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1.
J Addict Med ; 16(2): 143-151, 2022.
Article in English | MEDLINE | ID: mdl-33900228

ABSTRACT

OBJECTIVES: To review the currently available evidence on transfer strategies from methadone to sublingual buprenorphine used in clinical trials and observational studies of medication for opioid use disorder treatment, and to consider whether any strategies yield better clinical outcomes than others. METHODS: Six medical and public health databases were searched for articles and conference abstracts. The Cochrane Central Register of Controlled Trials and the World Health Organization International Clinical Trials Registry Platform were used to identify unpublished trial results. Records were dually screened, and data were extracted and checked independently. Results were summarized qualitatively and, when possible, analyzed quantitatively. RESULTS: Eighteen studies described transfer from methadone to buprenorphine. Transfer protocols were extremely varied. Most studies reported successful rates of transfer, even among studies involving transfer from high methadone doses, although lower pretransfer methadone dose was significantly associated with higher rate of successful transfer. Precipitated withdrawal was not reported frequently. A range of innovative approaches to transfer from methadone to buprenorphine remains untested. CONCLUSIONS: Few studies have used designs that enable comparison of different approaches to transfer patients from methadone to buprenorphine. Most international clinical guidelines provide recommendations consistent with the available evidence. However, clinical guidelines should be perceived as providing "guidance" rather than "protocols," and clinicians and patients need to exercise judgment when attempting transfers.


Subject(s)
Buprenorphine , Opioid-Related Disorders , Buprenorphine/therapeutic use , Humans , Methadone/therapeutic use , Opioid-Related Disorders/drug therapy , Opioid-Related Disorders/rehabilitation
2.
J Subst Abuse Treat ; 104: 148-157, 2019 09.
Article in English | MEDLINE | ID: mdl-31370979

ABSTRACT

Opioid use disorder (OUD) and its consequences are a major public health concern. The partial agonist buprenorphine is a safe and effective treatment for OUD, but concerns about abuse, misuse, and diversion of buprenorphine have been raised. This narrative review examined the rates and motives for use of illicit buprenorphine in the United States. Findings from the 17 included studies suggest the majority of study participants using illicit buprenorphine do so for reasons related to misuse (to manage opioid withdrawal symptoms or achieve or maintain abstinence from other opioids). A smaller percentage of study respondents reported using buprenorphine for reasons related to abuse (to get high). There appears to be a gap between need for buprenorphine and access to adequate treatment. Attenuation of policy-related barriers and adoption of appropriate buprenorphine use by the treatment community are critical tools in the continued effort to reduce the burdens associated with OUD.


Subject(s)
Analgesics, Opioid/therapeutic use , Buprenorphine/therapeutic use , Health Services Accessibility , Opiate Substitution Treatment , Opioid-Related Disorders/drug therapy , Prescription Drug Misuse , Health Services Accessibility/standards , Health Services Accessibility/statistics & numerical data , Humans , Opiate Substitution Treatment/standards , Opiate Substitution Treatment/statistics & numerical data , Prescription Drug Misuse/statistics & numerical data , United States
3.
JAMA ; 318(9): 845-858, 2017 09 05.
Article in English | MEDLINE | ID: mdl-28873167

ABSTRACT

Importance: Preschool vision screening could allow detection and treatment of vision abnormalities during a critical developmental stage, preserving function and quality of life. Objective: To review the evidence on screening for and treatment of amblyopia, its risk factors, and refractive error in children aged 6 months to 5 years to inform the US Preventive Services Task Force. Data Sources: MEDLINE, Cochrane Library, CINAHL, and trial registries through June 2016; references; and experts, with surveillance of the literature through June 7, 2017. Study Selection: English-language randomized clinical trials (RCTs) or prospective cohort studies that evaluated screening, studies evaluating test accuracy, RCTs of treatment vs inactive controls, and cohort studies or case-control studies assessing harms. Data Extraction and Synthesis: Dual review of abstracts, full-text articles, and study quality; qualitative synthesis of findings. Studies were not quantitatively pooled because of clinical and methodological heterogeneity. Main Outcomes and Measures: Visual acuity, amblyopia, school performance, functioning, quality of life, test accuracy, testability, and harms. Results: Forty studies were included (N = 34 709); 34 evaluated test accuracy. No RCTs compared screening with no screening, and no studies evaluated school performance, function, or quality of life. Studies directly assessing earlier or more intensive screening were limited by high attrition. Positive likelihood ratios were between 5 and 10 for amblyopia risk factors or nonamblyogenic refractive error in most studies of test accuracy and were greater than 10 in most studies evaluating combinations of clinical tests. Inability to cooperate may limit use of some tests in children younger than 3 years. Studies with low prevalence (<10%) of vision abnormalities showed high false-positive rates (usually >75%). Among children with amblyopia risk factors (eg, strabismus or anisometropia), patching improved visual acuity of the amblyopic eye by a mean of less than 1 line on a standard chart after 5 to 12 weeks for children pretreated with glasses (2 RCTs, 240 participants); more children treated with patching than with no patching experienced improvement of at least 2 lines (45% vs 21%; P = .003; 1 RCT, 180 participants). Patching plus glasses improved visual acuity by about 1 line after 1 year (0.11 logMAR [95% CI, 0.05-0.17]) for children not pretreated with glasses (1 RCT, 177 participants). Glasses alone improved visual acuity by less than 1 line after 1 year (0.08 logMAR [95% CI, 0.02-0.15], 1 RCT, 177 participants). Conclusions and Relevance: Studies directly evaluating the effectiveness of screening were limited and do not establish whether vision screening in preschool children is better than no screening. Indirect evidence supports the utility of multiple screening tests for identifying preschool children at higher risk for vision problems and the effectiveness of some treatments for improving visual acuity outcomes.


