Comparison of performances of SIREN or MFSRS in stroke risk prediction in an African environment.

BACKGROUND: The Modified Framingham Stroke Risk Score (MFSRS) is a widely utilized stroke risk assessment algorithm usually applied in international comparison. The Stroke Investigative Research and Educational Network (SIREN) is the only known African-specific stroke risk assessment algorithm. AIMS AND OBJECTIVES: To compare stroke risk estimates from the SIREN and the MFSRS in an African community. METHODS: This was a population-based cross-sectional survey involving consecutively recruited 310 consenting adult residents (mean age = 37.21 ± 15.84 years) of a Nigerian community. Risk factors of stroke were assessed among the participants and were utilized in calculating stroke risk estimates on the MFSRS and the SIREN. The obtained data were analyzed using descriptive statistics and the Spearman-rank order correlation test at an alpha level of 0.05. RESULTS: The percentage stroke risk scores estimated by the SIREN and the MFSRS were 34.5% and 6.79% respectively. The most prevalent risk factors among the participants were hypertriglyceridemia (100.0%), raised waist-hip ratio (50.6%), hypercholesterolemia (45.5), physical inactivity (43.2%), psychological stress (41.3%), and hypertension (37.7%). Only two (hypertriglyceridemia and high blood pressure) out of the six factors considered in the MFSRS were rated among the first 10 most impactful risks by the SIREN. There was a weak correlation between the total scores on the MFSRS and the SIREN (rho = 0.39; p < 0.01) suggesting that the two ratings were discordant. CONCLUSION: There were disagreements between the risk estimates on the SIREN and MFSRS with SIREN having a higher estimate that corresponded with the literature; this may be suggesting a poorer estimation of stroke risks by the MFSRS in an African environment. There is a need for large African-based quality control studies to determine and address these lapses.

Social Support as a Correlate of Depression and Quality of Life Among Nigerian Older Adults: a Cross-Sectional Study.

Reduced social support has been associated with presence of depression and reduced quality of life among older adults. The relationships may be better understood by exploring the interactions of individual domains among the constructs. This cross-sectional survey involved a consecutive sample of 206 (116 females and 90 males) older adults living in a Southern Nigeria community. The Multidimensional Scale of Perceived Social Support, Geriatric Depression Scale, and World Health Organization Quality of Life-OLD Questionnaire, were used to measure social support, depression, and quality of life respectively. Data was analyzed using frequency counts, percentages, mean, standard deviation, multiple regression and Spearman rank-order correlation coefficient, at 0.05 alpha level. Prevalence rate of depression among participants was 45.5%. Social support was perceived to be low by 37.4% of participants with the lowest mean social support score coming from friends domain. Participants' quality of life was generally fairly good (> 60%) with the lowest scores coming from the intimacy domain. Significant correlations between social support domains and each of quality of life (p < 0.05) and depression were respectively positive and negative; but weakest for the friend and strongest for significant others domains. All quality of life domains were significantly correlated with social support except the death and dying domain. All the domains of social support (family and significant other) were significant predictors of depression except the friend domain. Significant others around individual older adults particularly those with depression ought to be educated on the importance of their roles. Stakeholders including healthcare providers may create and support programmes for improved social networking for the older adults in order to enhance their general wellbeing and quality of life.

First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial.

