Chronic Headache Education and Self-management Study (CHESS) : Health Economics Analysis Plan [v2.0]

Objective The Chronic Headache Education and Self-management Study (CHESS) is a multicomponent programme of interlocking studies funded by an NIHR programme grant to develop an education and self-management support intervention for people living with chronic headache (here in referred to as the CHESS intervention) and assess its clinical and cost- effectiveness in a randomised controlled trial. This analysis plan relates to the economic evaluation of the CHESS intervention using data from the two-arm multi-centre randomised controlled trial component of the CHESS programme. The within-trial economic evaluation will aim to estimate the cost-effectiveness of the CHESS intervention compared with best supportive care over the 12-month trial period of follow-up. The purpose of the health economics analysis plan is to outline an explicit framework of methods that will be used to analyse the health economic data in a robust manner. The document has been written based on information contained in the trial protocol version 3.7 dated on 19.Sep.2019. Background rationale Chronic headaches present a major problem both for the individual and society. Previous studies on supportive self-management interventions in this population have largely been small studies with short term follow-up, they often did not report clinically relevant outcomes, or were conducted in different healthcare systems therefore difficult to translate into an NHS setting. These studies also did not necessarily focus on chronic headache but rather looked at headache with no frequency specified. Based on the results of our systematic review there may be potential for large gain through a combination of self-management education and appropriate use of prophylaxis and management of medication overuse headache in a chronic headache population. In order to develop the evidence base needed for self-management intervention for chronic headache there needs to be a carefully developed, piloted and evaluated intervention package which has been supported by good qualitative work on understanding outcomes of interest. There is therefore the need for a robust clinical and cost-effectiveness trial within an NHS setting. Objectives The objective is to answer the question: Amongst adults with chronic headache arising from migraine, chronic tension type headache or medication overuse headache, is the provision of a self-management support programme in addition to best usual NHS care clinically and cost effective

Socio-economic and demographic disparities in ownership and use of insecticide-treated bed nets for preventing malaria among rural reproductive-aged women in northern Ghana

Background Malaria continues to be a leading cause of morbidity and mortality in most countries in Sub-Saharan Africa. Insecticide-treated bed nets (ITNs) is one of the cost-effective interventions for preventing malaria in endemic settings. Ghana has made tremendous efforts to ensure widespread ownership and use of ITNs. However, national coverage statistics can mask important inequities that demand targeted attention. This study assesses the disparities in ownership and utilization of ITNs among reproductive-aged women in a rural impoverished setting of Ghana. Methods Population-based cross-sectional data of 3,993 women between the age of 15 and 49 years were collected in seven districts of the Upper East region of Ghana using a two-stage cluster sampling approach. Bivariate and multivariate regression models were used to assess the social, economic and demographic disparities in ownership and utilization of ITN and to compare utilization rates among women in households owning at least one ITN. Results As high as 79% of respondents were found to own ITN while 62% of ITN owners used them the night preceding the survey. We identified disparities in both ownership and utilization of ITNs in wealth index, occupational status, religion, and district of residence. Respondents in the relative richest wealth quintile were 74% more likely to own ITNs compared to those in the poorest quintile (p-value< 0.001, CI = 1.29–2.34) however, they were 33% less likely to use ITNs compared to the poorest (p-value = 0.01, CI = 0.50–0.91). Conclusion Interventions aimed at preventing and controlling malaria through the use of bed nets in rural Ghana and other similar settings should give more attention to disadvantage populations such as the poor and unemployed. Tailored massages and educational campaigns are required to ensure consistent use of treated bed nets

Measuring health-related quality of life in chronic headache: A comparative evaluation of the Chronic Headache Quality of Life Questionnaire and Headache Impact Test (HIT-6).

OBJECTIVE: To compare the quality and acceptability of a new headache-specific patient-reported measure, the Chronic Headache Quality of Life Questionnaire (CHQLQ) with the six-item Headache Impact Test (HIT-6), in people meeting an epidemiological definition of chronic headaches. METHODS: Participants in the feasibility stage of the Chronic Headache Education and Self-management Study (CHESS) (n = 130) completed measures three times during a 12-week prospective cohort study. Data quality, measurement acceptability, reliability, validity, responsiveness to change, and score interpretation were determined. Semi-structured cognitive interviews explored measurement relevance, acceptability, clarity, and comprehensiveness. RESULTS: Both measures were well completed with few missing items. The CHQLQ's inclusion of emotional wellbeing items increased its relevance to participant's experience of chronic headache. End effects were present at item level only for both measures. Structural assessment supported the three and one-factor solutions of the CHQLQ and HIT-6, respectively. Both the CHQLQ (range 0.87 to 0.94) and HIT-6 (0.90) were internally consistent, with acceptable temporal stability over 2 weeks (CHQLQ range 0.74 to 0.80; HIT-6 0.86). Both measures responded to change in headache-specific health at 12 weeks (CHQLQ smallest detectable change (improvement) range 3 to 5; HIT-6 2.1). CONCLUSIONS: While both measures are structurally valid, internally consistent, temporally stable, and responsive to change, the CHQLQ has greater relevance to the patient experience of chronic headache.Trial registration number: ISRCTN79708100. Registered 16th December 2015, http://www.isrctn.com/ISRCTN79708100

