Patient Assessment Of Quality Research Articles

Exploratory factor analysis of the reintegration to normal living index in a stroke population

Background: The reintegration to normal living index (RNLI) is a global assessment of patient quality of life often utilized in stroke populations. Previous studies in various general disability samples have consistently reported a two-factor solution for the RNLI. Despite its common use with stroke patients, the RNLI has not been psychometrically evaluated in an exclusively stroke sample. This study is believed to represent the first factor analysis of the RNLI using a sample comprised exclusively of individuals who have survived cerebral infarct.Objective: The aim of this study is to evaluate the psychometric properties of the RNLI in assessing quality of life of stroke survivors.Methods: We retrospectively examined RNLI scores of 928 adults with strokes of varying severities as part of a multidisciplinary, interinstitutional collaboration across an academic medical center, acute care hospital, and rehabilitation center. We utilized a principal component factor analysis to evaluate the factor structure of the RNLI.Results: Mean RNLI scores ±SD for the sample were 75.26 ± 19.85, ranging between 20 and 100. The Cronbach α was .94. A scree test for factor retention strongly suggested a single factor solution, explaining 64.50% of the total variance.Conclusions: Previous factor analyses on the RNLI utilizing general disability samples commonly report a two-factor solution. Our data support the presence of a single factor solution across the RNLI within a large sample comprised exclusively of stroke survivors. This suggests that the RNLI acts as more of a unitary measure of quality of life within a stroke sample relative to other disabled samples.

Recovery After Same-Day Surgery in Patients Receiving General Anesthesia: A Cohort Study Using the Quality of Recovery-40 Questionnaire

The contemporary rise in the number of elective procedures performed in same-day surgery (SDS) requires that health care professionals increase their knowledge of patient satisfaction and recovery, including patient-assessed quality of life. This study investigates the quality of recovery (QoR) of anesthetized SDS patients. Data from SDS patients were collected from hospital records at T1 (the morning before operation), T2 (day 1 postsurgery), and T3 (day 4 postsurgery). The QoR-40 and three questions that addressed tiredness, hoarseness, and thirst were used to measure health status at T2 and T3. QoR-40 mean score at T2 was 175 (SD=17.5; n = 328) and T3 was 181 (SD=16.6; n = 340). QoR improved significantly from T2 to T3 as did tiredness, hoarseness, and thirst. Patients who underwent throat, nose, or ear surgery had the lowest mean score at T3, whereas gynecology patients had the highest mean score at the same time point. Stepwise multiple linear regression analysis found the main predictor of QoR to be tiredness at T2, needing assistance with daily activities, preoperative education, not being discharged home, length of anesthesia, self-assessed mental health at T1, and hoarseness at T2 (R2 = 0.469). SDS patients needing assistance with daily activities, self-assessed in compromised mental health, who have undergone a lengthy anesthesia, and have not been discharged home need information, education, and special follow-up care.

Influence of patient-assessed quality of chronic illness care and patient activation on health-related quality of life.

To examine the association of the Patient Assessment of Chronic Illness Care (PACIC) with health-related quality of life (HRQoL) and the modulating effect of patient activation on this association. A population-based prospective cohort study of people with Type 2 diabetes in Queensland, Australia, using data from self-report questionnaires, collected annually from 2008 (n = 3761) to 2010 (n = 3040). Predictors were the 20-item PACIC (dichotomized at the score of 3), and the 13-item Patient Activation Measure (PAM), dichotomized into activation Levels 1 and 2 versus Levels 3 and 4. Analyses were restricted to participants whose PACIC and PAM categories did not change over 2 years of follow-up. Outcome variables were EQ-5D index and EQ VAS dichotomized at the uppermost quartile, and EQ-5D index also dichotomized at the median. An inverse probability weighted Poisson regression with a log-link function and a binary response variable for each outcome was used to obtain risk ratios (RRs), and the interaction between PACIC and PAM was statistically modelled, taking into consideration patient characteristics and the respective baseline outcome variable. The positive association between the PACIC and EQ VAS was seen only in participants with low activation (adjusted RR: 3.91; 95% CI: 1.40-10.95; P = 0.009), and not in those with high activation, indicating the non-synergistic interaction effect of the PACIC and PAM. This association was not found with EQ-5D index. Chronic care received consistently over time can positively affect health status, and benefit patients with low activation.

