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Results for “Randomized controlled trials”

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PubMed1999

A randomized controlled trial of nonpharmacologic approaches for relief of low back pain during labor.

BACKGROUND: Low back pain is common during labor. Our randomized controlled trial compared the effectiveness of 3 nonpharmacologic approaches for relief of back pain. METHODS: A total of 34 women suffering from low back pain during labor were randomly assigned to receive 1 of 3 treatments: (1) intracutaneous sterile water injections (ISW); (2) transcutaneous electrical nerve stimulation (TENS); and (3) standard care, including back massage, whirlpool bath, and liberal mobilization. Women self-evaluated both intensity and affective dimensions of pain using visual analog scales. Their evaluations of control and satisfaction were assessed using adapted versions of the Labour Agentry Scale and the Labor and Delivery Satisfaction Index. RESULTS: Women in the ISW group rated the intensity and unpleasantness of pain during the experimental period significantly lower than women in the standard care group or the TENS group, (P = .001 and P = .003, respectively). Similar results were observed for intensity (P = .01) and unpleasantness (P = .03) of pain assessed just before delivery or request for an epidural. Mean pain intensity at 15 and 60 minutes after randomization was significantly reduced in the ISW group compared with the 2 other groups. There was no significant difference in the 3 groups in the level of control and satisfaction with labor and delivery, but less women in the ISW group indicated that they would like to receive the same treatment for back pain during another delivery. CONCLUSIONS: Intracutaneous sterile water injections are more effective than standard care (back massage, bath, and mobilization) or transcutaneous electrical nerve stimulation for relieving low back pain during labor.

Analgesia, Obstetrical↗

PubMed2001

A randomized controlled trial to prevent patient lift and transfer injuries of health care workers.

STUDY DESIGN: Randomized controlled trial (RCT). OBJECTIVES: To compare the effectiveness of training and equipment to reduce musculoskeletal injuries, increase comfort, and reduce physical demands on staff performing patient lifts and transfers at a large acute care hospital. SUMMARY OF BACKGROUND DATA: Back injury to nursing staff during patient handling tasks is a major issue in health care. The value of mechanical assistive devices in reducing injuries to these workers is unclear. METHODS: This three-armed RCT consisted of a "control arm," a "safe lifting" arm, and a "no strenuous lifting" arm. A medical, surgical, and rehabilitation ward were each randomly assigned to each arm. Both intervention arms received intensive training in back care, patient assessment, and handling techniques. Hence, the "safe lifting" arm used improved patient handling techniques using manual equipment, whereas the "no strenuous lifting" arm aimed to eliminate manual patient handling through use of additional mechanical and other assistive equipment. RESULTS: Frequency of manual patient handling tasks was significantly decreased on the "no strenuous lifting" arm. Self-perceived work fatigue, back and shoulder pain, safety, and frequency and intensity of physical discomfort associated with patient handling tasks were improved on both intervention arms, but staff on the mechanical equipment arm showed greater improvements. Musculoskeletal injury rates were not significantly altered. CONCLUSIONS: The "no strenuous lifting" program, which combined training with assured availability of mechanical and other assistive patient handling equipment, most effectively improved comfort with patient handling, decreased staff fatigue, and decreased physical demands. The fact that injury rates were not statistically significantly reduced may reflect the less sensitive nature of this indicator compared with the subjective indicators.

Back Injuries↗

PubMed2005

Short-term risk of death after treatment with nesiritide for decompensated heart failure: a pooled analysis of randomized controlled trials.

