Incorporating development of a patient-reported outcome instrument in a clinical drug development program: examples from a heart failure program.

BackgroundPatient-reported outcome (PRO) measures can be used to support label claims if they adhere to US Food & Drug Administration guidance. The process of developing a new PRO measure is expensive and time-consuming. We report the results of qualitative studies to develop new PRO measures for use in clinical trials of omecamtiv mecarbil (a selective, small molecule activator of cardiac myosin) for patients with heart failure (HF), as well as the lessons learned from the development process.MethodsConcept elicitation focus groups and individual interviews were conducted with patients with HF to identify concepts for the instrument. Cognitive interviews with HF patients were used to confirm that no essential concepts were missing and to assess patient comprehension of the instrument and items.ResultsDuring concept elicitation, the most frequently reported HF symptoms were shortness of breath, tiredness, fluid retention, fatigue, dizziness/light-headedness, swelling, weight fluctuation, and trouble sleeping. Two measures were developed based on the concepts: the Heart Failure Symptom Diary (HF-SD) and the Heart Failure Impact Scale (HFIS). Findings from cognitive interviews suggested that the items in the HF-SD and HFIS were relevant and well understood by patients. Multiple iterations of concept elicitation and cognitive interviews were needed based on FDA request for a broader patient population in the qualitative study. Lessons learned from the omecamtiv mecarbil PRO/clinical development program are discussed, including challenges of qualitative studies, patient recruitment, expected and actual timelines, cost, and engagement with various stakeholders.ConclusionDevelopment of a new PRO measure to support a label claim requires significant investment and early planning, as demonstrated by the omecamtiv mecarbil program

Effects of cultivar and agrobotanical storage treatment on organolepetic quality of yam (Dioscorea rotundata)

There is current interest in the search and use of agrobotanicals in preference to conventional chemicals in agriculture as plant protectants hence the need to investigate the potential effects of some of the agrobotanicals on yam food after storage. This study was, therefore, conducted to assess the effects of yam cultivar and agrobotanical extracts on the organoleptic quality and acceptability of two yam based food forms: boiled yam and pounded yam. Tubers of four yam cultivars (Nwaopoko,Danacha, Ezakwukpolo and Pepa) were treated with aqueous leaf extracts of Neem (Azadiracta indica), Scent leaf (Occimum gratissimum), pod extracts of ‘Uda’ (Xylopia aethiopica), root extracts of Ginger (Zingibger officinale) and a synthetic phytohomorne (Gibberellic acid) and stored for six months. Thereafter, two food forms (boiled yam and pounded yam) were prepared from the stored yam tubers and a nine-member panel of judges enlisted to perform sensory quality assessment on them. The attributes scored with respect to boiled yam were colour, taste, texture, mealiness and general acceptability while pounded yam was assessed for its aroma, texture, colour and general acceptability. No significant differences were found among the sensory attributes due to the agrobotanical treatments rather, differences were due to yam cultivars. The results obtained and confirmed by the scatter plots and multiple linear regression showed that texture and taste contributed much to the general acceptability of boiled yam while aroma and consistency were the major qualities of pounded yam. Consistency of pounded yam was best with Nwaopoko and Danacha cultivars but significantly less so with other cultivars with or without agrobotanical treatment. The agrobotanical treatments did not affect the culinary quality of the stored yam tubers as no evidence of such treatment was noticed in the prepared yam foods. This result suggests that the constituent active ingredients imparted on the tubers during storage by the plant extracts were either water-soluble and heat labile or that their shelf lives were less than six months of the storage period and therefore had no effects on the quality attributes of food yams

Causal attribution of mental illness in south-eastern Nigeria

Background: Understanding of mental illness in sub-Saharan Africa has remained under-researched in spite of the high and increasing neuropsychiatric burden of disease in the region. Aims: This study investigated the causal beliefs that the Igbo people of south-eastern Nigeria hold about schizophrenia, with a view to establishing the extent to which the population makes psychosocial, biological and supernatural attributions. Method: Multi-stage sampling was used to select participants (N = 200) to which questionnaires were administered. Results: Mean comparison of the three causal models revealed a significant endorsement of supernatural causation. Logistic regressions revealed significant contributions of old age and female gender to supernatural attribution; old age, high education and Catholic religious denomination to psychosocial attributions; and high education to biological attributions. Conclusions: It is hoped that the findings would enlighten, augment literature and enhance mental health care service delivery

