Patient Self-reported Quality Of Life Research Articles

Quality of life of patients and caregivers affected by bronchopulmonary dysplasia: a systematic review.

To synthesize evidence on the impact of bronchopulmonary dysplasia (BPD) on the Quality of Life (QoL) of affected individuals from three perspectives: (i) QoL of caregiver; (ii) caregiver's perception of BPD patient's QoL; and (iii) BPD patient's self-reported QoL. Quantitative studies (case-control, cohort, and case series) on the QoL of BPD patients or their caregivers were considered. We conducted a systematic literature search of 6 databases (PubMed, Embase, World of Science, CINAHL, PsycINFO, and Chinese National Knowledge Infrastructure) for relevant studies. All databases were searched from the date of inception of the databases to 31 March 2022. Populations of interest were caregivers with preterm babies with BPD, or children/adults who were born premature and diagnosed with BPD. The main outcome measures were total and subdomain QoL scores, and factors affecting QoL. A total of 1078 articles were found; 10 were eligible for analysis, which included 247 caregivers and 1632 patients with BPD. The QoL of patients differed by domains-some were poorer or similar, but none of the QoL domains was better than QoL of healthy controls. Poor sleep and acute care needs of BPD patients negatively affected caregiver's QoL, while increasing illness acuity negatively affected the QoL of BPD patients. The QoL of BPD patients and their caregivers was most adversely affected during the immediate post-discharge period and tended to improve with time. The physical QoL of BPD patients was similar to that of preterm babies without BPD when assessed during late childhood and early adulthood. QoL assessment should be performed as an outcome measure and incorporated in the care plan for BPD patients and their caregivers. Systematic Review Registration PROSPERO CRD42021292253.

Prospective Evaluation of Taste Function in Patients With Head and Neck Cancer Receiving Intensity-Modulated Radiotherapy

The majority of the patients with head and neck cancer (HNC) experience taste dysfunction (TD) during or after radiotherapy (RT). However, prospectively collected data for taste dysfunction have been limited, especially in the era of intensity-modulated RT (IMRT). To evaluate the taste function in patients with HNC receiving IMRT by investigating the association between time course and recovery of TD in both acute and late phases. From August 2017 to November 2020, patients treated at the Chang Gung Memorial Hospital with curative or postoperative IMRT for HNC were enrolled in this prospective cohort study. The data analysis was performed from March 2021 to January 2022. IMRT with and without concurrent chemotherapy. Taste function was measured using the whole-mouth solution method for 4 tastes (salt, sweet, sour, and bitter). Subjective evaluations (National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.03] and Subjective Total Taste Acuity scale) were used. Patient self-reported quality of life was evaluated using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-H&N35). A total of 87 patients (78 [90%] men and 9 [10%] women; mean [range] age, 58 [31-80] years) were enrolled. Overall TD rates were 79 of 86 (91.9%), 63 of 83 (75.9%), 27 of 81 (33.3%), 5 of 56 (8.9%), and 2 of 30 (6.7%) during RT, and 1 week, 3 months, 6 months, and 1 year after RT, respectively. Positive correlation occurred between objectively measured taste loss for the 4 taste qualities and subjective perception of taste loss. Only oral cavity mean dose 4000 cGy or greater predicted TD 3 months after RT. The mean oral cavity doses to the predicted 15% (D15), 25% (D25), and 50% (D50) probabilities were 25, 38, and 60 Gy at 3 months and 57, 60, and 64 Gy at 6 months, respectively. In this cohort study, most patients still experienced TD during and at 3 months after RT. Only a few patients experienced long-term TD. A high oral cavity dose was associated with TD in patients with HNC receiving IMRT. Reducing oral cavity dose may promote early recovery of taste function after IMRT.

Prevalence of malnutrition and nutrition-related complications in patients with gastroenteropancreatic neuroendocrine tumours.