CONTEXT: Nesiritide improves symptoms in patients with acutely decompensated heart failure compared with placebo and appears to be safer than dobutamine. Its short-term safety relative to standard diuretic and vasodilator therapies is less clear. OBJECTIVE: To investigate the safety of nesiritide relative to noninotrope-based control therapies, primarily consisting of diuretics or vasodilators. DATA SOURCES: Primary reports of completed clinical trials as of December 2004 were obtained from the US Food and Drug Administration (FDA), the study sponsor (Scios Inc), a PubMed literature search using the terms nesiritide, clinical trials, and humans, and a manual search of annual meetings of 3 heart associations. STUDY SELECTION: Of 12 randomized controlled trials evaluating nesiritide, 3 met all inclusion criteria: randomized double-blind study of patients with acutely decompensated heart failure, therapy administered as single infusion (> or =6 hours), inotrope not mandated as control, and reported 30-day mortality. DATA EXTRACTION: Data were extracted from FDA and sponsor documents and corroborated with published articles when available. Thirty-day survival was assessed by meta-analysis using a fixed-effects model and time-dependent risk by Kaplan-Meier analysis with Cox proportional hazards regression modeling. Where deaths were described within a range of days after treatment, an extreme assumption was made favoring nesiritide over control therapy, an approach relevant to the time-dependent analyses. DATA SYNTHESIS: In the 3 trials, 485 patients were randomized to nesiritide and 377 to control therapy. Death within 30 days tended to occur more often among patients randomized to nesiritide therapy (35 [7.2%] of 485 vs 15 [4.0%] of 377 patients; risk ratio from meta-analysis, 1.74; 95% confidence interval [CI], 0.97-3.12; P = .059; and hazard ratio after adjusting for study, 1.80; 95% CI, 0.98-3.31; P = .057). CONCLUSIONS: Compared with noninotrope-based control therapy, nesiritide may be associated with an increased risk of death after treatment for acutely decompensated heart failure. The possibility of an increased risk of death should be investigated in a large-scale, adequately powered, controlled trial before routine use of nesiritide for acutely decompensated heart failure.

Diuretics↗

PubMed1996

Conducting a randomized controlled trial of CQI and academic detailing to implement clinical guidelines.

BACKGROUND: A multisite, randomized controlled trial was conducted from August 1994 through January 1996 to compare the impact of two strategies-academic detailing (AD) and continuous quality improvement (CQI) teams-on the implementation of national guidelines for the primary care of hypertension and depression. STUDY: Twelve small groups of providers at four clinics-two at Group Health Cooperative of Puget Sound (Seattle) and two at academic medical centers-were randomized in blocks along with their primary care patients to receive AD alone, AD plus CQI, or usual care. A detailing session conducted by a physician and two follow-up sessions conducted by a pharmacist lasted an average of 8-9 minutes. Each CQI team, which met, on average, 14 times in nine months, devised at least one intervention (for example, weight loss counseling for hypertensives by nurse practitioners). RESULTS: The detailing endeavors differed greatly across organizations. Although all teams generally worked well together, organizational factors such as staff layoffs and reorganizations competed for the teams' attention. Team leaders differed in their ability to inspire members to "run with" ideas and to motivate personnel outside the team to implement interventions. SUMMARY AND CONCLUSIONS: Surveys and semi-structured interviews suggest that both the AD and CQI interventions involved complex social interactions that resulted in varied implementation across the different organizations. Final analyses will need to focus on identifying factors associated with the relative success or failure of both clinical change techniques.

Academic Medical Centers↗

PubMed2002

Excision margins in the treatment of primary cutaneous melanoma: a systematic review of randomized controlled trials comparing narrow vs wide excision.

