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Results for “Randomized controlled trial”

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PubMed1997

Randomized controlled trial of trimebutine (anal sphincter relaxant) for pain after haemorrhoidectomy.

BACKGROUND: Anal sphincter spasm may aggravate pain after haemorrhoidectomy. The aims of this study were to investigate whether a trimebutine suppository (Proctolog) reduced anal resting pressure and, subsequently, to test its efficacy in relieving pain after haemorrhoidectomy. METHODS: Ten patients underwent anal manometry before and 4 h after Proctolog application. A controlled randomized trial was then conducted on 160 consecutive patients. A standard haemorrhoidectomy was performed. Eighty patients were then randomized to receive an application of Proctolog immediately after the procedure (group 1). The remaining 80 did not receive a suppository (controls, group 2). An independent, blinded observer determined the pain scores. RESULTS: Proctolog resulted in a mean 35 per cent reduction in resting anal pressure (P < 0.001). However, there were no differences in the pain score at 4 h after haemorrhoidectomy, maximum pain during the first 24 h, maximum pain during the second postoperative day, ketoprofen requirement or need for intramuscular pethidine injections between groups 1 and 2. CONCLUSION: Although Proctolog reduced mean resting anal pressure at 4 h after application, this did not affect pain after haemorrhoidectomy.

Female↗
PubMed2006

Quality of life in longterm exogenous subclinical hyperthyroidism and the effects of restoration of euthyroidism, a randomized controlled trial.

OBJECTIVE: The impact of prolonged subclinical hyperthyroidism on quality of life is unclear. Therefore, we evaluated quality of life in patients with differentiated thyroid carcinoma (DTC) on TSH-suppressive thyroxine therapy as a model for subclinical hyperthyroidism and we investigated whether restoration to euthyroidism affects quality of life. DESIGN: We performed a prospective, single-blinded, placebo-controlled, randomized trial of 6 months' duration with two parallel groups. PATIENTS AND METHODS: Twenty-four subjects with a history of differentiated thyroid carcinoma with > 10 years TSH-suppressive therapy with L-thyroxine completed the study. L-thyroxine dose was replaced by study medication containing L-thyroxine or L-thyroxine plus placebo. Medication was titrated to establish continuation of TSH suppression (low-TSH group) and euthyroidism (euthyroid group). Both groups consisted of 12 patients. We evaluated quality of life using five validated questionnaires. RESULTS: At baseline, the somatic disorder questionnaire (SDQ) indicated more somatic dysfunction in patients as compared with reference values, whereas the depression score (HADS) revealed a better score than the reference group. All other quality of life parameters were normal. At baseline, no significant differences between the low-TSH and the euthyroidism groups were observed. After 6 months, none of the quality of life parameters in the low-TSH group was different from baseline values. In the euthyroid group, motivation was significantly improved (Multidimensional Fatigue Index-20, P = 0.003), although this parameter did not differ from the reference group at baseline. A probable worsening in role limitations as a result of physical problems (Short Form-36; P = 0.050) was observed. No improvement in the SDQ score was observed. CONCLUSION: In summary, quality of life in patients with DTC and long-term subclinical hyperthyroidism in general is preserved. Restoration of euthyroidism in general does not affect quality of life.

Fatigue↗
PubMedDate not supplied

Women's hearts--stress management for women with ischemic heart disease: explanatory analyses of a randomized controlled trial.

PURPOSE: This randomized controlled study aimed to evaluate the effects on psychosocial variables of a 1-year group-based cognitive-behavioral stress management program developed specifically for women with ischemic heart disease. METHODS: The present explanatory (per protocol) analyses include 80 women who were randomized to a 1-year cognitive-behavioral stress management program and 86 who were randomized to usual care (age = 35-77 years). Data were obtained before randomization and after 1 year, when the intervention group had completed the program. RESULTS: There were no statistically significant differences between the intervention and usual care groups in the psychosocial endpoints at randomization. Both groups improved in all psychosocial variables during the 1-year study period, but the rate of improvement was significantly greater in the intervention group for self-rated stress behavior (P = .006) and vital exhaustion (P = .03). Although changes were in favor of the treatment group also for depressive mood and quality of life, the rates of improvement between the 2 groups did not reach statistical significance (P = .23 and P = .10, respectively). CONCLUSION: A 1-year cognitive-behavioral stress management program designed specifically for women improved psychological well-being in some aspects in comparison with usual care.

