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Health-related quality of life after interventional or conservative strategy in patients with unstable angina or non-ST-segment elevation myocardial infarction: one-year results of the third Randomized Intervention Trial of unstable Angina (RITA-3).

OBJECTIVES: We sought to compare the effects of an early interventional strategy (IS) versus a conservative strategy (CS) on health-related quality of life (HRQOL) in patients with non-ST-segment elevation acute coronary syndromes (ACS). BACKGROUND: The third Randomized Intervention Trial of unstable Angina (RITA-3) evaluated early IS (n = 895) versus CS (n = 915). We report one-year results of the RITA-3 trial concerning HRQOL. METHODS: The patients' HRQOL was assessed with the Short Form-36 (SF-36) and Seattle Angina Questionnaire (SAQ) at four-month and one-year follow-up, and the EuroQOL Visual Analogue Scale (EQ-VAS) and EuroQOL 5-Dimensional Classification (EQ-5D) also measured at baseline. Analysis was performed using the two-sample t test and analysis of co-variance. RESULTS: Mean changes from baseline EQ-VAS scores were better for IS than for CS at four months (treatment difference of 3.0, p < 0.001) and one year (2.3, p < 0.01). The EQ-5D utility scores were also higher for IS at four months (treatment difference: 0.036, p < 0.01) and at one year (0.016, p = 0.20). For SF-36, IS scored significantly better at four months for physical function, physical role function, emotional role function, social function, vitality, and general health. The SAQ scores for exertional capacity, anginal stability and frequency, treatment satisfaction, and disease perception were better for IS at four months. These treatment differences were present but attenuated by one-year follow-up. Improvements in HRQOL for IS could be attributed to improvements in anginal symptoms. CONCLUSIONS: In patients with non-ST-segment elevation ACS, an early IS provides greater gains in HRQOL, as compared with CS, mainly due to improvements in angina grade.

Adult↗

Impact of superficial bladder cancer and transurethral resection on general health-related quality of life: an SF-36 survey.

OBJECTIVES: To assess the general health-related quality of life (GHQOL) of patients with superficial bladder cancer who underwent transurethral resection (TUR). METHODS: We assessed the GHQOL a total of 178 times for 133 patients with superficial bladder cancer before multiple TURs. The GHQOL was assessed using the Medical Outcome Study Short-Form 36-item survey (SF-36). Ninety-three patients answered the questionnaire at the first TUR, 34 at the second TUR, 17 at the third TUR, and 34 at the fourth or later TUR. RESULTS: Compared with age-matched and sex-matched Japanese norms, the general health perception was severely impaired in patients with superficial bladder cancer. Their mental health was also severely impaired at the first TUR, but gradually returned to normal as TUR was repeated. The scores of physical functioning, social functioning, and role-emotional demonstrated a nadir at the second or third TUR, and increased thereafter if TUR was repeated four or more times. Intravesical treatment for prevention of recurrence increased the score of bodily pain. CONCLUSIONS: Although superficial bladder cancer is not frequently lethal, patients with this disease believed their general health was much impaired. Only two domains of bodily pain and vitality had no negative impact from this disease. As urologists, we should notice the considerable affect of superficial bladder cancer on the GHQOL of patients.

Aged↗

Add-on melatonin improves quality of life in epileptic children on valproate monotherapy: a randomized, double-blind, placebo-controlled trial.