BACKGROUND: Cemiplimab provided significant survival benefit to patients with advanced non-small-cell lung cancer with PD-L1 tumour expression of at least 50% and no actionable biomarkers at 1-year follow-up. In this exploratory analysis, we provide outcomes after 35 months' follow-up and the effect of adding chemotherapy to cemiplimab at the time of disease progression. METHODS: EMPOWER-Lung 1 was a multicentre, open-label, randomised, phase 3 trial. We enrolled patients (aged ≥18 years) with histologically confirmed squamous or non-squamous advanced non-small-cell lung cancer with PD-L1 tumour expression of 50% or more. We randomly assigned (1:1) patients to intravenous cemiplimab 350 mg every 3 weeks for up to 108 weeks, or until disease progression, or investigator's choice of chemotherapy. Central randomisation scheme generated by an interactive web response system governed the randomisation process that was stratified by histology and geographical region. Primary endpoints were overall survival and progression free survival, as assessed by a blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumours version 1.1. Patients with disease progression on cemiplimab could continue cemiplimab with the addition of up to four cycles of chemotherapy. We assessed response in these patients by BICR against a new baseline, defined as the last scan before chemotherapy initiation. The primary endpoints were assessed in all randomly assigned participants (ie, intention-to-treat population) and in those with a PD-L1 expression of at least 50%. We assessed adverse events in all patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT03088540. FINDINGS: Between May 29, 2017, and March 4, 2020, we recruited 712 patients (607 [85%] were male and 105 [15%] were female). We randomly assigned 357 (50%) to cemiplimab and 355 (50%) to chemotherapy. 284 (50%) patients assigned to cemiplimab and 281 (50%) assigned to chemotherapy had verified PD-L1 expression of at least 50%. At 35 months' follow-up, among those with a verified PD-L1 expression of at least 50% median overall survival in the cemiplimab group was 26·1 months (95% CI 22·1-31·8; 149 [52%] of 284 died) versus 13·3 months (10·5-16·2; 188 [67%] of 281 died) in the chemotherapy group (hazard ratio [HR] 0·57, 95% CI 0·46-0·71; p<0·0001), median progression-free survival was 8·1 months (95% CI 6·2-8·8; 214 events occurred) in the cemiplimab group versus 5·3 months (4·3-6·1; 236 events occurred) in the chemotherapy group (HR 0·51, 95% CI 0·42-0·62; p<0·0001). Continued cemiplimab plus chemotherapy as second-line therapy (n=64) resulted in a median progression-free survival of 6·6 months (6·1-9·3) and overall survival of 15·1 months (11·3-18·7). The most common grade 3-4 treatment-emergent adverse events were anaemia (15 [4%] of 356 patients in the cemiplimab group vs 60 [17%] of 343 in the control group), neutropenia (three [1%] vs 35 [10%]), and pneumonia (18 [5%] vs 13 [4%]). Treatment-related deaths occurred in ten (3%) of 356 patients treated with cemiplimab (due to autoimmune myocarditis, cardiac failure, cardio-respiratory arrest, cardiopulmonary failure, septic shock, tumour hyperprogression, nephritis, respiratory failure, [n=1 each] and general disorders or unknown [n=2]) and in seven (2%) of 343 patients treated with chemotherapy (due to pneumonia and pulmonary embolism [n=2 each], and cardiac arrest, lung abscess, and myocardial infarction [n=1 each]). The safety profile of cemiplimab at 35 months, and of continued cemiplimab plus chemotherapy, was generally consistent with that previously observed for these treatments, with no new safety signals INTERPRETATION: At 35 months' follow-up, the survival benefit of cemiplimab for patients with advanced non-small-cell lung cancer was at least as pronounced as at 1 year, affirming its use as first-line monotherapy for this population. Adding chemotherapy to cemiplimab at progression might provide a new second-line treatment for patients with advanced non-small-cell lung cancer. FUNDING: Regeneron Pharmaceuticals and Sanofi.

Neighborhood safety, fall indices, physical activity level and social participation restrictions from a population of community-dwelling older adults in Nsukka, Enugu State, Nigeria.

BACKGROUND: Restriction in physical activity (PA) and social participation restriction (PR) can be heightened in the presence of fear of fall (FOF), fall experience, and perceived unsafe neighborhood, particularly among older adults. Despite the enormous benefits of social participation and physical activity, many older adults remain vulnerable to participation restriction and this probably accounts for a significant proportion of health challenges for older adults. OBJECTIVE: This study investigated the relationship between neighborhood safety (NS), fall indices, physical activity, and social participation restriction among older adults from selected communities in Nsukka, Enugu state, Nigeria. METHODS: This was a cross-sectional survey of 170 recruited via consecutive non-probability sampling techniques. Socio-demographic variables, co-morbidities, and fall prevalence were obtained using a self-administered questionnaire. The study instruments include the PA neighborhood environment scale - Nigeria (PANES-N), PA scale for elderly (PASE), Participation scale (PS), Modified fall efficacy scale (MFES), and Fall risk assessment tool (FRAT) and fall indices. STATISTICAL ANALYSIS: Descriptive statistics of mean and standard deviations, frequency counts, and percentages were used to analyze the socio-demographic variables, and Inferential statistics of Spearman rank order correlation were used to determine the relationship among the neighborhood safety, fall indices, physical activity level, and participation restrictions. RESULTS: PR has a negative relationship with NS (r = -0.19, p- 0.01), and fall efficacy (r = -0.52, p- 0.001). However, PR has a positive relationship with fall risk (r = 0.36, p = 0.001). CONCLUSION: Participation restriction is negatively correlated with neighborhood safety, fall efficacy, and PA. The PR has a positive relationship with fall risk (FR).