Adult↗
PubMed2001

Prevention of venous thromboembolism after knee arthroscopy with low-molecular weight heparin (reviparin): Results of a randomized controlled trial.

PURPOSE: Deep venous thrombosis (DVT) is a common, important complication of major orthopaedic surgery, particularly knee arthroplasty. Knee arthroscopy is increasingly performed on an outpatient basis. Few reports have elucidated the incidence of venous thromboembolism (VTE) in patients undergoing arthroscopic surgery receiving no prophylaxis. The objective of the present trial was to evaluate the risk of VTE in those patients and to determine efficacy and safety of a low-molecular weight heparin (LMWH) in preventing VTE. TYPE OF STUDY: This is the first controlled randomized trial using objective diagnostic methods with blinded outcome assessment to reveal the incidence of VTE in outpatient arthroscopy and determine efficacy and safety of a LMWH (reviparin sodium) in preventing VTE in these patients. METHODS: There were 262 patients undergoing elective knee arthroscopy prospectively randomized to receive either no treatment or reviparin once daily subcutaneously for 7 to 10 days. The blindly assessed primary outcome measure was the incidence of DVT detected by compression color-coded sonography. Both groups were comparable with regard to demographics and baseline characteristics. RESULTS: 239 patients were evaluable (122 no treatment, 117 receiving LMWH). 6 DVT were detected - 5 in the control group (5/117 - 4.1%) and only one in the active treatment group (1/116 - 0.85%). This particular patient had a low level of protein C and a subnormal level of protein S. The odds ratio of 4.95 approximates a relative risk reduction of about 80%. Treatment with reviparin was safe and well tolerated. There was no major bleeding, four patients with minor bleedings. One patient had a transitory fall in platelet count below 100 giga-particles/L without any clinical symptoms. CONCLUSIONS: Patients undergoing knee arthroscopy have a moderate risk of VTE and effective prophylaxis can be achieved with LMWH (reviparin).

Adult↗
PubMed1995

The rational use of therapeutic drugs in the 21st century. Important lessons from cumulative meta-analyses of randomized control trials.

The use of randomized control trials to assess the usefulness of therapeutic drugs over the last half century has brought significant benefits to patient care. The full potential benefits, however, have been only partially fulfilled because available data are frequently poorly used. Meta-analysis has emerged as an important tool for combining clinical evidence. Several examples are presented that compared the results of cumulative meta-analysis of randomized control trials with clinical expert recommendations. These comparisons demonstrated that clinical expert recommendations are often not synchronized with accumulating evidence, and this lack of recognition often resulted in delays in the acceptance of effective drugs and the slow abandonment of possibly harmful therapeutic practices. The problems of inappropriate therapeutic drug use will only intensify as new drugs are introduced and new uses for established drugs are proposed. The rational use of therapeutic drugs can be achieved only through the routine use of meta-analysis on high-quality clinical data. Some suggestions are made to improve the quality of the original research and the ways of assembling meta-analyses and disseminating their results.

Diffusion of Innovation↗
PubMed2003

Does additional surgical training increase participation in randomized controlled trials?

