Randomised trial of treatment of hypertension in elderly patients in primary care

A randomised trial of the treatment of hypertension in 884 patients aged 60 to 79 years at the onset showed a reduction of 18/11 mm Hg in blood pressure over a mean follow up period of 4.4 years. The principal antihypertensive agents were atenolol and bendrofluazide. There was a reduction in the rate of fatal stroke in the treatment group to 30% of that in the control group (95% confidence interval 11-84%, p less than 0.025). The rate of all strokes (fatal and non-fatal) in the treatment group was 58% of that in the control group (95% confidence interval 35-96%, p less than 0.03). The incidence of myocardial infarction and total mortality was unaffected by treatment. Questionnaires completed by the patients and their relatives failed to identify any differences in symptoms that were likely to be due to treatment.     

Randomised controlled trial of pantoprazole versus ranitidine for the treatment of uninvestigated heartburn in primary care

OBJECTIVES: To investigate whether pantoprazole (20 mg/d) produces significantly greater symptom control than ranitidine (300 mg/d) in patients with gastro-oesophageal reflux disease (GORD). DESIGN: Multicentre, randomised, double-blind, parallel-group comparison. SETTING: 76 general practices in north-west Sydney and Newcastle, New South Wales (Australia), from 19 January 1999 to 22 September 2000. PATIENTS: 307 patients aged 18 years or over presenting with symptomatic GORD. INTERVENTIONS: Pantoprazole (20 mg once daily) or ranitidine (150 mg twice daily). MAIN OUTCOME MEASURES: Patient-assessed frequency and severity of heartburn using the Gastrointestinal Symptom Rating Scale (GSRS) and a patient heartburn diary. RESULTS: Pantoprazole was associated with significantly higher rates of complete control of GORD symptoms than ranitidine at four weeks (40% v 19%; P < 0.001), eight weeks (55% v 33%; P < 0.001), six months (71% v 56%; P = 0.007) and 12 months (77% v 59%; P = 0.001). CONCLUSIONS: Low-dose pantoprazole is an effective alternative to standard-dose ranitidine for initial and maintenance treatment of patients with symptomatic GORD.     

Randomised controlled trial to change the hospital management of unstable angina

OBJECTIVES: To examine the benefits of a guideline-based educational program to improve management of unstable angina pectoris (UAP) in hospital patients. DESIGN: Randomised controlled trial. SETTING: 37 public hospitals across New South Wales. PATIENTS: 1,872 patients admitted with a diagnosis of UAP between 1 February and 30 June 1996 (baseline survey), and 1,368 patients with the same diagnosis admitted between 1 July and 31 December 1998 (follow-up survey). INTERVENTION: Educational sessions run by local opinion leaders, presenting guidelines on management of UAP from the National Health and Medical Research Council and feedback on local practice using data from the baseline survey. Sessions were run between March and June 1998. MAIN OUTCOME MEASURES: Use of evidence-based practice, identified by review of medical records. RESULTS: Use of beta-blockers increased in intervention and control hospitals, although the increase was significant only in the former. Use of calcium-channel blockers decreased significantly in both intervention and control hospitals. However, the change in drug use between baseline and follow-up did not differ significantly between intervention and control hospitals. CONCLUSIONS: Despite some appropriate changes in drug use for UAP management between 1996 and 1998, there was no evidence that a guideline-based educational program was of benefit in changing management. This reaffirms the difficulty of changing doctors' behaviour through practice guidelines. Alternative methods of encouraging evidence-based practice should be considered.     

Collaborative care management of late-life depression in the primary care setting: a randomized controlled trial

Context  Few depressed older adults receive effective treatment in primary care settings. Objective  To determine the effectiveness of the Improving Mood–Promoting Access to Collaborative Treatment (IMPACT) collaborative care management program for late-life depression. Design  Randomized controlled trial with recruitment from July 1999 to August 2001. Setting  Eighteen primary care clinics from 8 health care organizations in 5 states. Participants  A total of 1801 patients aged 60 years or older with major depression (17%), dysthymic disorder (30%), or both (53%). Intervention  Patients were randomly assigned to the IMPACT intervention (n = 906) or to usual care (n = 895). Intervention patients had access for up to 12 months to a depression care manager who was supervised by a psychiatrist and a primary care expert and who offered education, care management, and support of antidepressant management by the patient's primary care physician or a brief psychotherapy for depresssion, Problem Solving Treatment in Primary Care. Main Outcome Measures  Assessments at baseline and at 3, 6, and 12 months for depression, depression treatments, satisfaction with care, functional impairment, and quality of life. Results  At 12 months, 45% of intervention patients had a 50% or greater reduction in depressive symptoms from baseline compared with 19% of usual care participants (odds ratio [OR], 3.45; 95% confidence interval [CI], 2.71-4.38; P<.001). Intervention patients also experienced greater rates of depression treatment (OR, 2.98; 95% CI, 2.34-3.79; P<.001), more satisfaction with depression care (OR, 3.38; 95% CI, 2.66-4.30; P<.001), lower depression severity (range, 0-4; between-group difference, -0.4; 95% CI, -0.46 to -0.33; P<.001), less functional impairment (range, 0-10; between-group difference, -0.91; 95% CI, -1.19 to -0.64; P<.001), and greater quality of life (range, 0-10; between-group difference, 0.56; 95% CI, 0.32-0.79; P<.001) than participants assigned to the usual care group. Conclusion  The IMPACT collaborative care model appears to be feasible and significantly more effective than usual care for depression in a wide range of primary care practices.      

