Redesigning Rural Acute Stroke Care: A Person-Centered Approach.

Stroke service delivery in rural areas in Australia lacks evidence-based, best practice care protocols as a result of limited resources and opportunity. Healthcare redesign is an approach to improving health services by understanding barriers and enablers to service provision and work with users to develop solutions for improvement. This research aimed to qualitatively evaluate stroke care in rural Tasmania using a person-centered approach, as part of a larger healthcare redesign initiative to improve acute stroke care. Semi-structured interviews, aimed at gaining insight into experiences of healthcare staff and users, were conducted. Thematic analysis revealed three global themes (communication, holistic care, and resourcing) that demonstrated some consistency between healthcare staff and user experience, highlighting that some needs and expectations were not being met. Results of this experiential study provide important perspectives for delivering needs-based improvements in service provision for acute stroke care. Overall, this study showed that systems of stroke care in rural areas could be improved by utilizing a redesign approach including healthcare staff and users in the development of solutions for health service improvement.

Health-care utilisation for low back pain: a systematic review and meta-analysis of population-based observational studies.

Low back pain (LBP) is a major public health problem globally, resulting in a significant personal and societal burden. However, little is known about health-care utilisation for optimal management of LBP. The aim of this systematic review and meta-analysis was to determine the prevalence rate of health-care utilisation for LBP. The electronic databases MEDLINE, EMBASE via Ovid, CINAHL, and Scopus were searched for peer-reviewed articles published in English before March 2018. Meta-analysis was performed using Stata version 14 software. The reported summary statistics including the pooled prevalence rate of health-care utilisation were calculated using a random-effects model. Of 5801 identified records, 20 met the inclusion criteria and were reviewed. The prevalence rate of health-care utilisation for LBP varied regionally, the pooled prevalence rate was 67%, 95% confidence interval (CI) 50-84 in the USA, 47%, 95% CI 39-56 in the UK and 48%, 95% CI 33-63 in Europe. General practitioners, chiropractors and physical therapists were health-care providers commonly engaged in the management of LBP patients, while medication treatment, exercise, massage therapy and spinal manipulation were common prescriptions. A range of factors influencing the decision to seek and use health-care for LBP were also identified. Despite LBP being a common public health problem, a significant proportion of people with the pain fail to use health-care. It is apparent from this review that there is possibly skewed data, as the evidence to date is largely from developed countries. Therefore, it is warranted that future studies investigate the epidemiology of health-care utilisation for LBP in developing countries.

Long-Term Efficacy and Toxicity of Low-Dose-Rate ¹²5I Prostate Brachytherapy as Monotherapy in Low-, Intermediate-, and High-Risk Prostate Cancer.

PURPOSE/OBJECTIVES: To report long-term efficacy and toxicity for a single-institution cohort of patients treated with low-dose-rate prostate brachytherapy permanent implant (PI) monotherapy. METHODS AND MATERIALS: From 1996 to 2007, 1989 patients with low-risk (61.3%), intermediate-risk (29.8%), high-intermediate-risk (4.5%), and high-risk prostate cancer (4.4%) were treated with PI and followed up prospectively in a registry. All patients were treated with (125)I monotherapy to 144 Gy. Late toxicity was coded retrospectively according to a modified Common Terminology Criteria for Adverse Events 4.0 scale. The rates of biochemical relapse-free survival (bRFS), distant metastasis-free survival (DMFS), overall survival (OS), and prostate cancer-specific mortality (PCSM) were calculated. We identified factors associated with late grade ≥3 genitourinary (GU) and gastrointestinal (GI) toxicity, bRFS, DMFS, OS, PCSM, and incontinence. RESULTS: The median age of the patients was 67 years, and the median overall and prostate-specific antigen follow-up times were 6.8 years and 5.8 years, respectively. The overall 5-year rates for bRFS, DMFS, OS, and PCSM were 91.9%, 97.8%, 93.7%, and 0.71%, respectively. The 10-year rates were 81.5%, 91.5%, 76.1%, and 2.5%, respectively. The overall rates of late grade ≥3 GU and GI toxicity were 7.6% and 0.8%, respectively. On multivariable analysis, age and prostate length were significantly associated with increased risk of late grade ≥3 GU toxicity. The risk of incontinence was highly correlated with both pre-PI and post-PI transurethral resection of the prostate. CONCLUSIONS: Prostate brachytherapy as monotherapy is an effective treatment for low-risk and low-intermediate-risk prostate cancer and appears promising as a treatment for high-intermediate-risk and high-risk prostate cancer. Significant long-term toxicities are rare when brachytherapy is performed as monotherapy.

