Individual, household and area predictors of anaemia among children aged 6-59 months in Nigeria.

Objectives: This study aims to determine the prevalence of anaemia among children aged 6-59 months in all states of Nigeria, including the Federal Capital Territory (FCT), and to quantify the predicted probabilities by individual, household and area factors. Study design: This study is a secondary analysis of data sets from two national representative cross-sectional surveys in Nigeria: the Nigeria Demographic and Health Survey (2018 NDHS) and the National Human Development Index (2018 NHDR). The state human development index (HDI) and the state multidimensional poverty index (MPI) from the 2018 NHDR were incorporated into the 2018 NDHS. Methods: The study included a weighted sample of 10,222 children aged 6-59 months. Both univariate and bivariate analyses were computed to determine the prevalence and factors associated with anaemia status, respectively. Multiple binary logistic regression analyses with adjusted predicted probabilities (APPs) were performed to quantify the predictors' probabilities. Results: The prevalence of anaemia among children aged 6-59 months in Nigeria was 68.1% (6962/10,222). Zamfara state had the highest prevalence (84.0% [266/317]), while Kaduna state recorded the lowest (50.0% [283/572]). The APPs of being anaemic decreased from 82.9% (95% confidence interval [CI]: 80.0-85.8) for children aged 6-18 months to 60.6% (95% CI: 56.8-64.4) for children aged 43-59 months, when other predictors were held constant. The APP for a child of an anaemic mother is 10.2% points higher than the APP for a child whose mother is not anaemic. In addition, the APPs for children decreased as the age group of their mothers increased. A child from a state that is mildly deprived in the MPI has a lower APP (67.2% [95% CI: 62.2-72.2]) compared with a child from highly deprived MPI state (79.0% [95% CI: 73.4-84.5]). Conclusions: Health strategies, including supplementation programmes, should be carried out at both ante-natal and post-natal clinics to reduce the prevalence of anaemia, especially in vulnerable population groups.

Observational cohort study in older women with early breast cancer: Use of radiation therapy and impact on health-related quality of life and mortality.

BACKGROUND: Radiotherapy reduces in-breast recurrence risk in early breast cancer (EBC) in older women. This benefit may be small and should be balanced against treatment effect and holistic patient assessment. This study described treatment patterns according to fitness and impact on health-related quality-of-life (HRQoL). METHODS: A multicentre, observational study of EBC patients aged ≥ 70 years, undergoing breast-conserving surgery (BCS) or mastectomy, was undertaken. Associations between radiotherapy use, surgery, clinico-pathological parameters, fitness based on geriatric parameters and treatment centre were determined. HRQoL was measured using the European Organisation for the Research and Treatment of Cancer (EORTC) questionnaires. RESULTS: In 2013-2018 2811 women in 56 UK study centres underwent surgery with a median follow-up of 52 months. On multivariable analysis, age and tumour risk predicted radiotherapy use. Among healthier patients (based on geriatric assessments) with high-risk tumours, 534/613 (87.1%) having BCS and 185/341 (54.2%) having mastectomy received radiotherapy. In less fit individuals with low-risk tumours undergoing BCS, 149/207 (72.0%) received radiotherapy. Radiotherapy effects on HRQoL domains, including breast symptoms and fatigue were seen, resolving by 18 months. CONCLUSION: Radiotherapy use in EBC patients ≥ 70 years is affected by age and recurrence risk, whereas geriatric parameters have limited impact regardless of type of surgery. There was geographical variation in treatment, with some fit older women with high-risk tumours not receiving radiotherapy, and some older, low-risk, EBC patients receiving radiotherapy after BCS despite evidence of limited benefit. The impact on HRQoL is transient.

Risk Factors Associated with Malnutrition among Children Under-Five Years in Sub-Saharan African Countries: A Scoping Review.

Background/Purpose: Malnutrition is a significant global public health burden with greater concern among children under five years in Sub-Saharan Africa (SSA). To effectively address the problem of malnutrition, especially in resource-scarce communities, knowing the prevalence, causes and risk factors associated with it are essential steps. This scoping review aimed to identify the existing literature that uses classical regression analysis on nationally representative health survey data sets to find the individual socioeconomic, demographic and contextual risk factors associated with malnutrition among children under five years of age in Sub-Sahara Africa (SSA). Methods: The electronic databases searched include EMBASE (OVID platform), PubMed (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, Web of Science (WoS) and Cochrane Library. Only papers written in the English language, and for which the publication date was between 1 January 1990 and 31 July 2020, were included. Results: A total of 229 papers were identified, of which 26 were studies that have been included in the review. The risk factors for malnutrition identified were classified as child-related, parental/household-related and community or area-related. Conclusions: Study-interest bias toward stunting over other anthropometric indicators of malnutrition could be addressed with a holistic research approach to equally address the various dimension of the anthropometric indicators of malnutrition in a population.

