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Showing papers on "Randomized controlled trial published in 1996"


Journal ArticleDOI
TL;DR: An instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research is described and its use to determine the effect of rater blinding on the assessments of quality is described.

15,740 citations


Journal ArticleDOI
28 Aug 1996-JAMA
TL;DR: For RCTs to ultimately benefit patients, the published report should be of the highest possible standard and should provide the reader with the ability to make informed judgments regarding the internal and external validity of the trial.
Abstract: THE RANDOMIZED controlled trial (RCT), more than any other methodology, can have a powerful and immediate impact on patient care. Ideally, the report of such an evaluation needs to convey to the reader relevant information concerning the design, conduct, analysis, and generalizability of the trial. This information should provide the reader with the ability to make informed judgments regarding the internal and external validity of the trial. Accurate and complete reporting also benefits editors and reviewers in their deliberations regarding submitted manuscripts. For RCTs to ultimately benefit patients, the published report should be of the highest possible standard. For editorial comment see p 649. Evidence produced repeatedly over the last 30 years indicates a wide chasm between what a trial should report and what is actually published in the literature. In a review of 71 RCTs with negative results published between 1960 and 1975, the authors reported that the vast

3,197 citations


Journal ArticleDOI
TL;DR: For RCTs to ultimately benefit patients, the published report should be of the highest possible standard and accurate and complete reporting is needed.

1,662 citations


Journal ArticleDOI
TL;DR: Daily screening of the respiratory function of adults receiving mechanical ventilation, followed by trials of spontaneous breathing in appropriate patients and notification of their physicians when the trials were successful, can reduce the duration of mechanical ventilation and the cost of intensive care and is associated with fewer complications than usual care.
Abstract: Background Prompt recognition of the reversal of respiratory failure may permit earlier discontinuation of mechanical ventilation, without harm to the patient. Methods We conducted a randomized, controlled trial in 300 adult patients receiving mechanical ventilation in medical and coronary intensive care units. In the intervention group, patients underwent daily screening of respiratory function by physicians, respiratory therapists, and nurses to identify those possibly capable of breathing spontaneously; successful tests were followed by two-hour trials of spontaneous breathing in those who met the criteria. Physicians were notified when their patients successfully completed the trials of spontaneous breathing. The control subjects had daily screening but no other interventions. In both groups, all clinical decisions, including the decision to discontinue mechanical ventilation, were made by the attending physicians. Results Although the 149 patients randomly assigned to the intervention group had more ...

1,301 citations


Journal ArticleDOI
TL;DR: The effects of two exercise approaches, Tai Chi and computerized balance training, on specified primary outcomes (biomedical, functional, and psychosocial indicators of frailty) and secondary outcomes (occurrence of falls) are evaluated.
Abstract: OBJECTIVE: To evaluate the effects of two exercise approaches, Tai Chi (TC) and computerized balance training (BT), on specified primary outcomes (biomedical, functional, and psychosocial indicators of frailty) and secondary outcomes (occurrence of falls). DESIGN: The Atlanta FICSIT (Frailty and Injuries: Cooperative Studies of Intervention Techniques), a prospective, randomized, controlled clinical trial with three arms (TC, BT, and education [ED]). Intervention length was 15 weeks, with primary outcomes measured before and after intervention and at 4-month follow-up. Falls were monitored continuously throughout the study. SETTING: Persons aged 70 and older living in the community. PARTICIPANTS: A total of 200 participants, 162 women and 38 men; mean age was 76.2. MEASUREMENTS: Biomedical (strength, flexibility, cardiovascular endurance, body composition), functional (IADL), and psychosocial well-being (CES-D scale, fear of falling questionnaire, self-perception of present and future health, mastery index, perceived quality of sleep, and intrusiveness) variables. RESULTS: Grip strength declined in all groups, and lower extremity range of motion showed limited but statistically significant changes. Lowered blood pressure before and after a 12-minute walk was seen following TC participation. Fear of falling responses and intrusiveness responses were reduced after the TC intervention compared with the ED group (P = .046 and P = .058, respectively). After adjusting for fall risk factors, TC was found to reduce the risk of multiple falls by 47.5%. CONCLUSIONS: A moderate TC intervention can impact favorably on defined biomedical and psychosocial indices of frailty. This intervention can also have favorable effects upon the occurrence of falls. Tai Chi warrants further study as an exercise treatment to improve the health of older people.

