a comprehensive review of published intervention studies to identify the best evidence available for guiding weight management interventions in postpartum women. Data Sources:, Electronic searches were conducted of three electronic databases: Cumulative Index to Nursing and Allied Health Literature; Medline; and the Science Citation Index, Expanded, in the Web of Science from 1994 to May 2007. Keyword searches were conducted using the terms obesity, obese, overweight, postpartum, pregnancy weight, and weight management in postpartum women. Study Selection:, Six studies were selected that met the inclusion criteria of testing interventions and one that reported preintervention planning and targeted a weight management intervention for postpartum women. Data Extraction:, All six interventions showed significant impact with diet and exercise or some combination on body composition in the targeted sample of women. Data Synthesis:, The strengths of previous studies include an emphasis on precision in outcome measures and experimental conditions; limitations were that the theoretical basis for the interventions was frequently omitted and limited attention given to the cultural, social, and contextual factors established in descriptive research. Conclusions:, Interventions need to target women early in their childbearing years to have the most significant long-term impact. [source] Modifying Women's Risk for Cardiovascular DiseaseJOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 2 2007Kathleen M. McCauley Objective:, To present current recommendations for cardiovascular disease risk reduction in women. Data Sources:, Medline databases were searched from 1990 to 2006 using keywords women and cardiovascular risk, hypertension, cholesterol, and hormone replacement therapy, as well as Web sites from scientific associations such as the American Heart Association, American College of Cardiology, Agency for Health Research and Quality, and the Centers for Disease Control for relevant scientific statements and guidelines. Study Selection:, Randomized controlled trials, particularly those that have influenced current practice recommendations, scientific statements, and clinical practice guidelines were selected. Data Extraction and Synthesis:, Factors contributing to women's particular risk and current practice recommendations. Conclusions:, Current research has clarified the importance of regular exercise (at least 30 minutes/day most days of the week); abstinence from smoking; a diet focused on whole grains, fruits, vegetables, and low-fat protein sources; and maintenance of normal weight. This lifestyle combined with a partnership with a health care provider to maintain a normal blood pressure (115/75 mm Hg) and optimal lipoproteins through pharmacotherapy when indicated can prevent 82% of cardiovascular disease events in women. JOGNN, 36, 116-124; 2007. DOI: 10.1111/J.1552-6909.2007.00125.x [source] A Review of Nursing Interventions to Foster Becoming a MotherJOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 5 2006Ramona T. Mercer Objective:, To determine the current state of knowledge of nursing interventions that foster the process of becoming a mother. Data Sources:, A literature search was conducted using CINAHL and PubMed electronic databases and other key references. Study Selection:, Reports on nursing intervention research published in English that focused on a facet of maternal behavior in the process of becoming a mother during pregnancy or during the first 4 months following birth, or both, were included. Twenty eight reports were found. Data Extraction:, Studies were reviewed, categorized, and analyzed and interventions synthesized to determine the current knowledge base for fostering becoming a mother. Categories included instructions for infant caregiving, building awareness of and responsiveness to infant interactive capabilities, promoting maternal-infant attachment, maternal/social role preparation, and interactive therapeutic nurse-client relationships. Data Synthesis:, Interactive therapeutic nurse-client relationships and maternal/social role preparation had greater impact on variables indicating progress in becoming a mother than formal teaching. Instructions without nurse input were ineffective. Conclusions:, Interactive reciprocal nursing interventions are the most effective in enhancing mother-infant interactions and maternal knowledge about infant care. Evidence is limited on how to foster the mother's feelings about herself in becoming a mother and attachment to her infant. JOGNN, 35, 568-582; 2006. DOI: 10.1111/J.1552-6909.2006.00080.x [source] Retention of Pregnancy-Related Weight in the Early Postpartum Period: Implications for Women's Health ServicesJOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 4 2005Lorraine O. Walker Objective: To examine the proportion of women who reached their prepregnant weight at 6 weeks postpartum and the average amount of weight retained or lost by this time; to determine predictors of early (6 week) postpartum weight retention; and to propose related implications for women's health care and services. Data Sources: The literature review was based on a search of Medline for the years 1986 to 2004 using the keywords postpartum weight with inclusion of additional articles known to the authors that did not appear in the electronic search. Study Selection: The resulting 83 articles were scrutinized to identify those that reported data on weight retention at 6 weeks postpartum (range, delivery to 3 months) and associated anthropometric, social, obstetric, or behavioral predictors. A total of 12 articles met inclusion criteria for the review. Data Extraction: Data were extracted related to the proportion of women achieving their postpartum weight at 6 weeks postpartum, the amount of weight retained or lost up to 6 weeks postpartum, and predictors of amount of weight retained or lost. Data Synthesis: On average, at 6 weeks postpartum, women retain 3 to 7 kg of the weight gained during pregnancy, with at least two thirds exceeding their prepregnant weights. Gestational weight gain is the most significant predictor of weight retention. Conclusions: Women vulnerable to obesity and weight gain need weight-related health care and improved