Need for aligning the definition and reporting of cytokine release syndrome (CRS) in immuno-oncology clinical trials.

As cancer immunotherapies continue to expand across all areas of oncology, it is imperative to establish a standardized approach for defining and capturing clinically important toxicities, such as cytokine release syndrome (CRS). In this paper, we provide considerations for categorizing the variety of adverse events that may accompany CRS and for recognizing that presentations of CRS may differ among various immunotherapies (e.g., monoclonal antibodies, CAR T cell therapies and T cell engagers, which can include bispecific antibodies and other constructs). The goals of this paper are to ensure accurate and consistent identification of CRS in patients receiving immunotherapies in clinical studies to aid in reporting; enable more precise evaluation of the therapeutic risk-benefit profile and cross-study analyses; support evidence-based monitoring and management of important toxicities related to cancer immunotherapies; and improve patient care and outcomes. These efforts will become more important as the number and variety of molecular targets for immunotherapies broaden and as therapies with novel mechanisms continue to be developed.

Cross-cultural adaptation and validation of the 15-item Geriatric Depression Scale (GDS-15) into Igbo language: a validation study.

BACKGROUND: Late-life experiences such as protracted and indisposing medical disorders can negatively impact older adults' psychological and mental health, making them vulnerable to depression. Majority of the assessment tools for depression were developed for use in western countries. There is therefore the need for availability of culture- and environment-specific tools for assessment of depression in low-and-middle-income countries. This study was designed to cross-culturally adapt and validate the Geriatric Depression Scale-15 (GDS-15) into Igbo language and culture. METHODS: The English version of the GDS-15 was translated into Igbo language; synthesized, back-translated, and underwent expert panel review, pretesting and cognitive debriefing interview, according to the American Academy of Orthopedic Surgeons' guidelines. The Igbo version of the GDS-15 was tested for concurrent and structural validities, and internal consistency among consecutively recruited 140 consenting older adults (62.9% females) in Enugu North Senatorial District at 0.05 level of significance. RESULTS: The English version of the GDS-15 was successfully cross-culturally adapted to Igbo with all the 15 items still retained on the Igbo version of the GDS-15. The Igbo version of the GDS-15 exhibited the same structure as the English version, and displayed a Cronbach's alpha value of 0.53 with no significant ceiling (0%) and floor (0%) effects. The correlation between the participants' total scores on the Igbo and the English versions of the GDS-15 (ρ = 0.86) was adequate. There was no significant difference between corresponding scores in the English and Igbo versions of the GDS-15 (p = 0.89). CONCLUSIONS: The Igbo version of the GDS-15 is a valid and culturally specific instrument, and can be used for assessing depression among Igbo older adults in Nigeria.

Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial.

