Significant Changes In Quality Of Life Research Articles

A Phase 2 Study to Assess the Immunomodulatory Capacity of a Lecithin-based Delivery System of Curcumin in Endometrial Cancer.

Curcumin is a botanical with anti-tumor and immunomodulatory properties. We hypothesized that curcumin supplementation might influence inflammatory biomarker levels in endometrial carcinoma (EC). In this open-label, non-randomized phase 2 study (NCT02017353), seven EC patients consumed 2 g/day Curcumin Phytosome (CP) orally for 2 weeks. Blood was taken at baseline, days 1, 7, 14, and 21. The following analytes were measured: curcuminoids and metabolites, 56 inflammatory biomarkers, COX-2, frequencies of myeloid-derived suppressor cells, dendritic cells and NK cells, expression of MHC molecules on leukocytes and monocytes and activation/memory status of T cells. Patients completed quality of life (QoL) questionnaires at baseline and end of treatment. Curcumin metabolites were detectable in plasma upon CP intake. CP downregulated MHC expression levels on leukocytes (P = 0.0313), the frequency of monocytes (P = 0.0114) and ICOS expression by CD8+ T cells (P = 0.0002). However, CP upregulated CD69 levels on CD16− NK cells (P = 0.0313). No differences were observed regarding inflammatory biomarkers, frequencies of other immune cell types, T cell activation and COX-2 expression. A non-significant trend to improved QoL was observed. Overall, CP-induced immunomodulatory effects in EC were modest without significant QoL changes. Given the small population and the observed variability in inter-patient biomarker levels, more research is necessary to explore whether benefits of CP can be obtained in EC by different supplementation regimens.Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02017353; www.clinicaltrialsregister.eu, identifier 2013-001737-40.

Meaning-making and quality of life in heart failure interventions: a systematic review.

Heart failure (HF) patients often report high levels of psychological distress and diminished quality of life (QoL). As such, interventions aimed at improving their QoL and other positive psychosocial outcomes are needed. Some interventions have shown promise, but results are mixed. Interventions directed toward physical well-being (e.g., self-care behaviors, medical adherence) may be less effective at improving QoL than those aimed at improving psychological well-being (e.g., stress reduction, coping strategies). We systematically reviewed recent HF interventions and compared results of those emphasizing coping strategies related to meaning-making to those lacking meaning-making components as a possible factor in QoL discrepancies. A systematic review of four databases produced 439 studies for potential inclusion, of which 25 qualified for review. These were coded into substantial or minimal meaning focus. Forty percent of all studies (n = 10) reported improved QoL due to intervention effects, while 60% reported no significant change in QoL (60%; n = 15). Fewer than one-third of minimal meaning focus studies demonstrated significant improvements in QoL (30.8%; n = 4). In contrast, half of substantial meaning focus studies demonstrated significant improvements in QoL (50%; n = 6). By clarifying the potential importance of promoting meaning-making in improving QoL of HF patients, we highlight its potential value in future interventions directed to this underserved, high-risk patient population.

Caregivers' education decreases depression symptoms and burden in caregivers of patients with dementia.

To determine whether providing education to caregivers of patients with dementia decreases their depression symptoms and burden. Eighty-three outpatients with dementia being treated at the Memory Clinic of Tokyo Medical University Hospital and their caregivers were enrolled. Forty-seven caregivers were enrolled in the caregivers' education (EDU) group and 36 were enrolled in the control (CTL) group. Caregivers were assessed for depression, burden, and quality of life (QoL). Patients were assessed for cognition, psychological symptoms, and QoL. Assessments were carried out at baseline and at 3 months (3M). Caregivers in the EDU group received lectures on symptoms and progression of dementia, management of symptoms, use of social resources etc. RESULTS: At 3M, prevalence of depression symptoms in the EDU group significantly decreased from 36% to 17%, whereas it significantly increased from 22% to 50% in the CTL group. Depression and burden were significantly improved at 3M in the EDU group, whereas they significantly worsened in the CTL group. Psychological symptoms showed a lower tendency at 3M for the EDU group. No significant changes in QoL of caregivers and patients were found in either group. Providing education to caregivers of patients with dementia improves their depression symptoms and sense of burden, and tends to improve the behaviour and psychological symptoms of dementia in the patients. Providing education to caregivers of dementia patients may hence result in beneficial effects for both the patients and their caregivers, and should be widely used in dementia care.