1,127 citations


Journal ArticleDOI
TL;DR: MMF is associated with a significantly lower rate of treatment failure compared with AZA during the first 6 months after renal transplantation and produces a clinically important reduction in the incidence, severity, and treatment of acute graft rejection.
Abstract: Mycopehenolate mofetil (MMF) is a powerful immunosuppressant that inhibits the proliferation of T and B lymphocytes by blocking the enzyme inosine monophosphate dehydrogenase. MMF has been shown to prevent acute graft rejection in animal experiments and may have an important role in clinical renal transplantation. We conducted a prospective, double-blind, multi-center trial to compare the efficacy and safety of MMF and azathioprine within standard immunosuppressive regimen for patients receiving a first or second cadaveric renal graft. A total of 503 patients were randomized to groups receiving MMF 3 g (n=164), MMF 2 g (n=173), or azathioprine (AZA) 100-150 mg (n=166) daily. All were treated simultaneously with equivalent doses of cyclosporine and oral corticosteroids and followed for 12 months. The primary endpoint was treatment failure, defined as the occurrence of biopsy-proven graft rejection, graft loss, patient death, or discontinuation of the study drug during the first 6 months after transplantation. Treatment failure occurred in 50.% of patients in the AZA group by 6 months after transplantation, compared with 34.8% in the MMF 3g group (P=0.0045) and 38.2 % in the MMF 2g group (P=0.0287). Biopsy-proven rejection occurred in 15.9% of patients in the MMF 3 g group and 19.7% in the MMF2 g group, compared with 35.5% in the AZA group. Rejection of histologic severity grade II or more developed in 6.1 %, 10.4% and 19.9% of patients in the MMF 3 g, MMF 2 g, and AZA groups, respectively. Patients receiving MMF required less frequent and less intensive treatment for acute rejection: 24.4% of patients on MMF 3 g and 31.0% on MMF 2 g were tested for acute rejection, compared with 47.5% on AZA. Only 4.9% on MMF 3 g and 8.8% on MMF 2 g required antilymphocyte antibodies for treatment of severe or steroid-resistant rejection, compared with 15.4% of the patients on AZA. At 1 year after transplantation, graft survival in the MMF groups was marginally superior to that in the AZA group, although this difference was not statistically significant. Gastrointestinal toxicity and tissue-invasive cytomegalovirus infection were more common in the MMF 3 g group. Noncutaneous malignancies occurred in six patients on MMF 3 g, three patients on MMF 2 g, and four patients on AZA. Lymphoproliferative disorders occurred in two patients per MMF group, compared with one patient receiving AZA. MMF appears to be an important advance in prophylaxis following renal transplantation. It is associated with a significantly lower rate of treatment failure compared with AZA during the first 6 months after renal transplantation and produces a clinically important reduction in the incidence, severity, and treatment of acute graft rejection. These differences persist throughout the first year of follow-up. Clinical benefit was greatest with a dose of MMF 3 g/day, but gastrointestinal effects, invasive cytomegalovirus infection, and malignancies were slightly more common at that dose. The appropriate dose may lie between 2 g and 3 g per day and may require individualization depending on clinical course or other factors.

1,010 citations


Journal ArticleDOI
TL;DR: A multifaceted primary care intervention improved adherence to antidepressant regimens and satisfaction with care in patients with major and minor depression.
Abstract: Background: This research study evaluates the effectiveness of a multifaceted intervention program to improve the management of depression in primary care. Methods: One hundred fifty-three primary care patients with current depression were entered into a randomized controlled trial. Intervention patients received a structured depression treatment program in the primary care setting that included both behavioral treatment to increase use of adaptive coping strategies and counseling to improve medication adherence. Control patients received "usual" care by their primary care physicians. Outcome measures included adherence to antidepressant medication, satisfaction with care of depression and with antidepressant treatment, and reduction of depressive symptoms over time. Results: At 4-month follow-up, significantly more intervention patients with major and minor depression than usual care patients adhered to antidepressant medication and rated the quality of care they received for depression as good to excellent. Intervention patients with major depression demonstrated a significantly greater decrease in depression severity over time compared with usual care patients on all 4 outcome analyses. Intervention patients with minor depression were found to have a significant decrease over time in depression severity on only 1 of 4 study outcome analyses compared with usual care patients. Conclusion: A multifaceted primary care intervention improved adherence to antidepressant regimens and satisfaction with care in patients with major and minor depression. The intervention consistently resulted in more favorable depression outcomes among patients with major depression, while outcome effects were ambiguous among patients with minor depression.

822 citations


Journal ArticleDOI
04 Dec 1996-JAMA
TL;DR: A program of counseling and support can substantially increase the time spouse-caregivers are able to care for AD patients at home, particularly during the early to middle stages of dementia when nursing home placement is generally least appropriate.
Abstract: Objective. —To determine the long-term effectiveness of comprehensive support and counseling for spouse-caregivers and families in postponing or preventing nursing home placement of patients with Alzheimer disease (AD). Design. —Randomized controlled intervention study. Setting. —Outpatient research clinic in the New York City metropolitan area. Participants. —Referred, volunteer sample of 206 spouse-caregivers of AD patients who enrolled in the study during a 31/2-year period. All patients were living at home at baseline and had at least 1 relative living in the area. Intervention. —Caregivers in the treatment group were provided with 6 sessions of individual and family counseling within 4 months of enrollment in the study and were required to join support groups. In addition, counselors were available for further counseling at any time. Main Outcome Measure. —Time from enrollment of caregivers in the study to placement of the AD patients in a nursing home. Results. —Using Kaplan-Meier survival analysis, we estimated that the median time (weighted average of estimates for male and female caregivers) from baseline to nursing home placement of AD patients was 329 days longer in the treatment group than in the control group ( z =2.29; P =.02). The relative risk (RR) from a Cox proportional hazard model of nursing home placement (intent-to-treat estimate) after adjusting for caregiver sex, patient age, and patient income was 0.65 (95% confidence interval [CI], 0.45 to 0.94; P =.02), indicating that caregivers were approximately two thirds as likely to place their spouses in nursing homes at any point in time if they were in the treatment group than if they were in the control group. Treatment had the greatest effect on risk of placement for patients who were mildly demented (RR, 0.18; 95% CI, 0.04 to 0.77) or moderately demented (RR, 0.38; 95% CI, 0.17 to 0.82). Conclusions. —A program of counseling and support can substantially increase the time spouse-caregivers are able to care for AD patients at home, particularly during the early to middle stages of dementia when nursing home placement is generally least appropriate.