Cross-sectional studies report that up to 25% of people with gastroenteropancreatic neuroendocrine tumours (GEP NET) are malnourished. However, the changes in nutritional status and dietary intake over time are unknown. The present study aimed to comprehensively describe the impact of a GEP NET on nutritional status and quality of life (QOL). Patients diagnosed with a GEP NET were recruited to this prospective longitudinal study on initial attendance to the NET Unit at two tertiary hospitals in Melbourne (VIC, Australia). Patient self-reported QOL measures (European Organisation for Research and Treatment Cancer QLC-C30 and QLC-GINET21) and nutritional outcomes (nutritional status, weight change, fat-free mass [FFM], dietary change, dietitian contact) were collected bi-monthly for six months. Sixty-one patients were recruited (66% male) with a mean ± SD age of 62 ± 12 years, predominantly diagnosed with small intestinal NET and Grade 1/2 disease. Commonly reported symptoms were fatigue (79%), abdominal discomfort (75%) and pain (68%). More patients were malnourished at baseline than at 6 months (29% vs. 13%). Over this 6months, 48% lost weight, 20% lost ≥ 5% of their body weight, and 62% lost FFM with an average FFM loss of 2.8kg (95% confidence interval=2.0, 3.6), consistent with altered body composition. Dietary change was reported by 56% at baseline and 53% at six months, but only 21% consulted a dietitian at baseline and 18% at 6 months. Clinically significant loss of weight and FFM affected many patients with a GEP NET; however, few patients were referred to/or received a consultation with a dietitian. Valid screening practices are needed to identify weight loss and nutrition issues in GEP NET patients, and to facilitate referral to dietitian services.

Integrative review and evaluation of quality of life related instruments in pediatric urology

While most paediatric urologists consider patients' quality of life (QOL) important, few actually measure this outcome. Our goal was to assess instruments used in the pediatric urology QOL literature, specifically looking at whether they captured QOL. We searched MEDLINE and EMBASE for articles with a self-described primary outcome of measuring QOL. All validated QOL instruments in the papers were analyzed by QOL instrument content experts. Instruments were classified as focusing on: Functioning or QOL (Table). The term Functioning focuses on performing activities. QOL captures person's perceptions about their position in life, informed by circumstances, functioning and conditions. QOL instruments were further subdivided into generic QOL, health-related QOL (HRQOL) and disease-specific HRQOL. Only direct patient self-reported QOL instruments were then assessed, since they are the most clinically useful, reliably assessing patients' own perception of their QOL. Forty-three publications met inclusion criteria (published 1999-2019). Most common conditions included urinary incontinence (16, 37.2%) and kidney transplantation (12, 27.9%). Overall, 22 unique instruments purporting to measure QOL were identified. Looking at the concepts measured by each instrument, nine instruments (40.9%) assessed Functioning. Nine instruments (40.9%) measured a combination of Functioning and QOL. Only the remaining 4 instruments (18.2%) assessed strictly QOL. The 13 instruments assessing any QOL focused on generic QOL (n=4), HRQOL (n=3) and disease-specific HRQOL (n=6). Of the subset of four instruments assessing strictly QOL, and not Functioning, all had patient self-reported versions available: two generic QOL instruments (KINDL, KIDSCREEN), one generic HRQOL (DISABKIDS), and one disease-specific HRQOL (QUALAS). Thirteen of 43 studies (30.2%) employed more than one instrument. Thirty-eight studies (88.4%) used an instrument measuring Functioning, with 19 (44.1%) measuring only Functioning, not QOL at all. Twenty-four studies (55.8%) used an instrument measuring actual QOL, although 17 (39.5%) used a combined Functioning/QOL instrument. Only nine (20.9%) used a strictly QOL instrument (strictly HRQOL instruments: 4.7%). We present encouraging evidence of sustained interest in QOL research in pediatric urology and identify areas needing improvement. Selecting appropriate QOL tools requires a working knowledge of their various underlying meanings and purposes. Whether it adequately assess QOL must be considered. We discuss strengths and weaknesses of instruments and a practical approach to QOL instrument selection. Much of pediatric urology is grounded in improving QOL. Unfortunately, most studies published to date focus on Functioning, rather than young people's perception-based QOL. Future QOL studies should ideally employ validated instruments capturing patient-reported QOL.