Long-Term Impact of Sleep-Disordered Breathing on Quality of Life in Children With Obesity.

(1) To determine baseline quality of life (QOL) among children with obesity and newly diagnosed moderate-severe sleep-disordered breathing (SDB) and to compare it to the reported QOL of children with obesity or SDB alone and healthy children. (2) To evaluate QOL change after 1 year. A prospective multicenter cohort study was conducted in children (8-16 years) with obesity, prescribed positive airway pressure (PAP) therapy for moderate-severe SDB. Outcomes included parent-proxy and self-report total and subscale scores on the PedsQL questionnaire (baseline and 1-year). Total PedsQL scores were indicative of impaired QOL in 69% of cases based on parent-report and in 62% on self-report. Parents reported significantly lower QOL in our cohort than that reported in other studies for children with obesity or SDB alone or healthy children, on total PedsQL score and on social and psychosocial subscales. PedsQL total scores for participants were significantly higher (mean difference 7.3 ± 15.3, P = .03) than those reported by parents. Parents reported significant improvements in total PedsQL (mean change 7.29 ± 13.73, P = .04) and social functioning (mean change 17.65 ± 24.69, P = .04) scores after 1 year. No significant differences were found by children's self-report or by PAP adherence. QOL of children with obesity and SDB is lower than in children with obesity or SDB alone or healthy children. One year later, children reported no significant changes in QOL; parents reported significant improvements in total PedsQL and social functioning scores. PAP adherence did not significantly affect QOL change in this population. A commentary on this article appears in this issue on page 307.

Treatment Success: Investigating Clinically Significant Change in Quality of Life Following Bariatric Surgery.

One of the most important outcomes following bariatric surgery is an improvement in health-related quality of life (QOL). This study aimed to explore what degree of weight loss is required after bariatric surgery in order to achieve a clinically significant change in QOL from pre-surgery to 4 to 5years after surgery. Participants were assessed prior to having surgery (N=280) and were invited to participate in a follow-up study 4 to 5years after surgery. Sixty-seven of the original participants agreed to take part and completed a Web-based survey, which included the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire. Several analyses were conducted to examine the association between weight loss and clinically significant change in QOL. Mean age was 48.13±10.37years, 51 (76%) were female, 62 (92.5%) Caucasian, and mean baseline body mass index (BMI) was 41.11±6.03kg/m2. The mean percent of excess weight loss (EWL) was 46% (17% total weight loss), and 64% (n=43) achieved a clinically significant change in QOL. The majority of those who lost ≥40% EWL had a clinically significant change in QOL, and their odds of achieving this change were 2.81 times higher than those that did not. Results indicated that an EWL of ≥40% may be sufficient for the majority of patients to achieve clinically significant change, but that ≥50% is a better predictor of clinically significant change.

Quality of Life Outcomes From a Phase 2 Trial of Short-Course Radiation Therapy Followed by FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer

A prospective phase 2 trial of short-course (SC) radiation therapy (RT) with 25Gy over 5 fractions, followed by 4 cycles of 5-fluorouracil, oxaliplatin, and leucovorin (mFOLFOX6) before surgery was recently completed at our institution. We present here the patient-reported quality of life (QOL) outcomes from this trial. Eighty patients with cT3/T4, any N, any M rectal adenocarcinoma planned for resection were enrolled between 2009 and 2012. The QOL data were obtained prospectively using the Functional Assessment of Cancer Therapy-Colon (FACT-C) questionnaire before RT, before surgery, and 1year after surgery. The previously validated minimally importance difference (MID) method was used to measure clinically significant QOL changes in FACT-C scores for each patient across time points. We examined the role of ostomy on QOL. We also compared QOL with disease outcomes and physician-reported toxicity. The FACT-C questionnaire was completed by 97% of patients before RT, 85% immediately before surgery, and 62% 1year after surgery. There was no statistically significant change in mean FACT-C scores from before treatment to after treatment. The majority of patients had either no change or an increase in QOL 1year after treatment using the MID method. There were significant changes in QOL between patients with ostomy versus no ostomy 1year after treatment for functional well-being (FWB) (14.81 vs 20.52, P=.018) and the colorectal cancer subscale (CCS) using the MID method (P=.004). Patients without ostomy reported stable changes in bowel control 1year after surgery. There was no statistically significant correlation between QOL and disease recurrence, pathologic complete response, pathologic T stage downstaging, or acute/late toxicity. SC-RT and sequential mFOLFOX6 as preoperative therapy for rectal cancer results in stable patient-reported QOL outcomes 1year after treatment. These findings in conjunction with previously reported oncologic outcomes support further evaluation of this regimen in a phase 3 setting.

