Study protocol for The GOAL Trial: comprehensive geriatric assessment for frail older people with chronic kidney disease to increase attainment of patient-identified goals-a cluster randomised controlled trial.

BACKGROUND: An increasing number of older people are living with chronic kidney disease (CKD). Many have complex healthcare needs and are at risk of deteriorating health and functional status, which can adversely affect their quality of life. Comprehensive geriatric assessment (CGA) is an effective intervention to improve survival and independence of older people, but its clinical utility and cost-effectiveness in frail older people living with CKD is unknown. METHODS: The GOAL Trial is a pragmatic, multi-centre, open-label, superiority, cluster randomised controlled trial developed by consumers, clinicians, and researchers. It has a two-arm design, CGA compared with standard care, with 1:1 allocation of a total of 16 clusters. Within each cluster, study participants ≥ 65 years of age (or ≥ 55 years if Aboriginal or Torres Strait Islander (First Nations Australians)) with CKD stage 3-5/5D who are frail, measured by a Frailty Index (FI) of > 0.25, are recruited. Participants in intervention clusters receive a CGA by a geriatrician to identify medical, social, and functional needs, optimise medication prescribing, and arrange multidisciplinary referral if required. Those in standard care clusters receive usual care. The primary outcome is attainment of self-identified goals assessed by standardised Goal Attainment Scaling (GAS) at 3 months. Secondary outcomes include GAS at 6 and 12 months, quality of life (EQ-5D-5L), frailty (Frailty Index - Short Form), transfer to residential aged care facilities, cost-effectiveness, and safety (cause-specific hospitalisations, mortality). A process evaluation will be conducted in parallel with the trial including whether the intervention was delivered as intended, any issue or local barriers to intervention delivery, and perceptions of the intervention by participants. The trial has 90% power to detect a clinically meaningful mean difference in GAS of 10 units. DISCUSSION: This trial addresses patient-prioritised outcomes. It will be conducted, disseminated and implemented by clinicians and researchers in partnership with consumers. If CGA is found to have clinical and cost-effectiveness for frail older people with CKD, the intervention framework could be embedded into routine clinical practice. The implementation of the trial's findings will be supported by presentations at conferences and forums with clinicians and consumers at specifically convened workshops, to enable rapid adoption into practice and policy for both nephrology and geriatric disciplines. It has potential to materially advance patient-centred care and improve clinical and patient-reported outcomes (including quality of life) for frail older people living with CKD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04538157. Registered on 3 September 2020.

Self-efficacy to overcome exercise barriers in individuals with cancer-related lymphedema.

Although cancer survivors are recommended to exercise, they may lack confidence (self-efficacy) to be active. This research aimed to measure exercise barriers and related selfefficacy in individuals with cancer-related lymphedema as well as examine relationships between self-efficacy and participant characteristics. A cross-sectional survey was undertaken in individuals with cancer-related lymphedema using a validated 14-item Likert scale assessing self-efficacy to overcome general and lymphedema-specific exercise barriers (0%=not at all confident, 100%=extremely confident). Demographic, medical and lymphedema data were also collected. Of 109 participants (52% response), 79% (n=86) had breast cancer-related lymphedema. Participants were found to be moderately confident to exercise when facing general (48% [95% CI: 44, 52]) and lymphedema- specific exercise barriers (51% [95% CI: 47, 55]). Participants who were female, sedentary (p<0.05), had lymphedema for ≥2 years, and reported greater symptom burden (p<0.05) recorded lower general exercise barriers selfefficacy. Lower lymphedema-specific exercise barriers self-efficacy was reported by individuals who were sedentary, had cancers other than breast, and higher symptom burden. These findings suggest general and lymphedema- specific barriers challenge exercise confidence in those with cancer-related lymphedema, and strategies tailored to improve confidence in overcoming exercise barriers are warranted. Supporting individuals to be sufficiently active during and following cancer treatment should consider behavior change strategies tailored to the unique needs faced by individuals with lymphedema.