The use of zoledronic acid in men receiving androgen deprivation therapy for prostate cancer with severe osteopenia or osteoporosis.

OBJECTIVES: To study the effect of zoledronic acid on patients with pre-existing osteoporosis on androgen deprivation therapy (ADT), who are at highest risk for fracture. Zoledronic acid is a potent bisphosphonate that can prevent osteoporosis in patients with nonmetastatic (M0), prostate cancer (CaP) who are initiating ADT. The effect of zoledronic acid on patients with pre-existing osteoporosis on ADT, who are highest risk for fracture, has not been adequately studied. METHODS: We enrolled 28 patients with M0 CaP on ADT with severe osteopenia or osteoporosis (baseline bone-mineral density (BMD) T score < -2.0) in this open-label, single-arm trial to assess the effect of zoledronic acid on BMD. All patients also received supplemental calcium and vitamin D, and were counseled about lifestyle modifications. Patients received zoledronic acid (4 mg) intravenously every 3 months for 4 treatments. BMD was measured by dual energy X-ray absorptiometry scan at enrollment, 6 and 12 months. Primary endpoint was percent change in lumbar spine BMD. RESULTS: This was a high-risk patient population-primarily older Caucasians (mean age, 73 years), former smokers, and moderate users of alcohol. Mean duration of ADT was 2.4 years. Pre-existing osteopenia or osteoporosis was observed in a single site in 9 patients and multiple sites in 19 (68%). After 12 months of zoledronic acid, lumbar spine BMD increased 4.17% (P < .0001), and BMD increased significantly (P < .05) in both hips and the right femoral neck. Seven patients (25%) experienced improved BMD into the nonosteoporotic range (T score > -2.0). Zoledronic acid infusion was well tolerated and without substantial renal toxicity. CONCLUSIONS: Zoledronic acid improves BMD in men with M0 CaP on ADT with severe osteopenia or osteoporosis (T scores < 2.0). This novel finding identifies a high-risk patient population that can potentially benefit from bisphosphonate therapy.

Association of percentage of tumour burden removed with debulking nephrectomy and progression-free survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted therapy.

OBJECTIVE: To determine if the fractional percentage of tumour volume (FPTV) removed with debulking nephrectomy was associated with progression-free survival (PFS) after subsequent targeted therapy, as a debulking nephrectomy is the standard of care in metastatic renal cell carcinoma (mRCC), but there are few data. PATIENTS AND METHODS: The Cleveland Clinic Taussig Cancer Institute Urologic Oncology database was retrospectively reviewed from 2005 to 2008 to identify patients with mRCC who had undergone debulking nephrectomy followed by vascular endothelial growth factor (VEGF)-targeted therapy, defined as sunitinib-, sorafenib- or bevacizumab-based therapy. FPTV was calculated as the largest diameter of the primary tumour divided by the total tumour burden (as per the Response Evaluation Criteria in Solid Tumors, RECIST) through investigator re-review of imaging. PFS was defined from the start date of systemic therapy to disease progression per RECIST criteria. RESULTS: Forty-six patients were identified (80% men, median age 61 years, all clear cell histology and 67% with an Eastern Cooperative Oncology Group performance status of 0). Patients received treatment with bevacizumab ± interleukin-2 (18), sunitinib (14), sorafenib (11) or sunitinib + bevacizumab (three). The median diameter of the primary tumour was 10.0 cm. The median (range) FPTV removed was 95 (80-99)%. In univariable analysis, the FPTV removed (P = 0.002) and normal haemoglobin level (P = 0.04) were associated with improved PFS. In multivariable analysis, the FPTV removed (P < 0.001), male gender (P = 0.001) and corrected calcium (P = 0.05) were independent predictors of PFS. CONCLUSION: A greater percentage of tumour burden removed at debulking nephrectomy is significantly associated with improved PFS on subsequent VEGF-targeted systemic therapy.

Intravenous zoledronic acid to prevent osteoporosis in a veteran population with multiple risk factors for bone loss on androgen deprivation therapy.

