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Nevin Manimala Statistics

Can a new role, the (Trainee) Associate Psychological Practitioner (T/APP), add value in General Practice? Results from the pilot year evaluation

Prim Health Care Res Dev. 2022 Sep 29;23:e61. doi: 10.1017/S1463423622000482.

ABSTRACT

BACKGROUND: The deployment of (Trainee) Associate Psychological Practitioners (T/APPs) to deliver brief psychological interventions focusing on preventing mental health deterioration and promoting emotional wellbeing in General Practice settings is a novel development in the North West of England. As the need and demand for psychological practitioners increases, new workforce supply routes are required to meet this growth.

AIMS: To evaluate the clinical impact and efficacy of the mental health prevention and promotion service, provided by the T/APPs and the acceptability of the role from the perspective of the workforce and the role to T/APPs, patients and services.

METHODS: A mixed-methods design was used. To evaluate clinical outcomes, patients completed measures of wellbeing (WEMWBS), depression (PHQ-9), anxiety (GAD-7) and resilience (BRS) at the first session, final session and at a 4-6 week follow-up. Paired-samples t-tests were conducted comparing scores from session 1 and session 4, and session 1 and follow-up for each of the four outcome measures. To evaluate acceptability, questionnaires were sent to General Practice staff, T/APPs and patients to gather qualitative and quantitative feedback on their views of the T/APP role. Quantitative responses were collated and summarised. Qualitative responses were analysed using inductive summative content analysis to identify themes.

RESULTS: T-test analysis revealed clinically and statistically significant reductions in depression and anxiety and elevations in wellbeing and resiliency between session 1 and session 4, and at follow-up. Moderate-large effect sizes were recorded. Acceptability of the T/APP role was established across General Practice staff, T/APPs and patients. Content analysis revealed two main themes: positive feedback and constructive feedback. Positive sub-themes included accessibility of support, type of support, patient benefit and primary care network benefit. Constructive sub-themes included integration of the role and limitations to the support.

CONCLUSIONS: The introduction of T/APPs into General Practice settings to deliver brief mental health prevention and promotion interventions is both clinically effective and acceptable to patients, General Practice staff and psychology graduates.

PMID:36172708 | DOI:10.1017/S1463423622000482

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Nevin Manimala Statistics

Development and validation of a measure to assess patients’ perceptions of their safety in an acute hospital setting

Nurse Res. 2022 Sep 29. doi: 10.7748/nr.2022.e1792. Online ahead of print.

ABSTRACT

BACKGROUND: Safety measurement tools have traditionally examined safety climate and culture from the perspective of healthcare professionals. A small number of studies have used tools to measure patients’ perceptions of safety.

AIM: To develop and check the validity of a questionnaire, the King’s Patient Safety Measure (KPSM), that assesses how patients perceive their safety when receiving acute care.

DISCUSSION: A cross-sectional survey of 158 patients was undertaken that was constructed to establish the validity and reliability of a 13-item questionnaire. A general linear model statistically tested how patients perceived the safety of their care and whether those views were associated with covariates that included characteristics such as age, gender, ethnic identity, socio-economic factors, how long they stayed in hospital and the way they were admitted to hospital.

CONCLUSION: The KPSM is a validated tool consisting of a single factor that is internally consistent.

IMPLICATIONS FOR PRACTICE: The KPSM is appropriate for and potentially applicable to a diverse range of patients and could act as an early warning tool.

PMID:36172707 | DOI:10.7748/nr.2022.e1792

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Nevin Manimala Statistics

Impact of community and provider-driven social accountability interventions on contraceptive uptake in Ghana and Tanzania

Int J Equity Health. 2022 Sep 28;21(1):142. doi: 10.1186/s12939-022-01736-y.

ABSTRACT

BACKGROUND: Social accountability, which is defined as a collective process for holding duty bearers and service providers to account for their actions, has shown positive outcomes in addressing the interrelated barriers to quality sexual and reproductive health services. The Community and Provider driven Social Accountability Intervention (CaPSAI) Project contributes to the evidence on the effects of social accountability processes in the context of a family planning and contraceptive programme.