This randomized, double-blind, placebo-controlled study in epileptic children aged 3-12 years evaluated the effects of add-on melatonin administration on the quality of life of these children on sodium valproate (VPA) monotherapy using a parental questionnaire. Quality of Life in Childhood Epilepsy is a questionnaire designed to assess a variety of age-relevant domains such as physical function, emotional well-being, cognitive function, social function, behavior, and general health. Of the 31 patients, 16 randomly received add-on melatonin (MEL), whereas 15 received add-on placebo (P). The questionnaire had good internal consistency reliability, because for most of the multi-item scales Cronbach's alpha reliability exceeded 0.5 (range: 0.59-0.94). To our knowledge, this is the first study assessing quality of life in epileptic children with add-on melatonin administration in the form of a randomized, double-blind, placebo-controlled trial. The study suggests a potential use of melatonin as an adjunct to antiepileptic therapy due to its diverse spectrum of action as an antioxidant, neuroprotector, and free radical scavenger, thus offering the advantage of reducing oxidant stress and subsequent damage. The beneficial effects of melatonin on sleep, its wide safety window, and its ability to cross the blood-brain barrier have the potential to improve quality of life in pediatric epilepsy.

Anticonvulsants↗

A controlled trial of cardiac rehabilitation in the home setting using electrocardiographic and voice transtelephonic monitoring.

OBJECTIVE: The goal of this study was to compare the effectiveness of home-based, transtelephonically monitored cardiac rehabilitation with standard, on-site, supervised cardiac rehabilitation. BACKGROUND: Participation in cardiac rehabilitation has been demonstrated to increase exercise capacity, decrease cardiovascular symptoms, improve psychosocial status, and decrease total and cardiovascular mortality rates in patients with coronary heart disease. Because of multiple factors, national overall participation is only at 15% of eligible patients. METHODS: Effects of a 3-month home-based, transtelephonically monitored rehabilitation program (n = 83 patients) with simultaneous voice and electrocardiographic transmission to a centrally located nurse coordinator were compared with effects of a standard on-site rehabilitation program (n = 50 patients). The study design was a multicenter, controlled trial. Primary outcome variables were peak aerobic capacity and quality of life, as measured by the Health Status Questionnaire. RESULTS: Patients in the home-based monitoring program increased peak aerobic capacity to a similar degree as patients who exercised on site (18% vs 23%). Quality of life domains of physical functioning, social functioning, physical role limitations, emotional role limitations, bodily pain, and energy/fatigue improved similarly in both groups. There were no circulatory arrests or other major exercise-related medical events in either group. A total of 3100 hours of home exercise were transtelephonically monitored. CONCLUSIONS: Patients with coronary heart disease can effectively participate in home-based, monitored cardiac rehabilitation, with exercise and quality of life improvements comparable to those demonstrated at on-site programs.

Age Factors↗

Esophageal reconstruction for benign disease: self-assessment of functional outcome and quality of life.

BACKGROUND: Little information exists regarding functional outcome and quality of life after esophagectomy and subsequent esophageal reconstruction for benign disease as evaluated by the patients themselves. METHODS: Eighty-one patients completed a combined two-part questionnaire regarding esophageal function and quality of life (MOS SF-36) a median of 9.8 years (range, 10 months to 18.9 years) after esophageal reconstruction for benign disease. There were 43 men (53.1%) and 38 women (46.9%). Median age at time of esophageal reconstruction was 51 years (range, 6 to 78 years). Intestinal continuity was established with stomach in 58 patients (71.6%), colon in 16 patients (19.8%), and small bowel in 7 patients (8.6%). RESULTS: Dysphagia to solids was present in 48 patients (59.3%) and 27 patients (33.3%) required at least one postoperative dilatation. Heartburn was present in 50 patients (61.7%) which required medication for control in 37 patients (45.7%). The number of meals per day was three to four in 58 patients (71.6%), more than four in 15 patients (18.5%), less than three in 6 patients (7.4%), and unknown in 2 patients (2.5%). The size of each meal was smaller than preoperatively in 46 patients (56.8%), larger in 22 patients (27.2%), unchanged in 12 patients (14.8%), and unknown in 1 patient (1.2%). The number of bowel movements per day increased in 37 patients (45.7%), was unchanged in 36 patients (44.4%), and decreased in 8 patients (9.9%). Resection for perforation was associated with smaller postoperative meals compared with resection for stricture (p < 0.05). Age, sex, and type of esophageal reconstruction did not affect late functional outcome. Regarding quality of life, physical functioning, social functioning, and health perception were decreased (p < 0.05). No significant change was observed in role-physical, mental health, bodily pain, energy/fatigue, and role-emotional scores. CONCLUSIONS: Self-assessment of postoperative esophageal symptoms after esophagectomy and reconstruction for benign disease demonstrates that symptoms are frequently present at long-term follow-up and unaffected by the type of reconstruction.