BACKGROUND: The prospective randomized controlled trial (PRCT) is agreeably the gold standard in reporting data on patient management. This study evaluates the impact of specialty training on the leadership, development, and enrollment in PRCT. METHODS: Questionnaires were sent to surgical oncology as well as general surgery graduates from 1985 to 1999. RESULTS: A total of 67% (201 of 300) of the surgeons responded, with one half of the respondents completing a surgical oncology (SO) fellowship (50%, 100 of 201), 33% (66 of 201) another type of fellowship (OF), and 17% (35 of 201) general surgery (GS) training alone. The utilization of PRCT in the decision making of their clinical practice was reported by a majority of SO graduates (99%) as well as GS graduates (88%) with a smaller number (77%) of OF trained surgeons. The opinions on PRCT were evenly distributed with breast disease, colorectal cancer, and melanoma having the greatest impact on surgeons practicing in these fields. A greater percentage of SO (89%) reported participation in a PRCT than did the GS (42%) or OF (54%). The most frequent reason for the lack of participation in a PRCT by both GS and OF trained graduates was absence of active recruitment (80%) to participate with the second most common being no time available (18%). CONCLUSIONS: PRCT are utilized and continue to change surgeons' decision making for a majority of the surgeons surveyed. There are certain disease sites for which PRCT have failed to influence practice decisions. Unfortunately, few surgeons take a leadership role in PRCT. Emphasizing the existence of PRCT at both meetings, and in journals, with a more aggressive recruitment of participating surgeons with minimal time commitment, should enhance the patients included in prospective randomized controlled trials.

Attitude of Health Personnel↗
PubMed2003

Retreatment of hepatitis C non-responsive to interferon. A placebo controlled randomized trial of ribavirin monotherapy versus combination therapy with Ribavirin and Interferon in 121 patients in the Benelux [ISRCTN53821378].

BACKGROUND: Evidence based medicine depends on unbiased selection of completed randomized controlled trials. For completeness it is important to publish all trials. This report describes the first large randomised controlled trial where combination therapy was compared to placebo therapy and to ribavirin monotherapy, which has not been published until now. METHODS: One hundred and twenty one patients with chronic hepatitis C and elevated transaminases who did not respond to previous treatment with standard interferon monotherapy, were included from 16 centers in Belgium, the Netherlands and Luxembourg between 1992 and 1996. Patient poor-response characteristics were: genotype 1 (69%), HCV RNA above 2 x 10(6) copies/ml (55%) and cirrhosis (38%). Patients were randomized to 6 months combination therapy with interferon alpha-2b (3 MU tiw) and ribavirin (1000-1200 mg/day), 6 months ribavirin monotherapy (1000-1200 mg/day) or 6 months ribavirin placebo. The study was double blinded for the ribavirin/placebo component. One patient did not fit the entry criteria, and 3 did not start. All 117 patients who received at least one dose of treatment were included in the intention to treat analysis. RESULTS: At the end of treatment, HCV RNA was undetectable in 35% of patients on combination therapy and in none of the patients treated with ribavirin monotherapy or placebo. The sustained virological response rate at 6 months after therapy was 15% for patients treated with interferon and ribavirin. During the 6 months treatment period 13% of patients on interferon ribavirin combination therapy, 13% of patients on ribavirin monotherapy and 11% of patients on placebo withdrew due to side effects or noncompliance. At 24 weeks of treatment the mean Hb level was 85% of the baseline value, which means a mean decrease from 9.1 mmol/l to 7.8 mmol/l. The Hb levels at the end of treatment were not significantly different from patients treated with ribavirin monotherapy (p = 0.76). End of treatment WBC was significantly lower in patients treated with combination therapy, compared to ribavirin (p < 0.01) as well as for patients treated with ribavirin monotherapy compared to placebo (p < 0.01). DISCUSSION: This belated report on the only placebo controlled study of interferon ribavirin combination therapy in non responders to standard doses of interferon monotherapy documents the effectiveness, be it limited, of this approach as well as the dynamics of the effects on blood counts.

Adult↗
PubMed1999

Continuous infusion ceftazidime in intensive care: a randomized controlled trial.

