Lisa Hartling

Meta-Analysis: Secondary Prevention Programs for Patients with Coronary Artery Disease

Cardiovascular disease remains the most common cause of office visits, hospitalizations, and death in the United States: More than 13 million Americans have documented coronary artery disease (CAD), and costs for CAD are expected to exceed

Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction : meta-analysis

393 billion in 2005 (1). Control of the CAD epidemic requires a multifaceted strategy targeting the currently recognized modifiable risk factors for CAD that account for more than 90% of risk, regardless of sex, age, or region (2). This strategy should include primary prevention maneuvers (for the general population and high-risk individuals) and secondary prevention programs (for patients with established CAD). Despite the abundant evidence base for CAD prevention (3), health outcomes studies consistently demonstrate gaps in applying this evidence to clinical practice; these gaps contribute to suboptimal patient outcomes (4). Secondary prevention programs are often proposed as a way to improve management and outcomes. Although several reviews have shown that cardiac rehabilitation reduces mortality in survivors of myocardial infarction (MI) (5-8), these conclusions are informed largely by trials that tested supervised exercise programs versus no exercise postinfarction. Since exercise training confers substantial physiologic and clinical benefits and activity levels are inversely proportional to cardiovascular mortality (9), it is not surprising that trials of exercise programs found positive effects on survival. However, few trials included in these reviews evaluated secondary prevention programs that were not primarily exercise-based. In an earlier review (10), we identified 12 randomized trials (9803 patients) of nonexercise-based secondary prevention programs in patients with established CAD. We demonstrated improvements in risk factor profiles and processes of care (particularly the prescription of proven efficacious therapies) but indeterminate effect on rates of death or recurrent MIs (10). Because current guidelines recommend that secondary prevention programs should not be restricted to supervised exercise programs but should address the full range of modifiable risk factors (11), we conducted a systematic review to update earlier work and to determine the effects of different types of secondary prevention programs (particularly those with a structured exercise component versus those without). Methods Data Sources We searched MEDLINE (19662004); the Cochrane Central Register of Controlled Trials, Issue 4, 2004; EMBASE (19802004); CINAHL (19822004); SIGLE (19802004); and PubMed (January 2004December 2004). We also conducted a cited reference search for our previous review (10) in Web of Science (19992004). We based the searches on the following terms: case management, comprehensive health care, disease management, health services research, home care services, clinical protocols, patient care planning, quality of health care, rehabilitation, nurse led clinics, special clinics, and myocardial ischemia. We hand-searched reference lists of all identified studies, review articles, and references provided by the Centers for Medicare & Medicaid Services and content experts (search strategy available upon request). We limited our search to English-language publications (no abstracts), and the search extends from 1966 to 2004 (we completed the search on 16 December 2004). Study Selection Two investigators independently reviewed the titles and abstracts of all citations to identify studies reporting the effect of secondary prevention programs on mortality, MI, or hospitalization rates in patients with CAD. Both investigators obtained the full text of potentially relevant articles and reviewed them by using prestandardized data abstraction forms and eligibility criteria defined a priori. Any discrepancies were resolved by consensus. We excluded studies if they were not randomized, if they did not include a usual care group, if the outcomes for CAD patients were not reported or were not obtainable from the study investigators, if they evaluated single-modality interventions except exercise (such as telephone follow-up), if they tested interventions delivered to inpatients, or if the interventions were not provided by health professionals (for example, mailed reminders, self-help groups, or self-directed interventions). Data Extraction and Quality Assessment Two investigators extracted all outcome data independently, and a third investigator checked the data. We assigned outcomes according to the intention-to-treat principle and by using the definitions from the primary studies. When necessary, we contacted original investigators to clarify the data for any trial published in the past decade. Authors for 10 of these 21 studies provided further data. Two investigators independently assigned each intervention to 1 of 3 groups: 1) programs that incorporated education and counseling about coronary risk factors with a supervised exercise