Effectiveness of a strategy to improve adherence to tuberculosis treatment in a resource-poor setting: a cluster randomized controlled trial

Context  Poor adherence to treatment remains a major obstacle to efficient tuberculosis (TB) control in developing countries. Innovative strategies to improve access and adherence to treatment are needed. Objectives  To assess the effectiveness of a contextualized intervention strategy aimed at improving patients' adherence to treatment and to evaluate its impact on TB control in a resource-poor country in Africa with prevalent TB infection. Design, Setting, and Patients  A cluster randomized controlled trial, conducted between June 2003 and January 2005, at 16 government district health centers in Senegal. Patients older than 15 years with newly diagnosed sputum smear–positive pulmonary TB were randomly assigned to the intervention or control group. Intervention  The intervention strategy included reinforced counseling through improved communication between health personnel and patients, decentralization of treatment, choice of directly observed therapy (DOT) supporter by the patient, and reinforcement of supervision activities. In the control group, the usual TB control program procedures remained unchanged. Main Outcome Measure  Proportion of patients successfully completing the 8-month course of treatment and the proportion of patients defaulting from treatment. Results  A total of 1522 patients were recruited into the study. Treatment was successful for 682 (88%) of 778 patients recruited in the intervention group, and for 563 (76%) of 744 patients recruited in the control group (adjusted risk ratio [RR], 1.18; 95% confidence interval [CI], 1.03-1.34). The proportion of patients defaulting was reduced in the intervention group to 5.5% (n = 43) compared with 16.8% (n = 125) in the control group (adjusted RR, 0.43; 95% CI, 0.21-0.89). Conclusion  The intervention package based on improved patients counseling and communication, decentralization of treatment, patient choice of DOT supporter, and reinforcement of supervision activities led to improvement in patient outcomes compared with the usual TB control procedures. This approach may be generalized in the context of TB control programs in resource-poor countries. Trial Registration  clinicaltrials.gov Identifier: NCT00412009      

Impact of a web-based personally controlled health management system on influenza vaccination and health services utilization rates: a randomized controlled trial

Objective

To assess the impact of a web-based personally controlled health management system (PCHMS) on the uptake of seasonal influenza vaccine and primary care service utilization among university students and staff.

Materials and methods

A PCHMS called Healthy.me was developed and evaluated in a 2010 CONSORT-compliant two-group (6-month waitlist vs PCHMS) parallel randomized controlled trial (RCT) (allocation ratio 1:1). The PCHMS integrated an untethered personal health record with consumer care pathways, social forums, and messaging links with a health service provider.

Results

742 university students and staff met inclusion criteria and were randomized to a 6-month waitlist (n=372) or the PCHMS (n=370). Amongst the 470 participants eligible for primary analysis, PCHMS users were 6.7% (95% CI: 1.46 to 12.30) more likely than the waitlist to receive an influenza vaccine (waitlist: 4.9% (12/246, 95% CI 2.8 to 8.3) vs PCHMS: 11.6% (26/224, 95% CI 8.0 to 16.5); χ²=7.1, p=0.008). PCHMS participants were also 11.6% (95% CI 3.6 to 19.5) more likely to visit the health service provider (waitlist: 17.9% (44/246, 95% CI 13.6 to 23.2) vs PCHMS: 29.5% (66/224, 95% CI: 23.9 to 35.7); χ²=8.8, p=0.003). A dose–response effect was detected, where greater use of the PCHMS was associated with higher rates of vaccination (p=0.001) and health service provider visits (p=0.003).

Discussion

PCHMS can significantly increase consumer participation in preventive health activities, such as influenza vaccination.

Conclusions

Integrating a PCHMS into routine health service delivery systems appears to be an effective mechanism for enhancing consumer engagement in preventive health measures.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12610000386033. http://www.anzctr.org.au/trial_view.aspx?id=335463.     