We randomized 18 critically ill patients to receive ceftazidime 6 g/day by continuous infusion or bolus dosing (2 g 8 hourly), each with a loading dose of 12 mg/kg ceftazidime. During the first 8 h, plasma ceftazidime concentration fell below 40 mg/L in only one patient (trough 38 mg/L) from the infusion group, compared with eight from the bolus group (2-33 mg/L) for periods ranging from 73 to 369 min. Thereafter all infusion patients remained above 40 mg/L for 40 h of study versus 20-30% of bolus patients. The pharmacokinetic and pharmacodynamic characteristics of ceftazidime suggest that continuous infusions should be clinically investigated in outcome studies.

Adult↗
PubMed2003

Interferon-alpha combined with ketoprofen as treatment of naïve patients with chronic hepatitis C: a randomized controlled trial.

In this randomized controlled study, we evaluated the efficacy and safety of interferon-alpha combined with ketoprofen to that of interferon-alpha alone in naïve patients with chronic hepatitis C. Forty patients were randomized to receive Interferon-alpha2a (3 million units three times a week) and ketoprofen (150 mg twice a day) and 40 to receive only interferon-alpha2a at the same dose. Patients were treated for 6 months and followed up for 6 months. Response was defined by undetectable HCV-RNA in serum at the end-of-treatment and after 6 months from the completion of therapy (long term response). At the end of treatment the response was similar in the two group. However, combination treatment showed significantly higher efficacy than monotherapy in achieving long term response (10%vs 32.5%; P = 0.014). Overall adverse events were similar in the two groups. 'Flu-like syndrome was significantly less common in the ketoprofen plus interferon group which experienced a significantly higher incidence of epigastric pain'. Our results indicate that the combination of ketoprofen plus interferon is significantly more effective than interferon alone in the treatment of naïve patients with chronic hepatitis C and is well tolerated. However this combined treatment appears to be less effective than the association of pegylated IFN and ribavirin which represent the current standard treatment. Thus, the role of ketoprofen in the treatment of chronic hepatitis C needs to be further evaluated against such a treatment.

Adult↗
PubMed2026

Understanding randomized controlled trial generalizability through an embedded molecular diagnostics trial.

BACKGROUND: Issues with randomized controlled trial generalizability are well described, but whether these issues result from differences in patient treatment across contexts remains unknown. We studied treatment of patients with high-risk prostate cancer after radical prostatectomy inside and outside a randomized controlled trial evaluating the impact of a genomic classifier on post-radical prostatectomy treatment decision making (Genomics in Michigan Impacting Observation of Radiation [G-MINOR]; ClinicalTrials.gov identifier NCT02783950). METHODS: G-MINOR enrolled 338 patients; propensity score-matched eligible but unenrolled patient cohorts (pretrial and trial contemporary) from the Michigan Urological Surgery Improvement Collaborative (MUSIC), in which the trial was embedded, were compared for rates and time to secondary treatment (adjuvant or salvage therapy) after prostatectomy. RESULTS: Among 338 patients in the G-MINOR cohort, 69 (31 adjuvant, 38 salvage) received secondary treatment compared with 266 (183 adjuvant, 83 salvage) and 104 (60 adjuvant, 44 salvage) in the 1014 contemporary and 338 pretrial-matched MUSIC cohorts. Time to secondary treatment was much shorter in the MUSIC cohort across all comparisons. For example, matching G-MINOR to synchronous MUSIC patients demonstrated 84% vs 74% estimated 2-year treatment-free survival for trial and real-world patients, respectively (P&#x2009;<&#x2009;.001). CONCLUSIONS: Controlling for key clinicopathologic factors, patients in the G-MINOR randomized controlled trial and MUSIC cohorts were treated differently, even after stratifying by genomic risk. These findings suggest that challenges in randomized controlled trial generalizability extend beyond the representativeness of trial participants. Differences in management may also explain why divergent patient outcomes are observed in randomized controlled trials vs real-world settings.