High-Grade Gliomas Located in the Right Hemisphere Are Associated With Worse Quality of Life

The impact of glioma location on quality of life (QOL) has not been conclusively studied, possibly due to the prohibitively high sample size that standard statistical analyses would require and the inherent heterogeneity of this disease. By using a novel algorithm, we investigated the impact of tumor location on QOL in a limited set of 53 consecutive patients. The glial tumors of 53 consecutive patients were segmented and registered to a standardized atlas. The Euclidian distance between 90 brain regions and each tumor's margin was calculated and correlated to the patient's self-reported QOL as measured by the Sherbrooke Neuro-Oncology Assessment Scale questionnaire. QOL was not correlated to tumor volume, though a significant correlation was observed with its proximity to these areas: right supramarginal gyrus, right rolandic operculum, right superior temporal gyrus, right middle temporal gyrus, right angular gyrus, and right inferior parietal lobule. Interestingly, all identified areas are in the right hemisphere, and localized in the temporoparietal region. We postulate that the adverse relation between proximity to these areas and QOL results from disruption in visuospatial functioning. Although the areas identified in this study are traditionally considered non-eloquent areas, tumor proximity to these regions showed more impact on QOL than any other brain regions. We postulate that thiseffect is mediated via an adverse impact on the visuospatial functioning.

470 OUTCOMES OF COMPOSITE REPAIR OF GIANT HIATAL HERNIA IN A LARGE SINGLE CENTRE COHORT.

Abstract Giant hiatus hernia (GHH) is usually symptomatic and can have significant impact on a patient’s quality of life. There is ongoing debate about optimal technique of giant hiatus hernia repair. This paper aims to look at the outcomes of laparoscopic composite repair of giant hiatus hernia from a large single centre cohort. Methods A retrospective analysis of prospectively maintained database was performed. Patients undergoing composite repair for GHH defined as >30% stomach above diaphragm were included. Primary outcome was hernia recurrence. Secondary outcomes were perioperative morbidity and mortality, correlation of symptoms and hernia recurrence post operatively, need for revision surgery, resolution of symptoms post operatively and patient self-reported quality of life (GIQOL, Visik score). Results Inclusion criteria were met by 221 patients. Post-operative endoscopic and/or barium swallow follow up was performed in 198 patients with 23.74% recurrence rate. There was no correlation with recurrence of hernia and persistent post-operative symptoms. The most common presenting symptom was shortness of breath, followed by dysphagia, chest pain and heartburn. Dysphagia was most common post-operative symptom. There was significant improvement in QOL post-operatively. Conclusion Laparoscopic composite repair was proven safe and effective in this cohort. Hernia recurrence was not associated with ongoing symptoms and did not have an effect on QOL. A small proportion of patients with recurrence required revision surgery. Overall satisfaction with surgery was high.

Comparison of Patient Self-Reported Quality of Life and Health Care Professional-Assessed Symptoms in Terminally ill Patients With Cancer.

Few studies evaluated whether health care professionals accurately assess several symptoms for patients with cancer in palliative care units. We determined the agreement level for several symptoms related to quality of life (QOL) between patient-reported QOL assessment and health care professional-assessed symptoms based on the Support Team Assessment Schedule (STAS). An observational study was performed with terminally ill patients with cancer hospitalized in the palliative care unit between June 2018 and December 2019. Patients and health care professionals independently assessed 7 symptoms at the time of hospitalization and after 1 week. Patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C15-PAL). In examining the proportions of exact agreement, "exact agreement" referred to the pairs of the scores (QLQ-C15-PAL vs STAS) being (1 vs 0), (2 vs 1), (3 vs 2 or 3), or (4 vs 4). The relationships of physical functioning between QLQ-C15-PAL and Palliative Performance Scale (PPS) were examined. Of 130 patients, approximately 60% had PPS scores from 40 to 60. The highest mean score on QLQ-C15-PAL was for fatigue (63.8). The exact agreement on symptoms between patients and health care professionals ranged from 15.4% (fatigue) to 57.7% (nausea and vomiting). The mean of the transformed QLQ-C15-PAL and proportions of exact agreement were negatively correlated (R 2 = 0.949, P < .05). The physical function scores in QLQ-C15-PAL for each PPS group showed no differences. We expect patient-reported outcomes including QLQ-C15-PAL to be added to health care professionals' assessment of serious symptoms such as fatigue in terminally ill patients with cancer.