The child survival impact of the Ghana Essential Health Interventions Program: A health systems strengthening plausibility trial in Northern Ghana

Background: The Ghana Health Service in collaboration with partner institutions implemented a five-year primary health systems strengthening program known as the Ghana Essential Health Intervention Program (GEHIP). GEHIP was a plausibility trial implemented in an impoverished region of northern Ghana around the World Health Organizations (WHO) six pillars combined with community engagement, leadership development and grassroots political support, the program organized a program of training and action focused on strategies for saving newborn lives and community-engaged emergency referral services. This paper analyzes the effect of the GEHIP program on child survival. Methods: Birth history data assembled from baseline and endline surveys are used to assess the hazard of child mortality in GEHIP treatment and comparison areas prior to and after the start of treatment. Difference-in-differences (DiD) methods are used to compare mortality change over time among children exposed to GEHIP relative to children in the comparison area over the same time period. Models test the hypothesis that a package of systems strengthening activities improved childhood survival. Models adjusted for the potentially confounding effects of baseline differentials, secular mortality trends, household characteristics such as relative wealth and parental educational attainment, and geographic accessibility of clinical care. Results: The GEHIP combination of health systems strengthening activities reduced neonatal mortality by approximately one half (HR = 0.52, 95% CI = 0.28,0.98, p = 0.045). There was a null incremental effect of GEHIP on mortality of post-neonate infants (from 1 to 12 months old) (HR = 0.72; 95% CI = 0.30,1.79; p = 0.480) and post-infants (from 1 year to 5 years old) -(HR = 1.02; 95% CI = 0.55–1.90; p = 0.940). Age-specific analyses show that impact was concentrated among neonates. However, effect ratios for post-infancy were inefficiently assessed owing to extensive survival history censoring for the later months of childhood. Children were observed only rarely for periods over 40 months of age. Conclusion: GEHIP results show that a comprehensive approach to newborn care is feasible, if care is augmented by community-based nurses. It supports the assertion that if appropriate mechanisms are put in place to enable the various pillars of the health system as espoused by WHO in rural impoverished settings where childhood mortality is high, it could lead to accelerated reductions in mortality thereby increasing survival of children. Policy implications of the pronounced neonatal effect of GEHIP merit national review for possible scale-up

Measuring health-related quality of life in chronic headache:a comparative evaluation of the Chronic Headache Quality of Life Questionnaire and Headache Impact Test (HIT-6)

Objective: To compare the quality and acceptability of a new headache-specific patient-reported measure the Chronic Headache Quality of Life Questionnaire (CHQLQ), with the Headache Impact Test–6 item (HIT-6), in people meeting an epidemiological definition of chronic headaches.Methods: Participants in the feasibility stage of the Chronic Headache Education and Self-management Study (CHESS) (N=130) completed measures three times during a 12-week prospective cohort study. Data quality, measurement acceptability, reliability, validity, responsiveness to change, and score interpretation were determined. Semi-structured cognitive interviews explored measurement relevance, acceptability, clarity, and comprehensiveness.Results: Both measures were well completed with few missing items. The CHQLQ’s inclusion of emotional wellbeing items increased its relevance to participant’s experience of chronic headache. End effects were present at item level only for both measures. Structural assessment supported the three and one-factor solutions of the CHQLQ and HIT-6, respectively. Both the CHQLQ (range 0.87 to 0.94) and HIT-6 (0.90) were internally consistent, with acceptable temporal stability over 2-weeks (CHQLQ range 0.74 to 0.80; HIT-6 0.86). Both measures responded to change in headache-specific health at 12-weeks (CHQLQ smallest detectable change (improvement) range 3 to 5; HIT-6 2.1). Conclusions: While both measures are structurally valid, internally consistent, temporally stable and responsive to change, the CHQLQ has greater relevance to the patient experience of chronic headache. <br/

A methodological framework for assessing agreement between cost-effectiveness outcomes estimated using alternative sources of data on treatment costs and effects for trial-based economic evaluations