Idiopathic Canine Laryngeal Paralysis as One Sign of a Diffuse Polyneuropathy: An Observational Study of 90 Cases (2007-2013).

To determine survival and incidence of complications in dogs with idiopathic laryngeal paralysis (ILP) and concurrent neurologic signs. Observational study. Dogs (n = 90) with ILP. Medical records (January 2007-June 2013) of dogs with ILP were reviewed. Neurologic comorbidities, including pelvic limb neurologic abnormalities and esophageal abnormalities were identified. Using medical record information and client interviews, the relationship between these comorbidities and postoperative survival (primary outcome measure) and postoperative complications (secondary outcome measure) was identified. Dogs that had surgical correction of ILP had a 2.6-fold reduction in the hazard of death throughout the study period (HR = 2.6; 95% CI: 1.34-4.84, P = .006). Owner assessed patient quality of life (10-point scale) increased by an average of 4.1 ± 1.4 units immediately postoperatively, and 4.9 ± 0.9 units until death or followup compared with preoperative values. Thirty-five of 72 dogs available for followup had evidence of diffuse neurologic comorbidities. Overall complication rate for dogs with neurologic comorbidities was 74%, compared with 32% for dogs without neurologic comorbidities. Presence of any neurologic comorbidity was associated with a significantly greater odds of any complication (OR = 4.04; 95% CI: 1.25-13.90, P = .019) as well as recurring complications (OR = 8.00; 95% CI: 1.49-54.38; P = .015). Surgical correction of ILP was positively associated with survival, and dogs with neurologic comorbidities were at greater risk for developing postoperative complications.

Association between patient activation and patient-assessed quality of care in type 2 diabetes: results of a longitudinal study.

Previous research using cross-sectional data has shown a positive relationship between patient activation and quality of care. The quantitative relationships in the same patients over time, however, remain undefined. To examine the relationship between changes in activation over time and patient-assessed quality of chronic illness care. Prospective cohort study. The study used data reported annually from 2008 (N = 3761) to 2010 (N = 3040), using self-report survey questionnaires, completed by patients with type 2 diabetes in a population-based cohort in Queensland, Australia. Principal measures were the 13-item Patient Activation Measure (PAM), and the 20-item Patient Assessment of Chronic Illness Care (PACIC) instrument. Nonparametric anova was used to determine the association between patient activation and patient-assessed quality of care in low and high patient activation groups at baseline (2008), and in 2009 and 2010, when patients had changed group membership. The Wilcoxon signed ranks test was used to compare the PACIC scores between baseline and each follow-up survey for the same patient activation level. Patient activation was positively associated with the median PACIC score within each survey year and within each of the groups defined at baseline (high- and low-activation groups; P < 0.001). Patient activation and the PACIC change in the same direction and should be considered together in the interpretation of patient care assessment. This can be carried out by interpreting PACIC scores within strata of PAM.

Quality of life and relation to disease in patients with bone sarcoma

The study aimed to investigate the basic aspects of quality of life and relation to disease in patients with malignant or premalignant bone tumors. Study participants (N=82) were aged 18 to 67 years (average age 34 ± 2 years). They were separated into three groups depending on diagnosis: patients with osteosarcoma, patients with giant cell tumor and patients with chondrosarcoma. The SF-36 Health Status Survey and the Quality of Life Questionnaire - Core 30 with Bone Metastasis (BM22) Module were used to assess patient quality of life. The type of relation to disease method (TOBOL) was used to determine the relation to disease of the patients.