Aged↗
PubMed2003

Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial was conducted. OBJECTIVE: To determine the efficacy of osteopathic manipulative treatment as a complementary treatment for chronic nonspecific low back pain. SUMMARY OF BACKGROUND DATA: Osteopathic manipulative treatment may be useful for acute or subacute low back pain. However, its role in chronic low back pain is unclear. METHODS: This trial was conducted in a university-based clinic from 2000 through 2001. Of the 199 subjects who responded to recruitment procedures, 91 met the eligibility criteria. They were randomized, with 82 patients completing the 1-month follow-up evaluation, 71 completing the 3-month evaluation, and 66 completing the 6-month evaluation. The subjects were randomized to osteopathic manipulative treatment, sham manipulation, or a no-intervention control group, and they were allowed to continue their usual care for low back pain. The main outcomes included the SF-36 Health Survey, a 10-cm visual analog scale for overall back pain, the Roland-Morris Disability Questionnaire, lost work or school days because of back pain, and satisfaction with back care. RESULTS: As compared with the no-intervention control subjects, the patients who received osteopathic manipulative treatment reported greater improvements in back pain, greater satisfaction with back care throughout the trial, better physical functioning and mental health at 1 month, and fewer cotreatments at 6 months. The subjects who received sham manipulation also reported greater improvements in back pain and physical functioning and greater satisfaction than the no-intervention control subjects. There were no significant benefits with osteopathic manipulative treatment, as compared with sham manipulation. CONCLUSIONS: Osteopathic manipulative treatment and sham manipulation both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain. It remains unclear whether the benefits of osteopathic manipulative treatment can be attributed to the manipulative techniques themselves or whether they are related to other aspects of osteopathic manipulative treatment, such as range of motion activities or time spent interacting with patients, which may represent placebo effects.

Chronic Disease↗
PubMedDate not supplied

Endoscopic sclerosis and esophageal balloon tamponade in acute hemorrhage from esophagogastric varices: a prospective controlled randomized trial.

A prospective randomized controlled clinical trial was performed in 43 consecutive histologically proved cirrhotic patients with endoscopically proved actively bleeding esophageal varices. Twenty-two were randomly selected to have esophageal tamponade with the Sengstaken-Blakemore tube, and 21 were selected to have endoscopic sclerosis of the esophageal wall. The two groups were similar in demographic, clinical and laboratory data. Bleeding was controlled by the Sengstaken-Blakemore tube in 16 of 22 patients (73%) and by endoscopic sclerosis in 20 of 21 (95%). Among those controlled by the Sengstaken-Blakemore tube, seven (44%) rebled and three (43%) were again controlled by the Sengstaken-Blakemore tube; in the endoscopic sclerosis group, four (20%) rebled and three (75%) were controlled. Thus, hemorrhage was definitively controlled in 52% of patients and 66% of bleeding episodes in the Sengstaken-Blakemore tube group and in 90% of patients and 92% of bleeding episodes in the endoscopic sclerosis group. The definite control of hemorrhage was significantly better in the endoscopic sclerosis group (p less than 0.01). The Sengstaken-Blakemore tube patients received no definitive therapy after bleeding had been controlled. Within 30 days, six patients (27%) in the Sengstaken-Blakemore tube group had died compared to 2 (10%) in the endoscopic sclerosis group which is statistically significant (p less than 0.01) in favor of endoscopic sclerosis. The frequency of complications was similar in the two groups. Endoscopic sclerosis patients received serial endoscopic sclerosis after bleeding had been stopped during the whole period of follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic↗
PubMed2026

Clinical performance of monolithic and veneered zirconia three-unit posterior FDPs: A five-year multicenter randomized controlled trial.