Improving the use of hospice services in nursing homes: a randomized controlled trial

Context  Hospice care may improve the quality of end-of-life care for nursing home residents, but hospice is underutilized by this population, at least in part because physicians are not aware of their patients’ preferences. Objective  To determine whether it is possible to increase hospice utilization and improve the quality of end-of-life care by identifying residents whose goals and preferences are consistent with hospice care. Design, Setting, and Participants  Randomized controlled trial (December 2003-December 2004) of nursing home residents and their surrogate decision makers (N=205) in 3 US nursing homes. Intervention  A structured interview identified residents whose goals for care, treatment preferences, and palliative care needs made them appropriate for hospice care. These residents’ physicians were notified and asked to authorize a hospice informational visit. Main Outcome Measures  The primary outcome measures were (1) hospice enrollment within 30 days of the intervention and (2) families’ ratings of the quality of care for residents who died during the 6-month follow-up period. Results  Of the 205 residents in the study sample, 107 were randomly assigned to receive the intervention, and 98 received usual care. Intervention residents were more likely than usual care residents to enroll in hospice within 30 days (21/107 [20%] vs 1/98 [1%]; P<.001 [Fisher exact test]) and to enroll in hospice during the follow-up period (27/207 [25%] vs 6/98 [6%]; P<.001). Intervention residents had fewer acute care admissions (mean: 0.28 vs 0.49; P = .04 [Wilcoxon rank sum test]) and spent fewer days in an acute care setting (mean: 1.2 vs 3.0; P = .03 [Wilcoxon rank sum test]). Families of intervention residents rated the resident’s care more highly than did families of usual care residents (mean on a scale of 1-5: 4.1 vs 2.5; P = .04 [Wilcoxon rank sum test]). Conclusion  A simple communication intervention can increase rates of hospice referrals and families’ ratings of end-of-life care and may also decrease utilization of acute care resources.      

Group interpersonal psychotherapy for depression in rural Uganda: a randomized controlled trial

Context  Despite the importance of mental illness in Africa, few controlled intervention trials related to this problem have been published. Objectives  To test the efficacy of group interpersonal psychotherapy in alleviating depression and dysfunction and to evaluate the feasibility of conducting controlled trials in Africa. Design, Setting, and Participants  For this cluster randomized, controlled clinical trial (February-June 2002), 30 villages in the Masaka and Rakai districts of rural Uganda were selected using a random procedure; 15 were then randomly assigned for studying men and 15 for women. In each village, adult men or women believed by themselves and other villagers to have depressionlike illness were interviewed using a locally adapted Hopkins Symptom Checklist and an instrument assessing function. Based on these interviews, lists were created for each village totaling 341 men and women who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for major depression or subsyndromal depression. Interviewers revisited them in order of decreasing symptom severity until they had 8 to 12 persons per village, totaling 284. Of these, 248 agreed to be in the trial and 9 refused; the remainder died or relocated. A total of 108 men and 116 women completed the study and were reinterviewed. Intervention  Eight of the 15 male villages and 7 of the 15 female villages were randomly assigned to the intervention arm and the remainder to the control arm. The intervention villages received group interpersonal psychotherapy for depression as weekly 90-minute sessions for 16 weeks. Main Outcome Measures  Depression and dysfunction severity scores on scales adapted and validated for local use; proportion of persons meeting DSM-IV major depression diagnostic criteria. Results  Mean reduction in depression severity was 17.47 points for intervention groups and 3.55 points for controls (P<.001). Mean reduction in dysfunction was 8.08 and 3.76 points, respectively (P<.001). After intervention, 6.5% and 54.7% of the intervention and control groups, respectively, met the criteria for major depression (P<.001) compared with 86% and 94%, respectively, prior to intervention (P = .04). The odds of postintervention depression among controls was 17.31 (95% confidence interval, 7.63-39.27) compared with the odds among intervention groups. Results from intention-to-treat analyses remained statistically significant. Conclusions  Group interpersonal psychotherapy was highly efficacious in reducing depression and dysfunction. A clinical trial proved feasible in the local setting. Both findings should encourage similar trials in similar settings in Africa and beyond.      