BACKGROUND: The optimal excision margin for primary cutaneous melanoma remains controversial, although several clinical studies have suggested that wide local excision is unnecessary. HYPOTHESIS: Wide excision margins do not improve survival in patients with melanoma. OBJECTIVES: To describe the published evidence and determine the effectiveness of wide surgical margins compared with narrow surgical margins. DESIGN: Systematic review of randomized controlled trials that compared narrow margins with wide excision margins for cutaneous melanoma. SETTING: Randomized controlled trials available by March 2001. SUBJECTS: The included trials comprised 2406 participants. INTERVENTION: Surgical excision of melanoma using narrow excision margins compared with excision using wide excision margins. MAIN OUTCOME MEASURE: Effect of width of excision margin on melanoma recurrences, disease-free survival, and overall survival. RESULTS: We identified and analyzed 4 randomized controlled trials. All 4 trials failed to demonstrate statistically significant differences in overall survival and disease-free survival when comparing wide vs narrow excision. Peto pooled odds ratio for overall survival was 0.79 (95% confidence interval, 0.61-1.04) and for disease-free survival was 0.89 (95% confidence interval, 0.69-1.13), indicating a statistically nonsignificant improvement with wide excision. CONCLUSIONS: Not one of the included studies showed any statistically significant difference between the 2 groups treated with narrow or wide excision margins with regard to recurrences and survival. However, current evidence is not sufficient to address the optimal surgical margins for all melanomas, and further research is required.

Disease-Free Survival↗

PubMed2005

A randomized controlled trial of elective preterm delivery of fetuses with gastroschisis.

BACKGROUND: Elective preterm delivery of the fetus with gastroschisis may help to limit injury to the extruded fetal gut and thus promote faster recovery of neonatal gut function and earlier hospital discharge. This hypothesis has not previously been tested in a prospective randomized controlled trial. METHODS: Between May 1995 and September 1999, all women referred to a single tertiary center before 34 weeks' gestation with a sonographically diagnosed fetal gastroschisis were invited to participate in a randomized controlled trial. Eligible patients were randomized to elective delivery at 36 weeks or to await the onset of spontaneous labor. The method of delivery was not prescribed by the trial. Primary outcome measures in the neonate were the time taken to tolerate full enteral feeding (150 mL/kg per day) and duration of hospital stay. RESULTS: Of 44 eligible women, 42 were randomized, 21 to elective delivery and 21 to await spontaneous labor. There were 20 liveborn infants in each group. Four babies in the elective group and 4 in the spontaneous group delivered before 36 weeks' gestation but were included in the analysis on an intention-to-treat basis. Mean gestational age at delivery was 35.8 weeks in the elective group and 36.7 weeks in the spontaneous group. Primary closure of the gastroschisis was achieved in a similar proportion (80%-85%) of infants in both groups. Two babies in the elective group died from short gut complications. In the survivors, there was a trend in favor of a shorter median time to achieve full enteral feeding (30.5 vs 37.5 days) and a shorter median duration of hospital stay (47.5 vs 53 days) in the elective group, but this was not statistically significant. These findings remained unaltered when the data were reanalyzed after (a) excluding infants with intestinal atresia or (b) excluding infants born before 36 weeks' gestation. CONCLUSIONS: Although limited by the small number of patients, this randomized controlled trial demonstrates no significant benefit from elective preterm delivery of fetuses with gastroschisis.

Adult↗

PubMed2001

A randomized, controlled trial of surgery for temporal-lobe epilepsy.

BACKGROUND: Randomized trials of surgery for epilepsy have not been conducted, because of the difficulties involved in designing and implementing feasible studies. The lack of data supporting the therapeutic usefulness of surgery precludes making strong recommendations for patients with epilepsy. We conducted a randomized, controlled trial to assess the efficacy and safety of surgery for temporal-lobe epilepsy. METHODS: Eighty patients with temporal-lobe epilepsy were randomly assigned to surgery (40 patients) or treatment with antiepileptic drugs for one year (40 patients). Optimal medical therapy and primary outcomes were assessed by epileptologists who were unaware of the patients' treatment assignments. The primary outcome was freedom from seizures that impair awareness of self and surroundings. Secondary outcomes were the frequency and severity of seizures, the quality of life, disability, and death. RESULTS: At one year, the cumulative proportion of patients who were free of seizures impairing awareness was 58 percent in the surgical group and 8 percent in the medical group (P<0.001). The patients in the surgical group had fewer seizures impairing awareness and a significantly better quality of life (P<0.001 for both comparisons) than the patients in the medical group. Four patients (10 percent) had adverse effects of surgery. One patient in the medical group died. CONCLUSIONS: In temporal-lobe epilepsy, surgery is superior to prolonged medical therapy. Randomized trials of surgery for epilepsy are feasible and appear to yield precise estimates of treatment effects.

