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\"This book provides an outline with methodological steps of how to use statistics to analyze your research data. The book begins with a general introduction, which discusses what you should be trying to achieve with your statistical analysis. This involves describing the subjects you investigated and their outcomes, determining whether there is statistically significant evidence of differences in outcomes between groups of subjects, quantitatively describing effect sizes, and also determining whether any changes are large enough to be of clinical significance. Next, the authors cover data types and choosing statistical tests. This includes identifying the factor and outcome, and also identifying the type of data used to record the outcome. Readers are then introduced to multiple testing, the Chi-square test, and independent samples and the two-sample t-test. The Man-Whitney test is discussed, as well as the One-way ANOVA. Readers are taught how to Carrying out the Kruskal-Wallis test and the McNemar's test. The Paired t-test is covered, as well as how to carry out the Wilcoxon paired samples test. Readers are shown how to carry out the repeated measures ANOVA and the Friedman test. This includes discussion of merits of change in median, change in proportions in categories, and changes in high/low categories. The book concludes with a discussion on correlation and regression methods, and a detailed analysis on Cronbach's alpha\"-- Provided by publisher.

In patients with platinum-sensitive recurrent serous ovarian cancer, maintenance monotherapy with the PARP inhibitor olaparib significantly improves progression-free survival versus placebo. We assessed the effect of maintenance olaparib on overall survival in patients with platinum-sensitive recurrent serous ovarian cancer, including those with BRCA1 and BRCA2 mutations (BRCAm). In this randomised, placebo-controlled, double-blind, phase 2 trial involving 82 sites across 16 countries, patients with platinum-sensitive recurrent serous ovarian cancer who had received two or more courses of platinum-based chemotherapy and had responded to their latest regimen were randomly assigned (1:1) using a computer-generated sequence to receive oral maintenance olaparib (as capsules; 400 mg twice a day) or a matching placebo by an interactive voice response system. Patients were stratified by ancestry, time to progression on penultimate platinum, and response to most recent platinum. Patients and investigators were masked to treatment assignment by the use of unique identifiers generated during randomisation. The primary endpoint of the trial was progression-free survival. In this updated analysis, we present data for overall survival, a secondary endpoint, from the third data analysis after more than 5 years’ follow-up (intention-to-treat population). We did the updated overall survival analysis, described in this Article at 77% data maturity, using a two-sided α of 0·95%. As the study was not powered to assess overall survival, this analysis should be regarded as descriptive and the p values are nominal. We analysed randomly assigned patients for overall survival and all patients who received at least one dose of treatment for safety. This trial is ongoing and is registered with ClinicalTrials.gov, number NCT00753545. Between Aug 28, 2008, and Feb 9, 2010, 265 patients were randomly assigned to olaparib (n=136) or placebo (n=129). 136 patients had deleterious BRCAm. The data cutoff for this analysis was Sept 30, 2015. An overall survival advantage was seen with maintenance olaparib versus placebo in all patients (hazard ratio [HR] 0·73 [95% CI 0·55–0·96]; nominal p=0·025, which did not meet the required threshold for statistical significance [p<0·0095]; median overall survival was 29·8 months [95% CI 26·9–35·7] for those treated with olaparib vs 27·8 months [24·9–33·7] for those treated with placebo), and in patients with BRCAm (HR 0·62 [95% CI 0·41–0·94] nominal p=0·025; 34·9 months [95% CI 29·2–54·6] vs 30·2 months [23·1–40·7]). The overall survival data in patients with BRCA wild-type were HR 0·83 (95% CI 0·55–1·24, nominal p=0·37; 24·5 months [19·8–35·0] for those treated with olaparib vs 26·6 months [23·1–32·5] for those treated with placebo). 11 (15%) of 74 patients with BRCAm received maintenance olaparib for 5 years or more. Overall, common grade 3 or worse adverse events in the olaparib and placebo groups were fatigue (11 [8%] of 136 patients vs four [3%] of 128) and anaemia (eight [6%] vs one [1%]). 30 (22%) of 136 patients in the olaparib group and 11 (9%) of 128 patients in the placebo group reported serious adverse events. In patients treated for 2 years or more, adverse events in the olaparib and placebo groups included low-grade nausea (24 [75%] of 32 patients vs two [40%] of five), fatigue (18 [56%] of 32 vs two [40%] of five), vomiting (12 [38%] of 32 vs zero), and anaemia (eight [25%] of 32 vs one [20%] of five); generally, events were initially reported during the first 2 years of treatment. Despite not reaching statistical significance, patients with BRCA-mutated platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy after platinum-based chemotherapy appeared to have longer overall survival, supporting the reported progression-free survival benefit. Clinically useful long-term exposure to olaparib was seen with no new safety signals. Taken together, these data support both the long-term clinical benefit and tolerability of maintenance olaparib in patients with BRCA-mutated platinum-sensitive recurrent serous ovarian cancer. AstraZeneca.