A prospective study of the short-term quality-of-life outcomes of patients undergoing transperineal prostate biopsy.

To investigate in a prospective, observational study whether transperineal prostate biopsy (TPbx) results in patient-reported quality-of-life (QoL) changes from baseline in the first 3-months after TPbx. Consenting patients completed the 26-item Expanded Prostate cancer Index Composite (EPIC-26), the Sexual Health Inventory for Men, the International Prostate Symptom Score, the Generalised Anxiety Disorder seven-item scale, the Patient Health Questionnaire nine-item scale, and a global question about willingness to have a repeat TPbx in a years' time. The instruments were scored using published scoring methods. Wilcoxon signed-rank tests and Mann-Whitney U-tests were used to investigate statistically significant differences. Clinically significant differences were also investigated defined by published minimal important differences for the EPIC-26 and changes in established categorical groups for the other instruments. In all, 53 patients consented to participate and completed the baseline questionnaire, in addition to at least one of the 1- or 3-month follow-up questionnaires. We found that most patients having a TPbx had no clinically significant change in QoL in the first 3 months after TPbx. However, 24% had clinically worse urinary function and 18% had worse sexual function at 1 month. At 3 months, 3% of patients had clinically worse urinary function and 25% continued to have worse sexual function compared with baseline. Patients who were subsequently diagnosed with cancer based on the results of the TPbx, had statistically significantly reduced QoL for the EPIC-26 urinary scales and reduced improvements in scores on the psychological scales at the 1-month follow-up compared with those who were not diagnosed with cancer. Most patients having a TPbx had no clinically significant change in QoL in the first 3 months after TPbx. However, patients should be advised that a quarter may have clinically worse urinary function and nearly 20% have clinically worse sexual function in the first month, and that sexual function deficits may continue up to 3 months. The results of this study provide a resource that the clinician can use when discussing TPbx with patients.

Effects of an Assisted Living Facility Specifically Designed for Individuals with Memory Disorders: A Pilot Study

Despite evidence suggesting the physical environment can enhance mood and quality of life (QoL) of dementia patients, this issue has not been examined extensively within the setting of an assisted living (AL) facility. This study investigated cognition, QoL, and neuropsychiatric symptoms in 39 individuals with a memory disorder during their initial 6 months at an AL facility designed specifically for this population. Despite continued decline in cognition, participants reported lessening of several negative emotions. No significant changes in QoL or neuropsychiatric symptoms were reported. Findings suggest that moving from home to an AL facility designed specifically for individuals with memory disorders has potential positive implications.

Poster 556 Feasibility of Peak Potential, an Adaptive Rock Climbing Program for Children with Cerebral Palsy and Physical Disabilities

Disclosures: P. D. Bolikal, No Disclosures: I Have No Relevant Financial Relationships to Disclose. Objective: To test the hypothesis that participation in Peak Potentiala structured, volunteer-run adaptive indoor rock climbing programwill be feasible and will improve quality of life (QOL) of children with cerebral palsy (CP) and physical disabilities. Design: Prospective repeated measures study. Setting: Indoor rock climbing gym. Participants: Thirty children between the ages of 4-17 have completed the study and preliminary data has been analyzed for the first 20 participants. Eighty-five percent of the participants had CP, 90% were minorities, 70% were male, and 65% were from lowincome families. Interventions: Weekly 1-hour climbing sessions for 12 weeks. Main Outcome Measures: QOL was measured at baseline, after week 6, and at completion of the program using the PedsQL scale, a standardized measure of QOL for children. Change in QOL was assessed using a within-subjects, repeatedmeasures analysis of variance (ANOVA). Self efficacy, as measured by the Perceived Physical Ability Scale for Children, was included in the analyses as a covariate. Rock climbing participation and progress were recorded weekly. Volunteer participation was also tracked. Results or Clinical Course: There was a small but non-significant increase in measures of self efficacy, and no statistically significant change in QOL. The participants collectively completed 760 climbs. Volunteers contributed 475 hours. The participant attendance rate was 77%. Conclusions: A 12 week adaptive rock climbing program for children with CP and physical disabilities is feasible with a good attendance rate. Although the data showed no significant change in QOL, the participants subjectively enjoyed the program and applied for more sessions. The lack of significance may be related to the small sample size and the relatively infrequent intervention (one session per week.) This is a pilot analysis of 20 children; further data will be available for analysis when more children have completed the program.