Adult↗

PubMedDate not supplied

The one-person randomized controlled trial.

Currently, the gold standard for collection of clinical evidence is the randomized controlled trial (RCT), preferably with large, multicenter samples of subjects. Although this approach provides valuable information, many clinicians find it difficult to translate RCT results to the individual patient level. In this report, a statistical approach called Design of Experiments (DOE) is described as a method of applying the principles of RCTs one person at a time. An overview of the method, with a simple clinical example, is presented. As shown, DOE is a more efficient method than the sequential approach often taken by clinicians and their patients when evaluating various treatment choices. Further, the effect of multiple interventions can be assessed, alone or in combination with each other. In this way, DOE can be an important addition to the field of evidence-based medicine, although further studies are needed.

Data Interpretation, Statistical↗

PubMed1991

Randomized, controlled trials using the Metro Firm System.

The Firm System at MetroHealth Medical Center was begun almost two decades ago to foster improved continuity of patient care and teaching of medical students and residents in Internal Medicine. For the past 8 years, these parallel teams of providers and patients also have been used to conduct clinical, educational, and health care delivery research. Randomized, controlled trials are made possible by ongoing random assignment of patients and providers to the three teams, or small group practices. Each group practice has equivalent inpatient and outpatient areas supported by nonrotating nursing, paramedical, and clerical staff. The system's current relationships were established after a controlled trial established both decreased costs and increased effectiveness of the "group practice model" as compared to more traditional approaches to patient care by residents in an academic medical center. Other trials, both on the inpatient and outpatient settings, have been used to guide ongoing institutional change. The unique advantages of the randomized controlled trial are high-lighted by contrasting the results of within-group changes during an intervention with results that incorporate control group changes. A variety of methodologic and logistical issues must be addressed when conducting controlled trials that use ongoing randomization within a single institution. These include determination that the groups are equivalent for all important parameters preintervention, choosing an analytic approach that accounts for potential differences among providers and patients, and, in trials designed to affect behavior, assurance that a "steady state" exists prior to initiating another trial designed to affect similar behavior. Consideration also must be given to the possibilities of cross-team contamination, the Hawthorne effect, the "dominant attending effect," and ethical issues related to informed consent. Clinical trials in a single institution may be performed for common problems and those with well defined stages of severity. Since the costs of maintaining the ongoing randomization are relatively small, the incremental costs of conducting randomized controlled trials are low by comparison to traditional approaches. The establishment of analogous systems at other institutions will permit multisite trials for less common clinical problems, enhance the generalizability of findings, and permit new types of health services research, including the rigorous evaluation of practice guidelines.

Health Services Research↗

PubMed2006

Neonatal adrenal function after repeat dose prenatal corticosteroids: a randomized controlled trial.

OBJECTIVE: Do repeat prenatal corticosteroids suppress neonatal cortisol concentrations? STUDY DESIGN: Randomized controlled trial of women given weekly repeat corticosteroids or saline placebo, while at risk of preterm birth, until 32 weeks' gestation. RESULTS: Cord serum cortisol concentrations in infants exposed to repeat corticosteroids were similar compared with infants exposed to a single course of corticosteroids (mean difference -26 nmol/L (95% CI -57, 5 nmol/L, P = .10), as were prestress salivary cortisol concentrations on day 3 (median 16.5 vs 15.3 nmol/L, P = .96). The adrenal response to a stressor on day 3 was lower in the repeat corticosteroid group compared with the single course group (median 11.9 vs 21.4 nmol/L, P = .02). Cortisol concentrations were lower in the repeat corticosteroid group on day 7 (median 11.7 vs 18.2 nmol/L, P = .04), but not on days 14 and 21. CONCLUSION: The short- or long-term clinical impact, if any, of these changes in adrenal function needs to be determined.