Treatment of complicated grief: a randomized controlled trial

Context  Complicated grief is a debilitating disorder associated with important negative health consequences, but the results of existing treatments for it have been disappointing. Objective  To compare the efficacy of a novel approach, complicated grief treatment, with a standard psychotherapy (interpersonal psychotherapy). Design  Two-cell, prospective, randomized controlled clinical trial, stratified by manner of death of loved one and treatment site. Setting  A university-based psychiatric research clinic as well as a satellite clinic in a low-income African American community between April 2001 and April 2004. Participants  A total of 83 women and 12 men aged 18 to 85 years recruited through professional referral, self-referral, and media announcements who met criteria for complicated grief. Interventions  Participants were randomly assigned to receive interpersonal psychotherapy (n = 46) or complicated grief treatment (n = 49); both were administered in 16 sessions during an average interval of 19 weeks per participant. Main Outcome Measure  Treatment response, defined either as independent evaluator-rated Clinical Global Improvement score of 1 or 2 or as time to a 20-point or better improvement in the self-reported Inventory of Complicated Grief. Results  Both treatments produced improvement in complicated grief symptoms. The response rate was greater for complicated grief treatment (51%) than for interpersonal psychotherapy (28%; P = .02) and time to response was faster for complicated grief treatment (P = .02). The number needed to treat was 4.3. Conclusion  Complicated grief treatment is an improved treatment over interpersonal psychotherapy, showing higher response rates and faster time to response.      

School-based mental health intervention for children affected by political violence in Indonesia: a cluster randomized trial

Wietse A. Tol, MA; Ivan H. Komproe, PhD; Dessy Susanty, MPsych; Mark J. D. Jordans, MA; Robert D. Macy, PhD; Joop T. V. M. De Jong, MD, PhD

JAMA. 2008;300(6):655-662.

Context  Little is known about the efficacy of mental health interventions for children exposed to armed conflicts in low- and middle-income settings. Childhood mental health problems are difficult to address in situations of ongoing poverty and political instability.

Objective  To assess the efficacy of a school-based intervention designed for conflict-exposed children, implemented in a low-income setting.

Design, Setting, and Participants  A cluster randomized trial involving 495 children (81.4% inclusion rate) who were a mean (SD) age of 9.9 (1.3) years, were attending randomly selected schools in political violence–affected communities in Poso, Indonesia, and were screened for exposure (1 events), posttraumatic stress disorder, and anxiety symptoms compared with a wait-listed control group. Nonblinded assessment took place before, 1 week after, and 6 months after treatment between March and December 2006.

Intervention  Fifteen sessions, over 5 weeks, of a manualized, school-based group intervention, including trauma-processing activities, cooperative play, and creative-expressive elements, implemented by locally trained paraprofessionals.

Main Outcome Measures  We assessed psychiatric symptoms using the Child Posttraumatic Stress Scale, Depression Self-Rating Scale, the Self-Report for Anxiety Related Disorders 5-item version, and the Children's Hope Scale, and assessed function impairment as treatment outcomes using standardized symptom checklists and locally developed rating scales.

Results  Correcting for clustering of participants within schools, we found significantly more improvement in posttraumatic stress disorder symptoms (mean change difference, 2.78; 95% confidence interval [CI], 1.02 to 4.53) and maintained hope (mean change difference, –2.21; 95% CI, –3.52 to –0.91) in the treatment group than in the wait-listed group. Changes in traumatic idioms (stress-related physical symptoms) (mean change difference, 0.50; 95% CI, –0.12 to 1.11), depressive symptoms (mean change difference, 0.70; 95% CI, –0.08 to 1.49), anxiety (mean change difference, 0.12; 95% CI, –0.31 to 0.56), and functioning (mean change difference, 0.52; 95% CI, –0.43 to 1.46) were not different between the treatment and wait-listed groups.

Conclusions  In this study of children in violence-affected communities, a school-based intervention reduced posttraumatic stress symptoms and helped maintain hope, but did not reduce traumatic-stress related symptoms, depressive symptoms, anxiety symptoms, or functional impairment.

Trial Registration  isrctn.org Identifier: ISRCTN25172408

     

卡比托辛减少阴道分娩后出血的随机对照研究

目的 本实验研究新型长效缩宫素类药物卡比托辛减少产后出血的疗效及其安全性.方法 选入妊娠32周至42周可经阴道分娩的孕产妇共231位,随机分组.试验组115例,断脐后单次肌注卡比托辛100 μg;缩宫素组116例,断脐后单次肌注缩宫素10 IU.观察比较两组分娩后24 h内的出血量及其他改变.结果 两组的均衡性良好.卡比托辛组的产后失血量和红细胞压积的改变均比缩宫素组有显著地降低(P＜0.05).而两组的副作用没有显著差别.结论 肌注卡比托辛降低阴道分娩后出血更为有效.     

