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Background A study within a trial (SWAT) is a self-contained research study embedded within one or more host trials to evaluate or explore alternative ways of delivering or organising a particular trial process. There is limited evidence of SWATs evaluating trial processes other than recruitment and retention. Purpose Embedding a SWAT into a host trial provides a potential method of evaluating an aspect of intervention implementation, such as engagement or compliance with the intervention. Research Design This paper presents two case studies of SWATs which aim to test the use of video animations to improve intervention implementation, with particular focus on enhancing understanding, engagement and compliance. These are important aspects of intervention implementation as they are directly linked to intervention effectiveness and therefore, important to study. Results In this paper, we present the potential benefits of conducting SWATs of intervention implementation processes as well as discussing the methodological considerations for embedding a SWAT of this nature within a host trial. Benefits include the opportunity to test minor refinements to intervention implementation within trials through robust randomised SWATs, and the possibility of increasing trial efficiency by maximising the quality or quantity of intervention implementation. Methodological considerations surrounding the design and conduct of the SWAT as well as statistical and health economics considerations are discussed in this paper. Conclusions This paper presents a novel application of SWAT methodology in investigating intervention implementation processes within trial conduct.

Background Care home residents are mainly inactive, leading to increased dependency and low mood. Although exercise classes may increase activity, a more sustainable model is to engage staff and residents in increasing routine activity. Objectives The objectives were to develop and preliminarily test strategies to enhance the routine physical activity of care home residents to improve their physical, psychological and social well-being through five overlapping workstreams. Design This trial had a mixed-methods research design to develop and test the feasibility of undertaking an evaluative study consisting of gaining an understanding of the opportunities for and barriers to enhancing physical activity in care homes (workstream 1); testing physical activity assessment instruments (workstream 2); developing an intervention through a process of intervention mapping (workstream 3); refining the provisional intervention in the care home setting and clarifying outcome measurement (workstream 4); and undertaking a cluster randomised feasibility trial of the intervention [introduced via three facilitated workshops at baseline (with physiotherapist input), 2 weeks (with artist input) and 2 months], with embedded process and health economic evaluations (workstream 5). Setting The trial was set in 12 residential care homes differing in size, location, ownership and provision in Yorkshire, UK. Participants The participants were elderly residents, carers, managers and staff of care homes. Intervention The intervention was MoveMore, designed for the whole home, to encourage and support the movement of residents in their daily routines. Main outcome measures The main outcome measures related to the feasibility and acceptability of implementing a full-scale trial in terms of recruitment and retention of care homes and residents, intervention delivery, completion and reporting of baseline data and outcomes (including hours of accelerometer wear, hours of sedentary behaviour and hours and type of physical activity), and safety and cost data (workstream 5). Results Workstream 1 – through a detailed understanding of life in a care home, a needs assessment was produced, and barriers to and facilitators of activity were identified. Key factors included ethos of care; organisation, management and delivery of care; use of space; and the residents’ daily routines. Workstream 2 – 22 (73.3%) out of 30 residents who wore a hip accelerometer had valid data (≥ 8 hours on ≥ 4 days of the week). Workstream 3 – practical mechanisms for increasing physical activity were developed, informed by an advisory group of stakeholders and outputs from workstreams 1 and 2, framed by the process of intervention mapping. Workstream 4 – action groups were convened in four care homes to refine the intervention, leading to further development of implementation strategies. The intervention, MoveMore, is a whole-home intervention involving engagement with a stakeholder group to implement a cyclical process of change to encourage and support the movement of residents in their daily routines. Workstream 5 – 12 care homes and 153 residents were recruited to the cluster randomised feasibility trial. Recruitment in the care homes varied (40–89%). Five care homes were randomised to the intervention and seven were randomised to usual care. Predetermined progression criteria were recruitment of care homes and residents (green); intervention delivery (amber); and data collection and follow-up – 52% of residents provided usable accelerometer data at 9 months (red), > 75% of residents had reported outcomes at 9 months (green, but self-reported resident outcomes were red), 26% loss of residents to follow-up at 9 months [just missing green criterion (no greater than 25%)] and safety concerns (green). Limitations Observations of residents’ movements were not conducted in private spaces. Working with care home residents to identify appropriate outcome measures was challenging. Take-up of the intervention was suboptimal in some sites. It was not possible to make a reliably informed decision on the most appropriate physical activity end point(s) for future use in a definitive trial. Conclusions A whole-home intervention was developed that was owned and delivered by staff and was informed by residents and staff. The feasibility of conducting a cluster randomised controlled trial was successfully tested: the target numbers of care homes and residents were recruited, demonstrating that it is possible to recruit care home residents to a cluster randomised trial, although this process was time-consuming and resource heavy. A large data set was collected, which provided a comprehensive picture of the environment, residents and staff in care homes. Extensive quantitative and qualitative work comprehensively explored a neglected area of health and social care research. Completion of ethnographic work in a range of settings enabled the production of an in-depth picture of life in care homes that will be helpful for other researchers considering organisational change in this setting. Future work The content and delivery of the intervention requires optimisation and the outcome measurement requires further refinement prior to undertaking a full trial evaluation. Consideration could be given to a recommended, simplified, core outcome set, which would facilitate data collection in this population. Trial registration Current Controlled Trials ISRCTN16076575. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grant for Applied Research programme and will be published in full in Programme Grant for Applied Research; Vol. 9, No. 9. See the NIHR Journals Library website for further project information.