Subject(s)
Amblyopia/diagnosis , Vision Screening , Amblyopia/therapy , Child, Preschool , Educational Status , False Positive Reactions , Female , Humans , Infant , Male , Mass Screening , Refractive Errors/diagnosis , Risk Assessment , Risk Factors , Strabismus/diagnosis , Visual Acuity
4.
J Altern Complement Med ; 23(12): 907-919, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28700248

ABSTRACT

OBJECTIVES: To report the comparative benefits and harms of exercise and complementary and alternative medicine (CAM) treatments with second-generation antidepressants (SGA) for major depressive disorder (MDD). DESIGN: Systematic review and meta-analysis. SETTINGS: Outpatient clinics. SUBJECTS: Adults, aged 18 years and older, with MDD receiving an initial treatment attempt with SGA. INTERVENTIONS: Any CAM or exercise intervention compared with an SGA. OUTCOME MEASURES: Treatment response, remission, change in depression rating, adverse events, treatment discontinuation, and treatment discontinuation due to adverse events. RESULTS: We found 22 randomized controlled trials for direct comparisons and 127 trials for network meta-analyses, including trials of acupuncture, omega-3 fatty acids, S-adenosyl methionine, St. John's wort, and exercise. For most treatment comparisons, we found no differences between treatment groups for response and remission. However, the risk of bias of these studies led us to conclude that the strength of evidence for these findings was either low or insufficient. The risk of treatment harms and treatment discontinuation attributed to adverse events was higher for selective serotonin receptor inhibitors than for St. John's wort. CONCLUSIONS: Although we found little difference in the comparative efficacy of most CAM therapies or exercise and SGAs, the overall poor quality of the available evidence base tempers any conclusions that we might draw from those trials. Future trials should incorporate patient-oriented outcomes, treatment expectancy, depressive severity, and harms assessments into their designs; antidepressants should be administered over their full dosage ranges; and larger trials using methods to reduce sampling bias are needed.


Subject(s)
Complementary Therapies , Depressive Disorder, Major/therapy , Complementary Therapies/adverse effects , Complementary Therapies/methods , Complementary Therapies/statistics & numerical data , Humans
5.
JAMA ; 317(4): 415-433, 2017 01 24.
Article in English | MEDLINE | ID: mdl-28118460

ABSTRACT

Importance: Many adverse health outcomes are associated with obstructive sleep apnea (OSA). Objective: To review primary care-relevant evidence on screening adults for OSA, test accuracy, and treatment of OSA, to inform the US Preventive Services Task Force. Data Sources: MEDLINE, Cochrane Library, EMBASE, and trial registries through October 2015, references, and experts, with surveillance of the literature through October 5, 2016. Study Selection: English-language randomized clinical trials (RCTs); studies evaluating accuracy of screening questionnaires or prediction tools, diagnostic accuracy of portable monitors, or association between apnea-hypopnea index (AHI) and health outcomes among community-based participants. Data Extraction and Synthesis: Two investigators independently reviewed abstracts and full-text articles. When multiple similar studies were available, random-effects meta-analyses were conducted. Main Outcomes and Measures: Sensitivity, specificity, area under the curve (AUC), AHI, Epworth Sleepiness Scale (ESS) scores, blood pressure, mortality, cardiovascular events, motor vehicle crashes, quality of life, and harms. Results: A total of 110 studies were included (N = 46 188). No RCTs compared screening with no screening. In 2 studies (n = 702), the screening accuracy of the multivariable apnea prediction score followed by home portable monitor testing for detecting severe OSA syndrome (AHI ≥30 and ESS score >10) was AUC 0.80 (95% CI, 0.78 to 0.82) and 0.83 (95% CI, 0.77 to 0.90), respectively, but the studies oversampled high-risk participants and those with OSA and OSA syndrome. No studies prospectively evaluated screening tools to report calibration or clinical utility for improving health outcomes. Meta-analysis found that continuous positive airway pressure (CPAP) compared with sham was significantly associated with reduction of AHI (weighted mean difference [WMD], -33.8 [95% CI, -42.0 to -25.6]; 13 trials, 543 participants), excessive sleepiness assessed by ESS score (WMD, -2.0 [95% CI, -2.6 to -1.4]; 22 trials, 2721 participants), diurnal systolic blood pressure (WMD, -2.4 points [95% CI, -3.9 to -0.9]; 15 trials, 1190 participants), and diurnal diastolic blood pressure (WMD, -1.3 points [95% CI, -2.2 to -0.4]; 15 trials, 1190 participants). CPAP was associated with modest improvement in sleep-related quality of life (Cohen d, 0.28 [95% CI, 0.14 to 0.42]; 13 trials, 2325 participants). Mandibular advancement devices (MADs) and weight loss programs were also associated with reduced AHI and excessive sleepiness. Common adverse effects of CPAP and MADs included oral or nasal dryness, irritation, and pain, among others. In cohort studies, there was a consistent association between AHI and all-cause mortality. Conclusions and Relevance: There is uncertainty about the accuracy or clinical utility of all potential screening tools. Multiple treatments for OSA reduce AHI, ESS scores, and blood pressure. Trials of CPAP and other treatments have not established whether treatment reduces mortality or improves most other health outcomes, except for modest improvement in sleep-related quality of life.