BACKGROUND: Before February, 2021, there was no standard treatment regimen for locally advanced basal cell carcinoma after first-line hedgehog inhibitor (HHI) therapy. Cemiplimab, a PD-1 antibody, is approved for treatment of advanced cutaneous squamous cell carcinoma and has shown clinical activity as monotherapy in first-line non-small-cell lung cancer. Here, we present the primary analysis data of cemiplimab in patients with locally advanced basal cell carcinoma after HHI therapy. METHODS: We did an open-label, multicentre, single-arm, phase 2 trial across 38 outpatient clinics, primarily at academic medical centres, in Canada, Europe, and the USA. Eligible patients (aged ≥18 years and with an Eastern Cooperative Oncology Group performance status of 0 or 1) with a histologically confirmed diagnosis of metastatic basal cell carcinoma (group 1) or locally advanced basal cell carcinoma (group 2) who had progressed on or were intolerant to previous HHI therapy were enrolled. Patients were not candidates for further HHI therapy due to progression of disease on or intolerance to previous HHI therapy or having no better than stable disease after 9 months on HHI therapy. Patients received cemiplimab 350 mg intravenously every 3 weeks for up to 93 weeks or until progression or unacceptable toxicity. The primary endpoint was objective response by independent central review. Analyses were done as per the intention-to-treat principle. The safety analysis comprised all patients who received at least one dose of cemiplimab. The primary analysis is reported only for group 2; group 1 data have not reached maturity and will be reported when the timepoint, according to the statistical analysis plan, has been reached. This study is registered with ClinicalTrials.gov, NCT03132636, and is no longer recruiting new participants. FINDINGS: Between Nov 16, 2017, and Jan 7, 2019, 84 patients were enrolled and treated with cemiplimab. At data cutoff on Feb 17, 2020, median duration of follow-up was 15 months (IQR 8-18). An objective response per independent central review was observed in 26 (31%; 95% CI 21-42) of 84 patients, including two partial responses that emerged at tumour assessments before the data cutoff and were confirmed by tumour assessments done subsequent to the data cutoff. The best overall response was five (6%) patients with a complete response and 21 (25%) with a partial response. Grade 3-4 treatment-emergent adverse events occurred in 40 (48%) of 84 patients; the most common were hypertension (four [5%] of 84 patients) and colitis (four [5%]). Serious treatment-emergent adverse events occurred in 29 (35%) of 84 patients. There were no treatment-related deaths. INTERPRETATION: Cemiplimab exhibited clinically meaningful antitumour activity and an acceptable safety profile in patients with locally advanced basal cell carcinoma after HHI therapy. FUNDING: Regeneron Pharmaceuticals and Sanofi.

Physical activity level, fear of falling and quality of life: a comparison between community-dwelling and assisted-living older adults.

BACKGROUND: Physical activity (PA), fear of falling (FOF) and quality of life (QOL) are very important constructs in geriatrics. The interplay among these constructs may vary between community-dwelling and assisted-living older adults. However, studies comparing the wellbeing of community-dwelling older adults with those residing in the assisted-living facilities (ALFs) are rather rare especially from developing countries. This study was aimed at comparing PA, FOF and QOL between assisted-living and community-dwelling older adults and also determining the correlations amongst the constructs for each group. METHODS: This cross-sectional survey involved consecutively sampled 114 older adults (≥65 years, ambulant and well-oriented in time, place and person) residing in conveniently selected ALFs (11.3% males) and adjoining communities (54.1% males). PA, FOF and QOL were evaluated using the Physical Activity Scale for the Elderly, the Modified Fall Efficacy Scale and the Short-form Health Survey (SF-36) questionnaire respectively. Data was analysed using descriptive statistics, analysis of covariance and Spearman rank-order correlation test at 0.05 level of significance. RESULTS: Participants from the ALFs had significantly lower domain and overall PA (F=5.6-103.34; p< 0.05) and QOL (F=11.12-118.05; p< 0,05) scores than community-dwelling groups. FOF was significantly more prevalent in assisted-living group (p< 0.05). There were significant positive correlations (p< 0.05) between each pair of PA, FOF and QOL for both assisted-living and community-dwelling groups. CONCLUSIONS: Older adults in the ALFs had lower PA and QOL scores with higher prevalence of FOF than their community-dwelling counterparts. Significant relationships existed between PA, FOF and QOL for participants in either group. Present results may be suggesting that ageing in place ensures better health outcomes than institutionalised ageing. Whenever possible, older adults should therefore be encouraged to age in place rather than moving into ALFs.

Cross-Cultural Adaptation and Validation of Nigerian (Igbo) Version of the Physical Activity Scale for the Elderly.