Background Care home (CH) residents are mainly inactive, leading to increased dependency and low mood. Strategies to improve activity are required. Design and setting Cluster randomised controlled feasibility trial with embedded process and health economic evaluations. Twelve residential CHs in Yorkshire, United Kingdom, were randomised to the MoveMore intervention plus usual care (UC) (n = 5) or UC only (n = 7). Participants Permanent residents aged ≥65 years. Intervention MoveMore: a whole home intervention involving all CH staff designed to encourage and support increase in movement of residents. Objectives and measurements Feasibility objectives relating to recruitment, intervention delivery, data collection and follow-up and safety concerns informed the feasibility of progression to a definitive trial. Data collection at baseline, 3, 6 and 9 months included: participants’ physical function and mobility, perceived health, mood, quality of life, cognitive impairment questionnaires; accelerometry; safety data; intervention implementation. Results 300 residents were screened; 153 were registered (62 MoveMore; 91 UC). Average cluster size: MoveMore: 12.4 CHs; UC: 13.0 CHs. There were no CH/resident withdrawals. Forty (26.1%) participants were unavailable for follow-up: 28 died (12 MoveMore; 16 UC); 12 moved from the CH. Staff informant/proxy data collection for participants was >80%; data collection from participants was Conclusions Recruiting CHs and residents was feasible. Intervention implementation and data collection methods need refinement before a definitive trial. There were no safety concerns.

Objectives to compare care staff proxies with care home residents’ self-assessment of their health-related quality of life (HRQoL). Methods we assessed the degree of inter-rater reliability between residents and care staff proxies for the EQ-5D-5L index, domains and EQ Visual Analogue Scale at baseline, 3 months and 6 months, collected as part of the PATCH trial. We calculated kappa scores. Interpreted as 0.6 substantial to almost perfect agreement. Qualitative interviews with care staff and researchers explored the challenges of completing these questions. Results over 50% of the HRQoL data from residents was missing at baseline compared with a 100% completion rate by care staff proxies. A fair-to-moderate level of agreement was found for the EQ-5D-5L index. A higher level of agreement was achieved for the EQ-5D-5L domains of mobility and pain. Resident ‘non-completers’ were more likely to: be older, have stayed a longer duration in the care home, have lower Barthel Index and Physical Activity and Mobility in Residential Care (PAM-RC) scores, a greater number of co-morbidities and have joined the trial through consultee agreement. Interviews with staff and researchers indicated that it was easier to rate residents’ mobility levels than other domains, but in general it was difficult to obtain data from residents or to make an accurate proxy judgement for those with dementia. Conclusions whilst assessing HRQoL by care staff proxy completion provides a more complete dataset, uncertainty remains as to how representative these values are for different groups of residents within care homes.