816 citations


Journal ArticleDOI
TL;DR: For veterans discharged from Veterans Affairs hospitals, the primary care intervention studied increased rather than decreased the rate of rehospitalization, although patients in the intervention group were more satisfied with their care.
Abstract: Background For chronically ill patients, readmission to the hospital can be frequent and costly. We studied the effect of an intervention designed to increase access to primary care after discharge from the hospital, with the goals of reducing readmissions and emergency department visits and increasing patients' quality of life and satisfaction with care. Methods In a multicenter randomized, controlled trial at nine Veterans Affairs Medical Centers, we randomly assigned 1396 veterans hospitalized with diabetes, chronic obstructive pulmonary disease, or congestive heart failure to receive either usual care or an intensive primary care intervention. The intervention involved close follow-up by a nurse and a primary care physician, beginning before discharge and continuing for the next six months. Results The patients were severely ill. Half of those with congestive heart failure (504 patients) had disease in New York Heart Association class III or IV; 30 percent of those with diabetes (751 patients) had end...

814 citations


Journal ArticleDOI
TL;DR: In this paper, the results of randomised controlled trials (RCTs) of interventions to help patients follow prescriptions for medications were summarised, and the most effective interventions did not lead to substantial improvements in adherence.

676 citations


Journal ArticleDOI
TL;DR: Whaley et al. as discussed by the authors reported on pretreatment characteristics, the treatments received, the local response observed, duration of response, time to local failure, distant progression and survival, and treatment toxicity of tbe 306 patients randomized.
Abstract: *MRC Cyclotron Unit, Hammersmith Hospital, London, United Kingdom; +MRC Cancer Trials Office, Cambridge, United Kingdom; *Departments of Hyperthermia and Statistics, Daniel den Hoed Cancer Center, Rotterdam,The Netherlands; “Department of Radiotherapy, Academic Medical Center, Amsterdam,The Netherlands; apartments of Radiation Oncology, Biostatistics, and Clinical Physics, Princess Margaret Hospital/Ontario Cancer Institute, University of Toronto, Canada purpose: Claims for the value of hyperthermia as an adjunct to radiotherapy in the treatment of cancer have mostly been based on small Phase I or II trials. To test the benefit of thii form of treatment, randomized phase III trials were needed. Methods and Materials: Five randomized trials addressing this question were started between 1988 and 1991. In these trials, patients were eligible if they had advanced prhnary or recurrent breast cancer, and local radiotherapy was indicated in preference to surgery. In addition, heating of the lesions and treatment with a prescribed (re)irradiation schedule had to be feasible and informed consent was obtained. The primary endpoint of ail trials was local complete response. Slow recruitment led to a decision to collaborate and combii the trial rest&s in one analysis, and report them simuhaneously in one publication. Interim analyses were carried out and the trials were closed to recruitment when a previously agreed statistically sign&ant difference in complete response rate was observed in the two larger trials. Results: We report on pretreatment characteristics, the treatments received, the local response observed, duration of response, time to local failure, distant progression and survival, and treatment toxicity of tbe 306 patients randomized. The overali CR rate for RT alone was 41% and for the combined treatment arm was 59%, giving, after stratification by trial, an odds ratio of 2.3. Not alI trials demonstrated an advantage for the combined treatment, although tbe 95% confidence intervals of the different trials all contain the pooled odds ratio. The greatest effect was observed in patients with recurrent lesions in previously irradiated areas, where further irradiation was limited to low doses. Conclusion: The combined result of the five trials has demonstrated the efficacy of hyperthemia as an adjunct to radiotherapy for treatment of recurrent breast cancer. The implication of these encouraging results is that hyperthermia appears to have an important role in the clinical management of this disease, and there should be no doubt that further studies of the use of hypertbermia are warranted. Breast cancer, Hyperthermia, Radiotherapy, Randomized trial. Reprint requests to: Jill B. Whaley, MRC Cancer Trials Office, 5 Shaftesbury Road, Cambridge CB2 2BW UK Accepted for publication 6 March 1996.