Adrenal Glands↗

PubMed2001

A prospective randomized control trial comparing medical and surgical treatment for early pregnancy failure.

A prospective randomized control trial was designed to assess the effectiveness of single dose, 800 microg misoprostol administered p.v. compared with surgical evacuation for the treatment of early pregnancy failure. A total of 80 women with a diagnosis of early pregnancy failure were randomized to study (vaginal misoprostol) and control (surgical curettage) groups. Success of treatment, side-effects as assessed during, immediately after and 10 days after treatment, and patient satisfaction were compared. Intravaginal misoprostol was successful in 82.5% (33 out of 40) of the patients. None of the control group patients required a repeat evacuation. The number of patients who experienced significant abdominal pain following treatment did not differ between the groups. The duration of pain was shorter in the control group; however, they required more analgesics during this short period. The number of patients with significant vaginal bleeding, the duration or severity of bleeding did not show any significant difference between the groups. All 33 patients in the study group who had successful treatment expressed satisfaction, whereas only 58% of the control group did so. In conclusion this randomized control study demonstrated the efficacy and safety of the administration of 800 microg of misoprostol p.v. for the management of early pregnancy failure.

Abortion, Incomplete↗

PubMed2005

Systematic review of randomized controlled trials of atypical antipsychotics and selective serotonin reuptake inhibitors for behavioural problems associated with pervasive developmental disorders.

A systematic review of randomized controlled trials of the use of atypical antipsychotics and selective serotonin reuptake inhibitors in the treatment of behavioural problems associated with pervasive developmental disorders is reported. A search through both published and unpublished literature, including contacting drug companies and known experts in the field was undertaken. Six trials met the criteria for inclusion in the review. They largely suffer from methodological weaknesses; only two trials had satisfactory methodological quality. The heterogeneity in outcome measurements prevented from conducting a meta-analysis. There is yet no coherent body of data concerning the effects of these medications across all sub-classifications of pervasive developmental disorders, across all age categories, and concerning their medium- and long-term effects, and their effects on quality of life. Atypical antipsychotics and selective serotonin reuptake inhibitors may be of benefit for behavioural problems associated with pervasive developmental disorders. Risperidone has been the best studied among these medications. Atypical antipsychotics appear to have a low risk of extrapyramidal symptoms during short-term treatment. The reviewed trials cannot provide data on the use of selective serotonin reuptake inhibitors in the treatment of children with pervasive developmental disorders. No firm conclusions for clinical practice can be drawn. Larger, well-conducted randomized controlled trials with long-term follow-up are needed.

Adolescent↗

PubMed1996

Treatments for postherpetic neuralgia--a systematic review of randomized controlled trials.

BACKGROUND: A number of different therapies have been used for postherpetic neuralgia. We decided to conduct a systematic review of existing randomized controlled trials. OBJECTIVE: To determine the efficacy of available therapies for relieving the pain of established postherpetic neuralgia. METHODS: We performed a systematic review, including meta-analysis, of existing randomized controlled trials. Eleven published trials and one unpublished trial were identified which met the inclusion criteria and were included in the current review. RESULTS: Pooled analysis of the effect of tricyclic antidepressants demonstrate statistically significant pain relief (OR 0.15, CI 0.08-0.27). Pooling of the results of the three trials comparing the effects of capsaicin and placebo could not be done due to heterogeneity. This heterogeneity was mainly attributable to an unpublished trial which differed in terms of the dose and duration of treatment. When this study was omitted, no heterogeneity was found and the pooled analysis revealed a statistically significant benefit (OR 0.29, 95% CI 0.16-0.54). However, problems with blinding in patients using capsaicin may have accounted for the positive effect. One small study of vincristine iontophoresis compared to placebo also yielded a favourable result (OR 0.05, 95% CI 0.01-0.26). Other treatment evaluated include lorazepam, acyclovir, topical benzydamine, and acupuncture. We found no evidence that these are effective in relieving pain associated with postherpetic neuralgia. CONCLUSION: Based on evidence from randomized trials, tricyclic anti-depressants appear to be the only agents of proven benefit for established postherpetic neuralgia.