High variability in anatomic patterns of cutaneous photodamage: a population-based study.

BACKGROUND: Skin cancer is strongly associated with photodamaged skin, but body sites are often referred to as 'exposed' or 'unexposed' to sun without recognizing extent of site-specific variation. OBJECTIVES: To assess whole-body patterns of photodamage in an Australian population. METHODS: A random sample of adult residents of Queensland underwent imaging across 10 body sites. Photodamage was graded from images using an ordinal photonumeric scale. We used cluster analysis to identify whole-body photodamage patterns and prevalence proportion ratios (PPRs) to assess associated factors. RESULTS: Of 190 adults (median age 52; 58% males), 58% showed severe or moderate-to-severe photodamage on most body sites. A higher proportion of woman had severe photodamage on the arms (upper: P = 0.002, lower: P = 0.034). A higher proportion of men had moderate or severe photodamage on the lower back (P = 0.004). We identified four photodamage patterns: 'severe general' (n = 24, 13%), 'moderate-severe general' (n = 86, 45%), 'moderate-severe v-neck' (n = 40, 21%) and 'mild-moderate upper body' (n = 12, 6%). All participants with 'severe-general' photodamage were >50 years and more likely to have past skin cancer (PPR: 2.54, 95% CI: 1.44-4.49) than those with 'moderate-severe v-neck' photodamage. Those with 'moderate-severe general' photodamage showed similar associations and were more likely female (PPR: 1.33, 95% CI: 1.04-1.69). Past or current smoking was associated with having higher levels of photodamage, with no smokers in those with 'mild-moderate upper body' photodamage. CONCLUSIONS: Moderate-to-severe photodamage across much of the body is common in Queensland adults and associated with age, sex, past skin cancer and smoking. Assuming a universal pattern of site-specific sun exposure could lead to spurious correlations, while accurate and objective assessment of site-specific photodamage can add to understanding of the development of sun-associated skin cancers, in particular site-specific skin carcinogenesis. Additionally, degree of site-specific photodamage has the potential to assist skin cancer screening.

[Implementation of emergency classifications-Where do we stand? : Results of a nationwide survey]. / Der Umgang mit Notfallklassifikationen ­ Wo stehen wir? : Ergebnisse einer deutschlandweiten Umfrage.

BACKGROUND: This study aimed to determine the current state of implementation of the recommendations for the classification of emergency surgery published in 2016 by the German societies of anesthesiology (BDA/DGAI), surgery (BDC/DGCH) and operating room management (VOPM). METHODS: Based on these societies' recommendations, various organizational issues were explored using an online questionnaire that was limited to German operating room (OR) managers and coordinators for hospitals that had surgical programs and at least 200 hospital beds. RESULTS: A total of 550 hospitals were contacted and 274 participated in the survey (49.8%). Of these 70.7% reported that they had implemented the recommendations, and 15.2% were aware of the recommendations but did not consistently apply them. Of the participating OR managers and coordinators that had either implemented or were aware of the recommendations, 78.2% agreed that the standardized definition of medical emergencies led to improvements in emergency treatment but 33.6% stated that the defined response intervals for emergency categories induced a certain degree of subjectivity in categorizing emergencies. Additional in-house guidelines specifically for the most frequent surgeries were or would be welcomed by 80.1% of the respondents and 39.1% of the surveyed hospitals had already implemented such guidelines. Of the OR managers and coordinators, 62.9% were informed about their emergency volumes and 47.3% stated that they regularly assessed them. There was no dedicated capacity for emergency care in 65.2% of hospitals. Of the respondents 3.9% stated that a separate emergency OR was reserved with a freely available team, which, during core operating hours, could be used for interdisciplinary emergency care and 26.2% of hospitals considered the capacity required for emergency procedures when planning the OR program or determining OR capacities. CONCLUSION: The recommendations for classifying emergency operations are an essential and generally accepted control mechanism in OR coordination. They simplify interdisciplinary coordination and communication when dynamically incorporating emergency procedures into an OR program. Most OR managers and coordinators view the recommendations as improving the speed of action in emergency care. To support the adoption of emergency classifications within an organization it may be advisable to incorporate them into the OR statutes and integrate them within the hospital information systems. The majority of participants supported additional specifications based on medical indicators for classifying the most frequent emergency operations. Being cognizant of key metrics concerning in-house emergency volume represents a crucial basis for interdisciplinary OR management and emergency care integration. Contrary to common perception, blocking fixed OR capacities remains the exception. When establishing a concept to provide emergency capacity, it is advisable to align developments with demand calculations based on in-house figures and to emphasize interdisciplinary participation and consensus.