METHODS: A quasi-experimental study utilizing an interrupted time series design with a control group (ITS-CG) was conducted to determine the actual number of new users of contraception amongst women 15-49 years old in eight intervention and eight control facilities per country in Ghana and Tanzania. A standardized facility audit questionnaire was used to collect facility data and completed every year in both intervention and control groups in each country from 2018-2020.

RESULTS: In Ghana, the two-segmented Poisson Generalized Estimating Equation (GEE) model demonstrated no statistically significant difference at post-intervention, between the intervention and control facilities, in the level of uptake of contraceptives (excess level) (p-value = 0.07) or in the rate of change (excess rate) in uptake (p-value = 0.07) after adjusting for baseline differences. Similarly, in Tanzania, there was no statistical difference between intervention and control facilities, in the level of uptake of contraceptives (excess level) (p-value = 0.20), with the rate of change in uptake (p-value = 0.05) after adjusting for the baseline differences. There was no statistical difference in the level of or rate of change in uptake in the two groups in a sensitivity analysis excluding new users recruited in outreach activities in Tanzania.

CONCLUSIONS: The CAPSAI project intervention did not result in a statistically significant increase in uptake of contraceptives as measured by the number of or increase in new users. In evaluating the impact of the intervention on the intermediate outcomes such as self-efficacy among service users, trust and countervailing power among social groups/networks, and responsiveness of service providers, cases of change and process evaluation should be considered.

TRIAL REGISTRATION: The CaPSAI Project has been registered at the Australian New Zealand Clinical Trials Registry (ACTRN12619000378123, 11/03/2019).

PMID:36171614 | DOI:10.1186/s12939-022-01736-y

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Nevin Manimala Statistics

Cytomegalovirus infection may be oncoprotective against neoplasms of B-lymphocyte lineage: single-institution experience and survey of global evidence

Virol J. 2022 Sep 29;19(1):155. doi: 10.1186/s12985-022-01884-1.

ABSTRACT

BACKGROUND: Although cytomegalovirus (CMV) is not considered tumorigenic, there is evidence for its oncomodulatory effects and association with hematological neoplasms. Conversely, a number of experimental and clinical studies suggest its putative anti-tumour effect. We investigated the potential connection between chronic CMV infection in patients with B-lymphocyte (B-cell) malignancies in a retrospective single-center study and extracted relevant data on CMV prevalences and the incidences of B-cell cancers the world over.

METHODS: In the clinical single-center study, prevalence of chronic CMV infection was compared between patients with B-cell leukemia/lymphoma and the healthy controls. Also, global data on CMV seroprevalences and the corresponding country-specific incidences of B- lineage neoplasms worldwide were investigated for potential correlations.

RESULTS: Significantly higher CMV seropositivity was observed in control subjects than in patients with B-cell malignancies (p = 0.035). Moreover, an unexpected seroepidemiological evidence of highly significant inverse relationship between country-specific CMV prevalence and the annual incidence of B-cell neoplasms was noted across the populations worldwide (ρ = -0.625, p < 0.001).

CONCLUSIONS: We try to draw attention to an unreported interplay between CMV infection and B-cell lymphomagenesis in adults. A large-scale survey across > 70 countries disclosed a link between CMV and B-cell neoplasms. Our evidence hints at an antagonistic effect of chronic CMV infection against B-lymphoproliferation.

PMID:36171605 | DOI:10.1186/s12985-022-01884-1

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Nevin Manimala Statistics

Determining optimal mobile neurofeedback methods for motor neurorehabilitation in children and adults with non-progressive neurological disorders: a scoping review

J Neuroeng Rehabil. 2022 Sep 28;19(1):104. doi: 10.1186/s12984-022-01081-9.

ABSTRACT

BACKGROUND: Brain-computer interfaces (BCI), initially designed to bypass the peripheral motor system to externally control movement using brain signals, are additionally being utilized for motor rehabilitation in stroke and other neurological disorders. Also called neurofeedback training, multiple approaches have been developed to link motor-related cortical signals to assistive robotic or electrical stimulation devices during active motor training with variable, but mostly positive, functional outcomes reported. Our specific research question for this scoping review was: for persons with non-progressive neurological injuries who have the potential to improve voluntary motor control, which mobile BCI-based neurofeedback methods demonstrate or are associated with improved motor outcomes for Neurorehabilitation applications?