Analgesics↗

PubMed2005

Implementation of new medical techniques: experience from the Swedish randomized controlled trial on fetal ECG during labor.

BACKGROUND: In a large Swedish multicenter randomized controlled trial (RCT) on intra partum fetal monitoring with automatic analysis of fetal ECG waveform (STAN) in combination with cardiotocography (CTG) (4966 parturients, 300 obstetricians and midwives managing the patients), interim analysis revealed protocol violations. By a post hoc analysis of the results over time, factors affecting the acceptance of the new technique were analyzed. METHODS: The rates of primary and secondary outcome measures (fetal outcome, operative deliveries) were compared in the two study groups (CTG + ST and CTG only). Changes over time were statistically evaluated using a test for homogeneity between the two periods. RESULTS: After retraining, the CTG + ST group showed the lowest rates of operative delivery for fetal distress, fetal blood sampling and admissions to neonatal intensive care unit. Operative deliveries (p = 0.02) and the number of fetal blood sampling decreased significantly over time (p = 0.001). CONCLUSIONS: Training and education probably predisposed the clinicians to a change and reinforced it when it occurred as a result of increased personal experience. The audit and feedback together with the influence of opinion leaders and inter-collegial interactions seem to have been of importance for the successively increasing acceptance of the new method during the RCT.

Cardiotocography↗

PubMed2004

Randomized controlled trial of sour milk on blood pressure in borderline hypertensive men.

BACKGROUND: A double-blind randomized controlled trial was carried out to assess the effect of sour milk, containing two tripeptides (valine-proline-proline and isoleucine-proline-proline), on blood pressure (BP). METHODS: A total of 46 borderline hypertensive men aged 23 to 59 years were recruited at their workplace for this trial. Subjects were randomly allocated into two groups; sour milk drink group (S-group, n = 23) and placebo (acidified milk) drink group (P-group, n = 23) for 4 weeks. Blood pressure was measured twice at each occasion by a physician, at the health center of the company, with a mercury at baseline, 2 and 4 weeks. Statistical analysis was performed by SPSS 10.0J. RESULTS: The S-group and P-group showed no significant difference in baseline systolic BP (mean [SD], S: 147.6 [9.6], P: 145.3 [13.0]) or diastolic BP (S: 95.3 [9.9], P: 91.5 [9.6]). In the S-group, change in systolic BP at 2 and 4 weeks were -4.3 mm Hg (95% confidence interval [CI] -8.3 to -0.4; P = .032) and -5.2 mm Hg (95% CI -10.1 to -0.3; P = .039), both statistically significant. Diastolic BP showed change from -1.7 mm Hg (95% CI -5.4 to 2.0) at 2 weeks and -2.0 (95% CI -5.4 to 1.5) at 4 weeks, respectively. In the P-group, change in systolic BP were -0.5 (95% CI -5.8 to 4.8) at 2 weeks and -3.7 (95% CI -8.3 to 0.9) and change in diastolic BP were -0.6 (95% CI -4.7 to 3.6) and -0.3 (95% CI -3.9 to 3.3), which were not statistically significant. CONCLUSIONS: This trial demonstrated the beneficial effect of sour milk on BP in borderline hypertensive men who were not taking antihypertensive medication.

Adult↗

PubMed2002

In-patient interventions supported by results of randomized controlled trials in Japan.

