Protocol for a randomised phase 3 trial evaluating the role of Finasteride in active surveillance for men with low and intermediate-risk prostate cancer: the FINESSE study

Background Prostate cancer (PCa) is the most common male malignancy in the western world. Many men (40%) are diagnosed with localised low or intermediate-risk PCa, which is suitable for active surveillance (AS). AS affords careful monitoring to identify changes in otherwise non-life-threatening cancers. While AS reduces overtreatment (and quality of life impact), long-term compliance can be poor, with many men undergoing radical treatment after starting AS. Methods and analysis Finasteride in Active Surveillance for men with low and intermediate-risk prostate cancer (FINESSE) is a prospective, open-label, two-arm, phase 3 trial, in which men with low or intermediate PCa are randomised (1:1) to receive AS with or without finasteride (5 mg once a day for 2 years). Randomisation is stratified by age and PCa risk. AS includes regular prostate-specific antigen testing, MRI scans and the offer of repeat biopsy (at 3 years, or if imaging suggests progression). Additional MRI scans and/or biopsies will be performed for biochemical or clinical indications. We aim to recruit 550 men (aged 50 to 75 years) from up to eight sites. Active outpatient follow-up will be for 3–5 years (depending on date recruited), followed by passive registry-based follow-up for up to 10 years. Primary outcome is adherence to AS. Secondary outcomes include rates and type of disease progression, treatments received (for PCa and benign prostatic enlargement), overall and PCa-specific mortality, an understanding of patients/professionals views of this approach and health-related quality of life. An external panel of experts blinded to allocation will review all AS cessation and progression events. Trial pathologist’s and radiologist’s, blinded to allocation, will review representative cases. Analysis is Intention to Treat. Ethics and dissemination The study received Health Research Authority and South-Central Oxford Research Ethics Committee (14/12/2021: 21/SC/0349) and CTA/MHRA (29/12/2021: 21304/0274/001–0001) approvals. Results will be made available to providers and researchers via publicly accessible scientific journals. Trial registration number ISRCTN1686795

Living knowledge of the healing plants: Ethno-phytotherapy in the Chepang communities from the Mid-Hills of Nepal

Contribution of indigenous knowledge in developing more effective drugs with minimum or no side effects helped to realise importance of study of indigenous remedies and the conservation of biological resources. This study analysed indigenous knowledge regarding medicinal plants use among the Chepang communities from ward number 3 and 4 of Shaktikhor Village Development Committee located in the central mid hills of Nepal. Data were collected in a one-year period and included interviews with traditional healers and elders. Chepangs are rich in knowledge regarding use of different plants and were using a total 219 plant parts from 115 species including one mushroom (belonging 55 families) for medicinal uses. Out of these, 75 species had 118 different new medicinal uses and 18 of them were not reported in any previous documents from Nepal as medicinal plants. Spiritual belief, economy and limitation of alternative health facilities were cause of continuity of people's dependency on traditional healers. Change in socio-economic activities not only threatened traditional knowledge but also resource base of the area. Enforcement of local institution in management of forest resources and legitimating traditional knowledge and practices could help to preserve indigenous knowledge

234 Woodlands for Expanding the Grazing Opportunity for Small Ruminants in the Southeast: Challenges and Opportunities

Abstract Woodlands account for around 60 percent of the land cover in the Southeast and offer a great potential for expanding the grazing opportunity for small ruminants. However, such opportunities and challenges associated with woodland grazing have not been documented well. The objectives of this study were to 1) develop strategies for increasing understory-vegetation biomass and its utilization by small ruminants and 2) identify challenges associated with the use of small ruminants in woodland plots. The study was initiated in 2017 using six woodland plots (0.4-ha each) that consisted of southern pines, as the main timber species, and numerous non-pine species. Each plot was virtually divided into four sections, and each section was randomly allocated to one of the cutting treatments or control. Treatments included the cutting of non-pine species into one of the three heights from the ground surface: 0 m, 0.9 m, or 1.5 m, and the control section did not receive any cut. Samples of understory vegetation were collected during the production period of 2018 and 2019, dried, and weighed. Small ruminants were rotationally stocked in the plots and their behavior (feeding: grazing, browsing; non-feeding: loafing, lying, and debarking) and landscape-use pattern (time spent by animals in different treatments or control in performing various behaviors) monitored. The understory-vegetation biomass increased tremendously in treatments compared to the control (33%-160%), with maximum increment (100%-160%) occurring in the section that received 0-m cut. Animals spent much of their feeding time in sections that received 0-m and 0.9-m cut consuming much of the vegetation available within their reach (goats or goats-sheep mixed: 0–1.5 m; sheep: 0–1.1 m from the ground). They selected dry and less vegetated areas containing shelters and tree shade for resting, visited the least to the control, and did not impose any damage to timber trees.</jats:p