Randomised controlled trial of nicotine chewing-gum

The effectiveness of 2 mg nicotine chewing-gum as an aid to stopping smoking was compared with a placebo containing 1 mg nicotine, but unbuffered, in a double-blind randomised trial. Of 58 subjects given the active gum, 27 (47%) were not smoking at one-year follow-up compared with 12 (21%) of the 58 subjects treated with placebo (p less than 0.025). By the most stringent criterion of outcome, 18 (31%) subjects in the active treatment group and eight (14%) in the placebo group had not smoked at all from the start of treatment to follow-up at one year (p less than 0.05). Subjects receiving the active gum experienced less severe withdrawal symptoms and rated their gum as more helpful than did the placebo group. Minor side effects were common but only gastric symptoms were more frequent with the active gum. Subjects receiving active gum used it for longer than those receiving placebo but most stopped using it within six months and only four (7%) developed longer-term dependence. The number of gums used daily correlated significantly with pretreatment blood nicotine concentrations in the active treatment group and with pretreatment cigarette consumption in the placebo group. A lower pretreatment blood nicotine value was the best predictor of success at one year (p less than 0.001) but there was no significant relation to cigarette consumption, sex, and social class. The results clearly confirm the usefulness of nicotine chewing-gum as an aid to stopping smoking and imply a definite role for nicotine in cigarette dependence and withdrawal. Successful use of the gum requires careful attention to subjects' expectations and clear instructions on how to use it.     

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.     

Randomised controlled trial of routine hospital clinic care versus routine general practice care for type II diabetics

Two hundred patients with type II diabetes were entered into a randomised controlled trial lasting five years to compare routine care of this condition by a hospital diabetic clinic with routine care in general practice. Fewer patients in the group being cared for by their general practitioner (general practice group) were regularly reviewed or had regular estimations of blood glucose concentration. More patients in the general practice group than in the hospital group were admitted to hospital for medical reasons during the study (25 (24%) compared with 17 (18%] and more patients in the general practice group died (18) than did in the hospital group (6). At the end of the study mean concentrations of haemoglobin A1 were higher in the general practice group (10.4%) than in the hospital group (9.5%). Routine care in general practice for patients with type II diabetes was less satisfactory than care by the hospital diabetic clinic.     

Telephone psychotherapy and telephone care management for primary care patients starting antidepressant treatment: a randomized controlled trial

Context  Both antidepressant medication and structured psychotherapy have been proven efficacious, but less than one third of people with depressive disorders receive effective levels of either treatment. Objective  To compare usual primary care for depression with 2 intervention programs: telephone care management and telephone care management plus telephone psychotherapy. Design  Three-group randomized controlled trial with allocation concealment and blinded outcome assessment conducted between November 2000 and May 2002. Setting and Participants  A total of 600 patients beginning antidepressant treatment for depression were systematically sampled from 7 group-model primary care clinics; patients already receiving psychotherapy were excluded. Interventions  Usual primary care; usual care plus a telephone care management program including at least 3 outreach calls, feedback to the treating physician, and care coordination; usual care plus care management integrated with a structured 8-session cognitive-behavioral psychotherapy program delivered by telephone. Main Outcome Measures  Blinded telephone interviews at 6 weeks, 3 months, and 6 months assessed depression severity (Hopkins Symptom Checklist Depression Scale and the Patient Health Questionnaire), patient-rated improvement, and satisfaction with treatment. Computerized administrative data examined use of antidepressant medication and outpatient visits. Results  Treatment participation rates were 97% for telephone care management and 93% for telephone care management plus psychotherapy. Compared with usual care, the telephone psychotherapy intervention led to lower mean Hopkins Symptom Checklist Depression Scale depression scores (P = .02), a higher proportion of patients reporting that depression was "much improved" (80% vs 55%, P<.001), and a higher proportion of patients "very satisfied" with depression treatment (59% vs 29%, P<.001). The telephone care management program had smaller effects on patient-rated improvement (66% vs 55%, P = .04) and satisfaction (47% vs 29%, P = .001); effects on mean depression scores were not statistically significant. Conclusions  For primary care patients beginning antidepressant treatment, a telephone program integrating care management and structured cognitive-behavioral psychotherapy can significantly improve satisfaction and clinical outcomes. These findings suggest a new public health model of psychotherapy for depression including active outreach and vigorous efforts to improve access to and motivation for treatment.      

