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.

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.

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.

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).

Social Support, Social Participation, and Life Accomplishment of Older Adult Residents of Assisted Living Facilities and Their Adjoining Communities.

Objectives: To assess and compare levels of social support (SS), social participation (SP) and life accomplishment (LA) among older adults in some assisted-living facilities (ALFs) and their community-dwelling (CD) peers. Methods: One hundred twenty older adults (54 ALF, 66 CD) from a Nigerian population participated in this cross-sectional survey. The Multidimensional Scale for Perceived Social Support, the Participation Scale and the Life Habit Questionnaires were used to evaluate levels of SS, SP, and LA, respectively. Data was analyzed using descriptive statistics, Mann-Whitney U test and Spearman rank order correlation, at .05 alpha level. Results: Participation restriction (PR) was significantly more prevalent among the ALF group compared to the CD group (χ2 = 12.74; p = .01) but the two groups enjoyed comparable level of SS. LA was significantly better for the CD group in the overall score. LA had significant correlation with PR in both the ALFs (r = -.44; p < .05) and CD (r = -.62; p < .05) group. Conclusions: Older adults in ALFs received moderate SS, had LA, and a high PR, while CD older adults received a high SS and LA but had no PR. The findings implicate that social participation and enhancing community support for older adults may be important for a sustainable community.

Population-based stroke risk profile from a West-African community.

Objectives: To determine the stroke risk profile of dwellers of Nnewi community in Nigeria. Methods: This was a cross-sectional survey involving consecutively recruited community-dwelling adults without a previous history of stroke. The Modified Framingham Stroke Risk Score (MFSRS) was used to evaluate the stroke risk profile of the participants. Data was analysed using descriptive and inferential statistics at an alpha level of 0.05. Result: 310 individuals (mean age = 37.21 ± 15.84 years; 68.7% females) participated in this study. The mean MFSRS (6.79 ± 5.21) of the participants was minimal with 16% having a moderate-to-high risk. Dyslipidaemia (100.0%), meat (88.1%) and sugar (70.6%) consumption, hypertension (37.7%), physical inactivity (43.2%), and psychological stress (41.3%) were the most prevalent risk factors in the population. Participants' MFSRS significantly and positively correlated with their body mass index (BMI), waist circumference (WC), and waist-hip ratio (WHR) and significantly differed across their gender, educational, and occupational categories (p < 0.05). Conclusion: According to MFSRS, the risk of stroke among the sampled community was minimal and was significantly influenced by their BMI, WC, WHR, gender, education, and occupation. However, results revealed that stroke risk might be higher in the population than was depicted by the MFSRS. Enlightenment on the risk of stroke is needed in the community.

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).

Effects of Otago Exercise Program on Physical and Psychosocial Functions Among Community-Dwelling and Institutionalized Older Adults: A Scoping Review.

To review the effects of Otago exercise program (performed individually or in group) on several physical and psychosocial outcomes for community-dwelling and institutionalized older adults. Fourteen articles met the inclusion criteria. Three electronic databases and reference lists of identified studies were searched. Eligibility criteria included clinical trials of the Otago exercise program conducted among older adults. Two studies were conducted in institutions, 2 in groups. None of the studies reviewed reported the post-intervention result of the Otago exercise program on depression or any other psychological construct. Otago exercise program was effective in reducing falls, improving balance, strength, mobility, and health-related quality of life within the community and in institutions. Available evidence suggests group performance may be better than individual programs. The Otago exercise program is an important and effective exercise strategy which can be administered in groups or individualized to both community-dwelling and institution-resident older adults. Future reviews, especially, systematic reviews with meta-analysis should be performed.

Validation of an iCare Health Monitor smartphone application in the assessment of vital signs among stroke survivors in a poor-resource country.