access to such care to promote weight loss after 6 weeks postpartum. [source] Postpartum Depression Beyond the Early Postpartum PeriodJOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 4 2004IBCLC, Janice H. Goodman MSN Objective: To review the literature concerning maternal postpartum depression beyond the early postpartum period. Data Sources: A literature search was conducted using Cinahl, Medline, and PsychInfo electronic databases. Keywords included postpartum depression, postpartum depressive symptoms, course, prevalence, incidence, and remission. Study Selection: Studies selected included incidence of maternal depression or depressive symptoms, existing in the early postpartum period, and measured again at postpartum points from 6 months through 2 1/2 years after delivery. Only studies published in English were included. Twenty-three articles were located, and a recent relevant study conducted by the current author also was included. Data Extraction: Studies were reviewed and data organized according to year, sample characteristics, time of depression assessment, instrument used, cutoff score, rate of depression, and factors associated with depression at later postpartum time points. Data Synthesis: For a significant percentage of women, postpartum depressive symptoms continue for months or even years after giving birth. Factors associated with postpartum depression at later time points are identified. Conclusions: Continued evaluation of women with elevated depression levels at initial screening, and treatment for women whose depression does not remit spontaneously within the first few weeks or months postpartum is recommended. Further research is needed to understand the phenomenon of persistent postpartum depression. [source] Women's Decision Making About the Use of Hormonal and Nonhormonal Remedies for the Menopausal TransitionJOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 6 2003Rosemary Theroux Objective: To critically review qualitative research on women's decision making about the use of hormonal and nonhormonal remedies for the menopausal transition. Data Sources: Computerized searches in CINAHL, MEDLINE, Medscape, and PsychINFO databases, using the keywords decision making, hormone therapy, herbal remedies, attitude toward hormone therapy, and qualitative research; and ancestral bibliographies. Study Selection: Articles from indexed journals from 1982 to 2001 in the English language relevant to the keywords were evaluated. Sixteen studies met inclusion criteria and were included in the analysis. Data Extraction: Study findings were organized into several categories and compared and contrasted across publications and categories. Data Synthesis: Half of the researchers described decision making as a weighing of benefits and risks. Women's considerations, beliefs, and values, as well as interaction with the environment, were primary influences on the process. Conclusions: Major gaps in care for midlife women were identified. Women need information about the process of menopause and the range of available options for menopause management. Nurses can play a major role in providing information, counseling, and developing decision aids. Women's values and beliefs, cultures, life contexts, and desire for involvement in the decision should guide interventions. [source] symptom Experience in Women After HysterectomyJOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 5 2001Kimberly H. Kim RN Objective: To review the literature addressing the symptom experience of women after hysterectomy. Data Sources: Computerized searches in MEDLINE and CINAHL, as well as texts and references cited in articles. Key concepts in the searches included hysterectomy, sleep disturbance and pain, hysterectomy and fatigue, hysterectomy, depression, and depressed mood. Study Selection: Articles and comprehensive works relevant to key concepts and published after 1970, with an emphasis on new findings from 1990 to 2000. Sixty-four citations were identified as useful to this review. Data Extraction: Data were organized under the following headings: women and hysterectomy, biopsychosocial perspectives, common symptoms after hysterectomy (pain, disturbed sleep, fatigue, depressed mood, anxiety), and significance of review (implications). Data Synthesis: Literature suggests that after a hysterectomy, women experience complications during the postoperative recovery period that may vary with the type of surgical procedure. During this period, the quantity and quality of sleep as well as other symptoms (pain, fatigue, anxiety, and depression) are influenced by various physiologic, psychologic, and social factors. Despite limited evidence that sleep problems may occur frequently during the recovery period, only a few researchers have systematically examined sleep patterns in women after hysterectomy. None of these studies, however, used objective sleep measures or examined multiple dimensions of these women's lives. Conclusions: This review conceptualized the women's symptom experience as the experience of specific symptoms (pain, sleep disturbance, fatigue, depressed mood, and anxiety) that were influenced by biopsychosocial factors. [source] Improving Adherence to Abnormal Pap Smear Follow-UpJOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 1 2001Priscilla DeRemer Abercrombie RN Objective: To gain a better understanding of factors that affect follow-up and the strategies that have been found to improve follow-up after an abnormal Papanicolaou (Pap) smear test. Data Sources: A computer-based search of the literature was conducted using MEDLINE with the keywords adherence, nonadherence, compliance, Follow-up, and abnormal Pap smears. Study Selection: Research studies published between 1985 and 1999 in the English language were included. If relevant studies were cited in the articles reviewed, these studies also were reviewed. A total of 25 studies were reviewed. Data Extraction: A critical review of these studies was conducted, with special attention to implications for clinical practice as well as future research. The studies fell into two groups: factors associated with nonadherence and strategies developed to improve adherence. Data Synthesis: A number of factors were identified that affect