OBJECTIVES: To cross-culturally adapt and validate the Physical Activity Scale for the Elderly (PASE) into Igbo culture. METHODS: The English version of the PASE (E-PASE) was translated into Igbo, harmonized, back-translated, subjected to expert panel review, and pretested. The final Igbo version of PASE (I-PASE), the E-PASE, and the International Physical Activity Questionnaire were then administered to consecutively recruited 109 consenting Igbo older adults. Data were analyzed using frequency, percentage, mean, standard deviation, Mann-Whitney U test, Spearman rank-order correlation, and Cronbach's alpha at .05 level of significance. RESULTS: All items on the E-PASE were retained on the I-PASE but some modifications were made. The I-PASE had poor internal consistency coefficient (α = .66), poor-to-excellent item, and total score known-group validity (ρ = .24-1.00) and moderate convergent validity (ρ = .50). CONCLUSION: The I-PASE is a valid, reliable, and culturally specific tool for assessing PA among Igbo older adults.

Community integration, self-esteem, and perceived stigma in a Nigerian sample with epilepsy.

OBJECTIVE: The objective of the study was to investigate the levels, interrelationships, and associated factors of community integration (CI), perceived stigma (PS), and self-esteem in people living with epilepsy (PWE) in Anambra and Enugu States of south-east Nigeria. METHODS: This was a cross-sectional survey involving 70 consenting adults living with epilepsy consecutively recruited from three purposively sampled specialized clinics in Anambra State. The Reintegration to Normal Living Index, the Epilepsy Stigma Scale, and the Rosenberg Self-Esteem Scale were used to estimate CI, PS, and self-esteem, respectively among the participants. Data were analyzed at 0.05 level of significance. RESULTS: The mean age of the participants (28.6% females) was 34.91 ±â€¯16.21 years. The participants had moderate PS score (43.54 ±â€¯14.20), poor self-esteem score (17.63 ±â€¯6.12), and mild-to-moderately restricted CI score (67.83 ±â€¯24.72). Participants' PS, CI, and self-esteem significantly correlated with one another (p < 0.05) with PS and self-esteem being significant predictors of CI. Participants' PS had a significant correlation with their age at onset of epilepsy, while their self-esteem and CI significantly correlated with their seizure episodes (p < 0.05). Participants' PS and CI were significantly different across different categories of their occupational and educational statuses. Perceived stigma also varied across participants' marital status with divorced participants having the worst score (p < 0.05). CONCLUSION: People living with epilepsy had moderate PS, poor self-esteem, and mild-to-moderate CI, which correlated significantly with one another. Results suggest the possibility of using CI as an outcome for assessing the effectiveness of stigma and self-esteem interventions during epilepsy rehabilitation.

Validation of Igbo version of the modified falls efficacy scale among community-dwelling older adults: a validation study.

BACKGROUND: Fear of falling (FOF) is a very pervasive problem among older adults. Consequently, many scales have been developed for its assessment. The Modified Falls Efficacy Scale (MFES) is one of the most popular FOF scales. The MFES was originally developed for use in developed countries, and thus may not be entirely suitable for use in developing countries due to cultural and environmental differences between the two country categories. This study was therefore designed to cross-culturally adapt and validate the MFES to Igbo culture and environment among community-dwelling older adults in Nnewi community using established guidelines. METHODS: The original English version of the MFES (E-MFES) was translated, synthesized, back-translated, subjected to expert panel review, and pretested before producing the final Igbo version of the MFES (I-MFES). The I-MFES and the Short Falls Efficacy Scale International were randomly administered to consecutively recruited 109 consenting older adult residents of Nnewi (43.1% males; mean age = 74.45 ± 8.78 years). Convergent and structural validities and internal consistency of the I-MFES were assessed at 0.05 level of significance. RESULTS: All the 14 items on the E-MFES were retained on the I-MFES. The I-MFES exhibited the same structure as the E-MFES. The correlation between the total scores on the I-MFES and the Short Falls Efficacy Scale International was excellent (rho = - 0.93) indicating evidence of convergent validity of the I-MFES. The Cronbach's alpha value of the I-MFES was 0.97 showing evidence of excellent internal consistency of the items on the I-MFES. CONCLUSION: This study provides evidence of some aspects of validity and reliability of the I-MFES.