Journal ArticleDOI
01 Oct 1996-Cancer
TL;DR: This data indicates that the addition of surgical extirpation prior to radiation therapy increased survival, neurologic function, and quality of life compared with radiation alone in patients with a single brain metastasis.
Abstract: BACKGROUND Cerebral metastasis is a common oncologic problem that occurs in 15–30% of cancer patients; approximately half such metastases are single. Previous retrospective studies and two randomized trials reported that the addition of surgical extirpation prior to radiation therapy increased survival, neurologic function, and quality of life compared with radiation alone in patients with a single brain metastasis. METHODS A randomized controlled trial was conducted in which patients with a single brain metastasis were allocated to undergo radiation alone or surgery plus radiation. Radiation consisted of 3000 centigray to the whole brain in 10 fractions. RESULTS Forty-three patients received radiation alone and 41 patients surgery plus radiation. All but two of the study patients died. No difference in survival was detected between the groups; the median survival for the radiation group was 6.3 months (95% confidence interval, 3–11.4) compared with 5.6 months for the surgery plus radiation group (95% confidence interval, 3.9–7.2) (P = 0.24). Most patients died within the first year (69.8% in the radiation arm vs. 87.8% in the surgery plus radiation arm). There were no significant differences in the 30-day mortality, morbidity, or causes of death. Extracranial metastases was an important predictor of mortality (relative risk, 2.3). The mean proportion of days that the Karnofsky performance status was; ce70% did not differ between the 2 groups. CONCLUSIONS This trial failed to demonstrate that the addition of surgery to radiation therapy improved outcome of patients with a single brain metastasis. Thus, the efficacy of surgery plus radiation compared with radiation alone needs to be addressed by further clinical trials and/or a meta-analysis. Cancer 1996;78:1470-6.

Journal ArticleDOI
TL;DR: The EORTC trial 22844 has not revealed the presence of radiotherapeutic dose-response for patients with LGG for the two dose levels investigated with this conventional setup, but objective prognostic parameters are recognized.
Abstract: Purpose : Cerebral low-grade gliomas (LGG) in adults are mostly compose of astrocytomas, oligodendrogliomas, and mixed oligoastrocytomas. There is at present no consensus in the policy of treatment of these tumors. We sought to determine the efficacy of radiotherapy and the presence of a dose-response relationship for these tumors in two multicentric randomized trials conducted by the European Organization for Research and Treatment of Cancer (EORTC). The dose-response study is the subject of this article. Methods and Materials : For the dose-response trial, 379 adult patients with cerebral LGGs were randomized centrally at the EORTC Data Center to receive irradiation postoperatively (or postbiopsy) with either 45 Gy in 5 weeks or 59.4 Gy in 6.6 weeks with quality-controlled radiation therapy. All known parameters with possible influences on prognosis were prospectively recorded. Conventional treatment techniques were recommended. Results : With 343 (91%) eligible and evaluable patients followed up for at least 50 months with a median of 74 months, there is no significant difference in terms of survival (58% for the low-dose arm and 59% for the high-dose arm) or the progression free survival (47% and 50%) between the two arms of the trial. However, this prospective trial has revealed some important facets about the prognostic parameters: The T of the TNM classifications as proposed in the protocol appears to be one of the most important prognostic factors (p Conclusion : The EORTC trial 22844 has not revealed the presence of radiotherapeutic dose-response for patients with LGG for the two dose levels investigated with this conventional setup, but objective prognostic parameters are recognized. The tumor size or T parameter as used in this study appears to be a very important factor.

Journal ArticleDOI
10 Feb 1996-BMJ
TL;DR: Compliance therapy is a pragmatic method for improving compliance with drug treatment in psychotic inpatients and its gains persist for at least six months and may lead to improved social functioning.
Abstract: Objective: To determine whether compliance therapy, a cognitive-behavioural intervention, could improve compliance with treatment and hence social adjustment in acutely psychotic inpatients, and if so, whether the effect persisted six months later. Design: Randomised controlled trial of compliance therapy and non-specific counselling, each comprising 4-6 sessions lasting 10-60 minutes. Setting: Acute psychiatric admissions ward serving an inner London catchment area. Subjects: 47 patients with psychosis. Main outcome measures: Informant and observer reported measure of compliance; observer assessed global functioning after intervention and three and six months later; self rated attitudes to drug treatment after the intervention and one month later; symptom scores after intervention and six months later. Results: 25 patients received compliance therapy and showed significantly greater improvements in their attitudes to drug treatment and in their insight into illness and compliance with treatment compared with the control group. These gains persisted for six months. The intervention group was 5.2 times more likely than the control group to reach a criterion level of compliance (95% confidence interval 1.5 to 18.3). Global functioning showed a tendency to improve more in the intervention group after a delay (odds ratio 3.0 (0.8 to 11.5) to reach the criterion level at six months). Four subjects given compliance therapy and six in the control group were readmitted during follow up (odds ratio 2.0 (0.48 to 8.2)). Conclusions: Compliance therapy is a pragmatic method for improving compliance with drug treatment in psychotic inpatients and its gains persist for at least six months. Overall functioning may also be enhanced. Key messages Key messages Compliance is strongly related to attitudes to treatment and to insight The study found that such attitudes may be influenced by a simple and brief intervention known as compliance therapy Compliance therapy compared with non-specific counselling leads to improved compliance The improvement is sustained for at least six months and may lead to improved social functioning

Journal ArticleDOI
TL;DR: This study demonstrates that a clinical pharmacist providing pharmaceutical care for elderly primary care patients can reduce inappropriate prescribing and possibly adverse drug effects without adversely affecting health-related quality of life.