Subject(s)
Advisory Committees , Evidence-Based Medicine , Sleep Apnea, Obstructive/diagnosis , Sleep Apnea, Obstructive/therapy , Adult , Bariatric Surgery , Continuous Positive Airway Pressure , Female , Humans , Male , Mandibular Advancement/instrumentation , Monitoring, Ambulatory/instrumentation , Outcome Assessment, Health Care , Randomized Controlled Trials as Topic , Respiratory System/surgery , Surveys and Questionnaires , Uncertainty , United States
6.
JAMA ; 316(9): 970-83, 2016 Sep 06.
Article in English | MEDLINE | ID: mdl-27599332

ABSTRACT

IMPORTANCE: Five to ten percent of individuals with latent tuberculosis infection (LTBI) progress to active tuberculosis (TB) disease. Identifying and treating LTBI is a key component of the strategy for reducing the burden of TB disease. OBJECTIVE: To review the evidence about targeted screening and treatment for LTBI among adults in primary care settings to support the US Preventive Services Task Force in updating its 1996 recommendation. DATA SOURCES: MEDLINE, Cochrane Library, and trial registries, searched through August 3, 2015; references from pertinent articles; and experts. Literature surveillance was conducted through May 31, 2016. STUDY SELECTION: English-language studies of LTBI screening, LTBI treatment with recommended pharmacotherapy, or accuracy of the tuberculin skin test (TST) or interferon-gamma release assays (IGRAs). Studies of individuals for whom LTBI screening and treatment is part of public health surveillance or disease management were excluded. DATA EXTRACTION AND SYNTHESIS: Two investigators independently reviewed abstracts and full-text articles. When at least 3 similar studies were available, random-effects meta-analysis was used to generate pooled estimates of outcomes. MAIN OUTCOMES AND MEASURES: Sensitivity, specificity, reliability, active TB disease, mortality, hepatotoxicity, and other harms. RESULTS: The review included 72 studies (n = 51 711). No studies evaluated benefits and harms of screening compared with no screening. Pooled estimates for sensitivity of the TST at both 5-mm and 10-mm induration thresholds were 0.79 (5-mm: 95% CI, 0.69-0.89 [8 studies, n = 803]; 10 mm: 95% CI, 0.71-0.87 [11 studies; n = 988]), and those for IGRAs ranged from 0.77 to 0.90 (57 studies; n = 4378). Pooled estimates for specificity of the TST at the 10-mm and 15-mm thresholds and for IGRAs ranged from 0.95 to 0.99 (34 studies; n = 23 853). A randomized clinical trial (RCT) of 24 weeks of isoniazid in individuals with pulmonary fibrotic lesions and LTBI (n = 27 830) found a reduction in absolute risk of active TB at 5 years from 1.4% to 0.5% (relative risk [RR], 0.35 [95% CI, 0.24-0.52]) and an increase in absolute risk for hepatoxicity from 0.1% to 0.5% (RR, 4.59 [95% CI, 2.03-10.39]) for 24 weeks of daily isoniazid compared with placebo. An RCT (n = 6886) found that 3 months of once-weekly rifapentine plus isoniazid was noninferior to 9 months of isoniazid alone for preventing active TB. The risk difference for hepatoxicity comparing isoniazid with rifampin ranged from 3% to 7%, with a pooled RR of 3.29 (95% CI, 1.72-6.28 [3 RCTs; n = 1327]). CONCLUSIONS AND RELEVANCE: No studies evaluated the benefits and harms of screening compared with no screening. Both the TST and IGRAs are moderately sensitive and highly specific within countries with low TB burden. Treatment reduced the risk of active TB among the populations included in this review. Isoniazid is associated with higher rates of hepatotoxicity than placebo or rifampin.