AIM: This randomized controlled clinical study compared monolithic, partially veneered, and fully veneered zirconia FDPs over a 5-year period with respect to survival, technical and biological complications, and patient-reported outcome measures (PROMs). MATERIALS AND METHODS: Sixty-four patients requiring three-unit posterior FDPs were randomly allocated to monolithic (MONO-FDP), partially veneered (PV-FDP), or fully veneered (FV-FDP) groups. All FDPs were fabricated from 4 mol% Y&#x2082;O&#x2083; partially stabilized zirconia (4Y-TZP). Follow-up examinations were conducted at baseline, 1, 3, and 5 years. Technical parameters were evaluated using modified USPHS criteria. Periodontal measurements (PPD, BOP, PI) and patient satisfaction were assessed at all time points. RESULTS: A total of 63 FDPs were evaluated at baseline, 57 at 3 years, and 54 at 5 years. Survival at 5 years was 94.7% for MONO-FDPs, 100% for FV-FDPs and 100% for PV-FDPs. Technical complications occurred exclusively in PV-FDP (33%) and FV-FDP (38%) groups and consisted of minor, polishable chipping; no chipping or fractures were recorded in MONO-FDPs (0%) with statistically significant difference between MONO-FDP and the other two groups (p &#x2264; 0.014). Biological parameters remained stable across all groups, with no significant differences in PPD, BOP, or PI. PV-FDPs and FV-FDPs tended to receive more favorable professional color ratings, whereas PROMs were similar among the groups. CONCLUSIONS: All three FDP designs-monolithic, partially veneered, and fully veneered-fabricated from 4Y-TZP zirconia demonstrated excellent 5-year clinical performance. Technical complications were limited to PV- and FV-FDPs and consisted of minor chipping. Biological outcomes and patient satisfaction were similar across groups. CLINICAL SIGNIFICANCE: The five-year outcomes suggest that veneered, partially veneered, and monolithic FDPs can be used with high clinical reliability; however, restorations incorporating veneering ceramic may present an elevated risk of ceramic chipping.

Humans↗
PubMed2002

Relaxation music decreases the dose of patient-controlled sedation during colonoscopy: a prospective randomized controlled trial.

BACKGROUND: A prospective randomized controlled trial was performed to test the hypotheses that music decreases the dose of sedative medication required for colonoscopy and that the combination of music and patient-controlled sedation improves patient acceptance of colonoscopy. METHODS: One hundred sixty-five patients scheduled to undergo elective colonoscopy were randomized to receive 1 of 3 different modes of sedation: Group 1, a combination of music and patient-controlled sedation with a mixture of propofol and alfentanil; Group 2, patient-controlled sedation alone; Group 3, music alone with diazemuls and meperidine administered intravenously if requested by the patient. Each bolus of patient-controlled sedation delivered 4.8 mg propofol and 12 microg alfentenil. Music was provided by means of a portable compact disc machine with headphones. Outcome measures assessed immediately after colonoscopy and 24 hours later included dose of patient-controlled sedation used, complications, recovery time, pain score, satisfaction score, and willingness to repeat the procedure with the same mode of sedation. RESULTS: The mean (SD) dose of propofol used in Group 1 was significantly less than Group 2 (0.84 mg/kg [0.69 mg/kg] vs. 1.15 mg/kg [0.83 mg/kg]; p = 0.02, t test). The mean (SD) satisfaction score was higher in Group 1 (7.8 [2.1]) compared with Group 2 (6.8 [2.3]) and Group 3 (7.4 [2.3]) (p = 0.05, 1-way analysis of variance). The majority of patients in Group 1 were willing to repeat the same mode of sedation when queried immediately after colonoscopy (87%) and 24 hours later (75%), which was significantly different from the corresponding results in the other 2 groups; p = 0.04 and p < 0.01 respectively, chi-square test. CONCLUSIONS: Music can decrease the dose of sedative medication required for colonoscopy. The combination of music and patient-controlled sedation was the best-accepted mode of sedation among 3 groups.

Adolescent↗
PubMed1999

Effect of insecticide-treated bed nets on haemoglobin values, prevalence and multiplicity of infection with Plasmodium falciparum in a randomized controlled trial in Tanzania.