Ipriflavone in the treatment of postmenopausal osteoporosis: a randomized controlled trial

CONTEXT: Data on the efficacy and safety of ipriflavone for prevention of postmenopausal bone loss are conflicting. OBJECTIVES: To investigate the effect of oral ipriflavone on prevention of postmenopausal bone loss and to assess the safety profile of long-term treatment with ipriflavone in postmenopausal osteoporotic women. DESIGN AND SETTING: Prospective, randomized, double-blind, placebo-controlled, 4-year study conducted in 4 centers in Belgium, Denmark, and Italy from August 1994 to July 1998. PARTICIPANTS: Four hundred seventy-four postmenopausal white women, aged 45 to 75 years, with bone mineral densities (BMDs) of less than 0.86 g/cm(2). INTERVENTIONS: Patients were randomly assigned to receive ipriflavone, 200 mg 3 times per day (n = 234), or placebo (n = 240); all received 500 mg/d of calcium. MAIN OUTCOME MEASURES: Efficacy measures included spine, hip, and forearm BMD and biochemical markers of bone resorption (urinary hydroxyproline corrected for creatinine and urinary CrossLaps [Osteometer Biotech, Herlev, Denmark] corrected for creatinine), assessed every 6 months. Laboratory safety measures and adverse events were recorded every 3 months. RESULTS: Based on intent-to-treat analysis, after 36 months of treatment, the annual percentage change from baseline in BMD of the lumbar spine for ipriflavone vs placebo (0.1% [95% confidence interval (CI), -7.9% to 8.1%] vs 0.8% [95% CI, -9.1% to 10.7%]; P =.14), or in any of the other sites measured, did not differ significantly between groups. The response in biochemical markers was also similar between groups (eg, for hydroxyproline corrected for creatinine, 20.13 mg/g [95% CI, 18.85-21.41 mg/g] vs 20.67 mg/g [95% CI, 19.41-21.92 mg/g]; P =.96); urinary CrossLaps corrected for creatinine, 268 mg/mol (95% CI, 249-288 mg/mol) vs 268 mg/mol (95% CI, 254-282 mg/mol); P =.81. The number of women with new vertebral fracture was identical or nearly so in the 2 groups at all time points. Lymphocyte concentrations decreased significantly (500/microL (0.5 x 10(9)/L]) in women treated with ipriflavone. Thirty-one women (13.2%) in the ipriflavone group developed subclinical lymphocytopenia, of whom 29 developed it during ipriflavone treatment. Of these, 15 (52%) of 29 had recovered spontaneously by 1 year and 22 (81%) of 29 by 2 years. CONCLUSIONS: Our data indicate that ipriflavone does not prevent bone loss or affect biochemical markers of bone metabolism. Additionally, ipriflavone induces lymphocytopenia in a significant number of women.     

Methadone maintenance in primary care: a randomized controlled trial

CONTEXT: Methadone maintenance is an effective treatment for opioid dependence, yet its use is restricted to federally licensed narcotic treatment programs (NTPs). Office-based care of stabilized methadone maintenance patients is a promising alternative but no data are available from controlled trials regarding this type of program. OBJECTIVE: To determine the feasibility and efficacy of office-based methadone maintenance by primary care physicians vs in an NTP for stable opioid-dependent patients. DESIGN: Six-month, randomized controlled open clinical trial conducted February 1999-March 2000. SETTING: Offices of 6 primary care internists and an NTP. PATIENTS: Forty-seven opioid-dependent patients who had been receiving methadone maintenance therapy in an NTP without evidence of illicit drug use for 1 year and without significant untreated psychiatric comorbidity were randomized; 1 patient refused to participate after treatment assignment to NTP. INTERVENTIONS: Patients were randomly assigned to receive office-based methadone maintenance from primary care physicians, who received specialized training in the care of opioid-dependent patients (n = 22), or usual care at an NTP (n = 24). MAIN OUTCOME MEASURES: Illicit drug use, clinical instability (persistent drug use), patient and clinician satisfaction, functional status, and use of health, legal, and social services, compared between the 2 groups. RESULTS: Eleven of 22 (50%; 95% confidence interval [CI], 29%-71%) patients in office-based care compared with 9 of 24 (38%; 95% CI, 21%-57%) of NTP patients had a self-report or urine toxicology test result indicating illicit opiate use (P =.39). Hair toxicology testing detected an additional 2 patients in each treatment group with evidence of illicit drug use, but this did not change the overall findings. Ongoing illicit drug use meeting criteria for clinical instability occurred in 4 of 22 (18%; 95% CI, 7%-39%) patients in office-based care compared with 5 of 24 (21%; 95% CI, 9%-41%) NTP patients (P =.82). Sixteen of the 22 (73%; 95% CI, 54%-92%) office-based patients compared with 3 of the 24 (13%; 95% CI, 0%-26%) NTP patients thought the quality of care was excellent (P =.001). There were no differences over time within or between groups in functional status or use of health, legal, or social services. CONCLUSIONS: Our results support the feasibility and efficacy of transferring stable opioid-dependent patients receiving methadone maintenance to primary care physicians' offices for continuing treatment and suggest guidelines for identifying patients and clinical monitoring.     