Adolescent↗

High-grade esophageal dysplasia: long-term survival and quality of life after esophagectomy.

BACKGROUND: Esophagectomy for high-grade dysplasia in Barrett's esophagus has been advocated. Although long-term survival data exist, little is known about functional outcome and quality of life in this particular subset of patients. METHODS: The records of all patients who underwent esophageal resection for high-grade dysplasia from June 1991 through July 1997 were reviewed. Long-term functional outcome and quality of life were assessed using a two-part written survey. RESULTS: There were 54 patients (48 men, 6 women). Median age was 64 years (range, 36 to 83 years). Ivor Lewis esophagogastrectomy was performed in 34 patients (63%), transhiatal esophagectomy in 10 (18%), extended esophagectomy in 8 (15%), and other in 2 (4%). Invasive carcinoma was found in 19 patients (35%). Five patients (9%) were stage 0, 7 (13%) stage I, 3 (6%) stage IIA, 1 (2%) stage IIB, and 3 patients (6%) stage III. There was one operative death (1.8%). Complications occurred in 31 patients (57%). Median hospitalization was 13 days (range, 11 to 44 days). Follow-up was complete in all patients and ranged from 6 months to 9 years (median, 63 months). Overall 5-year survival was 86% and did not differ significantly from a population matched for age and gender. Five-year survival for patients with only high-grade dysplasia was 96% and 68% for patients with cancer (p = 0.017). Quality of life was measured by the Medical Outcomes Study 36-Item Short-Form Health Survey. For patients with only high-grade dysplasia, the role-physical and role-emotional scores were better than for the control population (p < 0.03). For patients with cancer, the health perception score was worse than for the control population (p < 0.03). Scores measuring physical-function, social function, mental health, bodily pain, and energy/fatigue were similar. CONCLUSIONS: Although perioperative morbidity is significant, surgical resection of high-grade dysplasia in Barrett's esophagus provides excellent long-term survival with acceptable function and quality of life.

Adult↗

Quality of life and traumatic spinal cord injury.

OBJECTIVE: To determine associations between major outcome variables after traumatic spinal cord injury (SCI) and quality of life (QL). SUBJECTS: Of a total population of 353 SCI patients, 320 participated, 261 men and 59 women living in the greater Stockholm area: 124 were tetraplegic, 176 were paraplegic, and 20 had no classified level. Mean age was 42 years (range, 17 to 78). METHOD: The Swedish SF-36 Health Survey was used to assess QL. The SF-36 is a self-administered questionnaire containing 36 items, divided into 8 multi-item dimensions, covering physical function, physical and emotional role function, social function, bodily pain, mental health, vitality and overall evaluation of health. Neurologic, general medical, and psychosocial variables were obtained from the Stockholm Spinal Cord Injury Study (SSCIS) data base. QL indices were analyzed for the SCI group as a whole, as well as for subgroups. Descriptors for subgroups were demographic variables, presence or absence of common medical problems, and subjective evaluation of the degree of impact of the medical problem on well-being/daily activities. RESULTS: QL in individuals with SCI was significantly lower in all subscales as compared with a normative population. No difference in QL was seen in subgroups according to extent of lesion, with the exception of physical functioning. Several medical complications such as neurogenic pain, spasticity, and neurogenic bladder and bowel problems were associated with lower QL scores. SUMMARY: QL, as defined by SF-36, is better in persons injured many years ago, as compared with those recently injured, suggesting an adaptive process operating over a long period. The presence of complicating medical problems, such as severe pain, problematic spasticity, and incontinence, seem to have more negative effects on QL than the extent of SCI as such.