A randomized controlled trial of insecticide-treated bed nets (ITNs) was conducted in an area of high malaria transmission in Tanzania in order to assess the effects of ITNs on infection and anaemia. One hundred and twenty-two children, aged 5 to 24 months, were randomly allocated to 2 groups, one of which received ITNs. Outcome measures were assessed in 6 consecutive months with monthly cross-sectional surveys. These measures were haemoglobin values, Plasmodium falciparum prevalence and density, and multiplicity of infection determined by polymerase chain reaction-restriction fragment length polymorphism analysis (PCR-RFLP) of the msp2 locus. There was a significant increase in mean heamoglobin values and a significant decrease of 16.4% in microscopically determined P. falciparum prevalence in children in the ITN group six months after the start of the trial. Both effects were more pronounced in younger children. However, no significant difference was observed in parasite density or multiplicity of infection among infected children. Comparison with PCR results indicated that microscopically subpatent parasitaemia was more frequently found in children in the ITN group. This, together with the observed similar multiplicity in the 2 groups, suggests that infections are maintained despite ITN use, owing to the chronicity of infections. This study shows that ITNs reduce the risk of anaemia in highly exposed young children. The virtually unchanged multiplicity of infection indicates that the potentially protective concomitant immunity is not compromised.

Anemia, Iron-Deficiency↗
PubMed1987

A randomized control trial of cardiac rehabilitation.

A randomized trial using controls tested whether psycho-social rehabilitation of acute myocardial infarction (MI) patients would improve significantly their return to work rate and assessed the importance of various psychological, social, occupational, socio-demographic, and medical factors in facilitating or impeding rapid return to work. Eighty-nine patients were assigned randomly to participate in an experimental cardiac rehabilitation program (rehab care), and 91 patients were controls who received conventional hospital rehabilitation (usual care). By the first follow-up interview at three months, patients assigned to experimental treatment were significantly less distressed psychologically and less dependent on family support than controls (P = 0.04 and P = 0.05, respectively). By the final follow-up interview at 13 months, there was a marginally significant difference in favor of the experimental group in the frequency of reported deterrents to work resumption (P = 0.07). However, the intervention did not result in a statistically significant difference in the return to work rate (P greater than 0.10). In each group, 88% were back at work by approximately the first year after infarction. In addition, the two groups were similar in the amount of time patients remained out of the workforce (median days rehab care = 75, usual care = 81; P greater than 0.10). A multi-stage data analysis procedure utilizing the Cox regression technique indicated that while several independent variables had significant univariate associations with the length of time patients convalesced, outcome was most influenced by the patient's initial cardiological status and clinical course, by the patterns of family support, and by the several variables measuring the presence of obstacles to resuming work. Our findings suggest that rehabilitation programs intervening on multiple levels (psychological, social, occupational, and physical) may best meet the needs of chronically ill cardiac patients. Results indicate that implementing measures addressing the patient's general psycho-social adjustment to MI may improve existing programs.

Adolescent↗
PubMed2002

Early occupational health management of patients with back pain: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial in occupational health practice was conducted. OBJECTIVE: To study the efficacy of early management of workers with low back pain by occupational physicians, as compared with management by the supervisor only. SUMMARY OF BACKGROUND DATA: Health care and university workers with back pain and on sick leave for less than 1 month were included in the study. METHODS: Patients with low back pain for at least 10 days on sick leave were randomly assigned to early management by the occupational physician (n = 61) or to a reference group with management by the worker's supervisor during the first 3 months of sick leave (n = 59). The patients were observed for 1 year and compared in terms of time until return to work, pain intensity, functional disability, and general health perception. The occupational physicians were provided with management guidelines. RESULTS: No significant differences were found after 3 and 12 months of follow-up evaluation in terms of time until return to work (hazard ratio, 1.3; 95% CI, 0.90-1.90) or in terms of other health outcomes. Recurrences, however, occurred more frequently in the intervention group, but the total duration of sick leave in 1 year did not differ between the groups. CONCLUSIONS: The findings do not show a significant positive effect of an early intervention by occupational physicians on workers with low back pain. This might reflect the early phase of disability or the low intensity of the intervention resulting from overestimation of the physicians' compliance with the guidelines.

Adult↗