A new methodological framework for assessing agreement between cost-effectiveness endpoints generated using alternative sources of data on treatment costs and effects for trial-based economic evaluations is proposed. The framework can be used to validate cost-effectiveness endpoints generated from routine data sources when comparable data is available directly from trial case report forms or from another source. We illustrate application of the framework using data from a recent trial-based economic evaluation of the probiotic Bifidobacterium breve strain BBG administered to babies less than 31 weeks of gestation. Cost-effectiveness endpoints are compared using two sources of information; trial case report forms and data extracted from the National Neonatal Research Database (NNRD), a clinical database created through collaborative efforts of UK neonatal services. Focusing on mean incremental net benefits at £30,000 per episode of sepsis averted, the study revealed no evidence of discrepancy between the data sources (two-sided p values >0.4), low probability estimates of miscoverage (ranging from 0.039 to 0.060) and concordance correlation coefficients greater than 0.86. We conclude that the NNRD could potentially serve as a reliable source of data for future trial-based economic evaluations of neonatal interventions. We also discuss the potential implications of increasing opportunity to utilize routinely available data for the conduct of trial-based economic evaluations

Contraceptive use intentions and unmet need for family planning among reproductive-aged women in the Upper East Region of Ghana

Background Motivations for use of contraceptives vary across populations. While some women use contraceptives for birth spacing, others adopt contraception for stopping childbearing. As part of efforts to guide the policy framework to promote contraceptive utilization among women in Ghana, this paper examines the intentions for contraceptive use among reproductive-aged women in one of the most impoverished regions of Ghana. Methods This paper utilizes data collected in 2011 from seven districts in the Upper East Region of northern Ghana to examine whether women who reported the use of contraceptives did so for the purposes of stopping or spacing childbirth. A total of 5511 women were interviewed on various health and reproductive health related issues, including fertility and family planning behavior. Women were asked if they would like to have any more children (for those who already had children or those who were pregnant at the time of the survey). Results The prevalence of contraceptive use was low at 13%, while unmet need is highly pervasive and demand for family planning is predominantly for spacing future childbearing rather than for the purpose of stopping. Overall, about 31.7%of women not using contraceptives reported a need for spacing while 17.6% expressed a need for limiting. Thus, the latent demand for family planning is dominated by preferences for space rather than limiting childbearing. Conclusion Results show that there is latent demand for family planning and therefore if family planning programs are appropriately implemented they can yield the desired impact

Usual care and a self-management support programme versus usual care and a relaxation programme for people living with chronic headache disorders: a randomised controlled trial protocol (CHESS).

INTRODUCTION: Chronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches. METHODS AND ANALYSIS: Chronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained. ETHICS AND DISSEMINATION: This trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West - Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019. TRIAL REGISTRATION NUMBER: ISRCTN79708100

Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN)

Introduction Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. Methods We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethics and dissemination Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer-reviewed publications, including Health Technology Assessment, and presented at relevant conferences. Trial registration number ISRCTN64081839; Pre-results

Socio-economic and demographic determinants of under-five mortality in rural northern Ghana

Background: In spite of global decline in under-five mortality, the goal of achieving MDG 4 still remains largely unattained in low and middle income countries as the year 2015 closes-in. To accelerate the pace of mortality decline, proven interventions with high impact need to be implemented to help achieve the goal of drastically reducing childhood mortality. This paper explores the association between socio-economic and demographic factors and under-five mortality in an impoverished region in rural northern Ghana. Methods: We used survey data on 3975 women aged 15–49 who have ever given birth. First, chi-square test was used to test the association of social, economic and demographic characteristics of mothers with the experience of under-five death. Subsequently, we ran a logistic regression model to estimate the relative association of factors that influence childhood mortality after excluding variables that were not significant at the bivariate level. Results: Factors that significantly predict under-five mortality included mothers’ educational level, presence of co-wives, age and marital status. Mothers who have achieved primary or junior high school education were 45% less likely to experience under-five death than mothers with no formal education at all (OR = 0.55, p < 0.001). Monogamous women were 22% less likely to experience under-five deaths than mothers in polygamous marriages (OR = 0.78, p = 0.01). Similarly, mothers who were between the ages of 35 and 49 were about eleven times more likely to experience under-five deaths than those below the age of 20 years (OR = 11.44, p < 0.001). Also, women who were married had a 27% less likelihood (OR = 0.73, p = 0.01) of experiencing an under-five death than those who were single, divorced or widowed. Conclusion: Taken independently, maternal education, age, marital status and presence of co-wives are associated with childhood mortality. The relationship of these indicators with women’s autonomy, health seeking behavior, and other factors that affect child survival merit further investigation so that interventions could be designed to foster reductions in child mortality by considering the needs and welfare of women including the need for female education, autonomy and socioeconomic well-being