Journal ArticleDOI
TL;DR: Physician-based counseling for physical activity is efficacious in producing short-term increases in moderate physical activity among previously sedentary patients.

Journal ArticleDOI
TL;DR: The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), a randomized, double-blind trial in 40,000 high-risk hypertensive patients, is designed to determine whether the combined incidence of fatal coronary heart disease (CHD) and nonfatal myocardial infarction differs between persons randomized to diuretic treatment and each of three alternative treatments.

Journal ArticleDOI
TL;DR: Evidence from randomized controlled studies supports the effectiveness of data-driven computer-based reminder systems to improve prevention services in the ambulatory care setting.

Journal ArticleDOI
06 Jan 1996-BMJ
TL;DR: New findings show that patients referred to hospital for the chronic fatigue syndrome have a better outcome if they are given a course of cognitive behaviour therapy than if they receive only basic medical care.
Abstract: Objective: To evaluate the acceptability and efficacy of adding cognitive behaviour therapy to the medical care of patients presenting with the chronic fatigue syndrome. Design: Randomised controlled trial with final assessment at 12 months. Setting: An infectious diseases outpatient clinic. Subjects: 60 consecutively referred patients meeting consensus criteria for the chronic fatigue syndrome. Interventions: Medical care comprised assessment, advice, and follow up in general practice. Patients who received cognitive behaviour therapy were offered 16 individual weekly sessions in addition to their medical care. Main outcome measures: The proportions of patients (a) who achieved normal daily functioning (Karnofsky score 80 or more) and (b) who achieved a clinically significant improvement in functioning (change in Karnofsky score 10 points or more) by 12 months after randomisation. Results: Only two eligible patients refused to participate. All randomised patients completed treatment. An intention to treat analysis showed that 73% (22/30) of recipients of cognitive behaviour therapy achieved a satisfactory outcome as compared with 27% (8/30) of patients who were given only medical care (difference 47 percentage points; 95% confidence interval 24 to 69). Similar differences were observed in subsidiary outcome measures. The improvement in disability among patients given cognitive behaviour therapy continued after completion of therapy. Illness beliefs and coping behaviour previously associated with a poor outcome changed more with cognitive behaviour therapy than with medical care alone. Conclusion: Adding cognitive behaviour therapy to the medical care of patients with the chronic fatigue syndrome is acceptable to patients and leads to a sustained reduction in functional impairment. Key messages Key messages There is no generally accepted form of treatment New findings show that patients referred to hospital for the chronic fatigue syndrome have a better outcome if they are given a course of cognitive behaviour therapy than if they receive only basic medical care Clinical improvement with cognitive behaviour therapy may be slow but often continues after treatment has ended Cognitive behaviour therapy should be considered as an option for patients presenting with the chronic fatigue syndrome

Journal ArticleDOI
TL;DR: In this paper, the authors performed a statistical meta-analysis of 23 randomized controlled trials that evaluated the additional impact of psychosocial treatment of rehabilitation from documented coronary artery disease and found that psychosocially treated patients showed greater reductions in psychological distress, systolic blood pressure, heart rate, and cholesterol level (with effect size differences of 0.34, -0.24, 0.38, and -1.54, respectively).
Abstract: Background: Narrative review strategies and meta-analyses have shown that drug treatment and exercise rehabilitation regimens can reduce psychological distress and postmyocardial infarction mortality and recurrence. Objective: To question whether the addition of psychosocial interventions improves the outcome of a standard rehabilitation regimen for patients with coronary artery disease. Methods: We performed a statistical meta-analysis of 23 randomized controlled trials that evaluated the additional impact of psychosocial treatment of rehabilitation from documented coronary artery disease. Anxiety, depression, biological risk factors, mortality, and recurrence of cardiac events were the clinical end points that were studied. Mortality data were available from 12 studies, and recurrence data were available from 10 of the 23 studies. Results: The studies had evaluated 2024 patients who received psychosocial treatment vs 1156 control subjects. The psychosocially treated patients showed greater reductions in psychological distress, systolic blood pressure, heart rate, and cholesterol level (with effect size differences of 0.34, -0.24, -0.38, and -1.54, respectively). Patients who did not receive psychosocial treatment showed greater mortality and cardiac recurrence rates during the first 2 years of follow-up with log-adjusted odds ratios of 1.70 for mortality (95% confidence interval [CI], 1.09 to 2.64) and 1.84 for recurrence (CI, 1.12 to 2.99). Conclusions: The addition of psychosocial treatments to standard cardiac rehabilitation regimens reduces mortality and morbidity, psychological distress, and some biological risk factors. The benefits were clearly evident during the first 2 years and were weaker thereafter. At the clinical level, it is recommended to include routinely psychosocial treatment components in cardiac rehabilitation. The findings also suggest an urgent need to identify the specific, most effective types of psychosocial interventions via controlled research. (Arch Intern Med. 1996;156:745-752)