Paroxetine controlled release in the treatment of menopausal hot flashes: a randomized controlled trial

Context  Standard therapy for hot flashes has been hormone replacement with estradiol or progestational agents, but recent data suggest that antidepressants inhibiting serotonin reuptake may also be effective. Objective  To evaluate a selective serotonin reuptake inhibitor (paroxetine controlled release [CR]) in treating the vasomotor symptoms displayed by a general cross-section of menopausal women. Design and Setting  Randomized, double-blind, placebo-controlled, parallel group study conducted across 17 US sites, including urban, suburban, and rural clinics. Patients  A total of 165 menopausal women aged 18 years or older experiencing at least 2 to 3 daily hot flashes and must have discontinued any hormone replacement therapy for at least 6 weeks. Women were excluded if they had any signs of active cancer or were undergoing chemotherapy or radiation therapy. Intervention  After a 1-week placebo run-in phase, study participants were randomized to receive placebo or receive 12.5 mg/d or 25.0 mg/d of paroxetine CR (in a 1:1:1 ratio) for 6 weeks. Main Outcome Measures  Mean change from baseline to week 6 in the daily hot flash composite score (frequency x severity). Results  Fifty-six participants were randomly assigned to receive placebo and 51 to receive 12.5 mg/d and 58 to receive 25.0 mg/d of paroxetine CR. The mean reductions in the hot flash frequency composite score from baseline to week 6 were statistically significantly greater for those receiving paroxetine CR than for those receiving placebo. By week 6, the mean daily hot flash frequency went from 7.1 to 3.8 (mean reduction, 3.3) for those in the 12.5-mg/d and from 6.4 to 3.2 (mean reduction, 3.2) for those in the 25-mg/d paroxetine CR groups and from 6.6 to 4.8 (mean reduction, 1.8) for those in the placebo group. Mean placebo-adjusted reduction in hot flash composite scores were -4.7 (95% confidence interval, - 8.1 to -1.3; P = .007) comparing 12.5-mg/d paroxetine CR with placebo; and -3.6 (95% confidence interval, -6.8 to -0.4; P = .03) comparing 25.0-mg/d paroxetine CR with placebo. This corresponded to median reductions of 62.2% for those in the 12.5-mg/d and 64.6% for those in the 25.0-mg/d paroxetine CR groups compared with 37.8% for those in the placebo group. Conclusion  Paroxetine CR may be an effective and acceptable alternative to hormone replacement and other therapies in treating menopausal hot flash symptoms.      

Guggulipid for the treatment of hypercholesterolemia: a randomized controlled trial