10 Behavior and Landscape-Use Pattern of Small Ruminants Co-grazed in Woodlands with different Vegetation Characteristics

Abstract Woodland is the major landcover in Alabama (69%) and other states of the Southeast (≈60%). The understory vegetation present in woodlands can be a great feed resource for small ruminants when woodland grazing is practiced well, for which the understanding of animals’ landscape-use pattern is important. The study objective was to determine the diurnal behavior and landscape-use pattern of Kiko wethers and Katahdin rams co-stocked in woodlands. Eight Kiko wethers (77±2.5 kg. LW) and five Katahdin rams (92±4.6 kg. LW) were co-stocked rotationally in three woodland plots (0.4-ha. each) during May–August 2019 in Atkins Agroforestry Research and Demonstration site, Tuskegee University, Tuskegee, Alabama. Each study plot contained four treatments, where the average canopy height were 0.82 m, 1.34 m, 1.67 m and 1.73 m. The diurnal behavior (grazing, browsing, loafing, lying) and landscape-use pattern of animals were monitored from dawn to dusk when they were in each study plot at each rotation. Diurnal period was categorized into morning (dawn–11:00 am), midday (11:00 am–3:00 pm), and post-midday (3:00 pm–dusk) for the analysis and diurnal behavior and distribution pattern of animals were analyzed in SAS 9.4, GLM procedure with MANOVA option. Animal species differed in their feeding behavior (P &amp;lt; 0.0001), with wethers mostly browsing and rams grazing. Significant interaction effects of animal species and diurnal period occurred on all behavior categories, except loafing and lying (P &amp;lt; 0.0001). Wethers spent less time grazing (84–88%), but more time browsing (90%) during morning and post-midday vs. rams. Animals were actively feeding when the weather was nice and cool, and resting when it was hot. Feeding behavior was dominant during the post-midday period (3 PM–dusk) and lying during midday (11 AM–3 PM). The specific behavior and landscape-use pattern observed in this study can be useful to design and utilize woodland resources more efficiently.</jats:p

Barriers in the access, diagnosis and treatment completion for tuberculosis patients in central and western Nepal: A qualitative study among patients, community members and health care workers

BACKGROUND:Nepal has achieved a significant reduction of TB incidence over the past decades. Nevertheless, TB patients continue to experience barriers in access, diagnosis and completion of the treatment. The main objective of this study was to explore the factors affecting the access to the health services, diagnosis and the treatment completion for TB patients in central and western Nepal. METHODS:Data were collected using in-depth interviews (IDI) with the TB patients (n = 4); Focus Group Discussions (FGDs) with TB suspected patients (n = 16); Semi Strucutred Interviews (SSIs) with health workers (n = 24) and traditional healers (n = 2); and FGDs with community members (n = 8). All data were audio recorded, transcribed and translated to English. All transcriptions underwent thematic analysis using qualitative data analysis software: Atlas.ti. RESULTS:Barriers to access to the health centre were the long distance, poor road conditions, and costs associated with travelling. In addition, lack of awareness of TB and its consequences, and the belief, prompted many respondents to visit traditional healers. Early diagnosis of TB was hindered by lack of trained health personnel to use the equipment, lack of equipment and irregular presence of health workers. Additional barriers that impeded the adherence and treatment completion were the need to visit health centre daily for DOTS treatment and associated constraints, complex treatment regimen, and the stigma. CONCLUSIONS:Barriers embedded in health services and care seekers' characteristics can be dealt by strengthening the peripheral health services. A continuous availability of (trained) human resources and equipment for diagnosis is critical. As well as increasing the awareness and collaborating with the traditional healers, health services utilization can be enhanced by compensating the costs associated with it, including the modification in current DOTS strategy by providing medicine for a longer term under the supervision of a family member, peer or a community volunteer