Impact of pelvic floor muscle training on sexual function of women with urinary incontinence and a comparison of electrical stimulation versus standard treatment (IPSU trial): a randomised controlled trial.

AIMS: To evaluate the clinical and cost-effectiveness of electric stimulation plus standard pelvic floor muscle training compared to standard pelvic floor muscle training alone in women with urinary incontinence and sexual dysfunction. METHODS: Single centre two arm parallel group randomised controlled trial conducted in a Teaching hospital in England. Participants were women presenting with urinary incontinence and sexual dysfunction. The interventions compared were electric stimulation versus standard pelvic floor muscle training. OUTCOME MEASURES: included Prolapse and Incontinence Sexual function Questionnaire (PISQ) physical function dimension at post-treatment (primary); other dimensions of PISQ, SF-36; EQ-5D, EPAQ, resource use, adverse events and cost-effectiveness (secondary outcomes). RESULTS: 114 women were randomised (Intervention n=57; Control group n=57). 64/114 (56%). PARTICIPANTS: had valid primary outcome data at follow-up (Intervention 30; Control 34). The mean PISQ-PF dimension scores at follow-up were 33.1 (SD 5.5) and 32.3 (SD 5.2) for the Intervention and Control groups respectively; with the Control group having a higher (better) score. After adjusting for baseline score, BMI, menopausal status, time from randomisation and baseline oxford scale score the mean difference was -1.0 (95% CI: -4.0 to 1.9; P=0.474). There was no differences between the groups in any of the secondary outcomes at follow-up. Within this study, the use of electrical stimulation was cost-effective with very small incremental costs and quality adjusted life years (QALYs). CONCLUSIONS: In women presenting with urinary incontinence in conjunction with sexual dysfunction, physiotherapy is beneficial to improve overall sexual function. However no specific form of physiotherapy is beneficial over another. Trial registration ISRCTN09586238.

Consumer views on a new holistic screening tool for supportive and palliative-care needs: Sheffield Profile for Assessment and Referral for Care (SPARC): a survey of self-help support groups in health care.

BACKGROUND: Sheffield Profile for Assessment and Referral for Care (SPARC) was developed in response to concerns that palliative care may not be reaching all people who could benefit from it. Acceptability of the tool is an important step in developing its future use. AIMS: To elicit the views of a wide variety of members of consumer and self-help support groups concerned with health care on the relevance, acceptability and the overall perception of using SPARC as an early holistic needs assessment tool in supportive and palliative care. METHODS: This study was conducted in South Yorkshire and North Derbyshire (UK). Ninety-nine consumer and self-help groups were identified from information in the public domain. Thirty-eight groups participated. Packs containing study information and self-complete postal questionnaires were distributed to groups, and they were asked to circulate these to their members. Completed questionnaires were returned in pre-paid envelopes to the research team. RESULTS: 135 questionnaires and feedback forms were returned. The majority of respondents found SPARC easy to understand (93% (120/129; 95% Confidence Interval 87% to 96%) and complete (94% (125/133; 95% CI: 88% to 97%). A minority, 12.2% (16/131), of respondents found questions on SPARC 'too sensitive'. CONCLUSIONS: Overall, respondents considered SPARC an acceptable and relevant tool for clinical assessment of supportive and palliative-care needs. Whilst a small minority of people found SPARC difficult to understand (i.e. patients with cognitive impairments), most categories of service user found it relevant. Clinical studies are necessary to establish the clinical utility of SPARC.

A randomised controlled trial and cost-effectiveness evaluation of 'booster' interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods.