IntroductionHeart failure affects 26 million people globally, approximately 900 thousand people in the UK, and is increasing in incidence. Appropriate management of medicines for heart failure at the time of hospital discharge reduces readmissions, improves quality of life and increases survival. The Improving the Safety and Continuity Of Medicines management at Transitions (ISCOMAT) trial tests the effectiveness of the Medicines at Transition Intervention (MaTI), which aims to enhance self-care and increase community pharmacy involvement in the medicines management of heart failure patients.Methods and analysisISCOMAT is a parallel-group cluster randomised controlled trial, randomising 42 National Health Service trusts with cardiology wards in England on a 1:1 basis to implement the MaTI or treatment as usual. Around 2100 patients over the age of 18 admitted to hospital with heart failure with at least moderate left ventricular systolic dysfunction within the last 5 years, and planned discharge to the geographical area of the cluster will be recruited. The MaTI consists of training for staff, a toolkit for participants, transfer of discharge information to community pharmacies and a medicines reconciliation/review. Treatment as usual is determined by local policy and practices. The primary outcome is a composite of all-cause mortality and heart failure-related hospitalisation at 12 months postregistration obtained from national electronic health records. The key secondary outcome is continued prescription of guideline-indicated therapies at 12 months measured via patient-reported data and Hospital Episode Statistics. The trial contains a parallel mixed-methods process evaluation and an embedded health economics study.Ethics and disseminationThe study obtained approval from the Yorkshire and the Humber—Bradford Leeds Research Ethics Committee; REC reference 18/YH/0017. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media. Amendments to the protocol are disseminated to all relevant parties as required.Trial registration numberISRCTN66212970; Pre-results.

Background The majority of older people (> 65 years) in hospital have frailty and are at increased risk of readmission or death following discharge home. In the UK, following acute hospitalisation, around one third of older people with frailty are referred on for rehabilitation, termed ‘intermediate care’ services. Although this rehabilitation can reduce early readmission to hospital ( Methods A multi-centre individually randomised controlled trial, to evaluate the clinical and cost-effectiveness of the HOPE programme. This individualised, graded and progressive 24-week exercise programme is delivered by NHS physiotherapy teams to people aged 65 and older with frailty, identified using the Clinical Frailty Scale, following discharge from acute hospitalisation and linked intermediate care rehabilitation pathways. The primary outcome is physical health-related quality of life, measured using the physical component summary score of the modified Short Form 36- item health questionnaire (SF36) at 12 months. Secondary outcomes include self-reported physical and mental health, functional independence, death, hospitalisations, care home admissions. Plans include health economic analyses and an embedded process evaluation. Discussion This trial seeks to determine if extended rehabilitation, via the HOPE programme, can improve physical health-related quality of life for older people with frailty following acute hospitalisation. Results will improve awareness of the rehabilitation needs of older people with frailty, and provide evidence on the clinical and cost-effectiveness of the targeted exercise intervention. There is potential for considerable benefit for health and social care services through widespread implementation of trial findings if clinical and cost-effectiveness is demonstrated. Trial registration ISRCTN 13927531. Registered on April 19, 2017.