Background: Frequent and accurate monitoring of blood pressure (BP) is a vital part of stroke management. There is therefore the need for availability of simple, portable and accurate devices for monitoring BP at any point in time. Objective: To determine the validity and reliability of the iCare Health Monitor (iCHM) smartphone application in the measurement of BP, heart rate (HR) and respiratory rate (RR) amongst stroke survivors in Anambra State. Methods: This was a cross-sectional survey involving 86 stroke survivors (64.0% males; mean age = 65.23 ± 12.10 years) consecutively recruited from three conveniently selected centres in Anambra State. BP, PR and RR were assessed using both the standardised methods and iCHM. The parameters were reassessed with the iCHM after few minutes. Convergent validity and test-retest reliability of the iCHM were determined using Pearson product moment correlation and intra-class correlation coefficient respectively at an alpha level of 0.05. Results: The convergent validity of the iCHM was excellent in measuring systolic BP (SBP) (r = 0.96; p < 0.01), diastolic BP (DBP) (r = 0.93; p < 0.01), HR (r = 0.96; p < 0.01) but moderate in measuring RR (r = 0.74; p < 0.01). The test-retest reliability of the iCHM was excellent in assessing SBP (ICC = 0.95; p < 0.01), DBP (ICC = 0.94; p < 0.01) and HR (ICC = 0.92; p < 0.01) but poor in assessing RR (ICC = 0.35; p = 0.03). Also, the iCHM displayed clinically insignificant bias. Conclusion: The iCHM is a valid and reliable tool for assessing BP and HR (but not RR) among stroke survivors. Its use is therefore recommended especially in poor-resource countries where gadgets for assessing BP and PR might not easily be affordable and available.

IGBO Version of the Older People's Quality Of Life Questionnaire (OPQOL-35) Is Valid and Reliable: Cross-Cultural Adaptation and Validation.

To translate, cross-culturally adapt, and psychometrically evaluate the Older People's Quality of Life Questionnaire (OPQOL-35) among the Igbo older adult population in Enugu State. The original English OPQOL-35 (E-OPQOL-35) was translated into Igbo language, synthesized, back translated, and subsequently subjected to expert panel review, pre-testing and cognitive debriefing interview. The final Igbo version (I-OPQOL-35) was tested for internal consistency, concurrent, and structural validities in a cross-sectional study of 115 consenting apparently healthy older adults that were conveniently recruited from Enugu State, at 0.05 level of significance. The Spearman correlation coefficients between the participants' domain and total scores on the I-OPQOL-35 and E-OPQOL-35 (rho = .92-1.00) were excellent. The Mann-Whitney U test revealed no significant difference between corresponding scores in the E-OPQOL-35 and I-OPQOL-35 (P = .65-.94). The internal consistency coefficient of the I-OPQOL-35 was 0.78. The ceiling and floor effects were 0% respectively. The I-OPQOL-35 is therefore a valid and reliable instrument for the assessment of quality of life among Igbo older adults in Nigeria.

Social Support, General Self-Efficacy, Fear of Falling, and Physical Activity Among Older Adults in a Middle-Income Country.

Objectives: To investigate the levels and interrelationships between fear of falling (FOF), physical activity (PA), social support (SS), and general self-efficacy (GSE) among older adults in a Nigerian community. Methods: This was a cross-sectional survey involving 100 older adults (65.0% females; mean age = 74.25 ± 8.01 years) consecutively recruited from Nnewi community. Participants' FOF, PA, GSE, and SS were assessed using standardized questionnaires. Data were analyzed using descriptive statistics, Spearman rank order correlation, and structural equation modeling at a 0.05 level of significance. Results: The participants' mean FOF, PA, GSE, and SS scores were 15.22 ± 7.43 (fearful), 114.76 ± 90.18 (low), 21.64 ± 8.25 (low) and 5.72 ± 1.19 (high) respectively. There were significant correlations between each pair of FOF, PA, GSE, and SS scores of the participants (p < .05). FOF and GSE were significant predictors of PA while GSE and SS were significant predictors of FOF. Conclusion: FOF and SS were high while PA and GSE were low in this sample of Nigerian older adults. Significant correlations existed between FOF, SS, GSE, and PA, with FOF and GSE being predictors of PA while GSE and SS significantly predicted FOF. Measures should be geared towards reducing FOF and improving PA, GSE, and SS in this group.

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.

Body image, physical activity, quality of life, and community reintegration of individuals with acquired mobility disability in a Nigerian population.