adherence to follow-up among women with abnormal Pap smears. Some of these factors involve characteristics of the woman, such as demographics, social support, lack of understanding, and fear. Factors that pertain to the health care system, such as inconvenient clinic hours, male providers, and insensitive staff, also were identified. A number of strategies have been successful in improving follow-up, including telephone counseling, educational programs, and economic incentives. Conclusions: Nurses play a crucial role in Facilitating adherence to recommendations for follow-up. They can identify women at risk for poor follow-up, increase awareness of the factors that affect follow-up, and implement strategies shown to be successful in improving adherence. Future research should take into account the rnultifactoral nature of adherence as well as the patient's perspective. In addition, studies should be designed with special attention to generalizability and should include women from populations most at risk for cervical cancer. [source] Omega-3 Dietary Supplements and the Risk of Cardiovascular Events: A Systematic ReviewCLINICAL CARDIOLOGY, Issue 7 2009FCCM, Paul E. Marik MD Background Epidemiologic data suggest that omega-3 fatty acids derived from fish oil reduce cardiovascular disease. The clinical benefit of dietary fish oil supplementation in preventing cardiovascular events in both high and low risk patients is unclear. Objective To assess whether dietary supplements of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) decrease cardiovascular events across a spectrum of patients. Data Sources MEDLINE, Embase, the Cochrane Database of Systematic Reviews, and citation review of relevant primary and review articles. Study Selection Prospective, randomized, placebo-controlled clinical trials that evaluated clinical cardiovascular end points (cardiovascular death, sudden death, and nonfatal cardiovascular events) and all-cause mortality in patients randomized to EPA/DHA or placebo. We only included studies that used dietary supplements of EPA/DHA which were administered for at least 1 year. Data Extraction Data were abstracted on study design, study size, type and dose of omega-3 supplement, cardiovascular events, all-cause mortality, and duration of follow-up. Studies were grouped according to the risk of cardiovascular events (high risk and moderate risk). Meta-analytic techniques were used to analyze the data. Data Synthesis We identified 11 studies that included a total of 39 044 patients. The studies included patients after recent myocardial infarction, those with an implanted cardioverter defibrillator, and patients with heart failure, peripheral vascular disease, and hypercholesterolemia. The average dose of EPA/DHA was 1.8 ± 1.2 g/day and the mean duration of follow-up was 2.2 ± 1.2 years. Dietary supplementation with omega-3 fatty acids significantly reduced the risk of cardiovascular deaths (odds ratio [OR]: 0.87, 95% confidence interval [CI]: 0.79,0.95, p = 0.002), sudden cardiac death (OR: 0.87, 95% CI: 0.76,0.99, p = 0.04), all-cause mortality (OR: 0.92, 95% CI: 0.85,0.99, p = 0.02), and nonfatal cardiovascular events (OR: 0.92, 95% CI: 0.85,0.99, p = 0.02). The mortality benefit was largely due to the studies which enrolled high risk patients, while the reduction in nonfatal cardiovascular events was noted in the moderate risk patients (secondary prevention only). Meta-regression failed to demonstrate a relationship between the daily dose of omega-3 fatty acid and clinical outcome. Conclusions Dietary supplementation with omega-3 fatty acids should be considered in the secondary prevention of cardiovascular events. Copyright © 2009 Wiley Periodicals, Inc. [source] The feasibility of smoking reduction: an updateADDICTION, Issue 8 2005John R. Hughes ABSTRACT Aim To update conclusions of a previous review of smoking reduction on the extent to which (1) smokers spontaneously reduce their smoking, (2) smokers who try to quit and fail return to smoking less, (3) smokers can substantially reduce and maintain reductions via pharmacological and behavioral treatments and (4) smokers compensate when they reduce. Method Qualitative systematic review. Data sources Systematic computer searches and other methods. Study selection Published and unpublished studies of smokers not trying to stop smoking. We located 13,26 studies for each of the four aims. Data extraction The first author entered data with confirmation by second author. Data synthesis Due to the heterogeneity of methods and necessity of extensive recalculation, a meta-analysis was not feasible. Results Few daily smokers spontaneously reduce. Among those who try to stop smoking and relapse, some return to reduced smoking but whether they maintain this reduction is unclear. Nicotine replacement (and perhaps behavior therapies) can induce smokers not interested in quitting to make significant reductions in their smoking and maintain these over time. Some compensatory smoking occurs with reduction but significant declines in smoke exposure still occur. Conclusions These results indicate that reduction is feasible when aided by treatment. Whether reduction should be promoted will depend on the effect of reduction on health outcomes and future cessation. [source] Patient characteristics as predictors of primary health care preferences: a systematic literature analysisHEALTH EXPECTATIONS, Issue 2 2003Hans Peter Jung MD PhD GP Abstract Objective To identify associations between various cultural and demographic factors and patients' primary health care preferences. Search strategy Searches were performed in MEDLINE (1966,December 2000), PsycINFO (1977,May 2001) and Sociological Abstracts (1963,December 2000). Identified papers were checked for more papers. Inclusion criteria Studies with a focus on primary health care or health care in general, asking patients about preferences with regard to health care, reporting quantitative results and examining the relations between specific patient characteristics and patient preferences. Data extraction and synthesis Data were extracted from studies using a scoring form to register what methods were used, which patient characteristics were analysed and which patient characteristics significantly