Subject(s)
Antitubercular Agents/therapeutic use , Latent Tuberculosis/diagnosis , Latent Tuberculosis/drug therapy , Mass Screening/standards , Primary Health Care/standards , Adult , Humans , Interferon-gamma Release Tests , Reproducibility of Results , Sensitivity and Specificity , Tuberculin Test
7.
Addiction ; 111(12): 2115-2128, 2016 12.
Article in English | MEDLINE | ID: mdl-27223595

ABSTRACT

AIMS: To assess the safety of buprenorphine compared with methadone to treat pregnant women with opioid use disorder. METHODS: We searched PubMed, Embase and the Cochrane Library from inception to February 2015 for randomized controlled trials (RCT) and observational cohort studies (OBS) that compared buprenorphine with methadone for treating opioid-dependent pregnant women. Two reviewers assessed independently the titles and abstracts of all search results and full texts of potentially eligible studies reporting original data for maternal/fetal/infant death, preterm birth, fetal growth outcomes, fetal/congenital anomalies, fetal/child neurodevelopment and/or maternal adverse events. We ascertained each study's risk of bias using validated instruments and assessed the strength of evidence for each outcome using established methods. We computed effect sizes using random-effects models for each outcome with two or more studies. RESULTS: Three RCTs (n = 223) and 15 cohort OBSs (n = 1923) met inclusion criteria. In meta-analyses using unadjusted data and methadone as comparator, buprenorphine was associated with lower risk of preterm birth [RCT risk ratio (RR) = 0.40, 95% confidence interval (CI) = 0.18, 0.91; OBS RR = 0.67, 95% CI = 0.50, 0.90], greater birth weight [RCT weighted mean difference (WMD) = 277 g, 95% CI = 104, 450; OBS WMD = 265 g, 95% CI = 196, 335] and larger head circumference [RCT WMD = 0.90 cm, 95% CI = 0.14, 1.66; OBS WMD = 0.68 cm, 95% CI = 0.41, 0.94]. No treatment differences were observed for spontaneous fetal death, fetal/congenital anomalies and other fetal growth measures, although the power to detect such differences may be inadequate due to small sample sizes. CONCLUSIONS: Moderately strong evidence indicates lower risk of preterm birth, greater birth weight and larger head circumference with buprenorphine treatment of maternal opioid use disorder during pregnancy compared with methadone treatment, and no greater harms.


Subject(s)
Analgesics, Opioid/therapeutic use , Buprenorphine/therapeutic use , Methadone/therapeutic use , Opioid-Related Disorders/rehabilitation , Pregnancy Complications/rehabilitation , Abnormalities, Drug-Induced/prevention & control , Birth Weight/physiology , Female , Fetal Death/prevention & control , Fetal Development/drug effects , Humans , Infant, Newborn , Opiate Substitution Treatment/methods , Patient Safety , Pregnancy , Pregnancy Outcome , Premature Birth/prevention & control , Prenatal Care/methods , Randomized Controlled Trials as Topic , Sudden Infant Death/prevention & control
8.
Ann Intern Med ; 164(5): 331-41, 2016 Mar 01.
Article in English | MEDLINE | ID: mdl-26857743

ABSTRACT

BACKGROUND: Primary care patients and clinicians may prefer options other than second-generation antidepressants for the treatment of major depressive disorder (MDD). The comparative benefits and harms of antidepressants and alternative treatments are unclear. PURPOSE: To compare the benefits and harms of second-generation antidepressants and psychological, complementary and alternative medicine (CAM), and exercise treatments as first- and second-step interventions for adults with acute MDD. DATA SOURCES: English-, German-, and Italian-language studies from multiple electronic databases (January 1990 to September 2015); trial registries and gray-literature databases were used to identify unpublished research. STUDY SELECTION: Two investigators independently selected comparative randomized trials of at least 6 weeks' duration on health outcomes of adult outpatients; nonrandomized studies were eligible for harms. DATA EXTRACTION: Reviewers abstracted data on study design, participants, interventions, and outcomes; rated the risk of bias; and graded the strength of evidence. A senior reviewer confirmed data and ratings. DATA SYNTHESIS: 45 trials met inclusion criteria. On the basis of moderate-strength evidence, cognitive behavioral therapy (CBT) and antidepressants led to similar response rates (relative risk [RR], 0.90 [95% CI, 0.76 to 1.07]) and remission rates (RR, 0.98 [CI, 0.73 to 1.32]). In trials, antidepressants had higher risks for adverse events than most other treatment options; no information from nonrandomized studies was available. The evidence was too limited to make firm conclusions about differences in the benefits and harms of antidepressants compared with other treatment options as first-step therapies for acute MDD. For second-step therapies, different switching and augmentation strategies provided similar symptom relief. LIMITATION: High dropout rates, dosing inequalities, small sample sizes, and poor assessment of adverse events limit confidence in the evidence. CONCLUSION: Given their similar efficacy, CBT and antidepressants are both viable choices for initial treatment of MDD. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.