Context  Herbal extracts from Commiphora mukul (guggul) have been widely used in Asia as cholesterol-lowering agents, and their popularity is increasing in the United States. Recently, guggulsterones, the purported bioactive compounds of guggul, have been shown to be potent antagonists of 2 nuclear hormone receptors involved in cholesterol metabolism, establishing a plausible mechanism of action for the hypolipidemic effects of these extracts. However, there are currently no published safety or efficacy data on the use of guggul extracts in Western populations. Objective  To study the short-term safety and efficacy of 2 doses of a standardized guggul extract (guggulipid, containing 2.5% guggulsterones) in healthy adults with hyperlipidemia eating a typical Western diet. Design  Double-blind, randomized, placebo-controlled trial using a parallel design, conducted March 2000-August 2001. Participants and Setting  A total of 103 ambulatory, community-dwelling, healthy adults with hypercholesterolemia in the Philadelphia, Pa, metropolitan area. Intervention  Oral, 3 times daily doses of standard-dose guggulipid (1000 mg), high-dose guggulipid (2000 mg), or matching placebo. Main Outcome Measures  Percentage change in levels of directly measured low-density lipoprotein cholesterol (LDL-C) after 8 weeks of therapy. Secondary outcome measures included levels of total cholesterol, high-density lipoprotein cholesterol (HDL-C), triglycerides, and directly measured very low-density lipoprotein cholesterol (VLDL-C), as well as adverse events reports and laboratory safety measures including electrolyte levels and hepatic and renal function. Results  Compared with participants randomized to placebo (n = 36), in whom levels of LDL-C decreased by 5%, both standard-dose guggulipid (n = 33) and high-dose guggulipid (n = 34) raised levels of LDL-C by 4% (P = .01 vs placebo) and 5% (P = .006 vs placebo), respectively, at 8 weeks, for a net positive change of 9% to 10%. There were no significant changes in levels of total cholesterol, HDL-C, triglycerides, or VLDL-C in response to treatment with guggulipid in the intention-to-treat analysis. While guggulipid was generally well tolerated, 6 participants treated with guggulipid developed a hypersensitivity rash compared with none in the placebo group. Conclusions  Despite plausible mechanisms of action, guggulipid did not appear to improve levels of serum cholesterol over the short term in this population of adults with hypercholesterolemia, and might in fact raise levels of LDL-C. Guggulipid also appeared to cause a dermatologic hypersensitivity reaction in some patients.      

Enzyme replacement therapy in Fabry disease: a randomized controlled trial

CONTEXT: Fabry disease is a metabolic disorder without a specific treatment, caused by a deficiency of the lysosomal enzyme alpha-galactosidase A (alpha-gal A). Most patients experience debilitating neuropathic pain and premature mortality because of renal failure, cardiovascular disease, or cerebrovascular disease. OBJECTIVE: To evaluate the safety and efficacy of intravenous alpha-gal A for Fabry disease. DESIGN AND SETTING: Double-blind placebo-controlled trial conducted from December 1998 to August 1999 at the Clinical Research Center of the National Institutes of Health. PATIENTS: Twenty-six hemizygous male patients, aged 18 years or older, with Fabry disease that was confirmed by alpha-gal A assay. INTERVENTION: A dosage of 0.2 mg/kg of alpha-gal A, administered intravenously every other week (12 doses total). MAIN OUTCOME MEASURE: Effect of therapy on neuropathic pain while without neuropathic pain medications measured by question 3 of the Brief Pain Inventory (BPI). RESULTS: Mean (SE) BPI neuropathic pain severity score declined from 6.2 (0.46) to 4.3 (0.73) in patients treated with alpha-gal A vs no significant change in the placebo group (P =.02). Pain-related quality of life declined from 3.2 (0.55) to 2.1 (0.56) for patients receiving alpha-gal A vs 4.8 (0.59) to 4.2 (0.74) for placebo (P =.05). In the kidney, glomeruli with mesangial widening decreased by a mean of 12.5% for patients receiving alpha-gal vs a 16.5% increase for placebo (P =.01). Mean inulin clearance decreased by 6.2 mL/min for patients receiving alpha-gal A vs 19.5 mL/min for placebo (P =.19). Mean creatinine clearance increased by 2.1 mL/min (0.4 mL/s) for patients receiving alpha-gal A vs a decrease of 16.1 mL/min (0.3 mL/s) for placebo (P =.02). In patients treated with alpha-gal A, there was an approximately 50% reduction in plasma glycosphingolipid levels, a significant improvement in cardiac conduction, and a significant increase in body weight. CONCLUSION: Intravenous infusions of alpha-gal A are safe and have widespread therapeutic efficacy in Fabry disease.     

Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial

Context  There has been increasing interest in the use of health-related quality-of-life (HRQL) assessments in daily clinical practice, yet few empirical studies have been conducted to evaluate the usefulness of such assessments. Objective  To evaluate the efficacy of standardized HRQL assessments in facilitating patient-physician communication and increasing physicians' awareness of their patients' HRQL-related problems. Design  Prospective, randomized crossover trial. Setting  Outpatient clinic of a cancer hospital in the Netherlands. Participants  Ten physicians and 214 patients (76% women; mean age, 57 years) undergoing palliative chemotherapy who were invited to participate between June 1996 and June 1998. Intervention  At 3 successive outpatient visits, patients completed an HRQL questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30). The responses were computer scored and transformed into a graphic summary. Physicians and patients received a copy of the summary before the consultation. Main Outcome Measures  Audiotapes of the consultations were content analyzed to evaluate patient-physician communication. Physicians' awareness of their patients' health problems was assessed by comparing physicians' and patients' ratings on the Dartmouth Primary Care Cooperative Information Functional Health Assessment (COOP) and the World Organisation Project of National Colleges and Academics (WONCA) charts. Results  The HRQL-related issues were discussed significantly more frequently in the intervention than in the control group (mean [SD] communication composite scores: 4.5 [2.3] vs 3.7 [1.9], respectively (P = .01). Physicians in the intervention group identified a greater percentage of patients with moderate-to-severe health problems in several HRQL domains than did those in the control group. All physicians and 87% of the patients believed that the intervention facilitated communication and expressed interest in its continued use. Conclusion  Incorporating standardized HRQL assessments in daily clinical oncology practice facilitates the discussion of HRQL issues and can heighten physicians' awareness of their patients' HRQL.      

社会技能训练对有行为问题儿童影响的随机对照研究

目的:验证以社会技能训练为主的综合矫正模式对儿童行为问题的干预效果.方法:选取7～14岁符合Rutter行为问题标准的101名儿童,用隐藏式随机数字信封法将其随机分为干预组50人和对照组51人.对干预组采用以社会技能训练为主的干预方案,进行为期12周的干预;对照组等待12周,在干预组干预结束后才开始进行干预.采用Rutter儿童行为父母问卷、教师问卷和Achenbach儿童行为量表作为儿童行为问题评定工具.结果:干预后,比较两组Rutter儿童行为父母问卷的减分值,干预组总分减分(4.10±3.21)、A(反社会行为/违纪行为)分减分(1.10±1.37)和N(神经症行为)分减分(1.32±0.91)与对照组总分减分(1.29±3.15)、A分减分(0.53±1.17)和N分减分(0.71±1.10)相比差异有统计学意义(均为P＜0.05),干预组有34%的儿童恢复正常.比较两组的Rutter儿童行为教师问卷的减分值,干预组总分减分(2.50±1.96)、A分减分(0.74±1.10)和N分减分(0.96±0.95)与对照组总分减分(0.82±1.60)、A分减分(0.12±0.48)和N分减分(0.43±0.81)比较差异有统计学意义(均为P＜0.01),干预组有58%的儿童恢复正常.比较两组的Achenbach儿童行为量表,干预组总分减分(5.44±3.98)、体诉减分(1.10±1.27)和违纪减分(1.36±1.35)与对照组总分减分(1.49±3.34)、体诉减分(0.33±1.52)和违纪减分(0.65±1.26)相比差异有统计学意义(均为P＜0.01),干预组干预后的总有效率为54%.结论:以社会技能训练为主的综合矫正模式可以有效改善儿童的行为问题,并且切实可行.     

Alcohol: its health and social impact in India

Alcoholic beverages have been used in human societies since the beginning of recorded history. The patterns of alcohol intake around the world are constantly evolving, and alcohol is ubiquitous today. Research has contributed substantially to our understanding of the relation of drinking to specific disorders, and has shown that the relation between alcohol consumption and health outcomes is complex and multidimensional. Increases in the average volume of drinking are predicted for the most populous regions of the world in Southeast Asia including India. Cultural differences apparently influence the pattern of alcohol consumption. In addition, alcohol is linked to categories of disease whose relative impact on the global burden is predicted to increase. Therefore, it is appropriate to implement policies with targeted harm reduction strategies. The crucial need, from a public health perspective, is for regular means of coordination whereby prevention of alcohol-related problems is taken fully into account in policy decisions about alcohol control and regulation in the market for alcoholic beverages.