influenced patients' preferences with regard to different aspects of health care (P < 0.05). Main results A total of 145 studies were included with 2276 comparisons between subgroups of patients. Of all the comparisons, 607 (27%) showed a significant association between patient characteristics and preferences with regard to primary health care. Age and economic status significantly related to patient preferences in 38 and 33% of the comparisons, respectively. Education, health status, family situation, sex, and utilization of health care related significantly to patient preferences in less than 25% of the comparisons. Conclusions This review of the literature showed patient characteristics to be an important determinant of preferences regarding many aspects of primary health care defined as general practice care or health care, in general. All of the patient characteristics examined here showed at least some significant associations with preferences for primary health care. [source] Paliperidone palmitate , review of the efficacy, safety and cost of a new second-generation depot antipsychotic medicationINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 2 2010L. Citrome Summary Objective:, To describe the efficacy, safety and cost of paliperidone palmitate, a depot antipsychotic medication recently approved for the treatment of schizophrenia. Data sources:, A literature search was conducted by querying the websites http://www.pubmed.gov, http://www.fda.gov, http://www.accessdata.fda.gov/scripts/cder/drugsatfda and http://www.clinicaltrials.gov for the search term ,paliperidone palmitate'. Cost information was obtained from the pharmaceutical vendor servicing a local state-operated psychiatric facility. Study selection:, All available reports of studies were identified. Product labelling provided additional information. Data extraction:, Descriptions of the principal results and calculation of the number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the study reports and synopses. Additional safety outcomes subject to NNH analysis were obtained from product labelling. Data synthesis:, Paliperidone palmitate is a newly available depot formulation of paliperidone (the 9-OH metabolite of risperidone). Upon injection into the deltoid or gluteal muscle, the release of the drug starts as early as day 1, reaches maximum plasma concentrations at 13 days and lasts for as long as 126 days. Maximum concentration following deltoid injection is approximately 28% higher compared with injection into the gluteal muscle, and thus paliperidone palmitate requires initiation by two initial deltoid injections spread 1 week apart to achieve therapeutic concentrations rapidly. Subsequent injections are at 4-week intervals. Acute efficacy was evidenced by four short-term double-blind, randomised, placebo-controlled, fixed-dose studies of acutely relapsed adult inpatients who met DSM-IV criteria for schizophrenia. NNT for a 30% or greater decrease in the Positive and Negative Syndrome Scale total score compared with placebo was consistently lower for the higher dose strengths of 156 and 234 mg, suggesting a therapeutic dose,response. Treatment with paliperidone palmitate at doses between 39 and 156 mg significantly delayed the time to recurrence of symptoms of schizophrenia after 24 weeks of maintained symptom stability. The NNT vs. placebo to avoid a recurrence of symptoms was 5 (95% CI 4,7). Overall, paliperidone palmitate was reasonably well tolerated, with low rates of extrapyramidal symptoms or body weight gain; however, these may be more common at higher doses. Injection site reactions occurred at a rate ranging from 4% to 10%, depending on the dose regimen, compared with 2% for the pooled placebo arms. The acquisition cost of a maintenance dose of paliperidone palmitate calculated on a per day basis is similar to that for risperidone microspheres, but about double the cost for oral paliperidone and approximately 19 times the cost of oral generic risperidone. Conclusions:, Paliperidone palmitate is efficacious for the acute and maintenance treatment of schizophrenia and is reasonably well tolerated. It offers several advantages over other available second-generation depot antipsychotics: it comes in prefilled syringes in a number of different dosage strengths; it does not require refrigeration; it does not require supplementation with oral antipsychotics; it can be administered once monthly; it can be administered with a very small bore needle; the injection volume is small; the injection site can be either the deltoid or gluteal muscles; it does not require an additional precautionary observation period after the injection. For patients for whom oral risperidone or paliperidone is otherwise effective, paliperidone palmitate offers a guaranteed delivery system that enhances adherence. However, the high acquisition cost of paliperidone palmitate will likely be an important obstacle to its routine use. [source] Iloperidone for schizophrenia: a review of the efficacy and safety profile for this newly commercialised second-generation antipsychoticINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 8 2009L. Citrome Summary Objective:, The aim of the study was to describe the efficacy and safety of iloperidone for the treatment of schizophrenia. Data sources:, The pivotal registration trials were accessed by querying http://www.pubmed.gov, http://www.fda.gov and http://www.clinicaltrials.gov for the search term ,iloperidone'. Study selection:, Four published primary reports of phase III studies were identified as well as preclinical animal and receptor affinity studies that describe potential mechanisms of action and pharmacogenomic studies that identify potential genetic biomarkers for efficacy and tolerability. Product labelling provided additional data. Data extraction:, Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the study reports. Additional safety outcomes subject to NNH analysis were obtained from product labelling. Data synthesis:, Iloperidone is a second-generation antipsychotic agent indicated for the acute treatment of schizophrenia in adults. Iloperidone has been evaluated in several double-blind placebo-controlled clinical trials. The oral formulation has demonstrated efficacy