A Multicenter, Open-Label, Randomized Phase II Controlled Study of rh-Endostatin (Endostar) in Combination with Chemotherapy in Previously Untreated Extensive-Stage Small-Cell Lung Cancer

Based on promising efficacy in a single-arm study, a randomized phase II trial was designed to compare the efficacy and safety of adding rh-endostatin (Endostar) to first-line standard etoposide and carboplatin (EC) chemotherapy for treatment of extensive-stage small-cell lung cancer. One hundred forty Chinese patients with pathologically confirmed, extensive-stage small-cell lung cancer were randomly assigned to EC alone or rh-endostatin + EC for 4-6 cycles, followed by single-agent rh-endostatin until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival, Objective response rate (ORR), and quality of life. Median PFS was 6.4 months with rh-endostatin + EC (n = 69) and 5.9 months with EC (n = 69) (hazard ratio 0.8 [95% confidence interval 0.6-1.1]). PFS was significantly higher with rh-endostatin + EC than with EC (hazard ratio 0.4 [0.2-0.9; p = 0.020]) in female. Median overall survival was similar in both groups (12.1 versus 12.4 months, respectively [p = 0.82]). ORR was higher in the rh-endostatin + EC group (75.4%) than in the EC group (66.7%) (p = 0.348). The efficacy of rh-endostatin + EC relative to that of EC was reflected by greater improvements in patient-assessed quality of life scores after 4 and 6 weeks of treatment. There was no difference between each regimen in the incidence of nonhematological or Grade III-IV hematological toxicities. Addition of rh-endostatin to EC for the treatment of extensive-stage small-cell lung cancer had an acceptable toxicity profile, but did not improve overall survival, PFS, and ORR.

Применение отечественной системы индикаторов для оценки качества медицинской помощи больным с острым коронарным синдромом с подъемом сегмента ST: шаг навстречу практике публичных отчётов о качестве

Применение отечественной системы индикаторов для оценки качества медицинской помощи больным с острым коронарным синдромом с подъемом сегмента ST: шаг навстречу практике публичных отчётов о качестве

Herbal drug BNO 1016 is safe and effective in the treatment of acute viral rhinosinusitis

Conclusion: Daily intake of 480 mg of BNO 1016 for 15 days is an effective treatment in acute viral rhinosinusitis. Objectives: The pooled efficacy data of two similar randomized placebo-controlled clinical trials were analyzed. Safety was evaluated on the basis of the individual trials. Methods: The efficacy analysis was based on 589 patients. Treatment was performed orally with either 3 × 160 mg BNO 1016 (n = 294) or 3 × placebo (n = 295) for 15 days. In both trials patients underwent five visits to the investigational sites. Symptoms were evaluated according to the EPOS 2012 guideline. Ultrasonography was used to confirm the diagnosis at onset of treatment and the remission of symptoms at the last visit. Efficacy was evaluated by the investigator as the mean major symptom score (MSS) at the end of treatment (visit 5, day 14). Patients reported symptoms and social/emotional consequences of rhinosinusitis using a quality of life questionnaire (SNOT-20 GAV). Results: MSS improved during the treatment period by a mean of 10.02 ± 1.61 score points to 2.47 ± 2.55 for BNO 1016 and of 9.87 ± 1.52 to 3.63 ± 3.63 for placebo. Differences between treatment groups at end of therapy (1.16 ± 3.14 score points; p < 0.0001) and patient-assessed quality of life (p = 0.0015) were statistically significant in favor of BNO 1016.

Prospective Evaluation of Quality of Life in Adolescent Idiopathic Scoliosis Before and After Surgery

Prospective observational study. To assess patient quality of life before and after surgical treatment of adolescent idiopathic scoliosis (AIS) and determine whether an association exists between quality of life and curve magnitude, curve correction, and type of instrumentation. Assessment of AIS surgery outcomes has always been based on analysis of radiographic measurements and postoperative curve correction. However, there is a current trend toward greater emphasis on patient-centered outcomes. Assessment of treatment success on the basis of these outcomes requires prospective use of quality-of-life surveys before and after AIS treatment. Prospective study of 33 patients undergoing surgical treatment of AIS. Mean age was 15.6 years and mean Cobb angle was 70.5 degrees. Patients were randomly allocated into one of 2 instrumentation groups (hybrid and pedicle screws alone), and the Scoliosis Research Society-30 questionnaire (SRS-30) and Short Form-36 Health Survey (SF-36) questionnaires were administered preoperatively and at 3-, 6-, and 12-month follow-up. Statistical testing was performed to determine whether survey scores correlated with Cobb angle, curve correction, or type of instrumentation. SRS-30 and SF-36 scores improved significantly. The greatest changes occurred in the self-image and satisfaction with management domains of the SRS-30 survey. SRS-30 and SF-36 scores showed worsening pain and decreased function at 3-month follow-up, but significant improvement from baseline at 12 months. Total SRS-30 scores were significantly improved at 6- and 12-month follow-up, as were subscores in the general health, vitality, and social functioning domains of SF-36. Curve magnitude, percent curve correction, and type of instrumentation had no significant influence on final SRS-30 and SF-36 scores. Surgical treatment of AIS improved patient quality of life, as shown by significant improvement on all SRS-30 and SF-36 domains. Questionnaire scores did not correlate with Cobb angle, curve correction, or type of instrumentation.