Background Surgical robotics has been shown to improve the accuracy of bone preparation and soft tissue balance in unicondylar knee arthroplasty (UKA). However, although extensive data have emerged with regard to a CT scan-based haptically constrained robotic arm, little is known about the accuracy of a newer alternative, an imageless robotic system. Questions/purposes We assessed the accuracy of a novel imageless semiautonomous freehand robotic sculpting system in performing bone resection and preparation in UKA using cadaveric specimens. Methods In this controlled study, we compared the planned and final implant placement in 25 cadaveric specimens undergoing UKA using the new tool. A quantitative analysis was performed to determine the translational, angular, and rotational differences between the planned and achieved positions of the implants. Results The femoral implant rotational mean error was 1.04° to 1.88° and mean translational error was 0.72 to 1.29 mm across the three planes. The tibial implant rotational mean error was 1.48° to 1.98° and the mean translational error was 0.79 to 1.27 mm across the three planes. Conclusions The image-free robotic sculpting tool achieved accurate implementation of the surgical plan with small errors in implant placement. The next step will be to determine whether accurate implant placement translates into a clinical and functional benefit for the patient.

This study investigated the feasibility of the uncontrolled manifold approach (UCM) to analyse gait data variability in relation to the control of the centre of mass (COM) in adults with and without neuropathology. The proposed method was applied to six able-bodied subjects to characterise mechanisms of normal postural control during stance phase. This approach was repeated on an early stroke patient, who attended the laboratory three times at three monthly intervals, to characterise the variability of COM movement during walking with and without an orthosis. Both able-bodied subjects and the stroke participant controlled COM movement during stance but utilized a different combination of lower limb joint kinematics to ensure that the COM trajectory was not compromised. Interestingly, the stroke subject, despite a higher variability in joint kinematics, was able to maintain a stable COM position throughout stance phase. The stabilisation of the COM decreased when the patient walked unaided without the prescribed orthosis but increased over the six months of study. The UCM analysis demonstrated how a stroke patient used a range of lower limb motion pattern to stabilise the COM trajectory. It is suggested that this analysis can be used to track changes in these movement patterns in response to rehabilitation. As such we propose that this approach could have clinical utility to evaluate and prescribe rehabilitation in stroke patients.

Validation testing is a necessary step for inertial measurement unit (IMU) motion analysis for research and clinical use. Optical tracking systems utilize marker models which must be precise in measurement and mitigate skin artifacts. Prosthesis wearers present challenges to optical tracking marker model choice. Seven participants were recruited and underwent simultaneous motion capture from two marker sets; Plug in Gait (PiG) and the Strathclyde Cluster Model (SCM). Variability of joint kinematics within and between subjects was evaluated. Variability was higher for PiG than SCM for all parameters. The within-subjects variability as reported by the average standard deviation (SD), was below 5.6° for all rotations of the hip on the prosthesis side for all participants for both methods, with an average of 2.1° for PiG and 2.5° for SCM. Statistically significant differences in joint parameters caused by a change in the protocol were evident in the sagittal plane (p < 0.05) on the amputated side. Trans-tibial gait analysis was best achieved by use of the SCM. The SCM protocol appeared to provide kinematic measurements with a smaller variability than that of the PiG. Validation studies for prosthesis wearer populations must reconsider the marker protocol for gold standard comparisons with IMUs.