in reducing the symptoms of acute schizophrenia at fixed daily doses ranging from 12 to 24 mg. Data reported for categorical definitions of response using the Positive and Negative Syndrome Scale were limited to one study and specifically to rates of achieving a , 20% decrease in the positive subscale from baseline; significantly more patients receiving iloperidone 24 mg/day (72%) than placebo (52%) met this criterion, yielding a NNT of five. Iloperidone should be titrated slowly to avoid orthostatic hypotension, potentially delaying the achievement of a therapeutic dose level. There appears to be a dose relationship for adverse events such as dizziness, somnolence and dry mouth; for example NNH vs. placebo for somnolence was 25 for iloperidone 10,16 mg/day and 10 for 20,24 mg/day. There is a possibility of a therapeutic dose response as well. Iloperidone is essentially free of extra-pyramidal side effects. Iloperidone is associated with weight gain comparable with risperidone. Long-term double-blind maintenance studies have demonstrated iloperidone's non-inferiority to haloperidol for relapse prevention. Product labelling includes a warning about the potential for QT interval prolongation. At present there are no efficacy studies available that are powered to directly compare iloperidone with other second-generation antipsychotics. The development of a depot formulation of iloperidone as well as efforts to identify genetic biomarkers for prediction of both efficacy and tolerability are in progress. Conclusions:, Aside from paliperidone, iloperidone is the first new second-generation antipsychotic to be commercialised in the USA since 2002. From the limited registration data, iloperidone appears to be relatively well tolerated once titrated to a therapeutic level and can be a useful option to consider. The development of a depot formulation and potential for genetic biomarkers may make this agent compelling. Further comparisons with other available agents among patients with schizophrenia in the ,real world' are needed. [source] Effects of music listening on adult patients' pre-procedural state anxiety in hospitalINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 1 2008Elizabeth Gillen MSc Executive summary Background Anticipation of an invasive procedure in hospital is likely to provoke feelings of anxiety and stress in patients. An unfamiliar environment, loss of control, perceived or actual physical risk, dependence on strangers and separation from friends and family are all factors that can contribute to the development of such feelings. Recently, there has been considerable interest in the anxiolytic potential of music listening in a variety of clinical settings, yet thus far, little is known about the impact of music listening on the pre-procedural patient population. A systematic review of all literature to date was indicated to improve understanding of outcomes and impact of music listening on pre-procedural anxiety, thus helping nurses decide whether or not to incorporate music listening into practice and to highlight a need, or otherwise, for a related primary research agenda. Objective The objective of this review was to determine the best available evidence on the effectiveness of music listening in reducing adult hospital patients' pre-procedural state anxiety. Inclusion criteria Types of studies This review included randomised controlled trials and quasi-experimental research designs that examined the efficacy of music listening in reducing state anxiety among pre-procedural hospital patients published between January 1985 and February 2006. The search was limited to publications after 1985 to coincide with the increasing interest and use of complementary therapies within health care during the 1980s and 1990s. Types of participants Participants of interest to the review were adult day patients, ambulatory patients and inpatients who were about to undergo any type of clinical procedure. Types of intervention The review focused on studies that investigated pre-procedural music listening employed and prescribed as a potentially therapeutic activity. It excluded any other form of music therapy. Types of outcome measures The primary outcome measures examined were alterations in state anxiety and a variety of physiological variables such as blood pressure and respiration and heart rates. Search strategy A search for published and unpublished literature between January 1985 and February 2006 was conducted using all major electronic databases. A three-step search strategy was devised which consisted of using high-precision MeSH terminology and keywords to ensure that all material relevant to the review was captured. Critical appraisal The methodological quality of included studies was assessed by two reviewers, who appraised each study independently, using the standard Joanna Briggs Institute (JBI) critical appraisal tools. Data extraction and synthesis Data were extracted from the studies that were identified as meeting the criteria for methodological quality using a data-extraction tool developed for the review. Studies were grouped by outcome measure and summarised using tabular and narrative formats. Results The review demonstrated that state anxiety is defined and measured using both psychological and physiological parameters. Music listening had a consistently positive and statistically significant effect on reducing psychological parameters of pre-procedural state anxiety. However, the results from the measurement of various pre-procedural physiological parameters failed to reveal any consistent positive changes in patients who had listened to music. This calls into question the adequacy of the theories in this area which link anxiety and the automated and central nervous systems and the effect that music listening may have on these processes and physiological responses. Conclusions/implications for practice 1,In order to reduce anxiety, it is likely that patients will benefit psychologically from having the opportunity to listen to music in the immediate pre-procedural period. 2,Patients do not appear to experience any alteration in physiological status as a result of listening to music. 