Patient quality of life and pain improve after autologous islet transplantation (AIT) for treatment of chronic pancreatitis: 53 patient series at the University of Arizona

Background/objectivesPancreatectomy with autologous islet transplantation has slowly been proving to be an effective way of treating chronic pancreatitis while lessening the effects of the concomitant surgical diabetes of pancreatectomy alone. Assessing patient quality of life and pain after the procedure is particularly important as intractable pain is the main complaint for which patients undergo total pancreatectomy. MethodsWe used the Rand SF-36 and McGill pain questionnaires, and Visual Analogue Scale to assess patients preoperatively for quality of life and pain resulting from life with chronic pancreatitis. After undergoing total pancreatectomy with autologous islet transplantation (TPAIT), patients were followed with surveys administered at 1 month, 6 months, and 1 year to evaluate changes in their quality of life and pain experienced. ResultsSignificant improvement was reported in all components of every questionnaire within a year after surgery. Furthermore, patient reported mean scores on quality of life were found to fall within the range of the general population. ConclusionsFrom our experience with 53 patients at the University of Arizona, after pancreatectomy with autologous islet transplantation patients reported a higher quality of life when compared to preoperative values, as well as reduced levels of pain.

Sf-36 questionnaire as the instrument of the life quality assessment in patients with diabetes mellitus type 2

Today diabetes mellitus (DM) significantly reduces the parameters of the life quality of patients. Therefore, the life quality assessment is current and promising direction of medicine, which allows to determine a reasonable method of treatment. The aim of this study was the use of SF-36 questionnaire for determining the quality of life of patients with T2DM when applying different schemes of pharmacotherapy. The research objectives are: 1) carrying out retrospective analysis of medical histories and treatment sheets of T2DM patients in hospital environment; 2) carrying out frequency analysis of the treatment regimens used; 3) analysis of patients included in the study; 4) carrying out the survey by a nonspecific SF-36 questionnaire; 5) determination of the quality of life in T2DM patients. The research object is the quality of life in T2DM patients in hospital environment. The research methods were retrospective, frequency analysis, life quality assessment by a nonspecific SF-36 questionnaire. The pharmacoeconomic research included 2 groups of patients: the first group (25 patients) received the combination of metformin+gliclazide (43.1% of cases), the second one (56 patients) received the combination of metformin + glimepiride (16%). Patients did not significantly differ from all of the parameters analyzed, and it enabled to compare their quality of life. The life quality parameters were assessed by a nonspecific SF-36 questionnaire. When studying the life quality in patients with the metformin + gliclazide scheme the average physical health component was 24.64±0.63 and the average mental health component was 25.24±0.78; in patients with the metformin + glimepiride scheme the average physical health component was 23.89±1.1 and the average mental health component was 24.37±0.55. These results indicate that the quality of life in patients is fairly low and does not depend on the pharmacotherapeutic scheme used, obviously it is due to the severity of the T2DM course and the presence of complications. The quality of life in patients according to the physical and mental components has fairly low indicators irrespective of the pharmacotherapeutic scheme used.