Randomised controlled trial of graded exercise in chronic fatigue syndrome

OBJECTIVE: To investigate whether 12 weeks of graded exercise with pacing would improve specific physiological, psychological and cognitive functions in people with chronic fatigue syndrome (CFS). DESIGN: Randomised controlled trial. SETTING: Human performance laboratory at the University of Western Australia. PARTICIPANTS: 61 patients aged between 16 and 74 years diagnosed with CFS. INTERVENTIONS: Either graded exercise with pacing (32 patients) or relaxation/flexibility therapy (29 patients) performed twice a day over 12 weeks. MAIN OUTCOME MEASURES: Changes in any of the physiological, psychological or cognitive variables assessed. RESULTS: Following the graded exercise intervention, scores were improved for resting systolic blood pressure (P = 0.018), work capacity (W.kg(-1)) (P = 0.019), net blood lactate production (P = 0.036), depression (P = 0.027) and performance on a modified Stroop Colour Word test (P = 0.029). Rating of perceived exertion scores, associated with an exercise test, was lower after graded exercise (P = 0.013). No such changes were observed in the relaxation/flexibility condition, which served as an attention-placebo control. CONCLUSIONS: Graded exercise was associated with improvements in physical work capacity, as well as in specific psychological and cognitive variables. Improvements may be associated with the abandonment of avoidance behaviours.     

Computer assisted shared care in hypertension

A computer assisted shared care scheme for the long term management and follow up of hypertensive patients has been developed in the Grampian Region. The scheme aims at facilitating the exchange of clinically important information between doctors and at achieving target levels of blood pressure with treatment in patients at highest risk of cardiovascular events. The shared care scheme has been well received by the local practitioners. Two hundred and fifty seven patients (18%) of 1426 patients under current long term follow up are assigned to follow up in the hospital aspect of the scheme. At the most recent visit 32% of patients in the hospital aspect and 10% of 1169 patients in the general practice aspect had blood pressure recordings above the target levels of 160/95 mm Hg. The stratification of patients formerly attending hospital clinics into grades of risk has rationalised our follow up procedures to allow the specialist resources to be freed and concentrated on those patients at highest risk and with the most complex problems. This computer assisted patient records system could be applied to other groups of high risk patients in whom long term follow up and surveillance are necessary--for example, patients with diabetes mellitus--and has implications for optimising and monitoring the delivery and outcome of care without overwhelming limited hospital resources.     

急性心肌梗死患者PCI延时与无延时应用比伐芦定的对照研究

目的 评价急性心肌梗死(AMI)患者接受经皮冠状动脉介入治疗(PCI)时无延时比伐芦定联合仅冠脉内替罗非班方案的疗效和安全性。方法 选取2020年4月—2021年3月蚌埠市第二人民医院心内科收治的150例AMI患者,采用随机数字表法随机分为2组：试验组(无延时组,75例)和对照组(延时组,75例)。观察2组患者术后TIMI血流分级(TFG)及校正的TIMI血流帧数计数(cTFC),术后90 min心电图ST段回落(STR)情况,术后第7天心功能指标,术后30 d内所有出血事件及术后30 d主要不良心血管事件(MACE)。结果 2组TFG、cTFC、术后90 min心电图STR(Z=0.524,P=0.770)、MACE(1.3%vs. 0,P=0.999)、左心室射血分数[(49.5±6.6) vs.(50.6±5.7),t=-1.092,P=0.276]、左心室舒张末期内径[(50.0±8.9) mm vs.(51.2±7.6) mm,t=-0.888,P=0.376]及室壁运动异常(86.7%vs. 90.1%,χ²=0.597,P=0.440)比较,差异均无...     