Computational analysis of infant movement has significant potential to reveal markers of developmental health. We report two studies employing dynamic analyses of motor kinematics and motor behaviours, which characterise movement at two levels, in 9-month-old infants. We investigate the effect of preterm birth (< 33 weeks of gestation) and the effect of changing emotional and social-interactive contexts in the still-face paradigm. First, multiscale permutation entropy was employed to analyse acceleration kinematic timeseries data collected from Inertial Measurement Unit (IMU) sensors on infants’ torso, wrists, and ankles (N = 32: 10 term; 22 preterm). Second, Recurrence Quantification Analysis was used to characterise patterns of second-to-second behavioural changes, from observationally coded behavioural timeseries on infants’ emotional self-regulation (N = 111: 61 term; 50 preterm). We found frequency-specific effects of context on permutation entropy. Relative to infants born at term (> 37 weeks of gestation), infants born preterm showed greater permutation entropy in their left ankle and torso movements, but not in right ankle or wrist movements. We did not find effects of preterm birth or emotional context on micro-level behavioural dynamics. Our methodology and findings inform future work using multiscale entropy to study infant development. Dynamic analysis of behaviour is a relatively young field, and applications to emotional self-regulation requires further methodological development.

There exists consensus that the traditional means by which safety of chemicals is assessed—namely through reliance upon apical outcomes obtained following in vivo testing—is increasingly unfit for purpose. Whilst efforts in development of suitable alternatives continue, few have achieved levels of robustness required for regulatory acceptance. An array of “new approach methodologies” (NAM) for determining toxic effect, spanning in vitro and in silico spheres, have by now emerged. It has been suggested, intuitively, that combining data obtained from across these sources might serve to enhance overall confidence in derived judgment. This concept may be formalised in the “tiered assessment” approach, whereby evidence gathered through a sequential NAM testing strategy is exploited so to infer the properties of a compound of interest. Our intention has been to provide an illustration of how such a scheme might be developed and applied within a practical setting—adopting for this purpose the endpoint of rat acute oral lethality. Bayesian statistical inference is drawn upon to enable quantification of degree of confidence that a substance might ultimately belong to one of five LD50-associated toxicity categories. Informing this is evidence acquired both from existing in silico and in vitro resources, alongside a purposely-constructed random forest model and structural alert set. Results indicate that the combination of in silico methodologies provides moderately conservative estimations of hazard, conducive for application in safety assessment, and for which levels of certainty are defined. Accordingly, scope for potential extension of approach to further toxicological endpoints is demonstrated.

Background Polypharmacy is increasing and managing large number of medicines may create a burden for patients. Many patients have negative views of medicines and their use can adversely affect quality of life. No studies have specifically explored the impact of general long-term medicines use on quality of life. Objective To determine the issues which patients taking long-term medicines consider affect their day-to-day lives, including quality of life. Setting Four primary care general practices in North West England Methods Face-to-face interviews with adults living at home, prescribed four or more regular medicines for at least 1 year. Interviewees were identified from primary care medical records and purposively selected to ensure different types of medicines use. Interviews were recorded, transcribed and analysed thematically. Results Twenty-one interviews were conducted and analysed. Patients used an average of 7.8 medicines, 51 % were preventive, 40 % for symptom relief and 9 % treatment. Eight themes emerged: relationships with health professionals, practicalities, information, efficacy, side effects, attitudes, impact and control. Ability to discuss medicines with health professionals varied and many views were coloured by negative experiences, mainly with doctors. All interviewees had developed routines for using multiple medicines, some requiring considerable effort. Few felt able to exert control over medicines routines specified by health professionals. Over half sought additional information about medicines whereas others avoided this, trusting in doctors to guide their medicines use. Patients recognised their inability to assess efficacy for many medicines, notably those used for prophylaxis. All were concerned about possible side effects and some had poor experiences of discussing concerns with doctors. Medicines led to restrictions on social activities and personal life to the extent that, for some, life can revolve around medicines. Conclusion There is a multiplicity and complexity of issues surrounding medicines use, which impact on day-to-day lives for patients with long-term conditions. While most patients adapt to long-term medicines use, others did so at some cost to their quality of life.