Correction to: Effects of transcutaneous electrical nerve stimulation in the Management of PostInjection Sciatic Pain in a non-randomized controlled clinical trial in Nnewi, Nigeria.

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Informal caregivers' well-being and care recipients' quality of life and community reintegration - findings from a stroke survivor sample.

BACKGROUND: Stroke is highly debilitating and requires long-term care. Informal caregivers of stroke survivors play important roles in stroke rehabilitation. Caring for stroke survivors can negatively affect the caregivers' well-being and may adversely impact on their caregiving quality and subsequently on stroke survivors' well-being. There seems to be a dearth of research on the relationships between caregivers' and stroke survivors' well-being. AIMS AND OBJECTIVES: This study was designed to determine the relationships among informal caregivers' burden and quality of life (QOL) and stroke survivors' QOL and community reintegration. METHODS: This ethically certified cross-sectional survey involved 82 stroke survivors (mean age = 60.48 ± 11.13 years) and their 82 primary caregivers (mean age = 36.13 ± 13.69 years) consecutively recruited from seven conveniently sampled tertiary hospitals in Nigeria. Caregivers Strain Index, Igbo-culture adapted Maleka Stroke Community Reintegration Measure and Short-Form 36-item Health Survey questionnaires were used to assess the caregivers' burden, survivors' community reintegration and QOL (of survivors and caregivers), respectively. Data were analysed using descriptive statistics, Spearman rank, Mann-Whitney U and Kruskal-Wallis tests at alpha level of 0.05. RESULTS: The mean stroke survivors' community reintegration and QOL were 34.05 ± 21.54% and 34.93 ± 16 ± 49%, respectively. The mean caregivers' QOL and burden scores were 74.49 ± 12.61% and 9.13 ± 3.18, respectively. About 80.5% of the caregivers experienced significant burden. Stroke survivors' QOL and community reintegration, and caregivers' QOL and burden significantly correlated with one another (p < 0.05). Poststroke duration, survivor-caregiver cohabitation duration, survivors' community-dwelling duration and daily care-giving hours significantly correlated with each of stroke survivors' community reintegration and QOL, and caregivers' burden and QOL (p < 0.05). CONCLUSIONS: Stroke survivors' community reintegration and QOL were poor while caregivers' had moderate QOL and high prevalence of significant burden. Significant correlations exist between caregivers' well-being and stroke survivors' QOL and community reintegration. Interventions targeted at reducing caregivers' burden may help improve both caregivers and survivors' well-being.

Informal caregiving burden and perceived social support in an acute stroke care facility.

BACKGROUND: Providing informal caregiving in the acute in-patient and post-hospital discharge phases places enormous burden on the caregivers who often require some form of social support. However, it appears there are few published studies about informal caregiving in the acute in-patient phase of individuals with stroke particularly in poor-resource countries. This study was designed to evaluate the prevalence of caregiving burden and its association with patient and caregiver-related variables and also level of perceived social support in a sample of informal caregivers of stroke survivors at an acute stroke-care facility in Nigeria. METHODS: Ethical approval was sought and obtained. Fifty-six (21 males, 35 females) consecutively recruited informal caregivers of stroke survivors at the medical ward of a tertiary health facility in South-Southern Nigeria participated in this cross-sectional survey. Participants' level of care-giving strain/burden and perceived social support were assessed using the Caregiver Strain Index and the Multidimensional Scale of Perceived Social Support respectively. Caregivers' and stroke survivors' socio-demographics were also obtained. Data was analysed using frequency count and percentages, independent t-test, analysis of variance (ANOVA) and partial correlation at α =0.05. RESULTS: The prevalence of care-giving burden among caregivers is 96.7% with a high level of strain while 17.9% perceived social support as low. No significant association was found between caregiver burden and any of the caregiver- or survivor-related socio-demographics aside primary level education. Only the family domain of the Multidimensional Scale of Perceived Social Support was significantly correlated with burden (r = - 0.295). CONCLUSION: Informal care-giving burden was highly prevalent in this acute stroke caregiver sample and about one in every five of these caregivers rated social support low. This is a single center study. Healthcare managers and professionals in acute care facilities should device strategies to minimize caregiver burden and these may include family education and involvement.