Subject(s)
Antidepressive Agents, Second-Generation/therapeutic use , Cognitive Behavioral Therapy , Complementary Therapies , Depressive Disorder, Major/therapy , Exercise Therapy , Adult , Antidepressive Agents, Second-Generation/adverse effects , Complementary Therapies/adverse effects , Depressive Disorder, Major/drug therapy , Exercise Therapy/adverse effects , Humans , Remission Induction
11.
BMJ ; 351: h6019, 2015 Dec 08.
Article in English | MEDLINE | ID: mdl-26645251

ABSTRACT

STUDY QUESTION: What are the benefits and harms of second generation antidepressants and cognitive behavioral therapies (CBTs) in the initial treatment of a current episode of major depressive disorder in adults? METHODS: This was a systematic review including qualitative assessment and meta-analyses using random and fixed effects models. Medline, Embase, the Cochrane Library, the Allied and Complementary Medicine Database, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature were searched from January 1990 through January 2015. The 11 randomized controlled trials included compared a second generation antidepressant CBT. Ten trials compared antidepressant monotherapy with CBT alone; three compared antidepressant monotherapy with antidepressant plus CBT. SUMMARY ANSWER AND LIMITATIONS: Meta-analyses found no statistically significant difference in effectiveness between second generation antidepressants and CBT for response (risk ratio 0.91, 0.77 to 1.07), remission (0.98, 0.73 to 1.32), or change in 17 item Hamilton Rating Scale for Depression score (weighted mean difference, -0.38, -2.87 to 2.10). Similarly, no significant differences were found in rates of overall study discontinuation (risk ratio 0.90, 0.49 to 1.65) or discontinuation attributable to lack of efficacy (0.40, 0.05 to 2.91). Although more patients treated with a second generation antidepressant than receiving CBT withdrew from studies because of adverse events, the difference was not statistically significant (risk ratio 3.29, 0.42 to 25.72). No conclusions could be drawn about other outcomes because of lack of evidence. Results should be interpreted cautiously given the low strength of evidence for most outcomes. The scope of this review was limited to trials that enrolled adult patients with major depressive disorder and compared a second generation antidepressant with CBT, and many of the included trials had methodological shortcomings that may limit confidence in some of the findings. WHAT THIS STUDY ADDS: Second generation antidepressants and CBT have evidence bases of benefits and harms in major depressive disorder. Available evidence suggests no difference in treatment effects of second generation antidepressants and CBT, either alone or in combination, although small numbers may preclude detection of small but clinically meaningful differences. Funding, competing interests, data sharing This project was funded under contract from the Agency for Healthcare Research and Quality by the RTI-UNC Evidence-based Practice Center. Detailed methods and additional information are available in the full report, available at http://effectivehealthcare.ahrq.gov/.


Subject(s)
Antidepressive Agents, Second-Generation/therapeutic use , Cognitive Behavioral Therapy/methods , Depressive Disorder, Major/therapy , Humans
12.
Pharmacogenomics ; 15(13): 1687-700, 2014 Sep.
Article in English | MEDLINE | ID: mdl-25410894

ABSTRACT

AIM: To assess whether response to medications for alcohol use disorders varies by genotype. METHODS: Systematic review and meta-analysis. RESULTS: We found no studies that assessed the clinical utility of genotype-guided dosing strategies or genotype-guided medication selection, and none randomized by genotype. All included studies assessed the association between genotype and response to medication. Of 15 included studies, eight (n = 1365 participants) assessed variation in naltrexone response and polymorphisms of OPRM1. Our meta-analyses for return to heavy drinking found no significant difference between A allele homozygotes and those with at least one G allele, both without (risk difference: 0.26; 95% CI: -0.01-0.53; n = 174) and with inclusion of studies rated as high or unclear risk of bias (risk difference: 0.14; 95% CI: -0.03-0.3; n = 382). For all other polymorphism-medication pairs, we found just one eligible study. CONCLUSION: Estimates of effect for return to heavy drinking suggest it is possible that patients with at least one G allele of A118G polymorphism of OPRM1 might be more likely to respond to naltrexone, but confidence intervals were wide; additional studies are needed to improve confidence in the estimates.


Subject(s)
Alcohol-Induced Disorders/genetics , Polymorphism, Genetic , Alcohol-Induced Disorders/drug therapy , Genotype , Humans , Naltrexone/therapeutic use , Receptors, Opioid, mu/genetics
13.
Ann Intern Med ; 161(5): 336-46, 2014 Sep 02.
Article in English | MEDLINE | ID: mdl-25004169