[Process management in surgery]. / Prozessmanagement in der Chirurgie.

Process management is defined as the concept of identifying processes in a company or healthcare organization, analyzing them and improving productivity and efficiency. In hospitals, process management focuses on patient safety, an increase in economic resources and employee satisfaction. The integration of process management into clinical pathways helps to accelerate workflows and to improve the quality of patient service. The different types of process management encompass the radical concept of process renewal (revolutionary renewal) as well as the concept of evolutionary optimization. Process management in surgery is applied to preoperative, perioperative and postoperative procedures. The development and implementation of evidence-based treatment pathways can help to standardize and structure treatment processes in a surgical department. In this context, the operating room (OR) plays a particularly central role as the most important part of the healthcare provision of perioperative services. Process management is indispensable for the utilization of an optimal OR capacity taking a maximum patient safety and the desired optimal satisfaction of employees into account. The benefits of process management in the OR area are illustrated in an exemplary case study, demonstrating how innovative process management results in an increase of the operation capacity with a simultaneous reduction in costs.

Clinical utility of skin cancer and melanoma risk scores for population screening: TRoPICS study.

BACKGROUND: Screening for skin cancer can be cost-effective if focused on high-risk groups. Risk prediction tools have been developed for keratinocyte cancers and melanoma to optimize advice and management. However, few have been validated in a clinical setting over the past few years. OBJECTIVES: To assess the clinical utility of risk assessment tools to identify individuals with prevalent skin cancers in a volunteer-based screening clinic. METHODS: Participants were adults presenting for a skin check at a volunteer-based skin cancer screening facility. We used previously published tools, based on questionnaire responses, to predict melanoma and keratinocyte cancers [KCs; basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] and classified each participant into one of five risk categories. Participants subsequently underwent a full skin examination by a dermatologist. All suspicious lesions were biopsied, and all cancers were histopathologically confirmed. RESULTS: Of 789 people who presented to the clinic, 507 (64%) consented to the study. Twenty-two BCCs, 19 SCCs and eight melanomas were diagnosed. The proportion of keratinocyte cancers diagnosed increased according to risk category from <1% in the lowest to 24% in the highest risk category (P < 0.001). Subtype analysis revealed similar proportionate increases in BCC or SCC prevalence according to risk category. However, a similar proportion of melanoma cases were detected in the low-risk and high-risk groups. CONCLUSION: The risk prediction model for keratinocyte cancers can reliably identify individuals with a significant skin cancer burden prior to a skin examination in the community setting. The prediction tool for melanoma needs to be tested in a larger sample exposed to a wider range of environmental risk factors.

Challenges and controversies in the conservative management of uterine and ovarian cancer.

Uterine cancer is the fifth most common cancer in women worldwide with an estimated 320,000 annual diagnoses. Its most common form, endometrioid adenocarcinoma of the endometrium (endometrial adenocarcinoma [EAC]), is thought to develop through excessive proliferation of endometrial glands, and then increasing steadily in incidence. The current standard treatment for EAC is hysterectomy, which is often curative. However, it may be unacceptably expensive for women with severe medical comorbidities, those who are at risk of intra- and postoperative adverse events and those who desire fertility. Ovarian cancer is the most malignant of all gynaecological cancers, but patients with disease limited to one ovary and patients with non-epithelial tumours may expect a good prognosis. A selected group of young patients who desire fertility may be well treated with conservative surgery. This chapter reviews patient selection, diagnosis, pre-treatment evaluation, treatment options, surveillance and risk of relapse.