Adolescent↗

Self-delivery of hemodialysis care: a therapy in itself.

Patient autonomy, sense of control, and well-being are thought to be enhanced by self-care hemodialysis as a therapy for end-stage renal disease. Dialysis in a satellite setting reduces travel time and can diminish therapy intrusiveness. Health-related quality of life (HRQOL), in terms of functional status and well-being, was measured in a group of patients trained for self-care, and then measured again after these patients were transferred to a satellite unit. Comparison was made with an age- and comorbidity-matched cohort of full-care patients. Patients trained for self-care tended to score higher than the full-care patients in the psychosocial domains of HRQOL, such as role function, social function, and emotional well-being, before and after transfer to the satellite unit. Physiological measurements did not differ significantly between groups at any time during the study, indicating that differences in HRQOL were not attributable to differences in metabolic stability. We conclude that patients trained for self-care hemodialysis experience better subjective quality of life than their full-care counterparts. This study highlights both the usefulness of measuring HRQOL as an outcome of hemodialysis therapy and the potential benefits of therapies such as self-care and satellite dialysis.

Activities of Daily Living↗

Quality of life in patients on chronic dialysis: self-assessment 3 months after the start of treatment. The Necosad Study Group.

The aim of the present multicenter study was to assess quality of life of Dutch dialysis patients 3 months after the start of chronic dialysis treatment. The quality of life was compared with the quality of life of a general population sample, and the impact of demographic, clinical, renal function, and dialysis characteristics on patients' quality of life was studied. New end-stage renal disease (ESRD) patients who were started on chronic hemodialysis or peritoneal dialysis in 13 dialysis centers in The Netherlands were consecutively included. Patients' self-assessment of quality of life was measured by the SF-36, a 36-item Short Form Health Survey Questionnaire encompassing eight dimensions: physical functioning, social functioning, role-functioning physical, role-functioning emotional, mental health, vitality, bodily pain, and general health perceptions. One hundred twenty hemodialysis and 106 peritoneal dialysis patients completed the SF-36. Quality of life of hemodialysis and peritoneal dialysis patients was substantially impaired in comparison to the general population sample, particularly with respect to role-functioning physical and general health perceptions. Mean role-functioning physical and general health perceptions scores of the hemodialysis patients corresponded with the lowest scoring 8% and 12%, respectively, of the reference group. Mean role-functioning physical and general health perceptions scores of the peritoneal dialysis patients corresponded with the lowest scoring 10% and 12%, respectively, of the reference group. Hemodialysis patients showed lower levels of quality of life than peritoneal dialysis patients on physical functioning, role-functioning emotional, mental health, and pain. However, on the multivariate level, we could only demonstrate an impact of dialysis modality on mental health. A higher number of comorbid conditions, a lower hemoglobin level, and a lower residual renal function were independently related to poorer quality of life. The variability of the SF-36 scores explained by selected demographic, clinical, renal function, and dialysis characteristics was highest for physical functioning (29.7%). Explained variability of the other SF-36 dimensions ranged from 6.9% for general health perceptions to 15.4% for vitality. We conclude that quality of life of new ESRD patients is substantially impaired. Comorbid conditions, hemoglobin, and residual renal function could explain poor quality of life only to a limited extent. Further research exploring determinants and indices of quality of life in ESRD patients is warranted. From a clinical perspective, we may conclude that quality of life should be considered in the monitoring of dialysis patients.

Adolescent↗

The course of chronic pain in the community: results of a 4-year follow-up study.