Introduction Provision of care for care home residents with complex needs is challenging. Physiotherapists can play a major role in enhancing the confidence, skills and abilities of care home staff. The Skilful Care Training Package (SCTP) aims to provide staff with an understanding of good posture and training in skilled facilitation of movement. This process evaluation explored barriers and facilitators to delivery and uptake of the SCTP within the context of a feasibility cluster randomised controlled trial (cRCT) in 10 care homes. Methods A mixed methods process evaluation, incorporating non-participant observations and interviews, conducted in the five care homes receiving the SCTP intervention. Interviews were audio recorded and transcribed verbatim; resident conversations were captured via a Dictaphone and/or field-notes. Data analysis used the Framework approach. Results Fourteen staff training sessions were observed. Interviews with 22 staff and four trainers, and 13 conversations with residents were completed. Five factors influenced delivery and uptake of the SCTP:Organisational factors: strategies to publicise and facilitate access to training improved attendance; a convenient training location and trainer flexibility encouraged attendance and staff engagement.Intervention delivery: a practical participatory element to the training was highly valued; adapting the training to meet the needs of the homes was well-received.Engagement and interaction: relating training to workplace and residents’ experiences engaged staff; high levels of engagement and positive interaction within the training sessions were reported; challenges relating to staff hierarchy affected training delivery in some homes.Intervention content: posture and mobility elements were seen as important; however, some repetition with prior training was highlighted.Training impact: there were indications that staff adopted SCTP techniques. Staff reported an increase in their wellbeing and confidence in movement facilitation; cascade training was reported in some homes. Conclusions Training was well-received, and feedback on its impact was largely positive. Practical elements were viewed favourably over classroom-based learning. Intervention content should be revised to optimise focus and avoid overlap with other training.

International evidence indicates that older people with frailty are more likely to access social care services, compared to nonfrail older people. There is, however, no robust evidence on costs of social care provided for community-dwelling older people living with frailty in their own homes. The main objective of this study was to examine the relationship between community-dwelling older people living with frailty, defined using the cumulative deficit model, and annual formal social care costs for the 2012-2018 period. A secondary objective was to estimate formal social care spending for every 1% reduction in the number of older people who develop frailty over 1 year. Secondary analysis of prospective cohort data from two large nationally representative community-based cohort studies in England was performed. Respondents aged ≥75 were used in the main analysis and respondents aged 65-74 in sensitivity testing. We used regression tree modelling for formal social care cost analysis including frailty, age, gender, age at completing education and living with partner as key covariates. We employed a minimum node size stopping criteria to limit tree complexity and overfitting and applied 'bootstrap aggregating' to improve robustness. We assessed the impact of an intervention for every 1% decrease in the number of individuals who become frail over 1 year in England. Results show that frailty is the strongest predictor of formal social care costs. Mean social care costs for people who are not frail are £321, compared with £2,895 for individuals with frailty. For every 1% of nonfrail people not transitioning to frailty savings of £4.4 million in annual expenditures on formal social care in England are expected, not including expenditure on care homes. Given considerably higher costs for individuals classed as frail compared to nonfrail, a successful intervention avoiding or postponing the onset of frailty has the potential to considerably reduce social care costs.

Background Previous studies have summarized evidence on health-related quality of life for older people, identifying a range of measures that have been validated, but have not sought to present results by degree of frailty. Furthermore, previous studies did not typically use quality-of-life measures that generate an overall health utility score. Health utility scores are a necessary component of quality-adjusted life-year calculations used to estimate the cost-effectiveness of interventions. Methods We calculated normative estimates in mean and standard deviation for EQ-5D-5L, short-form 36-item health questionnaire in frailty (SF-36), and short-form 6-dimension (SF-6D) for a range of established frailty models. We compared response distributions across dimensions of the measures and investigated agreement using Bland-Altman and interclass correlation techniques. Results The EQ-5D-5L, SF-36, and SF-6D scores decrease and their variability increases with advancing frailty. There is strong agreement between the EQ-5D-5L and SF-6D across the spectrum of frailty. Agreement is lower for people who are most frail, indicating that different components of the 2 instruments may have greater relevance for people with advancing frailty in later life. There is a greater risk of ceiling effects using the EQ-5D-5L rather than the SF-6D. Conclusions We recommend the SF-36/SF-6D as an appropriate measure of health-related quality of life for clinical trials if fit older people are the planned target. In trials of interventions involving older people with increasing frailty, we recommend that both the EQ-5D-5L and SF36/SF6D are included, and are used in sensitivity analyses as part of cost-effectiveness evaluation.