Obesity in total laparoscopic hysterectomy for early stage endometrial cancer: health gain and inpatient resource use.

OBJECTIVE: To explore relationships between BMI (morbid/severe obesity; BMI ≥ 35 kg/m2 vs. non morbid/severe obesity; BMI < 35 kg/m2), postoperative health gain and hospital resource use for women who receive a Total Laparoscopic Hysterectomy (TLH) for early stage endometrial cancer. DESIGN: Secondary analysis of RCT data (LACE Study; Total Abdominal Hysterectomy vs. TLH). SETTING: 20 tertiary gynaecological cancer centres in Australia, New Zealand and Hong Kong. POPULATION: About 404 women who received TLH to treat early stage endometrial cancer. METHODS: For women with BMI < 35 vs. BMI ≥ 35 kg/m2, we compared (i) postoperative health gain, using utility scores derived from responses to the EQ-5D-3L health-related quality of life instrument, and (ii) inpatient hospital resource use, using adverse events, surgery duration and postoperative length of stay as indicators, to 6 months post-surgery. MAIN OUTCOME MEASURES: Health gain, resource use. RESULTS: Mean postoperative health gain was 0.07 units, and did not vary by BMI. Women with a BMI ≥ 35 had an increased rate of severe postoperative AEs (BMI ≥ 35 RR = 1.95, P = 0.02), and the surgery took on average 9.6 min longer (BMI < 35 kg/m2 122.5 min 95% CI 117.4-127.8; BMI ≥ 35 kg/m2 132.1 min 95% CI 126.3-138.2; P = 0.02). CONCLUSION: While postoperative health gain for women with BMI ≥ 35 was similar to that of women with lower BMI, the gain was achieved at the expense of greater resource use. Further work could definitively quantify the excess cost of TLH for obese patients with endometrial cancer, and investigate the potential for non-surgical treatment options, at least for those women at high risk of postoperative AEs.

Psychological distress among Indigenous Australian cancer survivors.

PURPOSE: The purpose of this study is to identify the level of and factors associated with distress in 155 Indigenous Australian cancer survivors approximately 6 months post-diagnosis. METHODS: The distress thermometer (DT) was used to assess clinically significant distress (defined as having a DT score ≥ 4). Logistic regression was used to identify sociodemographic and clinical factors associated with clinically significant distress. RESULTS: The mean distress score was 2.7 (SD 2.9), with about one in three Indigenous cancer survivors reporting clinically significant distress (35%; n = 54). After adjusting for age and sex, clinically significant distress was more likely among those who were separated/divorced/widowed than those who were married (odds ratio (OR) = 2.99, 95% confidence intervals (95% CI) 1.21-7.35, p = 0.017) and less likely among those residing in remote areas than those in major cities (OR = 0.23, 95% CI 0.08-0.71, p = 0.001) and in those receiving non-surgical treatment only compared with surgery only (OR = 0.24, 95% CI 0.08-0.68, p = 0.008). CONCLUSIONS: Despite increased screening for distress in cancer care, this is, to our knowledge, the first published assessment of distress among Indigenous Australian cancer survivors. The characteristics of Indigenous cancer survivors associated with greater likelihood of clinically significant distress indicate at-risk subgroups who would benefit from screening and early intervention. Further research is required to identify the specific aetiologies of distress. Our findings indicate a need to identify psychological distress and for survivorship care to include culturally sensitive and tailored psychological support for Indigenous cancer survivors.

Micromorphological differences of the implant-abutment junction and in vitro load testing for three different titanium abutments on Straumann tissue level implants.