PURPOSE: Androgen deprivation therapy for prostate cancer is associated with osteoporosis and increased fracture risk. Previous studies of zoledronic acid demonstrated bone loss prevention in patients initiating androgen deprivation therapy. There are limited data on patients on prolonged androgen deprivation therapy or in Veterans Affairs patients with multiple risk factors for osteoporosis. METHODS: We randomized 93 patients with M0 prostate cancer in this placebo controlled trial in the Veterans Affairs health care system. Preplanned strata included 50 patients on androgen deprivation therapy for less than 1 year (stratum 1) and 43 on androgen deprivation therapy for greater than 1 year (stratum 2). In each stratum patients were randomized to 4 mg zoledronic acid intravenously every 3 months for 4 treatments or intravenous placebo. The primary end point was the percent change in bone mineral density at the lumbar spine at 12 months. RESULTS: Age, race, body mass index and osteoporosis risk factors were similar for the 2 treatments. Most patients were former smokers, had moderate alcohol intake, were not on calcium/vitamin D supplements and were relatively sedentary at baseline. In stratum 1 spine bone mineral density increased 5.95% in the zoledronic acid arm and decreased 3.23% in the placebo arm (p = 0.0044). In stratum 2 spine bone mineral density increased 6.08% in the zoledronic acid arm and only increased 1.57% in the placebo arm (p = 0.0005). Treatment was well tolerated with minimal impact on renal function. CONCLUSIONS: Zoledronic acid improved bone mineral density in patients with M0 prostate cancer on androgen deprivation therapy for 1 year or less, or greater than 1 year. This finding indicates that bisphosphonate therapy remains effective when initiated later in the course of androgen deprivation therapy and is efficacious in Veterans Affairs patients with multiple risk factors for osteoporosis.

Surgical resection of renal cell carcinoma after targeted therapy.

PURPOSE: The development of targeted agents for renal cell carcinoma has renewed interest in consolidative surgery due to the robust clinical responses seen with these agents. The integration of targeted therapy and surgery requires careful consideration due to the potential for increased perioperative morbidity. MATERIALS AND METHODS: We retrospectively identified patients with renal cell carcinoma treated with sunitinib, sorafenib or bevacizumab plus interleukin-2 before tumor resection. RESULTS: Between June 2005 and August 2008, 19 patients were treated with targeted therapy and subsequently underwent resection. Surgical extirpation involved an open and a laparoscopic approach in 18 and 3 cases, respectively, for locally advanced (8), locally recurrent (6) and metastatic disease (3). Two patients with extensive bilateral renal cell carcinoma were also treated to downsize the tumors to enable partial nephrectomy. Perioperative complications were noted in 16% of patients. One patient had a significant intraoperative hemorrhage and disseminated intravascular coagulopathy from a concomitant liver resection. An anastomotic bowel leak and abscess were noted postoperatively in another patient who underwent en bloc resection of a retroperitoneal recurrence and adjacent colon. Two patients (11%) had minor wound complications, including a wound seroma and a ventral hernia. Pathological analysis of 20 specimens revealed clear cell, chromophobe and unclassified renal cell carcinoma in 80%, 5% and 10% of cases, respectively. One patient (5%) had a pathological complete response. CONCLUSIONS: Surgical resection of renal cell carcinoma after targeted therapy is feasible with low morbidity in most patients. However, significant complications can occur, raising concern for possible compromise of tissue and/or vascular integrity associated with surgery in this setting.

Salvage of local recurrence after primary thermal ablation for small renal masses.

The management of renal tumors has evolved rapidly over the last two decades, with the ascendance of nephron-sparing surgery (NSS), largely spurred by the increased incidental detection of small renal masses (SRMs) and evidence that preservation of renal parenchyma reduces the risk of chronic kidney disease. The field of NSS itself has advanced beyond the standard of open partial nephrectomy, with the application of minimally invasive techniques, such as laparoscopy and thermal ablation. Energy-based ablative therapies, which include cryoablation and radiofrequency ablation, are associated with reduced morbidity and represent a nascent but promising alternative to surgical extirpation in the treatment of SRMs. However, thermal ablation is associated with a higher rate of local tumor recurrence when compared with surgical excision, indicating that salvage therapy will be a necessity for some patients. With recent studies indicating that surgical excision of previously ablated kidneys can be complicated by significant fibrosis, clinicians who advocate thermal ablation must be cognizant of the sequelae of this treatment modality and versed on the potential difficulties associated with salvage surgery. We provide, herein, an assessment of the efficacy and limitations of primary thermal ablation and strategies for salvage treatment of local recurrence in this growing patient population.