ABSTRACT

BACKGROUND: Approximately 10% of ischemic strokes are caused by carotid artery stenosis (CAS). Estimated prevalence of asymptomatic CAS is 1%. PURPOSE: To evaluate evidence on screening and treating asymptomatic adults for CAS. DATA SOURCES: MEDLINE, the Cochrane Library, EMBASE, and trial registries through September 2013; MEDLINE through March 2014 for trials. STUDY SELECTION: Good- or fair-quality trials of screening, carotid endarterectomy (CEA), or stenting compared with medical therapy or of intensification of medical therapy; systematic reviews; multi-institution studies reporting harms; and externally validated risk-stratification tools. DATA EXTRACTION: Dual extraction and quality assessment. DATA SYNTHESIS: No trials compared screening with no screening or stenting with medical therapy or assessed intensification of medical therapy, and no externally validated, reliable risk-stratification tools were found. Given the specificity of ultrasonography (range, 88% to 94% for CAS ≥ 50% to ≥ 70%), its use in low-prevalence populations would yield many false-positive results. Absolute reduction of nonperioperative strokes was 5.5% (95% CI, 3.9% to 7.0%; 3 trials; 5223 participants) over approximately 5 years for CEA compared with medical therapy. The 30-day rates of stroke or death after CEA in trials and cohort studies were 2.4% (CI, 1.7% to 3.1%; 6 trials; 3435 participants) and 3.3% (CI, 2.7% to 3.9%; 7 studies; 17474 participants), respectively. Other harms of interventions included myocardial infarction, nerve injury, and hematoma. LIMITATIONS: Trials may have overestimated benefits and used highly selected surgeons. Medical therapy used in trials was outdated, and stroke rates have declined in recent decades. Harms may have been underreported. CONCLUSION: Current evidence does not establish incremental overall benefit of CEA, stenting, or intensification of medical therapy. Potential for overall benefit is limited by low prevalence and harms. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.


Subject(s)
Asymptomatic Diseases/therapy , Carotid Stenosis/diagnosis , Carotid Stenosis/therapy , Mass Screening , Stroke/prevention & control , Angioplasty , Carotid Arteries , Carotid Stenosis/complications , Endarterectomy, Carotid/adverse effects , Humans , Mass Screening/adverse effects , Mass Screening/methods , Postoperative Complications , Risk Assessment , Stents , Ultrasonography, Doppler, Duplex
14.
JAMA ; 311(18): 1889-900, 2014 May 14.
Article in English | MEDLINE | ID: mdl-24825644

ABSTRACT

IMPORTANCE: Alcohol use disorders cause substantial morbidity and early mortality yet remain greatly undertreated. Medications are considerably underused. OBJECTIVE: To conduct a systematic review and meta-analysis of the benefits and harms of medications (US FDA-approved and others) for adults with alcohol use disorders. DATA SOURCES: PubMed, Cochrane Library, PsycINFO, CINAHL, EMBASE, FDA website, and clinical trials registries (January 1, 1970, to March 1, 2014). STUDY SELECTION: Two reviewers selected randomized clinical trials (RCTs) with at least 12 weeks' duration that reported eligible outcomes and head-to-head prospective cohort studies reporting health outcomes or harms. DATA EXTRACTION AND SYNTHESIS: We conducted meta-analyses using random-effects models and calculated numbers needed to treat for benefit (NNTs) or harm (NNHs). MAIN OUTCOMES AND MEASURES: Alcohol consumption, motor vehicle crashes, injuries, quality of life, function, mortality, and harms. RESULTS: We included 122 RCTs and 1 cohort study (total 22,803 participants). Most assessed acamprosate (27 studies, n = 7519), naltrexone (53 studies, n = 9140), or both. The NNT to prevent return to any drinking for acamprosate was 12 (95% CI, 8 to 26; risk difference [RD], -0.09; 95% CI, -0.14 to -0.04) and was 20 (95% CI, 11 to 500; RD, -0.05; 95% CI, -0.10 to -0.002) for oral naltrexone (50 mg/d). The NNT to prevent return to heavy drinking was 12 (95% CI, 8 to 26; RD -0.09; 95% CI, -0.13 to -0.04) for oral naltrexone (50 mg/d). Meta-analyses of trials comparing acamprosate to naltrexone found no statistically significant difference between them for return to any drinking (RD, 0.02; 95% CI, -0.03 to 0.08) or heavy drinking (RD, 0.01; 95% CI, -0.05 to 0.06). For injectable naltrexone, meta-analyses found no association with return to any drinking (RD, -0.04; 95% CI, -0.10 to 0.03) or heavy drinking (RD, -0.01; 95% CI, -0.14 to 0.13) but found an association with reduction in heavy drinking days (weighted mean difference [WMD], -4.6%; 95% CI, -8.5% to -0.56%). Among medications used off-label, moderate evidence supports an association with improvement in some consumption outcomes for nalmefene (heavy drinking days per month: WMD, -2.0; 95% CI, -3.0 to -1.0; drinks per drinking day: WMD, -1.02; 95% CI, -1.77 to -0.28) and topiramate (% heavy drinking days: WMD, -9.0%; 95% CI, -15.3% to -2.7%; drinks per drinking day: WMD, -1.0; 95% CI, -1.6 to -0.48). For naltrexone and nalmefene, NNHs for withdrawal from trials due to adverse events were 48 (95% CI, 30 to 112) and 12 (95% CI, 7 to 50), respectively; risk was not significantly increased for acamprosate or topiramate. CONCLUSIONS AND RELEVANCE: Both acamprosate and oral naltrexone were associated with reduction in return to drinking. When directly compared with one another, no significant differences were found between acamprosate and naltrexone for controlling alcohol consumption. Factors such as dosing frequency, potential adverse events, and availability of treatments may guide medication choice.