BACKGROUND: More evidence is needed on the potential role of 'booster' interventions in the maintenance of increases in physical activity levels after a brief intervention in relatively sedentary populations. OBJECTIVES: To determine whether objectively measured physical activity, 6 months after a brief intervention, is increased in those receiving physical activity 'booster' consultations delivered in a motivational interviewing (MI) style, either face to face or by telephone. DESIGN: Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with nested qualitative research fidelity and geographical information systems and health economic substudies. Treatment allocation was carried out using a web-based simple randomisation procedure with equal allocation probabilities. Principal investigators and study statisticians were blinded to treatment allocation until after the final analysis only. SETTING: Deprived areas of Sheffield, UK. PARTICIPANTS: Previously sedentary people, aged 40-64 years, living in deprived areas of Sheffield, UK, who had increased their physical activity levels after receiving a brief intervention. INTERVENTIONS: Participants were randomised to the control group (no further intervention) or to two sessions of MI, either face to face ('full booster') or by telephone ('mini booster'). Sessions were delivered 1 and 2 months post-randomisation. MAIN OUTCOME MEASURES: The primary outcome was total energy expenditure (TEE) per day in kcal from 7-day accelerometry, measured using an Actiheart device (CamNtech Ltd, Cambridge, UK). Independent evaluation of practitioner competence was carried out using the Motivational Interviewing Treatment Integrity assessment. An estimate of the per-participant intervention costs, resource use data collected by questionnaire and health-related quality of life data were analysed to produce a range of economic models from a short-term NHS perspective. An additional series of models were developed that used TEE values to estimate the long-term cost-effectiveness. RESULTS: In total, 282 people were randomised (control = 96; mini booster = 92, full booster = 94) of whom 160 had a minimum of 4 out of 7 days' accelerometry data at 3 months (control = 61, mini booster = 47, full booster = 52). The mean difference in TEE per day between baseline and 3 months favoured the control arm over the combined booster arm but this was not statistically significant (-39 kcal, 95% confidence interval -173 to 95, p = 0.57). The autonomy-enabled MI communication style was generally acceptable, although some participants wanted a more paternalistic approach and most expressed enthusiasm for monitoring and feedback components of the intervention and research. Full boosters were more popular than mini boosters. Practitioners achieved and maintained a consistent level of MI competence. Walking distance to the nearest municipal green space or leisure facilities was not associated with physical activity levels. Two alternative modelling approaches both suggested that neither intervention was likely to be cost-effective. CONCLUSIONS: Although some individuals do find a community-based, brief MI 'booster' intervention supportive, the low levels of recruitment and retention and the lack of impact on objectively measured physical activity levels in those with adequate outcome data suggest that it is unlikely to represent a clinically effective or cost-effective intervention for the maintenance of recently acquired physical activity increases in deprived middle-aged urban populations. Future research with middle-aged and relatively deprived populations should explore interventions to promote physical activity that require less proactive engagement from individuals, including environmental interventions. STUDY REGISTRATION: Current Controlled Trials ISRCTN56495859, ClinicalTrials.gov NCT00836459. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 13. See the NIHR Journals Library website for further project information.

Therapist effects in randomised controlled trials: what to do about them.

AIMS AND OBJECTIVES: The aim of this study is to describe and compare three statistical methods to allow for therapist effects in individually randomised controlled trials. BACKGROUND: In an individually randomised controlled trial where the intervention is delivered by a health professional it seems likely that the effectiveness of the intervention, independent of any treatment effect, could depend on the skill of the health professional delivering it. This leads to a potential clustering of the outcomes for the patients being treated by the same health professional. DESIGN: Retrospective statistical analysis of outcomes from four example randomised controlled trial datasets with potential clustering by health professional. METHODS: Three methods to allow for clustering are described: cluster level analysis; random effects models and marginal models. These models were fitted to continuous outcome data from four example randomised controlled trial datasets with potential clustering by health professional. RESULTS: The cluster level models produced the widest confidence intervals. Little difference was found between the estimates of the regression coefficients for the treatment effect and confidence intervals between the individual patient level models for the datasets. The conclusions reached for each dataset match those published in the original papers. The intracluster correlation coefficient ranged from <0.001-0.04 for the outcomes, which shows only minor levels of clustering within the datasets. CONCLUSIONS: The models, which use individual level data are to be preferred. Treatment coefficients from these models have different interpretations. The choice of model should depend on the scientific question being asked. RELEVANCE TO CLINICAL PRACTICE: We recommend that researchers should be aware of any potential clustering, by health professional, in their randomised controlled trial and use appropriate methods to account for this clustering in the statistical analysis of the data.

Sample size and power estimation for studies with health related quality of life outcomes: a comparison of four methods using the SF-36.

We describe and compare four different methods for estimating sample size and power, when the primary outcome of the study is a Health Related Quality of Life (HRQoL) measure. These methods are: 1. assuming a Normal distribution and comparing two means; 2. using a non-parametric method; 3. Whitehead's method based on the proportional odds model; 4. the bootstrap. We illustrate the various methods, using data from the SF-36. For simplicity this paper deals with studies designed to compare the effectiveness (or superiority) of a new treatment compared to a standard treatment at a single point in time. The results show that if the HRQoL outcome has a limited number of discrete values (< 7) and/or the expected proportion of cases at the boundaries is high (scoring 0 or 100), then we would recommend using Whitehead's method (Method 3). Alternatively, if the HRQoL outcome has a large number of distinct values and the proportion at the boundaries is low, then we would recommend using Method 1. If a pilot or historical dataset is readily available (to estimate the shape of the distribution) then bootstrap simulation (Method 4) based on this data will provide a more accurate and reliable sample size estimate than conventional methods (Methods 1, 2, or 3). In the absence of a reliable pilot set, bootstrapping is not appropriate and conventional methods of sample size estimation or simulation will need to be used. Fortunately, with the increasing use of HRQoL outcomes in research, historical datasets are becoming more readily available. Strictly speaking, our results and conclusions only apply to the SF-36 outcome measure. Further empirical work is required to see whether these results hold true for other HRQoL outcomes. However, the SF-36 has many features in common with other HRQoL outcomes: multi-dimensional, ordinal or discrete response categories with upper and lower bounds, and skewed distributions, so therefore, we believe these results and conclusions using the SF-36 will be appropriate for other HRQoL measures.