program (either in a group setting, per traditional comprehensive cardiac rehabilitation programs, or individually delivered), 2) programs that included education and counseling about coronary risk factors but had no exercise component (either delivered in a group setting or individually), and 3) supervised exercise programs only. Data Synthesis and Analysis We performed analyses by using RevMan 4.2 (Update Software, Oxford, United Kingdom). Our outcomes of interest were all-cause mortality and recurrent MIs. Because the outcomes were relatively common, we calculated risk ratios and used the I2 statistic to assess for heterogeneity in each outcome of interest. We combined studies by using the DerSimonian and Laird random-effects model. For the primary analysis, we used data from the longest follow-up period reported in each trial. In a priori sensitivity analyses, we pooled data for 3 follow-up periods (12, 24, and 60 months). To evaluate whether different types of secondary prevention programs had different effects, we calculated the summary risk ratio for each program type and used adjusted indirect comparisons to compare different types of interventions, according to the method of Song and colleagues (12). Role of the Funding Source An earlier version of this evidence report was produced under contract to the Agency for Healthcare Research and Quality, Rockville, Maryland (contract no. 290-02-0023). The funding source had no role in the collection, analysis, or interpretation of the data or in the decision to submit the manuscript for publication. Results Study Selection and Evaluation We identified 6345 citations from electronic databases (n= 6207), reference lists (n= 45), and the Centers for Medicare & Medicaid Services (n= 93). After the initial screening, we reviewed 254 full manuscripts and excluded 179 of these studies after detailed evaluation (Figure 1). Figure 1. Flow of trials through the selection process. Sixteen disagreements among the reviewers about eligibility of the studies occurred for a value of 0.81. All disagreements were resolved by consensus. Of the randomized trials that were eligible for inclusion (13-87), 9 were reported in more than 1 publication. The second publication reported different end points in 2 cases (13-16), results from different follow-up periods in 5 cases (13, 17-26), and results from the subgroup of patients with cardiac disease in 1 case (27, 28). The ninth trial (the World Health Organization [WHO] trial) (29) included 24 collaborating centers; however, the original investigators excluded 7 sites because of poor participant follow-up and 4 sites because of statistically significant differences between the intervention and control groups at baseline. We included the outcome data from the remaining 13 sites as 1 trial for our analysis, an approach validated by the nonsignificant test results for statistical heterogeneity for all-cause mortality and MI. While the 2 Finnish centers in the WHO trial published their results separately (and for several follow-up periods), we included only their 3-year outcome data with the other 11 WHO sites for consistency of data presentation (30-32). Studies Included in the Systematic Review Table 1 presents summary data from the 63 unique randomized trials that were eligible for our systematic review (13-87). Our search retrieved 51 trials that were not included in our previous systematic review (which was limited to literature published before 1999 and excluded any studies with exercise components) (10) and 26 trials that were not included in a more recent systematic review of cardiac rehabilitation (which was limited to literature published before 2003 and included few individual counseling programs) (8). Table 1. Description of Included Studies Qualitative Data Synthesis In all trials, patients who were randomly assigned to the control groups received usual care (this was generally undefined). Table 1 describes the types of secondary prevention programs; few trials described the intensity of the interventions. Almost all trials enrolled highly selected study samples: Forty-five trials recruited patients after acute MI or a coronary revascularization procedure. Thirty-five trials excluded elderly patients, and 19 trials excluded women (Table 1). Indeed, women constituted fewer than 50% of study participants in all but 2 trials. No trial was double-blind (which is not surprising, considering the nature of the intervention), and very few trials described randomization procedures or accounted for discrepancies between sample sizes at recruitment and follow-up. As a result, Jadad quality scores clustered around 2 (Table 2). Furthermore, only 15 (24%) trial reports described adequate allocation concealment. Table 2. Methodologic Quality of Included Studies No trial reported side effects with the secondary prevention programs beyond the adverse clinical outcomes described later. Quantitative Data Synthesis All-Cause Mortality Only 1 of the 40 trials reporting this outcome f

The efficacy and safety of exogenous melatonin for primary sleep disorders a meta-analysis