3,Further research is indicated in order to replicate existing studies, to strengthen the evidence to support such interventions and to establish intervention parameters. 4,Further research is needed analysing the physiological mechanisms by which music listening is believed to reduce state anxiety and the contribution of the automated and other nervous systems to this reduction. [source] Nursing and midwifery management of hypoglycaemia in healthy term neonatesINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 7 2005Vivien Hewitt BSc(Hons) GradDipLib Executive summary Objectives The primary objective of this review was to determine the best available evidence for maintenance of euglycaemia, in healthy term neonates, and the management of asymptomatic hypoglycaemia in otherwise healthy term neonates. Inclusion criteria Types of studies The review included any relevant published or unpublished studies undertaken between 1995 and 2004. Studies that focus on the diagnostic accuracy of point-of-care devices for blood glucose screening and/or monitoring in the neonate were initially included as a subgroup of this review. However, the technical nature and complexity of the statistical information published in diagnostic studies retrieved during the literature search stage, as well as the considerable volume of published research in this area, suggested that it would be more feasible to analyse diagnostic studies in a separate systematic review. Types of participants The review focused on studies that included healthy term (37- to 42-week gestation) appropriate size for gestational age neonates in the first 72 h after birth. Exclusions ,,preterm or small for gestational age newborns; ,,term neonates with a diagnosed medical or surgical condition, congenital or otherwise; ,,babies of diabetic mothers; ,,neonates with symptomatic hypoglycaemia; ,,large for gestational age neonates (as significant proportion are of diabetic mothers). Types of intervention All interventions that fell within the scope of practice of a midwife/nurse were included: ,,type (breast or breast milk substitutes), amount and/or timing of feeds, for example, initiation of feeding, and frequency; ,,regulation of body temperature; ,,monitoring (including screening) of neonates, including blood or plasma glucose levels and signs and symptoms of hypoglycaemia. Interventions that required initiation by a medical practitioner were excluded from the review. Types of outcome measures Outcomes that were of interest included: ,,occurrence of hypoglycaemia; ,,re-establishment and maintenance of blood or plasma glucose levels at or above set threshold (as defined by the particular study); ,,successful breast-feeding; ,,developmental outcomes. Types of research designs The review initially focused on randomised controlled trials reported from 1995 to 2004. Insufficient randomised controlled trials were identified and the review was expanded to include additional cohort and cross-sectional studies for possible inclusion in a narrative summary. Search strategy The major electronic databases, including MEDLINE/PubMed, CINAHL, EMBASE, LILACS, Cochrane Library, etc., were searched using accepted search techniques to identify relevant published and unpublished studies undertaken between 1995 and 2004. Efforts were made to locate any relevant unpublished materials, such as conference papers, research reports and dissertations. Printed journals were hand-searched and reference lists checked for potentially useful research. The year 1995 was selected as the starting point in order to identify any research that had not been included in the World Health Organisation review, which covered literature published up to 1996. The search was not limited to English language studies. Assessment of quality Three primary reviewers conducted the review assisted by a review panel. The review panel was comprised of nine nurses with expertise in neonatal care drawn from senior staff in several metropolitan neonatal units and education programs. Authorship of journal articles was not concealed from the reviewers. Methodological quality of each study that met the inclusion criteria was assessed by two reviewers, using a quality assessment checklist developed for the review. Disagreements between reviewers were resolved through discussion or with the assistance of a third reviewer. Data extraction and analysis Two reviewers used a data extraction form to independently extract data relating to the study design, setting and participants; study focus and intervention(s); and measurements and outcomes. As only one relevant randomised controlled trial was found, a meta-analysis could not be conducted nor tables constructed to illustrate comparisons between studies. Instead, the findings were summarised by a narrative identifying any relevant findings that emerged from the data. Results Seven studies met the inclusion criteria for the objective of this systematic review. The review provided information on the effectiveness of three categories of intervention , type of feeds, timing of feeds and thermoregulation on two of the outcome measures identified in the review protocol , prevention of hypoglycaemia, and re-establishment and maintenance of blood or plasma glucose levels above the set threshold (as determined by the particular study). There was no evidence available on which to base conclusions for effectiveness of monitoring or developmental outcomes, and insufficient evidence for breast-feeding success. Given that only a narrative review was possible, the findings of this review should be interpreted with caution. The findings suggest that the incidence of hypoglycaemia in healthy, breast-fed term infants of appropriate size for gestational age is uncommon and routine screening of these infants is not indicated. The method and timing of early feeding has little or no influence on the neonatal blood glucose measurement at 1 h in normal term babies. In healthy, breast-fed term infants the initiation and timing of feeds in the first 6 h of life has no significant influence on plasma glucose levels. The colostrum of primiparous mothers provides sufficient nutrition for the infant in the first 24 h after birth, and supplemental feeds or extra water is unnecessary. Skin-to-skin contact appears to provide an optimal environment for fetal to neonatal adaptation after birth and can help to maintain body temperature and adequate blood glucose levels in healthy term newborn infants, as well as providing an ideal opportunity to establish early bonding behaviours. Implications for practice The seven studies analysed in this review confirm the World Health Organisation's first three recommendations for prevention and management of asymptomatic hypoglycaemia, namely: 1Early and exclusive breast-feeding is safe to meet the nutritional needs of healthy term newborns worldwide. 