Evaluation of a Breast and Colon Cancer Survivorship Program

This article describes a cancer survivorship program that addressed quality of life (QOL) changes related to chemotherapy. The program focused on adult breast and colon cancer survivors at a community oncology practice in the southeastern United States, and consisted of an educational visit designed to identify and address QOL changes that occurred as a result of chemotherapy. The QOL of Cancer Survivors (QOL-CS) survey administered before and after the visit analyzed QOL metrics, which were combined with program evaluation data to assess physical, psychosocial, social, and spiritual well-being changes that may have occurred as a result of program participation. Differences in QOL-CS scores did not represent statistically significant changes in QOL for program participants. However, program evaluation responses identified perceived changes in QOL as a result of participating in cancer treatment and a subsequent cancer survivorship program, which demonstrated clinical significance for program participants. Physical, psychosocial, social, and spiritual well-being measures were affected by program participation. Improvement in distress related to the initial cancer diagnosis and family distress were the most significant reported changes, and male gender and advanced age were associated with improved psychosocial well-being.

Effects of yoga on arm volume among women with breast cancer related lymphedema: A pilot study

Lymphedema affects 3-58% of survivors of breast cancer and can result in upper extremity impairments. Exercise can be beneficial in managing lymphedema. Yoga practice has been minimally studied for its effects on breast cancer related lymphedema (BCRL). The purpose of this study was to determine the effect of yoga on arm volume, quality of life (QOL), self-reported arm function, and hand grip strength in women with BCRL. Six women with BCRL participated in modified Hatha yoga 3×/week for 8 weeks. Compression sleeves were worn during yoga sessions. Arm volume, QOL, self-reported arm function, and hand grip strength were measured at baseline, half-way, and at the conclusion of yoga practice. Arm volume significantly decreased from baseline (2423.3 ml ± 597.2) to final measures (2370.8 ml ± 577.2) (p = .02). No significant changes in QOL (p = .12), self-reported arm function (p = .34), or hand grip strength (p = .26) were found. Yoga may be beneficial in the management of lymphedema.

Antihypertensive Treatment with Candesartan Monotherapy Does Not Improve the Quality of Life of Finnish Hypertensive Patients

Candesartan is an effective and widely used antihypertensive medication. The effect of candesartan alone or combined with hydrochlorothiazide and felodipine on the quality of life (QOL) of Finnish hypertensive patients was examined. Antihypertensive treatment was started and conducted according to protocol by candesartan 8 mg once daily and then increased to 16 mg once daily, if needed. Thereafter, hydrochlorothiazide 12.5 mg or 25 mg once daily and felodipine 5 mg once daily were added, if needed. QOL was measured using the SF-36 questionnaire at baseline and at 6, 12, 18 and 24 (end of study) weeks. The blood pressure target was a diastolic BP below or equal to 80 mmHg. Ninety-eight hypertensive patients, 42 men and 56 women were studied. The only statistically significant change in QOL was a reduction in QOL among the patients on candesartan monotherapy throughout the study. Their physical functioning, total physical and mental health and total SF-36 score decreased significantly. Non-significant increases in QOL were recorded among patients who had a reduction in their systolic blood pressure, who were older and who had a high systolic blood pressure in the beginning of the study. This study suggests that an adequate antihypertensive effect is an important predictor of QOL for patients being treated for high blood pressure. Candesartan alone without an adequate blood pressure decrease does not improve QOL.