METHODS: We searched PubMed, Web of Science, and Scopus databases with all steps from study selection to data extraction performed independently by at least 2 individuals. Search terms included: brain machine or computer interfaces, neurofeedback and motor; however, only studies requiring a motor attempt, versus motor imagery, were retained. Data extraction included participant characteristics, study design details and motor outcomes.

RESULTS: From 5109 papers, 139 full texts were reviewed with 23 unique studies identified. All utilized EEG and, except for one, were on the stroke population. The most commonly reported functional outcomes were the Fugl-Meyer Assessment (FMA; n = 13) and the Action Research Arm Test (ARAT; n = 6) which were then utilized to assess effectiveness, evaluate design features, and correlate with training doses. Statistically and functionally significant pre-to post training changes were seen in FMA, but not ARAT. Results did not differ between robotic and electrical stimulation feedback paradigms. Notably, FMA outcomes were positively correlated with training dose.

CONCLUSION: This review on BCI-based neurofeedback training confirms previous findings of effectiveness in improving motor outcomes with some evidence of enhanced neuroplasticity in adults with stroke. Associative learning paradigms have emerged more recently which may be particularly feasible and effective methods for Neurorehabilitation. More clinical trials in pediatric and adult neurorehabilitation to refine methods and doses and to compare to other evidence-based training strategies are warranted.

PMID:36171602 | DOI:10.1186/s12984-022-01081-9

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Nevin Manimala Statistics

Early identification of bleeding in trauma patients: external validation of traumatic bleeding scores in the Swiss Trauma Registry

Crit Care. 2022 Sep 28;26(1):296. doi: 10.1186/s13054-022-04178-8.

ABSTRACT

BACKGROUND: Early identification of bleeding at the scene of an injury is important for triage and timely treatment of injured patients and transport to an appropriate facility. The aim of the study is to compare the performance of different bleeding scores.

METHODS: We examined data from the Swiss Trauma Registry for the years 2015-2019. The Swiss Trauma Registry includes patients with major trauma (injury severity score (ISS) ≥ 16 and/or abbreviated injury scale (AIS) head ≥ 3) admitted to any level-one trauma centre in Switzerland. We evaluated ABC, TASH and Shock index (SI) scores, used to predict massive transfusion (MT) and the BATT score and used to predict death from bleeding. We evaluated the scores when used prehospital and in-hospital in terms of discrimination (C-Statistic) and calibration (calibration slope). The outcomes were early death within 24 h and the receipt of massive transfusion (≥ 10 Red Blood cells (RBC) units in the first 24 h or ≥ 3 RBC units in the first hour).

RESULTS: We examined data from 13,222 major trauma patients. There were 1,533 (12%) deaths from any cause, 530 (4%) early deaths within 24 h, and 523 (4%) patients who received a MT (≥ 3 RBC within the first hour). In the prehospital setting, the BATT score had the highest discrimination for early death (C-statistic: 0.86, 95% CI 0.84-0.87) compared to the ABC score (0.63, 95% CI 0.60-0.65) and SI (0.53, 95% CI 0.50-0.56), P < 0.001. At hospital admission, the TASH score had the highest discrimination for MT (0.80, 95% CI 0.78-0.82). The positive likelihood ratio for early death were superior to 5 for BATT, ABC and TASH. The negative likelihood ratio for early death was below 0.1 only for the BATT score.

CONCLUSIONS: The BATT score accurately estimates the risk of early death with excellent performance, low undertriage, and can be used for prehospital treatment decision-making. Scores predicting MT presented a high undertriage rate. The outcome MT seems not appropriate to stratify the risk of life-threatening bleeding.

TRIAL REGISTRATION: Clinicaltrials.gov, NCT04561050 . Registered 15 September 2020.

PMID:36171598 | DOI:10.1186/s13054-022-04178-8

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Nevin Manimala Statistics

Assessing the psychometric performance of EQ-5D-5L in dementia: a systematic review

Health Qual Life Outcomes. 2022 Sep 28;20(1):139. doi: 10.1186/s12955-022-02036-3.