IP037. Patient Reported Outcomes of Vascular Interventions and Disease on Health-Related Quality of Life: Preliminary Results

The impact of illness on quality of life(QOL) and its assessment continues to be increasingly recognized in patient care. Vascular disease, chronic and often debilitating, impacts patient's QOL before and after treatment. This study aimed to prospectively assess the impact of abdominal aortic aneurysm and accompanying vascular disease on patient's physical functioning, emotional and social well-being before and after surgical intervention, and compare our subset to a national average score. Patients treated in the outpatient clinic setting were approached for participation in PROVIDE HQL. The Patient Reported Outcomes Measurement Information System (PROMIS), a validated National Institutes of Health toolkit was used. Patients completed the PROMIS-57 Profile V2.0, PROMIS-Sexual Function Profile V1.0, and PROMIS-SF V1.1 Global Health questionnaires before aortic intervention, 1 month and 1 year after the intervention. A linear regression model was built to associate domain scores and length of hospital stay after the intervention. Twenty-one patients completed baseline PROMIS questionnaire to vascular intervention. Fifteen patients (76.2%) were male, with all 21 patients being white, and not identifying as Hispanic or Latino. The majority of patients presented for AAA repair (57% endovascular vs 43% open repair). Major comorbidities included hypertension (95.2%), prior tobacco use (66.7%), and coronary artery disease (57.%). Average length of stay after the intervention was 6.5 days. Thirty day all-cause readmission rate was 10%. Baseline global mental health scores ranged from very good (19%), to good (52%), to fair (29%). Baseline physical health scores ranged from good (29%), to fair (67%) to poor (5%), which is somewhat lower than national baseline for patients of similar age. At the 90% significance level, PROMIS domain scores significantly associated with length of stay included PROMIS-57 Physical Function and PROMIS-57 Anxiety/Fear. Patient self-reported QOL is important to understanding baseline for evaluation after vascular intervention. Consistent follow-up is needed at one month and 1 year after the intervention to monitor patient's return to or deviation from baseline levels. Ongoing research efforts in our outpatient clinic aim to complete this assessment.

Impact of the Thoracotomy Implant Approach on Patient Self-Reported Quality of Life in the HVAD LATERAL Trial

The less invasive thoracotomy approach for HVAD implantation has been shown in the LATERAL Trial to be a safe and effective, particularly for patients with a redo sternotomy. While health related quality of life is an important outcome for patients with advanced heart failure, the impact of less invasive surgical approaches on health related quality of life is not well-described.

Objective severity does not capture the impact of rosacea, acne scarring and photoaging in patients seeking laser therapy.

Measures of quality of life (QOL) and patient satisfaction are of great importance in dermatology, as both impact upon treatment adherence and health outcomes. Patients' assessment of QOL often differs from their doctors' predictions and their assessments of skin disease severity do not correlate with patients' own perceptions. The development of laser technology has facilitated successful treatment of many skin conditions, but studies on patient satisfaction are lacking. Our aim was to determine the extent of discordance between patient and dermatologist-assessed disease severity and assess the impact of acne scarring, rosacea and photoaging on QOL. Our secondary aim was to assess patient satisfaction with laser therapy. A prospective study of patients undergoing laser treatment for acne scarring, rosacea and photoaging was conducted over 1 year at the Skin & Cancer Foundation Australia. Subjective disease severity was determined using a visual analogue scale (VAS). Two dermatologists determined objective severity using validated grading scales to score photographs. QOL impact was measured by Skindex-16, satisfaction was measured using an amended Comprehensive Satisfaction Questionnaire (PSQ-18). A total of 147 individuals sought laser therapy for acne scarring, rosacea and photoaging. Dermatologists' subjective disease severity correlated weakly with patient-reported severity. All conditions negatively impacted upon QOL. Patients with rosacea had the most symptomatic impact; acne scarring was associated with the greatest self-esteem and social functioning issues; photoaging patients were the least affected. There were significant correlations between subjective severity assessment and Skindex-16 scores. There was notable discordance between dermatologist's skin severity assessment and patient's self-reported QOL impact. Skin conditions can have a profound impact on patient QOL, which is affected by patients' perception of disease severity and not fully appreciated by dermatologists' own severity assessments. Laser therapy is associated with high patient satisfaction.

Association of Facial Paralysis-Related Disability With Patient- and Observer-Perceived Quality of Life.