Journal ArticleDOI
22 May 1996-JAMA
TL;DR: In this article, the authors conducted a systematic search of human studies with Medical Subject Heading (MHE) terms to ascertain whether restriction of dietary sodium lowers blood pressure in hypertensive and normotensive individuals.
Abstract: Objective. —To ascertain whether restriction of dietary sodium lowers blood pressure in hypertensive and normotensive individuals. Data Sources. —An English-language computerized literature search, restricted to human studies with Medical Subject Heading terms, "hypertension," "blood pressure," "vascular resistance," "sodium and dietary," "diet and sodium restricted," "sodium chloride," "clinical trial," "randomized controlled trial," and "prospective studies," was conducted. Bibliographies of review articles and personal files were also searched. Trial Selection. —Trials that had randomized allocation to control and dietary sodium intervention groups, monitored by timed sodium excretion, with outcome measures of both systolic and diastolic blood pressure were selected by blinded review of the methods section. Data Extraction. —Two observers extracted data independently, using purposedesigned forms, and discrepancies were resolved by discussion. Data Synthesis. —The 56 trials that met our inclusion criteria showed significant heterogeneity. Publication bias was also evident. The mean reduction (95% confidence interval) in daily urinary sodium excretion, a proxy measure of dietary sodium intake, was 95 mmol/d (71-119 mmol/d) in 28 trials with 1131 hypertensive subjects and 125 mmol/d (95-156 mmol/d) in 28 trials with 2374 normotensive subjects. After adjustment for measurement error of urinary sodium excretion, the decrease in blood pressure for a 100-mmol/d reduction in daily sodium excretion was 3.7 mm Hg (2.35-5.05 mm Hg) for systolic ( P P =.09) in the hypertensive trials, and 1.0 mm Hg (0.51-1.56 mm Hg) for systolic ( P P =.64) in the normotensive trials. Decreases in blood pressure were larger in trials of older hypertensive individuals and small and nonsignificant in trials of normotensive individuals whose meals were prepared and who lived outside the institution setting. Conclusion. —Dietary sodium restriction for older hypertensive individuals might be considered, but the evidence in the normotensive population does not support current recommendations for universal dietary sodium restriction. ( JAMA . 1996;275:1590-1597)

Journal ArticleDOI
TL;DR: The first-year results of a randomized clinical trial in which the delayed and the immediate introduction of SAARDs were compared are described and the consequences of ignoring the treatment pyramid for patients with recent-onset rheumatoid arthritis are investigated.
Abstract: Objective : To compare two therapeutic strategies for patients with recent-onset rheumatoid arthritis. Design : Open, randomized clinical trial. Setting : Outpatient clinics of six clinical centers. Patients : 238 consecutive patients with recently diagnosed rheumatoid arthritis. Interventions : Delayed or immediate introduction of treatment with slow-acting antirheumatic drugs (SAARDs). Measurements : Primary end points were functional disability, pain, joint score, and erythrocyte sedimentation rate at 6 and 12 months and progression of radiologic abnormalities at 12 months. Results : Statistically significant advantages at 12 months for patients receiving the SAARD strategy (immediate treatment with SAARDs) with regard to all primary end points that may be clinically important are indicated by the differences in improvements from baseline and their 95% Cls. These differences were 0.3 (95% CI, 0.2 to 0.6) for disability (range, 0 to 3), 10 mm (CI, 1 to 19 mm) for pain (range, 0 to 100 mm), 39 (CI, 4 to 74) for joint score (range, 0 to 534), and 11 mm/h (CI, 3 to 19 mm/h) for erythrocyte sedimentation rate (range, 1 to 140 mm/h), all in favor of SAARD treatment. The SAARD strategy also appears to be advantageous at 6 months. Radiologic abnormalities progressed at an equal rate in the SAARD and the non-SAARD groups ; the difference in progression (range, 0 to 448) was 1 (CI, -3 to 5). Analyses were based on the intention-to-treat principle and thus included 29% of patients in the non-SAARD group who discontinued the non-SAARD treatment strategy ; treatment was usually discontinued because of insufficient effectiveness. The SAARD strategy including two alternative SAARDs could not be continued by 8% of patients, usually because of adverse reactions. Conclusions : Early introduction of SAARDs may be more beneficial than delayed introduction for patients with recently diagnosed rheumatoid arthritis.