Abstract Objective To conduct a systematic review of the efficacy and safety of exogenous melatonin in managing secondary sleep disorders and sleep disorders accompanying sleep restriction, such as jet lag and shiftwork disorder. Data sources 13 electronic databases and reference lists of relevant reviews and included studies; Associated Professional Sleep Society abstracts (1999 to 2003). Study selection The efficacy review included randomised controlled trials; the safety review included randomised and non-randomised controlled trials. Quality assessment Randomised controlled trials were assessed by using the Jadad Scale and criteria by Schulz et al, and non-randomised controlled trials by the Downs and Black checklist. Data extraction and synthesis One reviewer extracted data and another reviewer verified the data extracted. The inverse variance method was used to weight studies and the random effects model was used to analyse data. Main results Six randomised controlled trials with 97 participants showed no evidence that melatonin had an effect on sleep onset latency in people with secondary sleep disorders (weighted mean difference −13.2 (95% confidence interval −27.3 to 0.9) min). Nine randomised controlled trials with 427 participants showed no evidence that melatonin had an effect on sleep onset latency in people who had sleep disorders accompanying sleep restriction (−1.0 (−2.3 to 0.3) min). 17 randomised controlled trials with 651 participants showed no evidence of adverse effects of melatonin with short term use (three months or less). Conclusions There is no evidence that melatonin is effective in treating secondary sleep disorders or sleep disorders accompanying sleep restriction, such as jet lag and shiftwork disorder. There is evidence that melatonin is safe with short term use.

Risk of bias versus quality assessment of randomised controlled trials: cross sectional study.

BACKGROUND: Exogenous melatonin has been increasingly used in the management of sleep disorders.PURPOSE: To conduct a systematic review of the efficacy and safety of exogenous melatonin in the management of primary sleep disorders.DATA SOURCES: A number of electronic databases were searched. We reviewed the bibliographies of included studies and relevant reviews and conducted hand-searching.STUDY SELECTION: Randomized controlled trials (RCTs) were eligible for the efficacy review, and controlled trials were eligible for the safety review.DATA EXTRACTION: One reviewer extracted data, while the other verified data extracted. The Random Effects Model was used to analyze data.DATA SYNTHESIS: Melatonin decreased sleep onset latency (weighted mean difference [WMD]: −11.7 minutes; 95% confidence interval [CI]: −18.2, −5.2)); it was decreased to a greater extent in people with delayed sleep phase syndrome (WMD: −38.8 minutes; 95% CI: −50.3, −27.3; n=2) compared with people with insomnia (WMD: −7.2 minutes; 95% CI: −12.0, −2.4; n=12). The former result appears to be clinically important. There was no evidence of adverse effects of melatonin.CONCLUSIONS: There is evidence to suggest that melatonin is not effective in treating most primary sleep disorders with short-term use (4 weeks or less); however, additional large-scale RCTs are needed before firm conclusions can be drawn. There is some evidence to suggest that melatonin is effective in treating delayed sleep phase syndrome with short-term use. There is evidence to suggest that melatonin is safe with short-term use (3 months or less).

Social media use among patients and caregivers: a scoping review

Objectives To evaluate the risk of bias tool, introduced by the Cochrane Collaboration for assessing the internal validity of randomised trials, for inter-rater agreement, concurrent validity compared with the Jadad scale and Schulz approach to allocation concealment, and the relation between risk of bias and effect estimates. Design Cross sectional study. Study sample 163 trials in children. Main outcome measures Inter-rater agreement between reviewers assessing trials using the risk of bias tool (weighted κ), time to apply the risk of bias tool compared with other approaches to quality assessment (paired t test), degree of correlation for overall risk compared with overall quality scores (Kendall’s τ statistic), and magnitude of effect estimates for studies classified as being at high, unclear, or low risk of bias (metaregression). Results Inter-rater agreement on individual domains of the risk of bias tool ranged from slight (κ=0.13) to substantial (κ=0.74). The mean time to complete the risk of bias tool was significantly longer than for the Jadad scale and Schulz approach, individually or combined (8.8 minutes (SD 2.2) per study v 2.0 (SD 0.8), P<0.001). There was low correlation between risk of bias overall compared with the Jadad scores (P=0.395) and Schulz approach (P=0.064). Effect sizes differed between studies assessed as being at high or unclear risk of bias (0.52) compared with those at low risk (0.23). Conclusions Inter-rater agreement varied across domains of the risk of bias tool. Generally, agreement was poorer for those items that required more judgment. There was low correlation between assessments of overall risk of bias and two common approaches to quality assessment: the Jadad scale and Schulz approach to allocation concealment. Overall risk of bias as assessed by the risk of bias tool differentiated effect estimates, with more conservative estimates for studies at low risk.