2Healthy term newborns that are breast-fed on demand need not have their blood glucose routinely checked and need no supplementary foods or fluids. 3Healthy term newborns do not develop ,symptomatic' hypoglycaemia as a result of simple underfeeding. If an infant develops signs suggesting hypoglycaemia, look for an underlying condition. Detection and treatment of the cause are as important as correction of the blood glucose level. If there are any concerns that the newborn infant might be hypoglycaemic it should be given another feed. Given the importance of thermoregulation, skin-to-skin contact should be promoted and ,kangaroo care' encouraged in the first 24 h after birth. While it is important to main the infant's body temperature care should be taken to ensure that the child does not become overheated. [source] Association between pacifier use and breast-feeding, sudden infant death syndrome, infection and dental malocclusionINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 6 2005Ann Callaghan RN RM BNurs(Hons) Executive summary Objective, To critically review all literature related to pacifier use for full-term healthy infants and young children. The specific review questions addressed are: What is the evidence of adverse and/or positive outcomes of pacifier use in infancy and childhood in relation to each of the following subtopics: ,breast-feeding; ,sudden infant death syndrome; ,infection; ,dental malocclusion. Inclusion criteria, Specific criteria were used to determine which studies would be included in the review: (i) the types of participants; (ii) the types of research design; and (iii) the types of outcome measures. To be included a study has to meet all criteria. Types of participants,The participants included in the review were healthy term infants and healthy children up to the age of 16 years. Studies that focused on preterm infants, and infants and young children with serious illness or congenital malformations were excluded. However, some total population studies did include these children. Types of research design, It became evident early in the review process that very few randomised controlled trials had been conducted. A decision was made to include observational epidemiological designs, specifically prospective cohort studies and, in the case of sudden infant death syndrome research, case,control studies. Purely descriptive and cross-sectional studies were excluded, as were qualitative studies and all other forms of evidence. A number of criteria have been proposed to establish causation in the scientific and medical literature. These key criteria were applied in the review process and are described as follows: (i) consistency and unbiasedness of findings; (ii) strength of association; (iii) temporal sequence; (iv) dose,response relationship; (v) specificity; (vi) coherence with biological background and previous knowledge; (vii) biological plausibility; and (viii) experimental evidence. Studies that did not meet the requirement of appropriate temporal sequencing of events and studies that did not present an estimate of the strength of association were not included in the final review. Types of outcome measures,Our specific interest was pacifier use related to: ,breast-feeding; ,sudden infant death syndrome; ,infection; ,dental malocclusion. Studies that examined pacifier use related to procedural pain relief were excluded. Studies that examined the relationship between pacifier use and gastro-oesophageal reflux were also excluded as this information has been recently presented as a systematic review. Search strategy, The review comprised published and unpublished research literature. The search was restricted to reports published in English, Spanish and German. The time period covered research published from January 1960 to October 2003. A protocol developed by New Zealand Health Technology Assessment was used to guide the search process. The search comprised bibliographic databases, citation searching, other evidence-based and guidelines sites, government documents, books and reports, professional websites, national associations, hand search, contacting national/international experts and general internet searching. Assessment of quality, All studies identified during the database search were assessed for relevance to the review based on the information provided in the title, abstract and descriptor/MeSH terms, and a full report was retrieved for all studies that met the inclusion criteria. Studies identified from reference list searches were assessed for relevance based on the study title. Keywords included: dummy, dummies, pacifier(s), soother(s), comforter(s), non-nutritive sucking, infant, child, infant care. Initially, studies were reviewed for inclusion by pairs of principal investigators. Authorship of articles was not concealed from the reviewers. Next, the methodological quality of included articles was assessed independently by groups of three or more principal investigators and clinicians using a checklist. All 20 studies that were accepted met minimum set criteria, but few passed without some methodological concern. Data extraction, To meet the requirements of the Joanna Briggs Institute, reasons for acceptance and non-acceptance at each phase were clearly documented. An assessment protocol and report form was developed for each of the three phases of review. The first form was created to record investigators' evaluations of studies included in the initial review. Those studies that failed to meet strict inclusion criteria were excluded at this point. A second form was designed to facilitate an in-depth critique of epidemiological study methodology. The checklist was pilot tested and adjustments were made before reviewers were trained