环孢菌素A滴眼液治疗类固醇依赖性变应性结膜炎的随机对照研究

目的:评价0.05%环孢菌素A滴眼液治疗类固醇依赖性变应性结膜炎的有效性、安全性和疗效。方法:前瞻性随机对照双盲研究,使用安慰剂作为对照。比较对于类固醇依赖性角结膜炎和春季角结膜炎患者,使用环孢菌素A滴眼液或安慰剂后,在缓解症状、体征上的效果,以及是否能减少或停用皮质     

Geriatric care management for low-income seniors: a randomized controlled trial

Steven R. Counsell, MD; Christopher M. Callahan, MD; Daniel O. Clark, PhD; Wanzhu Tu, PhD; Amna B. Buttar, MD, MS; Timothy E. Stump, MS; Gretchen D. Ricketts, BSW

JAMA. 2007;298(22):2623-2633.

Context  Low-income seniors frequently have multiple chronic medical conditions for which they often fail to receive the recommended standard of care.

Objectives  To test the effectiveness of a geriatric care management model on improving the quality of care for low-income seniors in primary care.

Design, Setting, and Patients  Controlled clinical trial of 951 adults 65 years or older with an annual income less than 200% of the federal poverty level, whose primary care physicians were randomized from January 2002 through August 2004 to participate in the intervention (474 patients) or usual care (477 patients) in community-based health centers.

Intervention  Patients received 2 years of home-based care management by a nurse practitioner and social worker who collaborated with the primary care physician and a geriatrics interdisciplinary team and were guided by 12 care protocols for common geriatric conditions.

Main Outcome Measures  The Medical Outcomes 36-Item Short-Form (SF-36) scales and summary measures; instrumental and basic activities of daily living (ADLs); and emergency department (ED) visits not resulting in hospitalization and hospitalizations.

Results  Intention-to-treat analysis revealed significant improvements for intervention patients compared with usual care at 24 months in 4 of 8 SF-36 scales: general health (0.2 vs –2.3, P = .045), vitality (2.6 vs –2.6, P < .001), social functioning (3.0 vs –2.3, P = .008), and mental health (3.6 vs –0.3, P = .001); and in the Mental Component Summary (2.1 vs –0.3, P < .001). No group differences were found for ADLs or death. The cumulative 2-year ED visit rate per 1000 was lower in the intervention group (1445 [n = 474] vs 1748 [n = 477], P = .03) but hospital admission rates per 1000 were not significantly different between groups (700 [n = 474] vs 740 [n = 477], P = .66). In a predefined group at high risk of hospitalization (comprising 112 intervention and 114 usual-care patients), ED visit and hospital admission rates were lower for intervention patients in the second year (848 [n = 106] vs 1314 [n = 105]; P = .03 and 396 [n = 106] vs 705 [n = 105]; P = .03, respectively).

Conclusions  Integrated and home-based geriatric care management resulted in improved quality of care and reduced acute care utilization among a high-risk group. Improvements in health-related quality of life were mixed and physical function outcomes did not differ between groups. Future studies are needed to determine whether more specific targeting will improve the program's effectiveness and whether reductions in acute care utilization will offset program costs.

Trial Registration  clinicaltrials.gov Identifier: NCT00182962

     

Integrating primary medical care with addiction treatment: a randomized controlled trial

CONTEXT: The prevalence of medical disorders is high among substance abuse patients, yet medical services are seldom provided in coordination with substance abuse treatment. OBJECTIVE: To examine differences in treatment outcomes and costs between integrated and independent models of medical and substance abuse care as well as the effect of integrated care in a subgroup of patients with substance abuse-related medical conditions (SAMCs). DESIGN: Randomized controlled trial conducted between April 1997 and December 1998. SETTING AND PATIENTS: Adult men and women (n = 592) who were admitted to a large health maintenance organization chemical dependency program in Sacramento, Calif. INTERVENTIONS: Patients were randomly assigned to receive treatment through an integrated model, in which primary health care was included within the addiction treatment program (n = 285), or an independent treatment-as-usual model, in which primary care and substance abuse treatment were provided separately (n = 307). Both programs were group based and lasted 8 weeks, with 10 months of aftercare available. MAIN OUTCOME MEASURES: Abstinence outcomes, treatment utilization, and costs 6 months after randomization. RESULTS: Both groups showed improvement on all drug and alcohol measures. Overall, there were no differences in total abstinence rates between the integrated care and independent care groups (68% vs 63%, P =.18). For patients without SAMCs, there were also no differences in abstinence rates (integrated care, 66% vs independent care, 73%; P =.23) and there was a slight but nonsignificant trend of higher costs for the integrated care group ($367.96 vs $324.09, P =.19). However, patients with SAMCs (n = 341) were more likely to be abstinent in the integrated care group than the independent care group (69% vs 55%, P =.006; odds ratio [OR], 1.90; 95% confidence interval [CI], 1.22-2.97). This was true for both those with medical (OR, 3.38; 95% CI, 1.68-6.80) and psychiatric (OR, 2.10; 95% CI, 1.04-4.25) SAMCs. Patients with SAMCs had a slight but nonsignificant trend of higher costs in the integrated care group ($470.81 vs $427.95, P =.14). The incremental cost-effectiveness ratio per additional abstinent patient with an SAMC in the integrated care group was $1581. CONCLUSIONS: Individuals with SAMCs benefit from integrated medical and substance abuse treatment, and such an approach can be cost-effective. These findings are relevant given the high prevalence and cost of medical conditions among substance abuse patients, new developments in medications for addiction, and recent legislation on parity of substance abuse with other medical benefits.     