The Impact of Prostate Size on Patient-Assessed Quality of Life Following Proton Beam Radiation Therapy

to the baseline during the next years. The physical functioning score did follow the same trend as the global health score. The dyspnea score increased during the first 6 months to a score of 6, then ameliorated after the 1 year (score -3). During the following years, the dyspnea score gradually increased to a score of 17 at 5 years. The coughing score increased to 4 at 3 weeks after the treatment and slowly decreased during the first 2 years to -11. After the first 2 years, the score increased to a score of 8 at 5 years. The actuarial 2and 5-years overall survival was 62% and 31%, resp. The 5-years actuarial local control was 93%. Two patients had a local recurrence. The actuarial 2and 5-years disease free survival was 69% and 52%, resp. No grade 4 or 5 treatment related toxicity occurred. Conclusions: During the 5 years after the treatment, the quality of life was maintained and emotional functioning improved significantly after stereotactic radiation therapy for stage I NSCLC. Dyspnea slowly increased 2 years after the treatment. The local tumor control was high and toxicity was low. Author Disclosure: J. Nuyttens: None. R. Ubels: None. N. Van der Voort van Zyp: None.

106IN - If and When to Start Systemic Therapy As Palliation for People with Advanced Cancer

ABSTRACT To benefit patients, treatment must improve either duration or quality of survival. For patients with minimal symptoms, one should only start palliative systemic treatment if there is strong evidence that (i) treatment improves the duration of survival, and (ii) that this effect will be lost if treatment is delayed until symptoms occur. You cannot make a well patient feel better but you can make them feel worse because of side-effects of treatment. If a patient is symptomatic, then treatment should be initiated provided that probability of benefit is greater than probability of increasing symptoms from effects of treatment. These principles will be illustrated by case scenarios of metastatic prostate and breast cancer. Androgen deprivation therapy (ADT) is not necessary for an asymptomatic man with slowly-rising PSA (doubling time >3 months) and low-volume metastatic prostate cancer. ADT has subtle but sometimes serious side effects. Often the main symptom is anxiety due to knowledge of PSA; this requires counselling rather than drug treatment. For symptomatic men or those with rapidly-rising PSA, ADT is effective palliation, and benefits of ADT have increased with availability of abiraterone and enzalutamide. For men with castrate-resistant prostate cancer similar principles apply to initiating chemotherapy with docetaxel. Chemotherapy generally has more side-effects than ADT, but can improve quality of life and prolong survival; however benefits are less and toxicity greater for men with comorbidity. Similar principles apply to treatment of metastatic breast cancer. In women with slowly-progressive non-visceral ER+ disease and minimal symptoms, hormonal therapy is usually appropriate. Chemotherapy should only be commenced to combat symptoms that cannot be treated by simpler means, including local radiotherapy. Women with triple negative or HER2+ve breast cancer have more rapid progression and are more likely to have visceral metastases: chemotherapy (+/-HER2 targeted therapy) can prevent or relieve symptoms but needs to be planned in relation to age and comorbidity. Performance status and patient-assessed quality of life are predictive of benefit from chemotherapy. Disclosure: The author has declared no conflicts of interest.

Relationship Quality and Patient-Assessed Quality of Care in VA Primary Care Clinics: Development and Validation of the Work Relationships Scale

Efforts to better understand the impact of clinic member relationships on care quality in primary care clinics have been limited by the absence of a validated instrument to assess these relationships. The purpose of this study was to develop and validate a scale assessing relationships within primary care clinics. The Work Relationships Scale (WRS) was developed and administered as part of a survey of learning and relationships among 17 Department of Veterans Affairs (VA) primary care clinics. A Rasch partial-credit model and principal components analysis were used to evaluate item performance, select the final items for inclusion, and establish unidimensionality for the WRS. The WRS was then validated against semistructured clinic member interviews and VA Survey of Healthcare Experiences of Patients (SHEP) data. Four hundred fifty-seven clinicians and staff completed the clinic survey, and 247 participated in semistructured interviews. WRS scores were significantly associated with clinic-level reporting for 2 SHEP variables: overall rating of personal doctor/nurse (r(2) =0.43, P <.01) and overall rating of health care (r(2)= 0.25, P <.05). Interview data describing relationship characteristics were consistent with variability in WRS scores across low-scoring and high-scoring clinics. The WRS shows promising validity as a measure assessing the quality of relationships in primary care settings; moreover, primary care clinics with lower WRS scores received poorer patient quality ratings for both individual clinicians and overall health care. Relationships play an important role in shaping care delivery and should be assessed as part of efforts to improve patient care within primary care settings.