ABSTRACT

BACKGROUND: EQ-5D is widely used for valuing changes in quality of life for economic evaluation of interventions for people with dementia. There are concerns about EQ-5D-3L in terms of content validity, poor inter-rater agreement and reliability in the presence of cognitive impairment, but there is also evidence to support its use with this population. An evidence gap remains regarding the psychometric properties of EQ-5D-5L.

OBJECTIVES: To report psychometric evidence around EQ-5D-5L in people with dementia.

METHODS: A systematic review identified primary studies reporting psychometric properties of EQ-5D-5L in people with dementia. Searches were completed up to November 2020. Study selection, data extraction and quality assessment were undertaken independently by at least 2 researchers.

RESULTS: Evidence was extracted from 20 articles from 14 unique studies covering a range of dementia severity. Evidence of known group validity from 5 of 7 studies indicated that EQ-5D-5L distinguishes severity of disease measured by cognitive impairment, depression, level of dependence and pain. Convergent validity (9 studies) showed statistically significant correlations of weak and moderate strengths, between EQ-5D-5L scores and scores on other key measures. Statistically significant change was observed in only one of 6 papers that allowed this property to be examined. All seven studies showed a lack of inter-rater reliability between self and proxy reports with the former reporting higher EQ-5D-5L scores than those provided by proxies. Five of ten studies found EQ-5D-5L to be acceptable, assessed by whether the measure could be completed by the PwD and/or by the amount of missing data. As dementia severity increased, the feasibility of self-completing EQ-5D-5L decreased. Three papers reported on ceiling effects, two found some evidence in support of ceiling effects, and one did not.

CONCLUSIONS: EQ-5D-5L seems to capture the health of people with dementia on the basis of known-group validity and convergent validity, but evidence is inconclusive regarding the responsiveness of EQ-5D-5L. As disease progresses, the ability to self-complete EQ-5D-5L is diminished.

PMID:36171595 | DOI:10.1186/s12955-022-02036-3

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Nevin Manimala Statistics

Descriptive study of foodborne disease using disease monitoring data in Zhejiang Province, China, 2016-2020

BMC Public Health. 2022 Sep 28;22(1):1831. doi: 10.1186/s12889-022-14226-1.

ABSTRACT

BACKGROUND: This study aimed to identify the epidemiology, seasonality, aetiology and clinical characteristics of sporadic foodborne diseases in Zhejiang province during 2016-2020.

METHODS: Descriptive statistical methods were used to analyze the data from surveillance network established by the Zhejiang Provincial Center for Disease Control and Prevention. There were 31 designated hospitals in all 11 cities which were selected using probability proportionate to size sampling method.

RESULTS: During the study period, the surveillance system received 75,124 cases with 4826 (6.42%) hospitalizations from 31 hospitals. The most common cause was Norovirus, 6120 cases (42.56%), followed by Salmonella, 3351 cases (23.30%). A significant seasonal trend was observed for the V. parahaemolyticus, with the highest rates over the summer period, peaking in August, 1171 cases (38.75%), a similar trend was also observed with Salmonella and Diarrheagenic E. coli. Norovirus infections showed the highest rate in November (904, 14.77%) and March (660,10.78%), the lowest in August, 215 cases (3.51%). Patients between 19 ~ 40 years were more likely to infected by Norovirus, V. parahaemolyticus and Diarrheagenic E. coli, patients below 1 year were the highest among patients with Salmonella infection, 881 cases (26.3%). The Norovirus, V. parahaemolyticus and Diarrheagenic E. coli infection with the highest positive detection rates among the workers were observed. The largest number cases of food categories were from aquatic product infection. The private home was the most common exposure setting.

CONCLUSION: Our study highlighted the necessity for conducting an active, comprehensive surveillance for pathogens in all age groups, to monitor the changing dynamics in the epidemiology and aetiology of foodborne diseases to guide policies that would reduce related illnesses.