BACKGROUND: The aim of this study was to investigate the micromorphological differences among three commercially available titanium abutments on Straumann implants. Furthermore, the possible impact of functional loading on the micromorphology and potential complications was investigated with the use of in vitro testing. MATERIAL AND METHODS: Three groups of Titanium abutments (A: Straumann Variobase n = 5, B: EBI best Duo n = 5, and C: Implant Direct n = 5) were torqued on Straumann RN implants, as according to each of the manufacturer's instructions. The implant-abutment units were scanned with Micro-CT. Three units of each group were directly sliced in the microtome and photographed under different magnifications (10×-500×) through a Scanning Electron Microscope. Six units (two from each group) were restored with cement-retained crowns, subjected to 2000,000 load cycles with loads between 30 and 300 N at 2 Hz, examined through Micro-CT and finally sliced and photographed as described above. The micromorphology of each unit was studied, and the total length of tight contact (<3 µm) was calculated between the implant, abutment and screw contact areas. RESULTS: Major morphological differences were identified between the three units, as well as differences in the extent of tight contact in all areas examined. Despite the morphological differences, the 2M cycles of loading via in vitro test did not result in any noticeable complications although some changes in the micromorphology were observed. CONCLUSION: The examined implant-abutment units presented with major morphological differences. Two million cycles of in vitro loading did not appear to affect the stability of the units despite the micromorphological changes. These results need to be interpreted however under the limitations of the small sample size and the specific set-up of the in vitro testing.

Determinants of survival and attempted resection in patients with non-metastatic pancreatic cancer: An Australian population-based study.

BACKGROUND: There are indications that pancreatic cancer survival may differ according to sociodemographic factors, such as residential location. This may be due to differential access to curative resection. Understanding factors associated with the decision to offer a resection might enable strategies to increase the proportion of patients undergoing potentially curative surgery. METHODS: Data were extracted from medical records and cancer registries for patients diagnosed with pancreatic cancer between July 2009 and June 2011, living in one of two Australian states. Among patients clinically staged with non-metastatic disease we examined factors associated with survival using Cox proportional hazards models. To investigate survival differences we examined determinants of: 1) attempted surgical resection overall; 2) whether patients with locally advanced disease were classified as having resectable disease; and 3) attempted resection among those considered resectable. RESULTS: Data were collected for 786 eligible patients. Disease was considered locally advanced for 561 (71%) patients, 510 (65%) were classified as having potentially resectable disease and 365 (72%) of these had an attempted resection. Along with age, comorbidities and tumour stage, increasing remoteness of residence was associated with poorer survival. Remoteness of residence and review by a hepatobiliary surgeon were factors influencing the decision to offer surgery. CONCLUSIONS: This study indicated disparity in survival dependent on patients' residential location and access to a specialist hepatobiliary surgeon. Accurate clinical staging is a critical element in assessing surgical resectability and it is therefore crucial that all patients have access to specialised clinical services.

Consumer acceptance of patient-performed mobile teledermoscopy for the early detection of melanoma.

BACKGROUND: Mobile teledermoscopy allows consumers to send images of skin lesions to a teledermatologist for remote diagnosis. Currently, technology acceptance of mobile teledermoscopy by people at high risk of melanoma is unknown. OBJECTIVES: We aimed to determine the acceptance of mobile teledermoscopy by consumers based on perceived usefulness, ease of use, compatibility, attitude/intention, subjective norms, facilitators and trust before use. Consumer satisfaction was explored after use. METHODS: Consumers aged 50-64 years at high risk of melanoma (fair skin or previous skin cancer) were recruited from a population-based cohort study and via media announcements in Brisbane, Australia in 2013. The participants completed a 27-item questionnaire preteledermoscopy modified from a technology acceptance model. The first 49 participants with a suitable smartphone then conducted mobile teledermoscopy in their homes for early detection of melanoma and were asked to rate their satisfaction. RESULTS: The preteledermoscopy questionnaire was completed by 228 participants. Most participants (87%) agreed that mobile teledermoscopy would improve their skin self-examination performance and 91% agreed that it would be in their best interest to use mobile teledermoscopy. However, nearly half of participants (45%) were unsure about whether they had complete trust in the telediagnosis. The participants who conducted mobile teledermoscopy (n = 49) reported that the dermatoscope was easy to use (94%) and motivated them to examine their skin more often (86%). However, 18% could not take photographs in hard-to-see areas and 35% required help to submit the photograph to the teledermatologist. CONCLUSIONS: Mobile teledermoscopy consumer acceptance appears to be favourable. This new technology warrants further assessment for its utility in the early detection of melanoma or follow-up.