A Comparative Assessment of the Fatty Acid and Phospholipid Composition of Irvingia Gabonensis (African Wild Mango) and Citrullus Lanatus (Water Melon) Seed Oils

The fatty acid composition of Irvingia gabonensis (African wild mango) and Citrullus lanatus (water melon) seed oils were determined using gas chromatographic technique with flame ionization detector (GC-FID). The results indicated eight fatty acids in Citrullus lanatus and eleven in Irvingia gabonensis seed oils. Comparatively, fatty acids common to both seed oils are linoleic acid (61.07%, 22.98%), oleic acid (13.48%, 21.87%), palmitic acid (15.40%, 16.69%), palmitoleic acid (0.53%, 6.32%), linolenic acid   (0.52% , 17.55%) and erucic acid (0.54%,0.88%). Lauric acid, arachidic acid, myristic acid and behenic acid though found in Irvingia gabonensis were not traceable in citrullus lanatus while arachidonic acid was present in citrullus lanatus but not in irvingia gabonensis. Margaric acid and lignoceric acid were not found in both seed oils. Irvingia gabonensis seed oil presented potential for making hard soaps. The seed oils generally presented potential for industrial use. Phospholipid levels in Citrullus Lanatus and Irvingia gabonensis seed oils on the other hand was also determined using gas chromatographic technique with pulse flame photometric detector (GC-PFPD). The result showed six phospholipids in each seed oil namely phosphatidylcholine, phosphatidylinositol, phosphatidylethanolamine, phosphatidylserine, lysophosphatidylcholine and phosphatidic acid. The total phospholipid levels in Citrullus lanatus seed oil is higher (935.65 mg/100g) than that in Irvingia gabonensis (239.89 mg/100g) seed oils. Phosphatidylcholine was the most abundant in both seed oils while phosphatidylserine was the least concentrated. Citrullus lanatus seed oils present a higher potential for health benefits based on their phospholipid levels than Irvingia gabonensis. The study indicates that Irvingia gabonensis and citrullus lanatus would be useful in soap making industries and for improved health benefits respectively. Keywords: African wild mango, Citrullus lanatus, Chromatography, fatty acids, Irvingia gabonensis, industrial potential, Phospholipids, Phosphatidic acid, seed oil

Thermal responses of single zone offices on existing near-extreme summer weather data

There have been a number of attempts in the past to define “near extreme” weather for facilitating overheating analysis in free running buildings. The most recently efforts include CIBSE latest release of Design Summer Year (DSY) weather using multiple complete weather years and a newly proposed composite DSY. This research aims to assess how various single zone offices respond to these new definitions of near extreme weathers. Parametric studies were carried out on single zone offices through which four sampling sets of models were employed to examine the thermal responses of dry bulb temperature, global solar radiation & wind speed collectively. London weather data from 1976 to 1995 were used and the overheating assessments were made based on CIBSE Guide A & BS EN 15251. The research discovers that solar radiation and wind both influence the predicted indoor warmth with solar radiation has obvious stronger impacts than wind. No perfect correlation was found from observation and Spearman’s rank order analysis on the ranks between the weather warmth and the predicted indoor warmth. The ranks made using multiple weather parameters show better correlation than some of the dry bulb temperature only metrics. The research also discovers that the Test Reference Year weather behaves warmer than expected. It is also found that a single complete year can not represent the near-extreme consistently and there is no evidence a composite DSY is better statistically. These findings support the notion of using multiple complete warm weather years for overheating assessments