PMID:36171585 | DOI:10.1186/s12889-022-14226-1

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Nevin Manimala Statistics

Validating ORR and PFS as surrogate endpoints in phase II and III clinical trials for NSCLC patients: difference exists in the strength of surrogacy in various trial settings

BMC Cancer. 2022 Sep 29;22(1):1022. doi: 10.1186/s12885-022-10046-z.

ABSTRACT

OBJECTIVE: This study aims to systematically validate the performance of surrogate endpoints in phase II and III clinical trials for NSCLC patients under various trial settings.

METHODS: A literature search retrieved all registered phase II and III trials of NSCLC patients in which OS, with at least one of ORR and PFS, were reported. Associations between surrogate and true endpoints were assessed on two levels. On the arm level, three pairs of correlations, i.e., ORR vs. median OS, ORR vs. median PFS, and median PFS vs. median OS, were analysed using Spearman’s rho. On the trial level, similarly, three pairs of correlations, i.e., ΔORR vs. HR of OS, ΔORR vs. HR of PFS, and HR of PFS vs. HR of OS, were analysed using Spearman’s rho and weighted linear regression model respectively. Finally, sensitivity analyses were performed to explore surrogacy under various trial settings.

RESULTS: At arm level, three pairs of correlations are all high (Spearman’s rho = 0.700, 0.831, 0.755, respectively). At trial level, there is a low correlation between ΔORR and HR of OS, a high correlation between ΔORR and HR of PFS and a moderate correlation between HR of PFS and HR of OS (Spearman’s rho = 0.462, 0.764, 0.584, respectively). In the sensitivity analysis, we find correlations between surrogate and true endpoints vary by different trial settings. It is noteworthy that the strength of surrogacy of these intermediate endpoints in targeted therapy is greater than that in immunotherapy.

CONCLUSION: According to the arm-level and trial level-analysis, we suggest that in phase II and III trials of targeted therapy and immunotherapy for NSCLC patients: 1) ORR lacks validity for the surrogacy of OS, excluding in first-line therapy, and 2) ORR may be an appropriate surrogate endpoint for PFS, and 3) PFS may be considered a modest surrogacy for OS, with better performance in first-line therapy trials. Moreover, to provide more convincing evidence of surrogacy of the surrogate endpoints, patient-level analyses are in desperate need.

PMID:36171546 | DOI:10.1186/s12885-022-10046-z

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Nevin Manimala Statistics

Levels of depressive symptoms in cardiac patients attending cardiac rehabilitation with a history of depression: pre Covid-19 and Covid-19 period comparison

BMC Cardiovasc Disord. 2022 Sep 28;22(1):427. doi: 10.1186/s12872-022-02867-4.

ABSTRACT

BACKGROUND: The large-scale changes in cardiac rehabilitation (CR) programme delivery in response to COVID-19 has led to diminished provision. The influence of these service changes on the depression symptoms of patients in CR programmes is unknown. Our study investigated the extent of depressive symptoms prior to and during the COVID-19 periods in patients with a previous history of depression at the start of CR.

METHODS: Use of Registry routine practice data, National Audit of Cardiac Rehabilitation (NACR), from COVID-19 period Feb 2020 and Jan 2021, as well as pre COVID-19 period Feb 2019 and Jan 2020, was extracted. Depressive symptoms were defined according to Hospital Anxiety and Depression Score ≥ 8. Chi-square tests and independent samples t-tests were used to investigate baseline characteristics. Additionally, a binary logistic regression to examine the factors associated with high levels of depressive symptoms.

RESULTS: In total 3661 patients with a history of depression were included in the analysis. Patients attending CR during COVID-19 were found to be 11% more likely to have high levels of acute depressive symptoms compared to patients attending CR prior to COVID-19. Physical inactivity, increased anxiety, a higher total number of comorbidities, increased weight, and living in the most deprived areas were statistically significant factors associated with high levels of acute depressive symptoms at the start of CR following multivariate adjustments.

CONCLUSION: Our research suggests that following a cardiac event patients with prior history of depression have high levels of acute depressive symptoms at CR baseline assessment. This finding exists in both the pre Covid-19 and Covid-19 periods in patients with a history of depression.

PMID:36171545 | DOI:10.1186/s12872-022-02867-4