The interaction between patient- and observer-perceived quality of life (QOL) and facial paralysis-related disability and the resulting effect of these interactions on social perception are incompletely understood. To measure the associations between observer-perceived disability and QOL and patient-perceived disability and QOL in patients with facial paralysis. This prospective study in an academic tertiary referral center included 84 naive observers who viewed static and dynamic images of faces with unilateral, House-Brackmann grades IV to VI facial paralysis (n = 16) and demographically matched images of nonparalyzed control individuals (n = 4). Data were collected from June 1 to August 1, 2014, and analyzed from August 2 to December 1, 2014. Observers rated the patient and control images in 6 clinically relevant domains. The patients self-reported their disability and QOL using validated tools, such as the Facial Clinimetric Evaluation Scale. Quality of life, severity of paralysis, and disability were measured on a 100-point visual analog scale. The 84 observers (59 women [70%] and 25 men [30%]) ranged in age from 20 to 68 years (mean [SD] age, 35.2 [11.9]). Structural equation modeling showed that for each 1-point decrease in a patient's Facial Clinimetric Evaluation Scale score, the patient's visual analog scale QOL improved by 0.36 (SE, 0.03; 95% CI, 0.31-0.42) points. Similarly, from an observer perspective, as the perceived disability (-0.29 [SE, 0.04; 95% CI, -0.36 to -0.22]) and severity (-0.21 [SE, 0.03; 95% CI, -0.28 to -0.14]) decreased, the perceived QOL improved. Furthermore, attractive faces were viewed as having better QOL (disability, severity, and attractiveness regression coefficients, -0.29 [SE, 0.04; 95% CI, -0.36 to -0.22], -0.21 [SE, 0.03; 95% CI, -0.28 to -0.14], and 0.32 [SE, 0.03; 95% CI, 0.26 to 0.39], respectively). An inverse association was found between a paralyzed patient's self-reported QOL rating and the observers' perceived QOL. This association was complex and was mediated through perceived severity and disability. Observers judged the severity of paralyzed faces to be 3.61 (SE, 1.80; 95% CI, 0.09-7.14) points more severe when viewing dynamic rather than static images. Observers were more likely to rate QOL lower owing to disability than were the patients with paralysis. This finding may be explained by previous literature reporting that disabled people adjust their values to accommodate their disability, thereby limiting the negative effect on their QOL. Given the importance of QOL on social interaction, the dissonance between observers and patients in this area has important implications for the socialization of patients with facial paralysis. NA.

Comparison of atopic dermatitis with psoriasis on patient self-reported quality of life and productivity loss: Analysis of the National Health and Wellness Survey

Comparison of atopic dermatitis with psoriasis on patient self-reported quality of life and productivity loss: Analysis of the National Health and Wellness Survey

Impact of atopic dermatitis on patient self-reported quality of life, productivity loss, and activity impairment: An analysis using the National Health and Wellness Survey

Impact of atopic dermatitis on patient self-reported quality of life, productivity loss, and activity impairment: An analysis using the National Health and Wellness Survey

Analysis of patient-reported outcomes from the LUME-Lung 1 trial: A randomised, double-blind, placebo-controlled, Phase III study of second-line nintedanib in patients with advanced non-small cell lung cancer

IntroductionThe LUME-Lung 1 trial (NCT00805194; Study 1199.13) demonstrated a significant overall survival (OS) advantage for nintedanib plus docetaxel compared with placebo plus docetaxel as second-line therapy for patients with advanced non-small cell lung cancer (NSCLC) and adenocarcinoma histology. Patient-reported outcomes (PROs) for symptoms and health-related quality of life (QoL) are reported here. MethodsPROs were assessed at screening, on Day 1 of each 21-day treatment cycle, at the end of active treatment, and at the first follow-up visit. PRO instruments were the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Lung Cancer-13 supplement, and the EuroQol disease-generic questionnaire (EQ-5D and EQ-VAS). Analyses of PRO items for lung cancer-specific symptoms of cough, dyspnoea and pain were prespecified. ResultsRates of questionnaire completion were high. There was no significant difference in time to deterioration of global health status/QoL, or symptoms of cough, dyspnoea or pain, between the treatment groups for both the overall study population and the adenocarcinoma population. Time to deterioration of some gastrointestinal events was shorter with nintedanib versus placebo. Longitudinal analysis for the adenocarcinoma population showed comparable changes between the groups in symptom scores over time, with numerical differences in favour of nintedanib for cough and pain scales, and significant reductions in some pain items with nintedanib versus placebo. There was no statistically significant difference in EQ-5D or EQ-VAS between the groups. ConclusionThe significant OS benefit observed with the addition of nintedanib to docetaxel therapy was achieved with no detrimental effect on patient self-reported QoL.