in its use. When reviewers could not agree on an assessment, it was passed to additional reviewers and discussed until a consensus was reached. At this stage, studies other than cohort, case,control and randomised controlled trials were excluded. Issues of clarification were also addressed at this point. The final phase was that of integration. This phase, undertaken by the principal investigators, was assisted by the production of data extraction tables. Through a process of trial and error, a framework was formulated that adequately summarised the key elements of the studies. This information was tabulated under the following headings: authors/setting, design, exposure/outcome, confounders controlled, analysis and main findings. Results, With regard to the breast-feeding outcome, 10 studies met the inclusion criteria, comprising two randomised controlled trials and eight cohort studies. The research was conducted between 1995 and 2003 in a wide variety of settings involving research participants from diverse socioeconomic and cultural backgrounds. Information regarding exposure and outcome status, and potential confounding factors was obtained from: antenatal and postnatal records; interviews before discharge from obstetric/midwifery care; post-discharge interviews; and post-discharge postal and telephone surveys. Both the level of contact and the frequency of contact with the informant, the child's mother, differed widely. Pacifier use was defined and measured inconsistently, possibly because few studies were initiated expressly to investigate its relationship with breast-feeding. Completeness of follow-up was addressed, but missing data were not uniformly identified and explained. When comparisons were made between participants and non-participants there was some evidence of differential loss and a bias towards families in higher socioeconomic groups. Multivariate analysis was undertaken in the majority of studies, with some including a large number of sociodemographic, obstetric and infant covariates and others including just maternal age and education. As might be expected given the inconsistency of definition and measurement, the relationship between pacifier use and breast-feeding was expressed in many different ways and a meta-analysis was not appropriate. In summary, only one study did not report a negative association between pacifier use and breast-feeding duration or exclusivity. Results indicate an increase in risk for a reduced overall duration of breast-feeding from 20% to almost threefold. The data suggest that very infrequent use may not have any overall negative impact on breast-feeding outcomes. Six sudden infant death syndrome case,control studies met the criteria for inclusion. The research was conducted with information gathered between 1984 and 1999 in Norway, UK, New Zealand, the Netherlands and USA. Exposure information was obtained from a variety of sources including: hospital and antenatal records, death scene investigation, and interview and questionnaire. Information for cases was sought within 2 days after death, within 2,4 weeks after death and in one study between 3 and 11 years after death. Information for controls was sought from as early as 4 days of a nominated sudden infant death syndrome case, to between 1 and 7 weeks from the case date, and again in one study some 3,11 years later. In the majority of the studies case ascertainment was determined by post-mortem. Pacifier use was again defined and measured somewhat inconsistently. All studies controlled for confounding factors by matching and/or using multivariate analysis. Generally, antenatal and postnatal factors, as well as infant care practices, and maternal, family and socioeconomic issues were considered. All five studies reporting multivariate results found significantly fewer sudden infant death syndrome cases used a pacifier compared with controls. That is, pacifier use was associated with a reduced incidence of sudden infant death syndrome. These results indicate that the risk of sudden infant death syndrome for infants who did not use a pacifier in the last or reference sleep was at least twice, and possibly five times, that of infants who did use a pacifier. Three studies reported a moderately sized positive association between pacifier use and a variety of infections. Conversely, one study found no positive association between pacifier use at 15 months of age and a range of infections experienced between the ages of 6 and 18 months. Given the limited number of studies available and the variability of results, no meaningful conclusions could be drawn. Five cohort studies and one case,control study focused on the relationship between pacifier use and dental malocclusion. Not one of these studies reported a measure of association, such as an estimate of relative risk. It was therefore not possible to include these studies in the final review. Implications for practice, It is intended that this review be used as the basis of a ,best practice guideline', to make health professionals aware of the research evidence concerning these health and developmental consequences of pacifier use, because parents need clear information on which they can base child care decisions. With regard to the association between pacifier use and infection and dental malocclusion it was found that, due to the paucity of epidemiological studies, no meaningful conclusion can be drawn. There is clearly a need for more epidemiological research with regard to these two outcomes. The evidence for a relationship between pacifier use and sudden infant death syndrome is consistent, while the exact mechanism of the effect is not well understood. As to breast-feeding, research evidence shows that pacifier use in infancy is associated with a shorter duration and non-exclusivity. It is plausible that pacifier use causes babies to breast-feed less, but a causal relationship has not been irrefutably proven. Because breast-feeding confers an important advantage on all children and the incidence of sudden infant death syndrome is very low, it is recommended that health professionals generally advise parents against pacifier use, while taking into account individual circumstances. 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