Evaluation of short-term and long-term results after laparoscopic antireflux surgery: esophageal manometry and 24-h pH monitoring versus quality of life index

The objective of this long-term study is to compare data on postoperative quality of life with objective functional measurements in patients with gastroesophageal reflux disease who have undergone laparoscopic antireflux surgery. Between 1995 and 2005, 162 patients with gastroesophageal reflux disease underwent laparoscopic surgery. A minimum of 4 years after surgery, 60 patients were contacted at random, 29 of whom agreed to follow-up examination. The following examinations were performed preoperatively, 6 months postoperatively, and 4-12 years postoperatively: esophageal manometry, 24-h gastroesophageal pH-metry, and assessment of patient quality of life based on the gastrointestinal quality of life index (GIQLI). The number of postsurgical reflux episodes was reduced significantly, both at 6 months and at 4 or more years after surgery. The number of episodes dropped from 183 before surgery to 58 at 6 months after surgery and remained constant ≥ 4 years later. Surgery also produced a significant drop in reflux time, seen both 6 months and ≥ 4 years later. Six months after surgery, the median reflux time had fallen from 134 min (preoperatively) to 27 min, and at ≥ 4 years it was still significantly reduced at 35 min. Sphincter length (median preoperative length, 3 cm; median postoperative length (at 6 months and at ≥ 4 years), 4 cm) and sphincter pressure (median preoperative pressure, 3 mmHg; median at 6 months, 12 mmHg; median at ≥ 4 years, 10.9 mmHg) were significantly improved by surgery as well. Finally, surgery produced an improvement in quality of life. The median preoperative GIQLI was 102, while at 6 months after surgery it was 113 and at ≥ 4 years after surgery it was 124. Laparoscopic fundoplication guarantees long-term improvement in symptoms and quality of life for patients suffering from gastroesophageal reflux disease. The effectiveness of reflux surgery can thus be demonstrated by long-term quality of life assessments and postoperative functional measurements. No statistically significant correlation between total score (DeMeester) and GIQLI could be demonstrated.

Reconstruction of the Maxilla with Pedicled Temporalis Muscle

Objectives: Resection of the maxilla requires adequate restoration of the maxilla structure to replace form and functions, especially vocal and eating functions. A host of reconstructive options are available to restore the maxilla, most of which include free flap reconstruction. The aim of this study was to clinically evaluate the use of pedicled temporalis flap for reconstruction of the maxilla and to assess patient quality of life. Methods: In the period 2000-2007, a total of 32 patients with malignant tumors of the maxilla were operated with immediate reconstruction of the maxilla using pedicled temporalis flap at the ear, nose, and throat (ENT) department, Aarhus University Hospital. Follow up was implemented in 2007. Twenty-seven of 28 patients alive at the time of follow up participated in the study. The patients were evaluated objectively as well as subjectively by answering the European Organisation for Research and Treatment of Cancer’s (EORTC’s) standard questionnaire concerning quality of life and functional results. Results: Few patients had complaints and these were mostly minor functional deficits. The most common complaints were slightly impaired mouth opening. One temporalis muscle flap necrotized and was removed. Three patients developed oro-nasal/antral fistula, which were later closed using local flaps. Conclusions: The follow up study of 27 patients showed a most satisfactory result evaluated objectively as well as subjectively using the EORTC questionnaire.

Investigator-initiated pilot study of bicalutamide and raloxifene in hormone-resistant prostate cancer.