Little is known about the course of chronic pain in the community. Such information is needed for the prevention and management of chronic pain. We undertook a 4-year follow-up study of 2184 individuals living in Grampian, UK to describe patterns and predictors of change in chronic pain over time. In October 2000, participants completed a postal questionnaire including case definition questions, the chronic pain grade questionnaire, the SF-36 and socio-demographic questions. Information from this questionnaire was compared to information collected from a similar questionnaire in 1996. A response rate of 83% was achieved for the follow-up study. The overall prevalence of chronic pain (pain or discomfort present either all the time or on and off for 3 months or longer) increased from 45.5% at baseline to 53.8% at follow-up. Seventy-nine percent of those with chronic pain at baseline still had it at follow-up. The average annual incidence was 8.3% and the average annual recovery rate was 5.4%. Individuals in the study samples who are in lowest quartile of SF-36 domains--physical functioning, social functioning and bodily pain at baseline--were more likely to develop chronic pain at follow-up, and respondents who were retired were less likely to develop chronic pain. Individuals in the study samples in the lowest quartile of SF-36 domains, bodily pain and general health at baseline, were less likely to recover from their chronic pain, as were those aged 45-74 compared with those aged 25-34. We concluded that chronic pain is a common, persistent problem in the community with relatively high incidence and low recovery rates. The lack of association between onset or recovery from chronic pain and most traditional socio-demographic factors, highlights the need to broaden the range of factors included in studies of chronic pain aetiology.

Adult↗

Quality of life after coronary angioplasty or continued medical treatment for angina: three-year follow-up in the RITA-2 trial. Randomized Intervention Treatment of Angina.

OBJECTIVES: We sought to evaluate the impact of percutaneous transluminal coronary angioplasty (PTCA) and medical treatment on self-perceived quality of life among patients with angina. BACKGROUND: The second Randomized Intervention Treatment of Angina trial (RITA-2) implemented initial policies of PTCA or continued medical treatment in patients with angina, allowing assessment of long-term health consequences. METHODS: A total of 1,018 patients were randomly assigned (504 to PTCA and 514 to medical treatment). The short form 36 (SF-36) self-administered quality-of-life questionnaire was completed at randomization and three months, one year and three years later. To date, 98% of patients reached one year and 67% reached three years. RESULTS: The PTCA group had significantly greater improvements in physical functioning, vitality and general health at both three months and one year, but not at three years. These quality-of-life scores were strongly related to breathlessness, angina grade and treadmill exercise time both at baseline and at one year. The treatment differences in quality of life are explained by the PTCA group's improvements in breathlessness, angina and exercise time. The attenuation of treatment difference at three years is partly attributed to 27% of medically treated patients receiving nonrandomized interventions in the interim. For both groups, there were also improvements in ratings of physical role functioning, emotional role functioning, social functioning, pain and mental health, but for these the superiority of PTCA over medical treatment was less pronounced. After one year, 33% and 22% of the PTCA and medical groups, respectively, rated their health much better. CONCLUSIONS: Coronary angioplasty substantially improves patient-perceived quality of life, especially physical functioning and vitality, as compared with continued medical treatment. These differences are attributed to alleviation of cardiac symptoms (specifically, breathlessness and angina), but must be balanced against the small procedure-related risks of PTCA.

Activities of Daily Living↗

Comparative outcomes of total joint arthroplasty.

A prospective pre- and postoperative general health/quality-of-life factor comparison, using the Rand SF-36 Health Status Questionnaire (TyPE Specification, Quality Quest [Health Outcomes Institute, Minneapolis, MN]), was carried out on a consecutive series of patients with diagnosed osteoarthritis undergoing total hip and knee arthroplasty between March 1991 and March 1994. Study groups consisted of 85 total hip arthroplasty patients, 93 total knee arthroplasty patients, and 65 single-stage bilateral total knee arthroplasty patients, all treated at the same specialty hospital, under the care of three senior orthopaedic surgeons. The average patient age was 69 years. Significant improvements in quality-of-life measures including physical functioning, social functioning, role functioning/physical problem, role functioning/emotional problem, mental health, energy/fatigue, pain, and change in health were noted in all hip and knee arthroplasty patients 6 months, 1 year, and 2 years after surgery (P < .05). There appeared to be no significant differences in quality-of-life measures between hip and knee arthroplasty patients. Results therefore indicate that total hip and knee arthroplasty significantly improve the functional status and quality of life among patients suffering from osteoarthritis.