Effects of transcutaneous electrical nerve stimulation in the Management of Post-Injection Sciatic Pain in a non-randomized controlled clinical trial in Nnewi, Nigeria.

BACKGROUND: Many studies on transcutaneous electrical nerve stimulation (TENS) had been undertaken to explore its pain relieving efficiency on several medicals/surgical conditions but none, specifically, had been carried out to determine the effect it has on post-injection sciatic pain (PISP) which comes about from wrong administration of intramuscular pain. This study aims to assess the effects of TENS in the management of PISP. METHODS: A total of 72 PISP subjects comprising 40 test subjects and 32 control subjects participated in a non-randomized controlled clinical trial in the current study. Participants were recruited from Department of Physiotherapy, Nnamdi Azikiwe University Teaching Hospital, Nnewi and Landmark Physiotherapy Services, Nnewi. The participants were however blinded to the intervention method they will receive before being allotted conveniently to test/experimental group (TG) or control group (CG). A written informed consent was obtained from participants before enrollments in the study. TENS and sham TENS (STENS) was applied to 40 test and 32 subjects respectively, 3 times a week, and 1 hour per session for the 10 weeks the study lasted. The Visual Analogue Scale was used to collect baseline data as well as those of 2nd, 4th, 6th, 8th and 10th weeks after TENS and STENS interventions. The data analysis was performed with the Descriptive statistic of Mean ± SD, mean comparison test, repeated analysis of variance and paired wise t-test. Statistical level of significance was set at P < 0.05. RESULT: Results of repeated measure ANOVA showed that the pain level among participants in the treatment group at the end (after 10 weeks) of the intervention was significantly lower than that of their counterparts in the control group (F = 16.26; p = 0.01); with the intervention accounting for the 19% of the variance. The effect size (partial eta squared) = 0.19. CONCLUSION: The outcome of this research has proved the effectiveness of TENS in the management of PISP and is being recommended in the management of PISP. TRIAL REGISTRATION: Pan Africa Clinical Trial Registry ( PACTR201805003408271 ). The study was registered retrospectively on the 29th May, 2018.

Fear of falling and quality of life of apparently-healthy elderly individuals from a Nigerian population.

Ageing is associated with increased morbidity, increased fear of falling (FOF) and reduced activity. These may consequently impair the quality of life (QOL) of the elderly. Studies from Africa investigating FOF and its relationship with QOL among elderly individuals are rare. This study investigated the prevalence of FOF and QOL of apparently-healthy elderly residents of two Local Government Areas (LGAs) from Anambra State, Nigeria and also determined the relationship between the two variables. Two hundred and sixty-one (131 males and 130 females) volunteering elderly individuals, from three randomly-selected communities from each of the LGAs, participated in this cross-sectional survey. The Modified Fall Efficacy Scale (MFES) and the Short-Form Health Survey 36-item (SF-36) questionnaire were used to evaluate FOF and QOL respectively. Data were analysed using frequency, percentage, mean and standard deviation, Chi-square, Independent t-test, Pearson correlation and multivariate regression analysis statistics. Alpha level was set at 0.05. FOF was markedly prevalent in the population at 23.4 % and the QOL score of 55.27 ± 17.28 was just modest. QOL was particularly low in the role limitations due to the physical and emotional problems domains but high in the mental health, social function and bodily pain domains. Significant relationship was found between FOF and all the QOL domains. FOF was present in nearly one of every four elderly individuals in the sample and was related to their QOL. FOF should be routinely investigated in community-dwelling elderly and strategies devised to combat it.

Relationship between hamstrings-quadriceps strength ratio and the performance of tasks in Berg's Balance Scale among stroke survivors in Abakaliki, Nigeria.