PURPOSE: To assess the quality of life (QOL), physical activity (PA), community reintegration (CR), and body image (BI) among adults with acquired mobility disabilities. Relationships between the constructs were also assessed in order to ascertain how a change in one construct could influence the other. MATERIALS AND METHODS: This cross-sectional survey involved 157 adults (mean age = 47.51 ± 21.08 years) consecutively recruited from conveniently selected centers in South-east Nigeria. The Short-Form 36-Item Health Survey, the Multidimensional Body Self Relations, the Reintegration to Normal Living Index, and the Short-Form 7-Day International Physical Activity questionnaires were used to assess participants' QOL, BI, CR, and PA respectively. Participants' scores and socio-demographic information were summarised using descriptive statistics while the Spearman test analysed the relationships between constructs. RESULTS: Participants' mean QOL (43.23 ± 13.07), CR (48.09 ± 22.84), and BI (2.91 ± 0.51) scores were poor while their mean PA score (4.39 ± 4.56 × 103 MET-min/week) was high. PA had significant positive relationships with CR (rho = 0.25; p < 0.01) and QOL (rho = 0.33; p < 0.01). BI had a significant positive relationship with CR (rho = 0.28; p = 0.01). CONCLUSIONS: PA was high for this sample of individuals with mobility disability receiving physiotherapy but QOL, CR, and BI were poor. Based on observed correlations, rehabilitation interventions for enhancing PA may help improve QOL and CR.IMPLICATIONS FOR REHABILITATIONMobility disabilities are very common and burdensome in Nigeria and other African countries.Quality of life, physical activity, community reintegration, and body image can be adversely affected among individuals with mobility disabilities.Understanding relationships between these constructs among individuals with mobility disabilities could help in enhancing rehabilitation planning and outcomes.Physical activity relates to both community reintegration and life quality, whereas body image relates to community integration.

Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis.

BACKGROUND: To provide pooled longer term data from three groups of a phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC), and to determine duration of response (DOR) and impact on quality of life (QoL). METHODS: Patients received cemiplimab 3 mg/kg every 2 weeks (group 1, metastatic CSCC [mCSCC], n=59; group 2, locally advanced CSCC, n=78) or cemiplimab 350 mg every 3 weeks (group 3, mCSCC, n=56). Primary endpoint was objective response rate (ORR) per independent central review (ICR). QoL was repeatedly measured at day 1 of each treatment cycle (groups 1 and 2: 8 weeks; group 3: 9 weeks). RESULTS: Median duration of follow-up was 15.7 months. Overall, ORR per ICR was 46.1% (95% CI: 38.9% to 53.4%). Complete response (CR) rates were 20.3%, 12.8%, and 16.1% for groups 1, 2, and 3, respectively. Median time to CR was 11.2 months. Among patients with partial response or CR, the estimated proportion of patients with ongoing response at 12 months from the first objective response was 87.8% (95% CI: 78.5% to 93.3%), with median DOR not reached. Kaplan-Meier estimated probability of overall survival (OS) was 73.3% (95% CI: 66.1% to 79.2%) at 24 months, with median OS not reached. Global Health Status (GHS)/QoL improvements were observed as early as cycle 2 and were significantly improved and durable until last assessment. Kaplan-Meier estimate of median time to first clinically meaningful improvement for pain was 2.1 (95% CI: 2.0 to 3.7) months and was significantly improved in responders versus non-responders (p<0.0001). CONCLUSIONS: This is the largest (n=193) clinical dataset for a programmed cell death-1 inhibitor against advanced CSCC, confirming the sustained substantial clinical activity of cemiplimab in these patients, including new findings of improved CR rates over time, increasing DOR, and durable pain control and GHS/QoL improvement. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT02760498), https://clinicaltrialsgov/ct2/show/NCT02760498.

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.

Towards cardiovascular disease prevention in Nigeria: A mixed method study of how adolescents and young adults in a university setting perceive cardiovascular disease and risk factors.

BACKGROUND: Cardiovascular disease (CVD) is a global problem but its increasing prevalence in the working age group in developing countries like Nigeria is concerning and needs urgent attention. METHODS: The study was a mixed method design: quantitative phase with 402 participants and qualitative phase with 16 participants in two focus groups. The participants in the quantitative survey phase completed two questionnaires on the knowledge and perception of CVD and its risk factors. Data from the quantitative cross-sectional survey were analysed using descriptive and inferential statistics. The qualitative data were analysed using content thematic analysis. RESULTS: We report that 39.1% of the participants had high knowledge whilst 61.9% had low and average knowledge of CVD and its risk factors. Of the participants, 78.1% had a wrong perception of CVD and its risk factors. Participants from faculties of veterinary medicine and basic medical sciences had better knowledge than others who were not medically inclined (F = 16.11; p 0.001). Only participants from the faculty of veterinary medicine had the right perception of CVD and its risk factors. There was no significant difference in knowledge and perception scores between male and female participants. The qualitative study buttressed the results from the cross-sectional survey, where adolescents and young adults highlighted academic stress and poverty as major risk factors for CVD. CONCLUSION: Adolescents and young adults in this study did not have good knowledge of CVD and its risk factors. They also had a wrong perception about CVD and its risk factors.