Long-term outcome after radioiodine therapy with adjuvant rhTSH treatment: comparison between patients with non-toxic and pre-toxic large multinodular goitre

In multinodular goitre (MNG), low radioiodine (RAI) activity after recombinant human (rh) TSH is able to reduce thyroid volume (TV) and improve symptoms. Our aim was to evaluate the long-term outcome of RAI after rhTSH treatment in patients who were divided according to their baseline TSH levels. Eighteen patients (69.2 ± 6.1 year) presented non-toxic (TSH >0.3 mIU/l) MNG (TV: 61.0 ± 3.8 ml; group 1), while 13 patients (74.1 ± 7.9 year) had non-autoimmune pre-toxic (TSH <0.3 mIU/l) MNG (TV: 82.6 ± 14.4 ml; group 2). TSH, thyroid hormones, TV (by ultrasonography), body mass index (BMI), symptoms and quality of life (QoL) were evaluated. Treatment induced short-term thyrotoxicosis in both groups, but this was slightly more marked in group 2 than in group 1. The number and severity of adverse events were similar. The follow-up period was 55.3 ± 4.1 months in group 1 and 57.2 ± 5.1 months in group 2. The final TV reduction was similar in groups 1 (63.4 ± 3.6%) and 2 (57.2 ± 4.6%) and TV reduction positively correlated only with initial TV. At the last examination, 14 group-1 subjects were on L-T4 therapy, while 2 group-2 subjects were on methimazole. An increase in BMI was noted only in group 2. MNG-related symptoms were significantly reduced in both groups. Symptoms related to sub-clinical hyperthyroidism improved in group 2, while no significant changes in QoL were noted in either group. This study confirms the effectiveness of rhTSH adjuvant treatment in reducing TV after low RAI activities, irrespective of baseline thyroid status. TSH levels <0.3 mIU/l proved to be predictive of a more severe thyrotoxic phase after rhTSH and RAI, while initial TSH levels >0.3 mIU/l were more frequently followed by a need for L-T4 therapy. Compressive symptoms improved in the majority of subjects.

Hemi salvage HIFU in patients with radio recurrent prostate cancer: Early experience and results.

99 Background: One third of patients treated with External beam radiation therapy (EBRT) for localized prostate cancer (PCa) experience local recurrence. Salvage treatment options include prostatectomy, cryoablation, and High Intensity Focused Ultrasound (HIFU). Whole gland treatment in these patients offers acceptable cancer control, but carries a risk of severe urinary incontinence in at least 20% of cases and reduction of Quality of Life (QoL). In patients with unilateral local relapse, focal HIFU is feasible. The aim of this prospective study was to evaluate the effect of Hemi HIFU in patients with unilateral recurrence after radiotherapy. Methods: Between 2009 and 2012, 48 patients were prospectively included in 2 centers. Inclusion criteria were positive MRI and biopsy in one lobe diagnosing unilateral cancer after EBRT (46 patients) and after brachytherapy (2 patients). Mean age was 68.8 ± 6 years, mean pre HIFU PSA was 5.2 ± 5.2 ng/mL and the repartition of Gleason score was ≤7: 28, ≥8: 18 and not determined: 2. Median follow-up was 16.3 months [range 3-43]. Treatments were performed with Ablatherm® HIFU device. Results: The mean PSA nadir value was 0.69 ± 0.83 (median: 0.4). Disease progression occured in 16 patients (35,5%). Local recurrence was found in 4 patients in the controlateral lobe, and in 4 patients in both lobes. Six patients developped metastases and 2 had rising PSA without local recurence or proven metastasis. Fifteen of these 16 patients received salvage treatments (3 re-HIFU, 11 androgen-deprivation, and 1 re-HIFU plus androgen-deprivation). Thirthy-six patients (75%) were pad-free. Seven patients (14.6 %) required 1 pad a day. Severe incontinence occured in 5 patients (10.4%). One of them received artificial urinary sphincter. Paired results indicated no significant change in QoL and IPSS scores: EORTC-QLC-30: (from 35.7 ± 8.7 to 36.8 ± 8.6, p=0.22) and IPSS: (from 7 ± 5.6 to 8.5 ± 5.1, p=0.13) Conclusions: Hemi-salvage HIFU is efficient in patients with unilateral radio-recurrent PCa with a preserved QoL offering comparable cancer control to whole gland treatment.