Systematic review of knowledge translation strategies in the allied health professions

Objective To map the state of the existing literature evaluating the use of social media in patient and caregiver populations. Design Scoping review. Data sources Medline, CENTRAL, ERIC, PubMed, CINAHL Plus Full Text, Academic Search Complete, Alt Health Watch, Health Source, Communication and Mass Media Complete, Web of Knowledge and ProQuest (2000–2012). Study selection Studies reporting primary research on the use of social media (collaborative projects, blogs/microblogs, content communities, social networking sites, virtual worlds) by patients or caregivers. Data extraction Two reviewers screened studies for eligibility; one reviewer extracted data from relevant studies and a second performed verification for accuracy and completeness on a 10% sample. Data were analysed to describe which social media tools are being used, by whom, for what purpose and how they are being evaluated. Results Two hundred eighty-four studies were included. Discussion forums were highly prevalent and constitute 66.6% of the sample. Social networking sites (14.8%) and blogs/microblogs (14.1%) were the next most commonly used tools. The intended purpose of the tool was to facilitate self-care in 77.1% of studies. While there were clusters of studies that focused on similar conditions (eg, lifestyle/weight loss (12.7%), cancer (11.3%)), there were no patterns in the objectives or tools used. A large proportion of the studies were descriptive (42.3%); however, there were also 48 (16.9%) randomised controlled trials (RCTs). Among the RCTs, 35.4% reported statistically significant results favouring the social media intervention being evaluated; however, 72.9% presented positive conclusions regarding the use of social media. Conclusions There is an extensive body of literature examining the use of social media in patient and caregiver populations. Much of this work is descriptive; however, with such widespread use, evaluations of effectiveness are required. In studies that have examined effectiveness, positive conclusions are often reported, despite non-significant findings.

Music for Pain and Anxiety in Children Undergoing Medical Procedures: A Systematic Review of Randomized Controlled Trials

BackgroundKnowledge translation (KT) aims to close the research-practice gap in order to realize and maximize the benefits of research within the practice setting. Previous studies have investigated KT strategies in nursing and medicine; however, the present study is the first systematic review of the effectiveness of a variety of KT interventions in five allied health disciplines: dietetics, occupational therapy, pharmacy, physiotherapy, and speech-language pathology.MethodsA health research librarian developed and implemented search strategies in eight electronic databases (MEDLINE, CINAHL, ERIC, PASCAL, EMBASE, IPA, Scopus, CENTRAL) using language (English) and date restrictions (1985 to March 2010). Other relevant sources were manually searched. Two reviewers independently screened the titles and abstracts, reviewed full-text articles, performed data extraction, and performed quality assessment. Within each profession, evidence tables were created, grouping and analyzing data by research design, KT strategy, targeted behaviour, and primary outcome. The published descriptions of the KT interventions were compared to the Workgroup for Intervention Development and Evaluation Research (WIDER) Recommendations to Improve the Reporting of the Content of Behaviour Change Interventions.ResultsA total of 2,638 articles were located and the titles and abstracts were screened. Of those, 1,172 full-text articles were reviewed and subsequently 32 studies were included in the systematic review. A variety of single (n = 15) and multiple (n = 17) KT interventions were identified, with educational meetings being the predominant KT strategy (n = 11). The majority of primary outcomes were identified as professional/process outcomes (n = 25); however, patient outcomes (n = 4), economic outcomes (n = 2), and multiple primary outcomes (n = 1) were also represented. Generally, the studies were of low methodological quality. Outcome reporting bias was common and precluded clear determination of intervention effectiveness. In the majority of studies, the interventions demonstrated mixed effects on primary outcomes, and only four studies demonstrated statistically significant, positive effects on primary outcomes. None of the studies satisfied the four WIDER Recommendations.ConclusionsAcross five allied health professions, equivocal results, low methodological quality, and outcome reporting bias limited our ability to recommend one KT strategy over another. Further research employing the WIDER Recommendations is needed to inform the development and implementation of effective KT interventions in allied health.