Randomized, controlled trial of clonidine for smoking cessation in a primary care setting

Clonidine hydrochloride has been reported to reduce tobacco withdrawal symptoms and facilitate smoking cessation. We enrolled 185 subjects, 92 receiving clonidine and 93 receiving placebo, in a randomized, double-blind study of clonidine for smoking cessation in a primary care setting. Clonidine had no demonstrable effect on withdrawal (8 of 11 measures favoring placebo). At 4 weeks, 17 (18%) subjects receiving clonidine had quit compared with 13 (14%) receiving placebo (chi 2 = 0.7; 90% confidence interval of benefit from clonidine, -4% to 13%). At 4 weeks, the mean number of cigarettes smoked was 17.7 for those receiving clonidine and 17.5 for those receiving placebo (t = 0.1; 90% confidence interval of benefit from clonidine, -4.1 to 3.7 cigarettes per day). These results provide little support for a beneficial effect of clonidine on tobacco withdrawal symptoms, quitting, or smoking reduction in a primary care setting.     

Randomised controlled comparative study of methyldopa and oxprenolol in treatment of hypertension in pregnancy

One hundred pregnant women with hypertension (defined as diastolic blood pressure at or above 95 mm Hg) were allocated at random to treatment with methyldopa or oxprenolol and were compared with nonhypertensive controls matched according to parity and gestation at delivery. The patients were also stratified into those entering the study early (before 32 weeks' gestation) and those entering late (after 32 weeks' gestation). Although there were no differences in diastolic blood pressure between the hypertensive groups before or during treatment, in the early entry group the systolic blood pressure at entry of those allocated to oxprenolol was significantly higher than that of those receiving methyldopa; this difference remained throughout the treatment period. Also in the early entry group further increments of drug treatment were required to control blood pressure of patients receiving oxprenolol than in those receiving methyldopa. The eventual fetal outcome for all patients treated with methyldopa was the same as that for those treated with oxprenolol; birth weight, placental weight, head circumference, and Apgar score were not significantly different and there were no stillbirths in either group.     

水中分娩与标准加强法用于第一产程难产的效果比较：随机对照试验

目的 评价第一产程水中分娩对初产妇硬膜外镇痛率和手术分娩率的影响。 设计 随机对照试验。 地点 南英格兰大学教学医院。 参与者 99例低并发症风险的难产(活跃期宫颈扩张<1厘米／小时)初产妇。 干预 浸入分娩池水中或标准处理难产的加强法(羊膜穿破术和静点催产素)。 主要结局测定 第一级:硬膜外镇痛率和手术分娩率。第二级:采用羊膜穿破术和催产素的加强率、产程长度、母婴发病率包括感染、母亲的疼痛分数,以及母亲对护理的满意度。 结果 随机分至水中分娩的妇女较加强组者有较低的硬膜外镇痛率(47％比66％,相对风险0.71[95％可信限0.49-1.01),需治疗的病人数目(NNT)为51。两组的手术分娩率没有差别[49％比50％,0.98(0.65-1.47),NNT98],但前者接受加强法[71％比96％,0.74(0.59-0.88),NNT4]或任何形式的产科干预(羊膜穿破术、催产素、硬膜外或手术分娩)明显减少[80％比98％,0.81(0.67-0.92),NNT5]。水中分娩组有更多的新生儿收入新生儿病房(6比0,P=0.013),但Apgar评分、感染率或脐血pH无差异。 结论 在助产士护理下的水中分娩对产程进展缓慢者也许是一种选择,它可降低对产科干预的需求,并提供了一个可供选择的处理疼痛的方法。     

影像诊断学计算机阅片考试的尝试

对97级学生进行计算机影像诊断学阅片考试.问卷调查显示学生"乐意"或"可以接受"此种考试,并认为能"准确"或"可以"反映平时掌握情况者占95.5%.与传统灯箱阅片考试相比,计算机阅片考试能真实地反映出学生的实际阅片能力,提高学生的阅片考试成绩.