Effect of childbirth on pelvic organ support and quality of life: a longitudinal cohort study

Although childbirth is known to be a major risk factor for pelvic floor disorders, there is a paucity of prospective, long-term data addressing this issue. The aim of our study was to evaluate the changes of pelvic organ support, symptoms and quality of life (QOL) after childbirth. Pelvic organ support was objectively assessed using the Pelvic Organ Prolapse Quantification method (POP-Q) and pelvic floor symptoms were subjectively evaluated using a validated questionnaire performed in the second trimester, 14 weeks, 1 and 5 years after delivery. We recruited 182 nulliparae and 97 (53.3 %) returned for follow-up at 5 years. POP-Q stage after vaginal delivery (VD) worsened at all time points. After caesarean the worsening in POP-Q stage was temporary at 14 weeks. Prolapse symptoms worsened at 14 weeks (p<0.001) and 1 year (p=0.006) after VD but not at 5 years. No changes in prolapse symptoms occurred after caesarean. Significant increase in faecal incontinence was observed in both delivery groups 5 years after delivery. For all pelvic floor disorder domains there were no significant changes in QOL irrespective of mode of delivery, except for worsening in general sexual QOL after VD. Five years after childbirth the stage of prolapse worsened after VD but not after caesarean. However, there was no impact on prolapse symptoms or QOL. After VD women were more likely to experience a worsening in general sex score, but no other difference in QOL measures.

FACT-Br for assessment of quality of life in patients receiving treatment for brain metastases: a literature review

Introduction: Brain metastases are a significant cause of morbidity and mortality for patients with advanced cancers, and quality-of-life (QoL) end points are most appropriate for this population. The Functional Assessment of Cancer Therapy (FACT) questionnaires are commonly used to assess cancer-related QoL issues. The FACT-Brain (FACT-Br) provides an additional set of disease-specific questions pertaining to brain neoplasms. We aim to provide a comprehensive review to examine the use of the FACT-Br as a QoL assessment for patients with brain metastases. Materials & methods: A review of the literature was conducted and all studies utilizing the FACT-Br for QoL assessment of patients with brain metastases were included. Study information and relevant information regarding the FACT-Br were extracted. Results: A total of 14 studies were identified representing various treatment options (radiation, chemotherapy and surgery) for patients with brain metastases. All studies utilized at least part of the FACT-Br as the main QoL assessment. In addition, neurocognitive and performance status assessments were performed in nine and 12 out of 14 studies, respectively. Issues of poor accrual, compliance and attrition were common and posed problems in reaching statistically significant changes in QoL despite changes in raw QoL scores. Conclusion: Studies involving patients with brain metastases should continue to utilize QoL tools such as the FACT-Br; however, this tool still requires validation for use in this patient population. Additional studies should observe the relationship between neurocognitive function and QoL, and attempt to minimize poor accrual and compliance issues through modifications of trial design and reduction of patient burden.

Improvement of bowel dysfunction with sacral neuromodulation for refractory urge urinary incontinence

Sacral nerve stimulation (SNS) is approved for urologic indications in the USA and, recently, fecal incontinence. This study described concomitant bowel dysfunction and improvements in bowel and urinary symptoms and quality of life (QOL) in women with refractory urge urinary incontinence (UUI) receiving SNS. Women (N = 36) with refractory UUI receiving SNS were prospectively enrolled. Surveys and exams were completed at baseline and follow-up, with symptom and QOL scores measured using validated scales (0-100, none-worst). A total 24 women were followed up at a median of 4.0 months post-implantation. Of these, 20 (83%) had bowel dysfunction, 13 (54%) used bowel medications at baseline, and 11 (45%) continued them after SNS. The mean/median urinary (54.8 to 32.6) and bowel (23.4 to 14.1) symptom scores improved significantly, as did urinary (64.2 to 14.3) but not bowel (2.4 to 0.0) QOL scores. Bowel dysfunction is common in women with refractory UUI. SNS improves urinary symptoms and QOL, but improvement in bowel symptoms does not translate into significant QOL changes.

Physical conditioning and mental stress reduction - a randomised trial in patients undergoing cardiac surgery