Background Frailty is characterised by increased vulnerability to falls, disability, hospitalisation and care home admission. However, it is relatively reversible in the early stages. Older people living with frailty often have multiple health and social issues which are difficult to address but could benefit from proactive, person-centred care. Personalised care planning aims to improve outcomes through better self-management, care coordination and access to community resources. Methods This feasibility cluster randomised controlled trial aims to recruit 400 participants from 11 general practice clusters across Bradford and Leeds in the north of England. Eligible patients will be aged over 65 with an electronic frailty index score of 0.21 (identified via their electronic health record), living in their own homes, without severe cognitive impairment and not in receipt of end of life care. After screening for eligible patients, a restricted 1:1 cluster-level randomisation will be used to allocate practices to the PROSPER intervention, which will be delivered over 12 weeks by a personal independence co-ordinator worker, or usual care. Following initial consent, participants will complete a baseline questionnaire in their own home including measures of health-related quality of life, activities of daily living, depression and health and social care resource use. Follow-up will be at six and 12 months. Feasibility outcomes relate to progression criteria based around recruitment, intervention delivery, retention and follow-up. An embedded process evaluation will contribute to iterative intervention optimisation and logic model development by examining staff training, intervention implementation and contextual factors influencing delivery and uptake of the intervention. Discussion Whilst personalised care planning can improve outcomes in long-term conditions, implementation in routine settings is poor. We will evaluate the feasibility of conducting a cluster randomised controlled trial of personalised care planning in a community population based on frailty status. Key objectives will be to test fidelity of trial design, gather data to refine sample size calculation for the planned definitive trial, optimise data collection processes and optimise the intervention including training and delivery. Trial registration ISRCTN12363970 – 08/11/18.

Background provision of care for care home residents with complex needs is challenging. Physiotherapy and activity interventions can improve well-being but are often time-limited and resource intensive. A sustainable approach is to enhance the confidence and skills of staff who provide care. This trial assessed the feasibility of undertaking a definitive evaluation of a posture and mobility training programme for care staff. Design and setting a cluster randomised controlled feasibility trial with embedded process evaluation. Ten care homes in Yorkshire, United Kingdom, were randomised (1:1) to the skilful care training package (SCTP) or usual care (UC). Participants residents who were not independently mobile. Intervention SCTP—delivered by physiotherapists to care staff. Objectives and measurements key objectives informed progression to a definitive trial. Recruitment, retention and intervention uptake were monitored. Data, collected by a blinded researcher, included pain, posture, mobility, hospitalisations and falls. This informed data collection feasibility and participant safety. Results a total of 348 residents were screened; 146 were registered (71 UC, 75 SCTP). Forty two were lost by 6 months, largely due to deaths. While data collection from proxy informants was good (>95% expected data), attrition meant that data completion rates did not meet target. Data collection from residents was poor due to high levels of dementia. Intervention uptake was variable—staff attendance at all sessions ranged from 12.5 to 65.8%. There were no safety concerns. Conclusion care home and resident recruitment are feasible, but refinement of data collection approaches and intervention delivery are needed for this trial and care home research more widely.