Subject(s)
Alcohol-Related Disorders/drug therapy , Acamprosate , Fructose/adverse effects , Fructose/analogs & derivatives , Fructose/therapeutic use , Harm Reduction , Humans , Naltrexone/adverse effects , Naltrexone/analogs & derivatives , Naltrexone/therapeutic use , Outpatients , Randomized Controlled Trials as Topic , Taurine/adverse effects , Taurine/analogs & derivatives , Taurine/therapeutic use , Topiramate
15.
J Prim Care Community Health ; 4(4): 294-306, 2013 Oct.
Article in English | MEDLINE | ID: mdl-23799670

ABSTRACT

BACKGROUND: Depression concomitant with chronic medical conditions is common and burdensome in primary care. OBJECTIVE: To assess the effectiveness of practice-based interventions for improving depression and chronic medical outcomes. DATA SOURCES: MEDLINE, Embase, the Cochrane Library, CINAHL, and PsycINFO from inception to June 11, 2012. STUDY SELECTION, APPRAISAL, AND SYNTHESIS: Two reviewers independently selected, extracted data from, and rated the quality of trials and systematic reviews. Strength of evidence (SOE) was graded using established criteria. RESULTS: Twenty-four published articles reported data from 12 studies, all at least 6 months long. All studies compared a form of collaborative care with usual or enhanced usual care. Studies evaluated adults with arthritis, cancer, diabetes, heart disease, HIV, or multiple medical conditions. Meta-analyses found that intervention recipients achieved greater improvement than controls in depression symptoms, response, remission, and depression-free days (moderate SOE); satisfaction with care (moderate SOE); and quality of life (moderate SOE). Few data were available on outcomes for chronic medical conditions. Meta-analyses revealed that patients with diabetes receiving collaborative care exhibited no difference in diabetes control compared with control groups (change in HbA1c: weighted mean difference 0.13, 95% confidence interval = -0.22 to 0.48 at 6 months; 0.24, 95% confidence interval = -0.14 to 0.62 at 12 months; low SOE). The only study to use HbA1c as a predefined outcome measure and a "treat-to-target" intervention for diabetes as well as depression, TEAMcare, reported significant reductions in HbA1c (7.42 vs 7.87 at 6 months; 7.33 vs 7.81 at 12 months; overall P < .001). LIMITATIONS: Few relevant trials reported on medical outcomes. CONCLUSIONS: Collaborative care interventions improved outcomes for depression and quality of life in primary care patients with varying medical conditions. Few data were available on medical outcomes. Future studies of concomitant depression and chronic medical conditions should consider measures of medical outcomes as primary outcomes.


Subject(s)
Chronic Disease/therapy , Cooperative Behavior , Delivery of Health Care , Depression/therapy , Depressive Disorder/therapy , Primary Health Care , Arthritis/therapy , Depression/complications , Depressive Disorder/complications , Diabetes Mellitus/therapy , HIV Infections/therapy , Heart Diseases/therapy , Humans , Neoplasms/therapy
16.
Ann Intern Med ; 157(9): 645-54, 2012 Nov 06.
Article in English | MEDLINE | ID: mdl-23007881

ABSTRACT

BACKGROUND: Alcohol misuse, which includes the full spectrum from risky drinking to alcohol dependence, is a leading cause of preventable death in the United States. PURPOSE: To evaluate the benefits and harms of behavioral counseling interventions for adolescents and adults who misuse alcohol. DATA SOURCES: MEDLINE, EMBASE, the Cochrane Library, CINAHL, PsycINFO, International Pharmaceutical Abstracts, and reference lists of published literature (January 1985 through January 2012, limited to English-language articles). STUDY SELECTION: Controlled trials at least 6 months' duration that enrolled persons with alcohol misuse identified by screening in primary care settings and evaluated behavioral counseling interventions. DATA EXTRACTION: One reviewer extracted data and a second checked accuracy. Two independent reviewers assigned quality ratings and graded the strength of the evidence. DATA SYNTHESIS: The 23 included trials generally excluded persons with alcohol dependence. The best evidence was for brief (10- to 15-minute) multicontact interventions. Among adults receiving behavioral interventions, consumption decreased by 3.6 drinks per week from baseline (weighted mean difference, 3.6 drinks/wk [95% CI, 2.4 to 4.8 drinks/wk]; 10 trials; 4332 participants), 12% fewer adults reported heavy drinking episodes (risk difference, 0.12 [CI, 0.07 to 0.16]; 7 trials; 2737 participants), and 11% more adults reported drinking less than the recommended limits (risk difference, 0.11 [CI, 0.08 to 0.13]; 9 trials; 5973 participants) over 12 months compared with control participants (moderate strength of evidence). Evidence was insufficient to draw conclusions about accidents, injuries, or alcohol-related liver problems. Trials enrolling young adults or college students showed reduced consumption and fewer heavy drinking episodes (moderate strength of evidence). Little or no evidence of harms was found. LIMITATIONS: Results may be biased to the null because the behavior of control participants could have been affected by alcohol misuse assessments. In addition, evidence is probably inapplicable to persons with alcohol dependence and selective reporting may have occurred. CONCLUSION: Behavioral counseling interventions improve behavioral outcomes for adults with risky drinking. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.