BackgroundPreoperative anxiety and physical unfitness have been shown to have adverse effects on recovery from cardiac surgery. This study involving cardiac surgery patients was primarily aimed at assessing the feasibility of delivering physical conditioning and stress reduction programs within the public hospital setting. Secondary aims were to evaluate the effect of these programs on quality of life (QOL), rates of postoperative atrial fibrillation (AF) and length of stay (LOS) in hospital.MethodsElective patients scheduled for coronary artery bypass graft and/or valve surgery at a public hospital in Melbourne, Australia were enrolled. Patients were randomized to receive either holistic therapy (HT) or usual care (UC). HT consisted of a series of light physical exercise sessions together with a mental stress reduction program administered in an outpatient setting for the first two weeks after placement on the waiting list for surgery. A self-administered SF-36 questionnaire was used to measure QOL and hospital records to collect data on LOS and rate of postoperative AF.ResultsThe study population comprised 117 patients of whom 60 received HT and 57 received UC. Both programs were able to be delivered within the hospital setting but ongoing therapy beyond the two week duration of the program was not carried out due to long waiting periods and insufficient resources. HT, as delivered in this study, compared to UC did not result in significant changes in QOL, LOS or AF incidence.ConclusionsPreoperative holistic therapy can be delivered in the hospital setting, although two weeks is insufficient to provide benefits beyond usual care on QOL, LOS or postoperative AF. Further research is now required to determine whether a similar program of longer duration, or targeted to high risk patients can provide measurable benefits.Trial registrationThis trial was conducted as part of a larger study and according to the principles contained in the CONSORT statement 2001.

A randomised controlled trial of a pharmaceutical care programme in high-risk diabetic patients in an outpatient clinic

Abstract Objective To determine the impact of a pharmaceutical care programme (PCP) in diabetic patients. Design Randomised controlled study of high-risk diabetic patients. Setting Outpatient clinic at Fremantle hospital (FH), Western Australia. Method Patients over 18 years of age who could communicate freely in English and fulfilled pre-determined criteria for being high-risk for the development of diabetic complications, were randomly assigned to the PCP or control groups in a ratio of 2:1. In the PCP arm, a clinical pharmacist reviewed and monitored all aspects of the patients' drug therapy in collaboration with other health care professionals at six-weekly intervals for six months. The control patients received usual outpatient care. Main outcome measures Glycosylated haemoglobin (HbA1c), quality of life (QOL), patient satisfaction with health care providers and changes in drug therapy during the PCP. Results Seventy-three patients were recruited into the study, of whom 48 (66 per cent) were randomised to the PCP. There were no significant differences between the PCP (cases) and the control groups for demographic variables. The mean (±SD) HbA1c for the cases was 8.4±1.4 per cent at the beginning and 8.2±1.5 per cent at the end of the study period (P&amp;gt;0.05). There was similarly no change in the control group (8.5±1.6 per cent to 8.1±1.6 % P&amp;gt;0.05). There were no significant changes in QOL for cases or controls over the period of the study. During the PCP, there was a significant increase in patient satisfaction with the care provided by the clinical pharmacist (P=0.007) and the provision of drug information (P=0.036). The clinical pharmacist facilitated 39 drug interventions in the 48 cases. A high level of complementary medicine usage was found in the PCP group (16.7 per cent). Conclusions PCPs provide patients with important medication information and result in changes to drug therapy. However, in diabetic patients under specialist care, a six-month PCP did not lead to an improvement in glycaemic control. The role for pharmacist intervention in primary care now needs to be evaluated.

Change in quality of life after combined orthodontic-surgical treatment of dentofacial deformities

To determine changes in quality of life (QoL) after orthodontic-surgical treatment in patients with dentofacial deformities, using generic health, generic oral health, and condition-specific QoL approaches. Patients were evaluated at baseline (T(0)), postoperative 6 weeks (T(1)), postoperative 6 months (T(2)), and after orthodontic treatment (T(3)). Generic health-related QoL, generic oral health-related QoL, and condition-specific QoL were assessed using the 36-item Short Form Health Survey (SF-36), the 14-item Short Form Oral Health Impact Profile (OHIP-14), and the 22-item Orthognathic Quality of Life Questionnaire (OQLQ), respectively. There were significant changes in Physical-Health Component Scores (PCS) (P < .001) and Mental-Health Component Scores (MCS) (P < .01) of SF-36, in OHIP-14 scores (P < .001), and in OQLQ scores (P < .001) during the trajectory of treatment. A transient decrease in PCS was found at T(1) (P < .001) and an increase in MCS was found only at T(3) (P < .05). There was a significant decrease in OHIP-14 scores at T(2) and T(3) (P < .001) and in OQLQ scores at all time points compared with T(0) (P < .05). Significant changes in QoL occurred after orthodontic-surgical treatment. A comprehensive assessment of QoL using generic health, generic oral health, and condition-specific approaches proved to be useful in determining the trajectory of changes.