Activities of Daily Living↗

Predicting quality-of-life outcomes following total joint arthroplasty. Limitations of the SF-36 Health Status Questionnaire.

A group of 114 patients undergoing total hip and knee arthroplasty were evaluated to assess the effect of total joint arthroplasty on quality of life, as measured by the SF-36 Health Status Questionnaire, and to determine the predictive relationship between preoperative and postoperative scores. A highly significant improvement was seen comparing preoperative with postoperative scores at 2 years for physical function, social function, physical role function, emotional role function, mental health, energy, and pain. Despite a significant change in health status (P < or = .001), no change was seen in the patient's health perception (P = .61). Regression analysis failed to indicate a predictive relationship between preoperative and postoperative scores for any scale. Total joint arthroplasty dramatically improves the quality of life and function of patients afflicted with arthritis; however, because of the poor ability of the SF-36 to predict postoperative improvement on an individual basis, it cannot be used alone to determine treatment selection.

Activities of Daily Living↗

Effects on cancer patients' health-related quality of life after the start of morphine therapy.

To investigate the effects of morphine on cancer patients' health-related quality of life (HRQL), we prospectively studied 40 cancer patients with moderate or severe pain despite treatment with "weak" opioids. The patients were titrated to pain relief using immediate-release (IR) morphine and then switched to slow-release (SR) morphine in the same daily dosages. HRQL was measured by the European Organization for Research and Treatment of Cancer core quality-of-life questionnaire (EORTC QLQ-C30) before the start of morphine (baseline), after stabilization with IR-morphine, and 3 days after start of SR-morphine. The mean titrated daily morphine dosage was 97 mg (range, 60-180). The EORTC QLQ-C30 global health score increased after IR morphine titration (baseline score 40, IR morphine period score 49), but a significant difference from baseline did not persist during the SR morphine period (score 44). The other functional HRQL scores showed no significant fluctuations. After start of IR morphine, two of the HRQL symptom scores increased, nausea/vomiting and constipation, but these changes also did not persist during the SR morphine period. Intensity of pain was associated with a lower level of function and higher intensity of symptoms, but only with relatively small (not higher than 0.44) correlation coefficients. Compared to normative data from the general population, physical function, role function, social function, and global health were impaired in the study patients. The patients also suffered more fatigue, pain, nausea/vomiting, appetite loss, and constipation. In conclusion, in cancer patients with reduced HRQL, the start of morphine therapy had no major influence on aspects of HRQL other than pain.

Adult↗

Relationship of domain-specific measures of health to perceived overall health among older subjects.

The associations between nine domain-specific measures of health (e.g., depressive symptoms, psychological distress, mental health, physical functioning, role functioning, social functioning, bodily pain, somatic symptoms, and chronic medical morbidity) and a single-item measure for perceived overall health were studied in an extensive community-based sample of elderly persons (n = 5279). The results showed that: (1) the discriminative power of perceived overall health compared to domain-specific measures of health was moderate to large only at the fair/poor end of the perceived overall health spectrum; (2) a single-item measure of perceived overall health did not cover domain-specific measurements of health since only 41.8% of the variance in perceived overall health was explained by all domain-specific measures; and (3) the affective domains of functioning (psychological distress, mental health) were weakly related to perceived overall health. Bodily pain, chronic medical morbidity and, to a lesser extent, physical functioning were more strongly related to perceived overall health. These results were fairly consistent for men and women and for three age groups. We conclude that a global, single-item measure of perceived health and domain-specific health measures are not exchangeable in evaluation, survey, or epidemiological research.

Activities of Daily Living↗

Responsiveness to change in health-related quality of life in a randomized clinical trial: a comparison of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a trial specific module. European Organization for Research and Treatment of Cancer.