Journal ArticleDOI
TL;DR: The prospective data in patients with NIDDM suggest that hyperglycemia is a risk factor for cardiovascular disease, but insufficient data exist to determine whether there is a glycemic threshold for macrovascular disease.
Abstract: Purpose: To report the progress (after 9-year follow-up) of a study designed to determine whether improved glucose control in patients with newly diagnosed non–insulin-dependent diabetes mellitus (...

Journal ArticleDOI
TL;DR: Severity of depressive symptoms was reduced more rapidly and more effectively among patients randomized to pharmacotherapy or psychotherapy than among patients assigned to a physician's usual care.
Abstract: Background: We studied whether standardized treatments of major depression whose efficacy was established with psychiatric patients are equally effective when provided to primary care patients, and whether standardized treatments are more effective than a primary care physician's usual care. Methods: A randomized controlled trial was conducted, in which primary care patients meeting DSM-III-R criteria for a current major depression were assigned to nortriptyline (n=91) or interpersonal psychotherapy (n=93) provided within well-structured parameters, or a physician's usual care (n=92). The main outcome measures were degree and rate of improvement in severity of depressive symptoms and proportion of patients recovered at 8 months. Results: Severity of depressive symptoms was reduced more rapidly and more effectively among patients randomized to pharmacotherapy or psychotherapy than among patients assigned to a physician's usual care. Among treatment completers, approximately 70% of patients participating in the full pharmacotherapy or psychotherapy protocol but only 20% of usual care patients were judged as recovered at 8 months. Conclusions: Pharmacotherapy and psychotherapy effectively treat major depression among primary care patients when provided within specific parameters and for the full acute and continuation phases. Treatment principles recommended by the Depression Guideline Panel of the Agency for Health Care Policy and Research are supported.

Journal ArticleDOI
01 Aug 1996-Spine
TL;DR: Cervical spine manipulation and mobilization probably provide at least short‐term benefits for some patients with neck pain and headaches, and the potential for adverse outcomes must be considered because of the possibility of permanent impairment or death.
Abstract: Study design Cervical spine manipulation and mobilization were reviewed in an analysis of the literature from 1966 to the present. Objectives To assess the evidence for the efficacy and complications of cervical spine manipulation and mobilization for the treatment of neck pain and headache. Summary of background data Although recent research has demonstrated the efficacy of spinal manipulation for some patients with low back pain, little is known about its efficacy for neck pain and headache. Methods A structured search of four computerized bibliographic data bases was performed to identify articles on the efficacy and complications of cervical spine manual therapy. Data were summarized, and randomized controlled trials were critically appraised for study quality. The confidence profile method of meta-analysis was used to estimate the effect of spinal manipulation on patients' pain status. Results Two of three randomized controlled trials showed a short-term benefit for cervical mobilization for acute neck pain. The combination of three of the randomized controlled trials comparing spinal manipulation with other therapies for patients with subacute or chronic neck pain showed an improvement on a 100-mm visual analogue scale of pain at 3 weeks of 12.6 mm (95% confidence interval, -0.15, 25.5) for manipulation compared with muscle relaxants or usual medical care. The highest quality randomized controlled trial demonstrated that spinal manipulation provided short-term relief for patients with tension-type headache. The complication rate for cervical spine manipulation is estimated to be between 5 and 10 per 10 million manipulations. Conclusions Cervical spine manipulation and mobilization probably provide at least short-term benefits for some patients with neck pain and headaches. Although the complication rate of manipulation is small, the potential for adverse outcomes must be considered because of the possibility of permanent impairment or death.

Journal ArticleDOI
TL;DR: CT appears to be a potent adjunct to pharmacotherapy and standard care for acute psychosis with the objective of hastening the resolution of positive symptoms and reducing residual symptoms.
Abstract: BACKGROUND The application of cognitive therapy (CT) to psychosis is currently being developed in the UK. This paper reports a trial of CT in acute psychosis with the objective of hastening the resolution of positive symptoms and reducing residual symptoms. METHOD Of 117 patients with acute non-affective psychosis, 69 satisfied inclusion criteria and 40 proceeded to stratified randomisation. The experimental intervention involving individual and group CT was compared with a group receiving matched hours of therapist input providing structured activities and informal support; routine pharmacotherapy was provided by clinicians blind to group allocation. Patients were monitored weekly using self-report and mental state assessments during admission and over the subsequent nine months. RESULTS Both groups showed a decline in positive symptoms but this was more marked in the CT group (P < 0.001). At 9 months 5% of the CT group, v.56% of the control group, showed moderate or severe residual symptoms. CONCLUSION CT appears to be a potent adjunct to pharmacotherapy and standard care for acute psychosis. Issues concerning internal and external validity of the study and opportunities for further research are discussed.