Benefits and Harms of Treating Gestational Diabetes Mellitus: A Systematic Review and Meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research

OBJECTIVE The aim of this study was to conduct a systematic review of the efficacy of music therapy (MT) on pain and anxiety in children undergoing clinical procedures. METHODS We searched 16 electronic databases of published and unpublished studies, subject bibliographies, reference lists of relevant articles, and trials registries. Two reviewers independently screened 4559 citations and reviewed the full manuscript of 393 studies. Nineteen studies met the inclusion criteria: randomized controlled trial, children aged 1 month to 18 years were examined, music was used as an intervention, and the study measured pain or anxiety. Music therapy was considered active if a music therapist was involved and music was used as a medium for interactive communication. Passive music therapy was defined as listening to music without the involvement of a music therapist. RESULTS The 19 included trials involved 1513 subjects. The methodological quality of the studies was generally poor. Overall, MT showed a significant reduction in pain and anxiety (standardized mean difference [SMD] -0.35; 95% confidence interval [CI], -0.55 to -0.14; 9 studies; N = 704; I(2) = 42%). When analyzed by outcome, MT significantly reduced anxiety (SMD -0.39; 95% CI, -0.76 to -0.03; 5 studies; n = 284; I(2) = 52.4%) and pain (SMD -0.39; 95% CI, -0.66 to -0.11; 5 studies; N = 465; I(2) = 49.7%). There was no evidence of publication bias. CONCLUSIONS Music is effective in reducing anxiety and pain in children undergoing medical and dental procedures. Music can be considered an adjunctive therapy in clinical situations that produce pain or anxiety.

Children Are Not Just Small Adults: The Urgent Need for High-Quality Trial Evidence in Children

BACKGROUND Outcomes of treating gestational diabetes mellitus (GDM) are not well-established. PURPOSE To summarize evidence about the maternal and neonatal benefits and harms of treating GDM. DATA SOURCES 15 electronic databases from 1995 to May 2012, gray literature, Web sites of relevant organizations, trial registries, and reference lists. STUDY SELECTION English-language randomized, controlled trials (n = 5) and cohort studies (n = 6) of women without known preexisting diabetes. DATA EXTRACTION One reviewer extracted data, and a second reviewer verified them. Two reviewers independently assessed methodological quality and evaluated strength of evidence for primary outcomes by using a Grading of Recommendations Assessment, Development and Evaluation approach. DATA SYNTHESIS All studies compared diet modification, glucose monitoring, and insulin as needed with no treatment. Women who were treated had more prenatal visits than those in control groups. Moderate evidence showed fewer cases of preeclampsia, shoulder dystocia, and macrosomia in the treated group. Evidence was insufficient for maternal weight gain and birth injury. Low evidence showed no difference between groups for neonatal hypoglycemia. Evidence was insufficient for long-term metabolic outcomes among offspring. No difference was found for cesarean delivery (low evidence), induction of labor (insufficient evidence), small-for-gestational-age neonates (moderate evidence), or admission to a neonatal intensive care unit (low evidence). LIMITATIONS Evidence is low or insufficient for many outcomes of greatest clinical importance. The strongest evidence supports reductions in intermediate outcomes; however, other factors (for example, maternal weight and gestational weight gain) may impart greater risk than GDM, particularly when glucose levels are modestly elevated. CONCLUSION Treating GDM results in less preeclampsia, shoulder dystocia, and macrosomia; however, current evidence does not show an effect on neonatal hypoglycemia or future poor metabolic outcomes. There is little evidence of short-term harm of treating GDM other than an increased demand for services.

Chorioamnionitis as a risk factor for bronchopulmonary dysplasia: a systematic review and meta-analysis

Terry Klassen and colleagues discuss a new study examining whether children and adults with drug-resistant partial epilepsy respond differently to antiepileptic drugs.