Aim: The study was designed to establish the relationship between hamstrings-quadriceps (H-Q) strength ratio and the performance of tasks in Berg's Balance Scale among stroke survivors. Method: Twenty-five stroke survivors participated in the study. The hamstrings and quadriceps muscle strengths of both the paretic and non-paretic sides were determined at 60° knee flexion with an electronic tensiometer. The participants undertook the tasks in Berg's Balance Scale. Results: The moment of correlation between the paretic H-Q strength ratio and the total score of the Berg's Balance Scale was 0.630, while the non-paretic was -0.144. Tasks such as standing unsupported (0.360), sitting unsupported (0.348) and standing with eyes closed (0.262) showed a weak correlation with the paretic H-Q strength ratio. Sitting to standing (0.469), standing to sitting (0.405), transfers (0.470), standing with feet together (0.565), retrieving an object from the floor (0.544), turning to look behind (0.400), turning 360° (0.589) and one leg stance (0.649) showed moderate correlation with the paretic H-Q strength ratio; while reaching forward (0.768), placing alternate foot on stool (0.710) and tandem standing (0.744) showed strong correlation with the paretic H-Q strength ratio. Conclusion: The study concluded that the H-Q strength ratios of the paretic limbs of stroke survivors showed significant relationships with the performance of tasks in Berg's Balance Scale. It is recommended that the H-Q strength ratio is considered as a clinical measurement tool in the balance rehabilitation of stroke survivors.

Post-Stroke Depression and Suicidal Ideations: Relationship with Gender and Marital Status: A Cross Sectional Study.

OBJECTIVES: To determine the prevalence and contributing factors of depression and suicidal ideations among stroke survivors in Nigeria. METHODS: This was a cross-sectional study comprising 75 consenting stroke survivors who were purposively recruited from 2 tertiary hospitals. Suicidal ideations and depression were measured using standard questionnaires. Obtained data was analyzed with appropriate statistical tools. RESULTS: 9.3% of the participants had depression while 4% reported suicidal ideations. Significant correlation existed between suicidal ideations and depression (ρ = .31, P = .01), and levels of depression and suicidal ideations (χ2 = 85.76; P < .01). Depression had a significant relationship with gender and marital status, while suicidal ideations had a significant relationship with marital status. Females were significantly more depressed than their male counterparts (U = 512.50, P = .04) and also had a higher score on suicidal ideations. The widowed/divorced recorded the highest scores on depression (χ2 = 8.77, P = .01) and suicidal ideations (χ2 = 6.62; P = .04). CONCLUSION: A worrisome prevalence of depression was reported among the study participants. The level of suicidal ideations was quite low. Depression and suicidal ideations were higher among females and those who lost their life partners (either by divorce or death).

High response rate with extended dosing of cemiplimab in advanced cutaneous squamous cell carcinoma.

BACKGROUND: Cemiplimab (Libtayo®), a human monoclonal immunoglobulin G4 antibody to the programmed cell death-1 receptor, is approved for the treatment of patients with advanced cutaneous squamous cell carcinoma (CSCC), who are not candidates for curative surgery or curative radiation, using an every-3-weeks (Q3W) dosing interval. Pharmacokinetic modeling indicated that Ctrough of extended intravenous dosing of 600 mg every 4 weeks (Q4W) would be comparable to the approved intravenous dosage of 350 mg Q3W. We examined the efficacy, pharmacokinetics, and safety of cemiplimab dosed Q4W. METHODS: In this open-label, phase II trial (ClinicalTrials.gov identifier NCT02760498), the cohort of patients ≥18 years old with advanced CSCC received cemiplimab 600 mg intravenously Q4W for up to 48 weeks. Tumor measurements were recorded every 8 weeks. The primary endpoint was objective response rate by independent central review. RESULTS: Sixty-three patients with advanced CSCC were treated with cemiplimab. The median duration of follow-up was 22.4 months (range: 1.0-39.8). An objective response was observed in 39 patients (62%; 95% CI: 48.8% to 73.9%), with 22% of patients (n=14) achieving complete response and 40% (n=25) achieving partial response. The most common treatment-emergent adverse events were diarrhea, pruritus, and fatigue. CONCLUSIONS: Extended dosing of cemiplimab 600 mg intravenously Q4W exhibited substantial antitumor activity, rapid and durable responses, and an acceptable safety profile in patients with advanced CSCC. These results confirm that cemiplimab is a highly active therapy for advanced CSCC. Additional data would help ascertain the benefit-risk profile for the 600 mg intravenous dosing regimen compared with the approved regimen.