Evaluation of Toxicological Effects of Spondias Mombin in Adult Male Wistar Rats

Spondias mombin is relied on for various herbal remedies for numerous conditions. This study is to evaluate the acute toxic effect of mombin in adult male Wistar rats. Acute toxicity test was carried out with modified Lorke’s method. Twenty-five male rats weighing between 120-180g were used for the sub-chronic study. The rats were divided into five groups A- E (n=5). Group A served as control. Group B and C received respectively 250mgkg-1 and 500mgkg-1 body weight doses of aqueous leaf extract,  groups D and E received  250mgkg-1 and 500mgkg-1 body weight doses of ethanolic extract. Treatments lasted for twenty eight days. Acute toxicity test carried out showed that leaf extracts of Spondias mombin did not produce mortality in rats.  Significant (p<0.05) reduction in brain and kidney weights was observed in group E treated with 500mgkg-1 of ethanolic extract. Similarly, significant (p<0.05) reduction was observed in spleen weights in groups C and E that were treated with 500mgkg-1 of both extracts. The levels of LDL (p<0.001) and ALP (p<0.05) were significantly reduced.  Alterations in the histology of the liver and kidney of extracts treated groups were observed. Conclusion: This result suggests that although the use of the leaf extracts of Spondias mombin is relatively safe, hepatic and renal toxicity may occur with prolonged use. Keywords: Adverse effects, Mortality, Methods, Complication, Utilizatio

Assessment of Potential Human Health Risk of Heavy Metals in Waterleaf (Talinum triangulare) Sold in Major Markets in Calabar, Nigeria

Sequel to the high rate at which waterleaf (Talinum triangulare) is consumed in Southern Nigeria and the excellent phytoextraction and bioaccumulation potentials of the plant, an assessment of the safety status and potential human health risk of Lead (Pb), Calcium (Cd), Chromium (Cd) and Nickel (Ni) through consumption of waterleaf sold in major markets in Calabar, Nigeria was carried out between February and April, 2021. A total of 36 composite samples obtained from 180 waterleaf vendors was used for the study. Heavy metals concentrations were determined using Atomic Absorption Spectrophotometer (Shimadzu, Model AA-6800, Japan) after wet digestion. The concentration (Mg Kg-1) ranged from 0.26-0.59 for lead, 0.04-0.42 for cadmium, 0.35-1.02) and 1.35-4.32 for nickel.  The mean metals content of edible tissues (leaves and tender stem) of waterleaf were found to be above FAO/WHO permissible limits and the EU maximum Levels for the metals in leafy vegetable except for chromium. The Estimated Daily Intake of the metals were above their respective Recommended Daily Intake and Upper Tolerable Daily Intake except for nickel. The average Target Hazard Quotients were greater than 1.00 except for chromium. The Hazard Index for the respective markets were greater than unity. The study concludes that Talinum triangulare purchased from the markets under study is not safe for human consumption as it poses significant toxicological risk with respect to lead, cadmium, and nickel and chromium intoxication

Digitization methods of grinding pins for technological process planning

International Conference on Flexible Automation and Intelligent Manufacturing, FAIM (30th. 2021. Athens, Greece

SPARC 2017 retrospect & prospects : Salford postgraduate annual research conference book of abstracts

Welcome to the Book of Abstracts for the 2017 SPARC conference. This year we not only celebrate the work of our PGRs but also the 50th anniversary of Salford as a University, which makes this year’s conference extra special. Once again we have received a tremendous contribution from our postgraduate research community; with over 130 presenters, the conference truly showcases a vibrant PGR community at Salford. These abstracts provide a taster of the research strengths of their works, and provide delegates with a reference point for networking and initiating critical debate. With such wide-ranging topics being showcased, we encourage you to exploit this great opportunity to engage with researchers working in different subject areas to your own. To meet global challenges, high impact research inevitably requires interdisciplinary collaboration. This is recognised by all major research funders. Therefore engaging with the work of others and forging collaborations across subject areas is an essential skill for the next generation of researchers

Co-composting of faecal sludge with solid waste to improve FSM practice in Sakhipur municipality

Sakhipur municipality with 32,000 inhabitants mostly comprise of onsite septic tank and pit toilet of different types. When the pit or septic tank is full, the usual practice is to engage professional sweepers are employed to manually empty them and deposit the wastes in mostly the nearby water bodies. A co-compost plant was designed by the Sakhipur municipality and partners and it’s been in operation since 2016 to tackle faecal sludge generated from pit toilets and septic tanks, and solid waste from households exploring sanitation service chain. This study provides a description of an innovative co-composting system which improves current FSM practice in municipality regime. The generated lessons against tackling the operational challenges of sanitation service chain will provide good learnings for replicating similar practice in other municipalities