INTRODUCTION: The Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) was developed to be a pragmatic outcome measure for clinical trials in symptomatic men with advanced hormone-resistant prostate cancer. DESIGN AND SETTING: A comparative assessment of responsiveness was made with longitudinal data from a positive multicenter randomized trial of palliative chemotherapy in 161 symptomatic men with advanced hormone-resistant prostate cancer. INSTRUMENTS: The PROSQOLI, the European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30), and a specific quality of life module for advanced prostate cancer [QLM-P14] were administered every 3 weeks while patients received their allocated treatment. FINDINGS: Sixteen of the 19 health-related quality of life (HRQL) scales demonstrated improvements in palliative responders. All three pain scales detected a beneficial effect of palliative chemotherapy. The relative efficiency statistics favored the PROSQOLI for physical symptoms and physical function but the QLQ-C30 for emotional function, social function, and global perceptions. The PROSQOLI linear analog scale was the most responsive measure of pain. Bootstrap confidence intervals for the relative efficiency statistics were wide. CONCLUSIONS: Both the PROSQOLI and the analogous scales from the QLQ-C30 were responsive to improvements in HRQL. Differences between the instruments were generally subtle. The PROSQOLI is a short, simple, responsive measure of HRQL in men receiving systemic treatment for advanced hormone-resistant prostate cancer.

Aged↗

Quality of life during radiotherapy for rectal cancer.

The aim of this study was to assess symptoms and health-related quality of life (HRQL) during (neo)adjuvant radiotherapy for rectal cancer. Patients receiving pelvic radiotherapy 50 Gy for rectal cancer, were studied prospectively (n=42). The European Organization for Research and Treatment of Cancer (EORTC) questionnaires quality of life-core 30 QLQ-C30 and QLQ-CR38 and a 5-day symptom diary were completed at the start and end of radiotherapy and 4-6 weeks later. At the end of radiotherapy, mean scores of diarrhoea, fatigue and appetite loss had significantly increased (P<0.01) compared with pretreatment scores, but this was not observed for scores for nausea or pain. At the end of radiotherapy, diarrhoea, fatigue, appetite loss, physical function, social function and global quality of life (QL) were significantly worse than the population-based norms. 64% of the patients reported an increase in fatigue and 52% an increase in diarrhoea during radiotherapy. HRQL scores had returned to pre-treatment levels 4-6 weeks after radiotherapy. Thus, diarrhoea, fatigue and appetite loss increased transiently during pelvic radiotherapy.

Adult↗

Acupuncture for low back pain: results of a pilot study for a randomized controlled trial.

OBJECTIVES: To pilot procedures to be used in a randomized controlled trial of acupuncture for low back pain. DESIGN: Uncontrolled clinical trial. SETTING: Primary care and acupuncture clinics in York, England. SUBJECTS: 20 patients with low back pain lasting 1 month or more. INTERVENTIONS: 10 sessions of individualized acupuncture from a traditional acupuncturist. MAIN OUTCOME MEASURES: Change in Oswestry low back pain disability questionnaire; present pain intensity scale; effect on daily living scale, and SF-36 general health questionnaire at post-treatment and 6 months after the end of treatment. RESULTS: 14 patients completed follow-up. Patients had similar severity scores at baseline to those referred to an NHS outpatient clinic. Post-treatment, there were statistically significant improvements in Oswestry, present pain intensity, effect on daily living and the physical functioning, social functioning, bodily pain, vitality and mental health sub-scales of the SF36. Similar results were found at the six month follow-up. Oswestry scores showed reduced levels of pain at 6 months compared to than at post-treatment, falling approximately 40% from baseline. CONCLUSIONS: Though the improvements in pain and quality in life may be due to the natural course of back pain, the promising responses justify further research. The procedures used in the study are appropriate for a randomized controlled trial. Drop-out could be reduced by more careful patient monitoring.

Activities of Daily Living↗