Subject(s)
Alcohol-Related Disorders/therapy , Behavior Therapy/methods , Counseling , Primary Health Care , Alcohol Drinking , Alcohol-Related Disorders/complications , Humans , Randomized Controlled Trials as Topic
17.
Med Care Res Rev ; 68(1): 3-33, 2011 Feb.
Article in English | MEDLINE | ID: mdl-20675353

ABSTRACT

Over the past 10 years, the field of health services and management research has seen renewed interest in the use of qualitative research methods. This article examines the volume and characteristics of qualitative research articles published in nine major health services and management journals between 1998 and 2008. Qualitative research articles comprise 9% of research articles published in these journals. Although the publication rate of qualitative research articles has not kept pace with that of quantitative research articles, citation analysis suggests that qualitative research articles contribute comparably to the field's knowledge base. A wide range of policy and management topics has been examined using qualitative methods. Case study designs, interviews, and documentary sources were the most frequently used methods. Half of qualitative research articles provided little or no detail about key aspects the study's methods. Implications are discussed and recommendations are offered for promoting the publication of qualitative research.


Subject(s)
Health Services Research/methods , Qualitative Research , Data Collection , Humans , Research Design
18.
J Health Care Poor Underserved ; 19(4): 1044-59, 2008 Nov.
Article in English | MEDLINE | ID: mdl-19029736

ABSTRACT

INTRODUCTION: The community health worker (CHW) model is a popular method for reaching vulnerable populations with diabetes. This study assessed implementation and effectiveness of the model within diabetes programs. METHODS: Four databases were searched to identify diabetes programs implementing the CHW model. Corresponding articles were reviewed and semi-structured interviews were conducted with directors of each program. RESULTS: Eight studies met inclusion criteria for review and their program managers were interviewed. Five CHW roles were identified: educator, case manager, role model, program facilitator, and advocate. Roles, responsibilities and training varied greatly across programs. Selected outcomes also varied, ranging from physiologic measures, to health behaviors, to measures of health care utilization and cost. CONCLUSIONS: Research regarding application of the community health worker model in diabetes management is limited and consensus regarding the scope of the CHW's role is lacking. Future studies should rigorously examine how best to integrate this promising model into chronic disease management.


Subject(s)
Community Health Workers , Diabetes Mellitus/therapy , Health Services Accessibility/organization & administration , Diabetes Mellitus/prevention & control , Health Behavior , Health Education/organization & administration , Health Knowledge, Attitudes, Practice , Humans , Personnel Selection/organization & administration , Professional Role
19.
Diabetes Educ ; 34(5): 824-33, 2008.
Article in English | MEDLINE | ID: mdl-18832287

ABSTRACT

PURPOSE: The purpose of this qualitative study was to examine methods of implementation of the community health worker (CHW) model within diabetes programs, as well as related challenges and lessons learned. METHODS: Semi-structured interviews were conducted with program managers. Four databases (PubMed, CINAHL, ISI Web of Knowledge, PsycInfo), the CDC's 1998 directory of CHW programs, and Google Search Engine were used to identify CHW programs. Criteria for inclusion were: DM program; used CHW strategy; occurred in United States. Two independent reviewers performed content analyses to identify major themes and findings. Sixteen programs were assessed, all but 3 focused on minority populations. Most CHWs were recruited informally; 6 programs required CHWs to have diabetes. RESULTS: CHW roles and responsibilities varied across programs; educator was the most commonly identified role. Training also varied in terms of both content and intensity. All programs gave CHWs remuneration for their work. Common challenges included difficulties with CHW retention, intervention fidelity and issues related to sustainability. Cultural and gender issues also emerged. Examples of lessons learned included the need for community buy-in and the need to anticipate nondiabetes related issues. CONCLUSIONS: Lessons learned from these programs may be useful to others as they apply the CHW model to diabetes management within their own communities. Further research is needed to elucidate the specific features of this model necessary to positively impact health outcomes.


Subject(s)
Diabetes Mellitus/rehabilitation , Patient Education as Topic , Humans , Interviews as Topic , Mentors , Multicenter Studies as Topic , Patient Advocacy , Self Care , Teaching/methods , United States
20.
Med Care Res Rev ; 65(4): 379-436, 2008 Aug.
Article in English | MEDLINE | ID: mdl-18511812

ABSTRACT

Health care practitioners and change experts contend that organizational readiness for change is a critical precursor to successful change implementation. This article assesses how organizational readiness for change has been defined and measured in health services research and other fields. Analysis of 106 peer-reviewed articles reveals conceptual ambiguities and disagreements in current thinking and writing about organizational readiness for change. Inspection of 43 instruments for measuring organizational readiness for change reveals limited evidence of reliability or validity for most publicly available measures. Several conceptual and methodological issues that need to be addressed to generate knowledge useful for practice are identified and discussed.


Subject(s)
Health Facility Administration , Organizational Culture , Organizational Innovation
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