OBJECTIVE: To determine to what extent the results of randomized controlled trials (RCTs) support medical interventions for in-patients at the department of general medicine of a university hospital in Japan. DESIGN: Retrospective analysis. By reviewing discharge summaries, two physicians first independently decided on patients' respective primary problems at admission and up to two secondary problems. Next, up to five interventions for the primary problem and one intervention for each of the secondary problems were selected. Differences of opinion (if any) between the two physicians regarding these selected interventions were resolved by discussion. MEDLINE and/or the Cochrane Library were used as data sources for literature regarding the selected interventions. SETTING: A ward of the department of general medicine of a Japanese university hospital, 1995-1997. MAIN MEASURES: The proportion of therapeutic interventions supported by RCT results and associated meta-analyses. RESULTS: For the primary problems, 103 (48.8%) of the 211 most important interventions were supported by the results of RCTs, as were 47.8% of all the interventions including the most important and the adjunctive ones. Furthermore, 56.2% of the most important interventions for the secondary problems were also supported by the RCT results. CONCLUSIONS: Approximately half of the therapeutic interventions performed at an academic medical in-patient unit in Japan were RCT-supported. This was true not only for the most important interventions for primary problems but also for the adjunct interventions for the primary problems and the interventions for secondary problems.

Adolescent↗

PubMed2003

A study of interventions and related outcomes in a randomized controlled trial of occupational therapy and leisure therapy for community stroke patients.

OBJECTIVE: To undertake a detailed analysis of therapy provided in a multicentred randomized controlled trial of activities of daily living (ADL) and leisure (TOTAL), testing the hypothesis that specific interventions given in the trial affected specific aspects of outcome. SUBJECTS: Three hundred and nine stroke patients who had been randomly allocated to receive either occupational therapy aimed at ADL activities (n = 156) or leisure (n = 153). MEASURES: Number, duration and type of activity undertaken per patient. Barthel Index, Extended Activities of Daily Living Scale (EADL) and Nottingham Leisure Questionnaire (NLQ) six months after entry to the study. METHOD: Activities that had been used in treatment were coded and categorized. Frequently used activities identified. These activities were matched to items from the six-month outcome measures. Patient independence in these outcome items was compared between the leisure and ADL groups. RESULTS: Three hundred and nine therapy record forms were returned. Patients received a median of ten sessions with a median duration of 55 minutes. The ADL group received significantly more, mobility training, transfer training, cleaning, dressing, cooking and bathing training (chi-squared, p < 0.05). Sport, creative activities, games, hobbies, gardening, entertainment and shopping were used significantly more in the leisure group (chi-squared, p < 0.05) than the ADL group. Fifteen items from the outcome measures were identified as specific to these interventions. There were no statistically significant differences in outcome on these 15 items between the ADL and leisure groups (chi-squared, p > 0.05). CONCLUSIONS: We found no evidence that specific ADL or leisure interventions led to improvements in specific relevant outcomes. We believe that these findings should prompt a review of the relationship between process and outcome of occupational therapy.

Activities of Daily Living↗

PubMed2004

In a randomized controlled trial, missing data led to biased results regarding anxiety.

BACKGROUND AND OBJECTIVE: Randomization does not protect against bias due to missing observations. In addition, different reasons for missing observations may lead to different invalid results. The purpose of this study was to illustrate how randomized intervention studies can be threatened by bias due to missing observations because of death or nonresponse. METHODS: A randomized clinical trial of the effect of psychosocial intervention on well-being after an operation for colorectal cancer was conducted in Denmark. Patients were interviewed 3, 6, 12, and 24 months after discharge from hospital. RESULTS: We found that the probability of nonresponse decreased with increasing anxiety score in the intervention group, but it increased with increasing anxiety score in the control group. This could lead to severe bias in an analysis of the effect of intervention on anxiety. Low physical functioning and low global health status and quality of life were related to an increased probability of dying before the next follow-up, and this association could explain the associations between anxiety and depression, respectively, and the probability of dying observed in crude analyses. CONCLUSION: Our study emphasizes the importance of performing specific missing data analyses in any study of well-being variables.

Aged↗