Health-related quality of life among Indigenous Australians diagnosed with cancer.

PURPOSE: Health-related quality of life (HRQoL) and associated factors were assessed among 155 Indigenous Australian adult cancer patients 6 months post-diagnosis. METHODS: The Assessment of Quality of Life-4D Questionnaire was used to assess HRQoL. Differences in the median utility score among subgroups of interest were examined using nonparametric tests. Factors associated with excellent HRQoL were assessed through logistic regression. RESULTS: Participants' mean age was 52 years (range 20-78), and the majority were female (60 %), unemployed (72 %), and recruited from outpatients clinics (64 %). Breast cancer (27 %) was the most common diagnosis. The median HRQoL score was 0.62; 14 % of participants reported excellent HRQoL (>0.90). After adjusting for age, admission status, and treatment, excellent HRQoL was more likely among participants of Torres Strait Islander origin [adjusted odds ratio (AOR) 3.68; 95 % CI 1.23-11.01], those living in regional areas (AOR 5.59; 95 % CI 1.42-22.06), and those whose main language spoken at home was not English (AOR 3.60; 95 % CI 1.08-11.99) and less likely among those reporting less contact with Indigenous people (AOR 0.23; 95 % CI 0.68-0.81). CONCLUSION: Assessing HRQoL is important to identifying and improving the length and quality of cancer survivorship, especially in groups that have significantly poorer cancer outcomes, such as Indigenous Australians. Acknowledging the study's observational nature, we found HRQoL was lower than reported for other Australians, and we identified some socio-demographic factors that were associated with excellent HRQoL. Such assessments are an important component of identifying and evaluating appropriate interventions to improve the health and well-being of Indigenous cancer patients.

QLU-C10D: a health state classification system for a multi-attribute utility measure based on the EORTC QLQ-C30.

PURPOSE: To derive a health state classification system (HSCS) from the cancer-specific quality of life questionnaire, the EORTC QLQ-C30, as the basis for a multi-attribute utility instrument. METHODS: The conceptual model for the HSCS was based on the established domain structure of the QLQ-C30. Several criteria were considered to select a subset of dimensions and items for the HSCS. Expert opinion and patient input informed a priori selection of key dimensions. Psychometric criteria were assessed via secondary analysis of a pooled dataset comprising HRQOL and clinical data from 2616 patients from eight countries and a range of primary cancer sites, disease stages, and treatments. We used confirmatory factor analysis (CFA) to assess the conceptual model's robustness and generalisability. We assessed item floor effects (>75 % observations at lowest score), disordered item response thresholds, coverage of the latent variable and differential item function using Rasch analysis. We calculated effect sizes for known group comparisons based on disease stage and responsiveness to change. Seventy-nine cancer patients assessed the relative importance of items within dimensions. RESULTS: CFA supported the conceptual model and its generalisability across primary cancer sites. After considering all criteria, 12 items were selected representing 10 dimensions: physical functioning (mobility), role functioning, social functioning, emotional functioning, pain, fatigue, sleep, appetite, nausea, bowel problems. CONCLUSIONS: The HSCS created from QLQ-C30 items is known as the EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D). The next phase of the QLU-C10D's development involves valuation studies, currently planned or being conducted across the globe.