Dosimetric and patient correlates of quality of life after prostate stereotactic ablative radiotherapy

Background and purposeInitial results of Stereotactic Ablative Body Radiotherapy (SABR) in the treatment of localized prostate cancer appear promising however long-term quality of life (QOL) outcomes and dosimetric correlates are necessary. Material and methodsA phase I/II study was performed where low risk prostate cancer patients received SABR 35Gy in 5 fractions, once weekly. Patient self-reported QOL was measured using the Expanded Prostate Cancer Index Composite (EPIC) at baseline and q6month up to 5years. Urinary, bowel and sexual domains were analyzed. A minimally clinical important change (MCIC) was defined as 0.5∗standard deviation of the baseline. Univariate and multivariate logistic regression were used to identify dosimetric predictors of MCIC. Results84 patients were included. The median follow-up was 50.8months (interquartile range [IQR], 44.7–56.3). 17.9%, 26.2% and 37.5% of patients reported worse QOL on follow up in the urinary, bowel and sexual domains respectively. On univariate analysis Rectal V31.8>10%, D1cc>35Gy were associated with bowel MCIC, penile bulb (PB) V35>4%, V20>40% with sexual MCIC. Of these factors only rectal D1cc and PB V35 were predictors of worse QOL on multivariate analysis. ConclusionsLong-term single-institution QOL outcomes are encouraging. Rigorous dosimetric constraints are needed to keep bothersome side effects low.

Concordance of patient and caregiver reports in evaluating quality of life in patients with malignant gliomas and an assessment of caregiver burden.

Given the neurocognitive impairment experienced by many patients with malignant gliomas, caregiver reports can be critical in assessing the quality of life (QOL) of these patients. In this study, we explored whether assessment of patient QOL by the primary caregiver shows concordance with the patient's self-reported QOL, and we quantified the burden faced by caregivers. QOL of 45 patients was evaluated by both the patient and primary caregiver on 3 or more separate occasions using the Functional Assessment of Cancer Therapy-Brain (FACT-Br) instrument, and concordance between the 2 reports was evaluated. Caregiver burden was measured using the Caregiver Quality of Life Index-Cancer (CQOL-C) instrument. Overall, good concordance was observed between the patient and caregiver FACT-Br reports (intraclass correlation coefficient = 0.74). Patient-reported FACT-Br scores were 4.75 (95% CI, 1.44-8.05) points higher than paired caregiver reports on the 200-point scale (P = .008); however, this difference did not achieve clinical significance. Caregiver burden, as measured by the CQOL-C, was significantly greater among caregivers in this study than those previously reported for caregivers of patients with lung, breast, or prostate cancer (P < .001). Despite minor discrepancies in caregiver assessments of patient QOL relative to patient self-reports, our results suggest that the caregiver assessments can serve as adequate proxies for patient reports. Our results also illustrate the particularly heavy burden faced by caregivers of patients with malignant glioma. Further research into both of these areas is warranted.

Health-Related Quality of Life After Stereotactic Body Radiation Therapy for Localized Prostate Cancer: Results From a Multi-institutional Consortium of Prospective Trials

To evaluate the early and late health-related quality of life (QOL) outcomes among prostate cancer patients following stereotactic body radiation therapy (SBRT). Patient self-reported QOL was prospectively measured among 864 patients from phase 2 clinical trials of SBRT for localized prostate cancer. Data from the Expanded Prostate Cancer Index Composite (EPIC) instrument were obtained at baseline and at regular intervals up to 6 years. SBRT delivered a median dose of 36.25 Gy in 4 or 5 fractions. A short course of androgen deprivation therapy was given to 14% of patients. Median follow-up was 3 years and 194 patients remained evaluable at 5 years. A transient decline in the urinary and bowel domains was observed within the first 3 months after SBRT which returned to baseline status or better within 6 months and remained so beyond 5 years. The same pattern was observed among patients with good versus poor baseline function and was independent of the degree of early toxicities. Sexual QOL decline was predominantly observed within the first 9 months, a pattern not altered by the use of androgen deprivation therapy or patient age. Long-term outcome demonstrates that prostate SBRT is well tolerated and has little lasting impact on health-related QOL. A transient and modest decline in urinary and bowel QOL during the first few months after SBRT quickly recovers to baseline levels. With a large number of patients evaluable up to 5 years following SBRT, it is unlikely that unexpected late adverse effects will manifest themselves.

Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of quality of life outcome measures in clinical practice

Transcranial magnetic stimulation (TMS) is an effective and safe therapy for major depressive disorder (MDD). This study assessed quality of life (QOL) and functional status outcomes for depressed patients after an acute course of TMS. Forty-two, U.S.-based, clinical TMS practice sites treated 307 outpatients with a primary diagnosis of MDD and persistent symptoms despite prior adequate antidepressant pharmacotherapy. Treatment parameters were based on individual clinical considerations and followed the labeled procedures for use of the approved TMS device. Patient self-reported QOL outcomes included change in the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the EuroQol 5-Dimensions (EQ-5D) ratings from baseline to end of the acute treatment phase. Statistically significant improvement in functional status on a broad range of mental health and physical health domains was observed on the SF-36 following acute TMS treatment. Similarly, statistically significant improvement in patient-reported QOL was observed on all domains of the EQ-5D and on the General Health Perception and Health Index scores. Improvement on these measures was observed across the entire range of baseline depression symptom severity. These data confirm that TMS is effective in the acute treatment of MDD in routine clinical practice settings. This symptom benefit is accompanied by statistically and clinically meaningful improvements in patient-reported QOL and functional status outcomes.

Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial

SummaryBackgroundSurgical intervention for advanced Parkinson's disease is an option if medical therapy fails to control symptoms adequately. We aimed to assess whether surgery and best medical therapy improved self-reported quality of life more than best medical therapy alone in patients with advanced Parkinson's disease.MethodsThe PD SURG trial is an ongoing randomised, open-label trial. At 13 neurosurgical centres in the UK, between November, 2000, and December, 2006, patients with Parkinson's disease that was not adequately controlled by medical therapy were randomly assigned by use of a computerised minimisation procedure to immediate surgery (lesioning or deep brain stimulation at the discretion of the local clinician) and best medical therapy or to best medical therapy alone. Patients were analysed in the treatment group to which they were randomised, irrespective of whether they received their allocated treatment. The primary endpoint was patient self-reported quality of life on the 39-item Parkinson's disease questionnaire (PDQ-39). Changes between baseline and 1 year were compared by use of t tests. This trial is registered with Current Controlled Trials, number ISRCTN34111222.Findings366 patients were randomly assigned to receive immediate surgery and best medical therapy (183) or best medical therapy alone (183). All patients who had surgery had deep brain stimulation. At 1 year, the mean improvement in PDQ-39 summary index score compared with baseline was 5·0 points in the surgery group and 0·3 points in the medical therapy group (difference −4·7, 95% CI −7·6 to −1·8; p=0·001); the difference in mean change in PDQ-39 score in the mobility domain between the surgery group and the best medical therapy group was −8·9 (95% CI −13·8 to −4·0; p=0·0004), in the activities of daily living domain was −12·4 (−17·3 to −7·5; p<0·0001), and in the bodily discomfort domain was −7·5 (−12·6 to −2·4; p=0·004). Differences between groups in all other domains of the PDQ-39 were not significant. 36 (19%) patients had serious surgery-related adverse events; there were no suicides but there was one procedure-related death. 20 patients in the surgery group and 13 in the best medical therapy group had serious adverse events related to Parkinson's disease and drug treatment.InterpretationAt 1 year, surgery and best medical therapy improved patient self-reported quality of life more than best medical therapy alone in patients with advanced Parkinson's disease. These differences are clinically meaningful, but surgery is not without risk and targeting of patients most likely to benefit might be warranted.FundingUK Medical Research Council, Parkinson's UK, and UK Department of Health.

Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial

BackgroundChronic (systolic) heart failure (CHF) is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs) (Train the trainer = TTT) on patient and performance outcomes.MethodsThis paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control) were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control) were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ), total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9), behavioural change (European Heart Failure Self-Care Behaviour Scale), patient-perceived quality of care (EUROPEP) and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted.ResultsThere was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30). The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2–13; p = 0.02).ConclusionThe intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under-recruitment of practices and patients alongside a selection bias of participating GPs, prohibit definite conclusions, but the CI indicates a non-effectiveness of the intervention in this sample. We describe the lessons learned from conducting the trial for the future planning and conduct of confirmatory trials in primary care.Trial registrationISRCTN08601529.