Journal ArticleDOI
14 Sep 1996-BMJ
TL;DR: General practice follow up of women with breast cancer in remission is not associated with increase in time to diagnosis, increase in anxiety, or deterioration in health related quality of life.
Abstract: OBJECTIVE: To assess the effect on time to diagnosis of recurrence and on quality of life of transferring primary responsibility for follow up of women with breast cancer in remission from hospital to general practice. DESIGN: Randomised controlled trial with 18 month follow up in which women received routine follow up either in hospital or in general practice. SUBJECTS AND SETTING: 296 women with breast cancer in remission receiving regular follow up care at district general hospitals in England. MAIN OUTCOME MEASURES: Time between first presentation of symptoms to confirmation of recurrence; quality of life measured by specific dimensions of the SF-36 schedule, the EORTC symptom scale, and hospital anxiety and depression scale. RESULTS: Most recurrences (18/26, 69%) presented as interval events, and almost half (7/16, 44%) of the recurrences in the hospital group presented first to general practice. The median time to hospital confirmation of recurrence was 21 days in the hospital group (range 1-376 days) and 22 days in the general practice group (range 4-64). The differences between groups in the change in SF-36 mean scores from baseline were small: -1.8 (95% confidence interval -7.2 to 3.5) for social functioning, 0.5 (-4.1 to 5.1) for mental health, and 0.6 (-3.6 to 4.8) for general health perception. The change from baseline in the mean depression score was higher in the general practice group at the mid-trial assessment (difference 0.6, 0.1 to 1.2) but there was no significant difference between groups in the anxiety score or the EORTC scales. CONCLUSION: General practice follow up of women with breast cancer in remission is not associated with increase in time to diagnosis, increase in anxiety, or deterioration in health related quality of life. Most recurrences are detected by women as interval events and present to the general practitioner, irrespective of continuing hospital follow up.

Journal ArticleDOI
TL;DR: Addition of chemotherapy to local definitive treatment has significantly increased the morbidity of treatment as well as the chance of initial tumor response and local control.
Abstract: PURPOSEUsing the technique of meta-analysis, we aim to illustrate the potential benefit, or lack of it, in adding chemotherapy to locoregional definitive treatment in a prospective randomized setting.PATIENTS AND METHODSMantel-Haenszel summary analyses were used to test 42 prospective and properly randomized trials for statistically significant differences in the proportion with side effects and in the proportion with response to treatment between the experimental treatment arm (including chemotherapy) and control arm (local definitive treatment only) of the study. Summarized estimates of relative risks of side effects and relative proportions of positive responses were obtained using the summarizing options in PROC FREQ in the SAS computer package. In 25 of 42 studies, sufficient survival information was available to estimate the effect of chemotherapy on the rate of dying per person per unit of time.RESULTSChemotherapy, when added to local definitive treatment, was found to increase toxicity. This incre...

Journal ArticleDOI
TL;DR: Interventions designed to achieve supraphysiologic goals of cardiac index, DO2, and VO2 did not significantly reduce mortality rates in all critically ill patients, however, there may be a benefit in those patients in which the therapy is initiated preoperatively.
Abstract: Objective : To systematically review the effect of interventions designed to achieve supraphysiologic values of cardiac index, oxygen delivery (Do 2 ), and oxygen consumption (Vo 2 ) in critically ill patients. Data Sources : Computerized bibliographic search of published research, citation review of relevant articles, and contact with primary investigators. Study Selection : We included all randomized clinical trials of adult intensive care unit (ICU) patients that evaluated interventions (fluids, inotropes, and vasoactive drugs) designed to achieve supraphysiologic values of cardiac index, Do 2 , andlor Vo 2 . Independent review of 64 articles identified seven relevant studies of 1,016 patients. Data Extraction : We abstracted data on the population, interventions, outcomes, and methodologic quality of the studies by duplicate independent review. Agreement was high (weighted kappa 0.73) ; differences were resolved by consensus. Data Synthesis : Targeting therapy to achieve supraphysiologic end points in critically ill patients is associated with a nonstatistically significant trend toward decreased mortality rates (relative risk 0.86, 95% confidence intervals 0.62 to 1.20). For the two studies in which supraphysiologic goals were initiated preoperatively, the relative risk was 0.20 (95% confidence intervals 0.07 to 0.55). This value differed significantly from the combined estimate of the remaining studies, in which the intervention was started after ICU admission (relative risk 0.98, 95% confidence intervals 0.79 to 1.22 ; p <.01). However, there are several methodologic problems with the primary studies. In no trials were caregivers or outcome assessors blinded to treatment allocation. Only three of seven trials analyzed patients according to the group to which they were allocated. None adequately controlled for cointerventions, and there was considerable crossover between groups (patients in the control group achieved the goals of the intervention group and vice versa). Conclusions : Interventions designed to achieve supraphysiologic goals of cardiac index, Do 2 , and Vo 2 did not significantly reduce mortality rates in all critically ill patients. However, there may be a benefit in those patients in which the therapy is initiated preoperatively. Methodologic limitations weaken the inferences that can be drawn from these studies and preclude any evidence-based clinical recommendations.

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TL;DR: A cognitive behavioural model of body image is presented with specific reference to body dysmorphic disorder (BDD) and makes specific hypotheses from the model for testing BDD patients in comparison with patients with "real" disfigurements who seek cosmetic surgery and healthy controls without any defect.