e16065 Background: Estrogens, in addition to androgen may contribute to the progression of prostate cancer.The combination of bicalutamide, a non-steroidal anti-androgen, and raloxifene, a selective estrogen receptor modulator, has a synergistic effect on cell death of prostate cancer cell lines such as DU145 and PC3. We investigated the safety of combined treatment of bicalutamide and raloxifene on quality of life in patients affected by hormone-resistant prostate cancer. Methods: Eligibility requirements included metastatic hormone-resistant prostate cancer, Eastern Cooperative Oncology Group performance status of 0 or 1. Patients received the combination of bicalutamide, 50 mg, and raloxifene, 60 mg, daily in 28 day cycles for a maximum of 6 cycles. The primary endpoint was to describe the adverse event profile of combined treatment with bicalutamide and raloxifene. The secondary endpoint was to describe the quality of life of patients receiving the combination. Adverse events were graded by the investigator using the NCI Common Terminology Criteria for Adverse Events version 4.0 and the quality of life was assessed by the patient using aLinear Analog Scale Assessment (scale of 0-100). Serum levels of estradiol and testosterone were monitored during treatment. Results: Eighteen evaluable patients were included in the statistical analysis after an initial run-in safety cohort of six patients. Two patients completed 6 cycles per protocol, the remaining sixteen patients were taken off protocol after disease progression. Patients completed a median of 2 cycles. There were no grade 4 events and grade 3 adverse events consisted of hypertension (5.6%) and back pain (5.6%). Erectile dysfunction (grade 1) was the most common adverse event (77.8%). Patient assessment of quality of life (mental, physical, social, emotional, spiritual) did not reveal any statistically different changes after 2 cycles of treatment. An analysis of testosterone and estradiol levels will be reported. Conclusions: We conclude that combination of bicalutamide and raloxifene is well-tolerated. The combination of androgen and estrogen receptor blockade warrants further study for efficacy in hormone-resistant prostate cancer. Clinical trial information: NCT01050842.

Response to Weiss HR, Moramarco M: “indication for surgical treatment in patients with adolescent idiopathic scoliosis – a critical appraisal” (Patient Saf. Surg. 2013, 7:17)

Response to Weiss HR, Moramarco M: “indication for surgical treatment in patients with adolescent idiopathic scoliosis – a critical appraisal” (Patient Saf. Surg. 2013, 7:17)

A nurse- and peer-led support program to assist women in gynaecological oncology receiving curative radiotherapy, the PeNTAGOn study (Peer and nurse support trial to assist women in gynaecological oncology): study protocol for a randomised controlled trial

BackgroundWomen who undergo radiotherapy for gynaecological cancer (GC) can experience distressing side effects which impact on psychosocial functioning and intimate relationships. Cancer-related distress may be ameliorated by comprehensive preparation for treatment and addressing women’s informational, physical, psychological and psychosexual needs. This paper describes the protocol for a multisite randomised controlled trial (RCT) testing a novel intervention package which combines tailored specialist nursing consultations and telephone peer support with the primary aim to reduce psychological distress. Secondary aims assess patient quality of life, symptom distress, unmet supportive care needs, preparation for treatment, psychosexual functioning and vaginal stenosis.Methods/designThis multifaceted intervention comprises four nurse-led consultations coupled with four phone calls from a peer support volunteer (GC survivor). The evidence-based intervention will be delivered at critical points in the illness trajectory: pre-treatment, mid-treatment, treatment completion and post-treatment. Nurses and peers undergo 2-day intensive training workshops, are guided by comprehensive study intervention manuals and receive ongoing supervision and support. Eligible patients will have a diagnosis of GC, be scheduled to receive curative radiotherapy, be aged 18 years or over and speak English. Three-hundred and six participants will be randomized to receive usual care or usual care with the intervention package. Study outcome measures will be collected at baseline, day 1 of radiotherapy and 1, 6 and 12 months post radiotherapy. Clinical assessments of vaginal toxicity will occur at baseline, and 3, 6, and 12 months post radiotherapy.DiscussionThis timely research has the potential to substantially reduce the physical, psychosexual and supportive care needs of women with GC. Using a telephone peer support model, the intervention package ensures equitable access to support services for geographically isolated patients. The novel intervention engages peer volunteers who liaise with nurses to encourage adherence to professionally-delivered information and provide emotional support. It has been designed to be potentially transferable to a range of treatment settings and diseases. Based on pilot data, the proposed intervention was found to be useful and acceptable to patients and clinicians. If effective and feasible in the multisite RCT, the program could be widely disseminated.Trial registrationAustralian New Zealand Clinical Trial Registry ACTRN12611000744954