Essential Statistics for the Pharmaceutical Sciences is targeted at all those involved in research in pharmacology, pharmacy or other areas of pharmaceutical science; everybody from undergraduate project students to experienced researchers should find the material they need. This book will guide all those who are not specialist statisticians in using sound statistical principles throughout the whole journey of a research project - designing the work, selecting appropriate statistical methodology and correctly interpreting the results.  It deliberately avoids detailed calculation methodology.  Its key features are friendliness and clarity.   All methods are illustrated with realistic examples from within pharmaceutical science. This edition now includes expanded coverage of some of the topics included in the first edition and adds some new topics relevant to pharmaceutical research. * a clear, accessible introduction to the key statistical techniques used within the pharmaceutical sciences * all examples set in relevant pharmaceutical contexts. * key points emphasised in summary boxes and warnings of potential abuses in 'pirate boxes'. * supplementary material - full data sets and detailed instructions for carrying out analyses using packages such as SPSS or Minitab – provided at: https://www.wiley.com/go/rowe/statspharmascience2e [https://www.wiley.com/go/rowe/statspharmascience2e] An invaluable introduction to statistics for any science student and an essential text for all those involved in pharmaceutical research at whatever level.

Rehabilitation improves poststroke recovery with greater effect for many when applied intensively within enriched environments. The failure of health care providers to achieve minimum recommendations for rehabilitation motivated the development of a technology-enriched rehabilitation gym (TERG) that enables individuals under supervision to perform high-intensity self-managed exercises safely in an enriched environment. This study aimed to assess the feasibility of the TERG approach and gather preliminary evidence of its effect for future research. This feasibility study recruited people well enough to exercise but living with motor impairment following a stroke at least 12 months previously. Following assessment, an 8-week exercise program using a TERG (eg, virtual reality treadmills, power-assisted equipment, balance trainers, and upper limb training systems) was structured in partnership with participants. The feasibility was assessed through recruitment, retention, and adherence rates along with participant interviews. Effect sizes were calculated from the mean change in standard outcome measures. In total, 70 individuals registered interest, the first 50 were invited for assessment, 39 attended, and 31 were eligible and consented. Following a pilot study (n=5), 26 individuals (mean age 60.4, SD 13.3 years; mean 39.0, SD 29.2 months post stroke; n=17 males; n=10 with aphasia) were recruited to a feasibility study, which 25 individuals completed. Participants attended an average of 18.7 (SD 6.2) sessions with an 82% attendance rate. Reasons for nonattendance related to personal life, illness, weather, care, and transport. In total, 19 adverse events were reported: muscle or joint pain, fatigue, dizziness, and viral illness, all resolved within a week. Participants found the TERG program to be a positive experience with the equipment highly usable albeit with some need for individual tailoring to accommodate body shape and impairment. The inclusion of performance feedback and gamification was well received. Mean improvements in outcome measures were recorded across all domains with low to medium effect sizes. This study assessed the feasibility of a holistic technology-based solution to the gap between stroke rehabilitation recommendations and provision. The results clearly demonstrate a rehabilitation program delivered through a TERG is feasible in terms of recruitment, retention, adherence, and user acceptability and may lead to considerable improvement in function, even in a chronic stroke population. RR2-doi.org/10.3389/fresc.2021.820929.