Background Benefits of laparoscopic surgery are well recognised but uptake in rural settings of low- and middle-income countries is limited due to implementation barriers. Gasless laparoscopy has been proposed as an alternative but requires a trained rural surgical workforce to upscale. This study evaluates a feasibility of implementing a structured laparoscopic training programme for rural surgeons of North-East India. Methods A 3-day training programme was held at Kolkata Medical College in March 2019. Laparoscopic knowledge and Fundamentals of Laparoscopic Skills (FLS) were assessed pre and post simulation training using multiple choice questions and the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS), respectively. Competency with an abdominal lift device was assessed using the Objective Structured Assessment of Technical Skills (OSATS) and live operating performance via the Global Operative Assessment of Laparoscopic Skills (GOALS) scores during live surgery. Costs of the training programme and qualitative feedback were evaluated. Results Seven rural surgeons participated. There was an improvement in knowledge acquisition (mean difference in MCQ score 5.57 (SD = 4.47)). The overall normalised mean MISTELS score for the FLS tasks improved from 386.02 (SD 110.52) pre-to 524.40 (SD 94.98) post-training (p = 0.09). Mean OSATS score was 22.4 out of 35 (SD 3.31) indicating competency with the abdominal lift device whilst a mean GOALS score of 16.42 out of 25 (SD 2.07) indicates proficiency in performing diagnostic laparoscopy using the gasless technique during live operating. Costs of the course were estimated at 354 USD for trainees and 461 USD for trainers. Conclusion Structured training programme in gasless laparoscopy improves overall knowledge and skills acquisition in laparoscopic surgery for rural surgeons of North-East India. It is feasible to deliver a training programme in gasless laparoscopy for rural surgeons. Larger studies are needed to assess the benefits for wider adoption in a similar context., Highlights • Structured training in gasless laparoscopy is feasible for rural surgeons. • Demonstrates overall improvement in knowledge and skill acquisition. • The training environment is an essential component for rural surgeons. • Lower costs support wider adoption in LMIC.

Background There are more than a quarter of a million individuals aged ≥ 65 years who are resident in care homes in England and Wales. Care home residents have high levels of cognitive impairment, physical disability, multimorbidity and polypharmacy. Research is needed to ensure there are robust, evidence-based interventions to improve the quality of life of this frail group. However, there is a paucity of research studies in this area. Recruiting care homes and their residents to research is challenging. A feasibility, cluster randomised controlled trial was undertaken as part of a research programme to identify ways to develop and test methods to enhance the physical activity of care home residents. This paper describes two methods of recruiting care homes to the trial and draws out learning to inform future studies. Methods Eligible care homes met the following criteria: they were within a defined geographical area in the north of England; provided residential care for adults ≥ 65 years of age; had not previously been involved in the research programme; were not taking part in a conflicting study; were not recorded on the Care Quality Commission website as ‘inadequate’ or ‘requiring improvements’ in any area; and had ≥ 10 beds. Care homes were identified by a ‘systematic approach’ using the Care Quality Commission website database of care homes or a ‘targeted approach’ via a network of research-ready care homes. A standardised method was used to recruit care homes including eligibility screening; invitation letters; telephone contact; visits; formal letter of agreement. Results In the systematic approach, 377 care homes were screened, 230 (61%) were initially eligible and invited to participate, 11 were recruited (recruitment rate (RR) 4.8%). In the targeted approach, 15 care homes were invited to participate, two were recruited (RR 13.3%). Overall, 245 care homes were approached and 13 recruited (RR 5.3%). A variety of care homes were recruited to the trial in terms of size, location, ownership and care provision. Conclusions Systematic recruitment of care homes to the study was time-consuming and resource-heavy but led to a variety of care homes being recruited. The targeted approach led to a higher recruitment rate. Trial registration ISRCTN registry, ISRCTN16076575. Registered on 25 June 2015.

Background: Residents of care homes have high levels of disability and poor mobility, but the promotion of health and wellbeing within care homes is poorly realised. Residents spend the majority of their time sedentary which leads to increased dependency and, coupled with poor postural management, can have many adverse outcomes including pressure sores, pain and reduced social interaction. The intervention being tested in this project (the Skilful Care Training Package) aims to increase the awareness and skills of care staff in relation to poor posture in the older, less mobile adult and highlight the benefits of activity, and how to skilfully assist activity, in this group to enable mobility and reduce falls risk. Feasibility work will be undertaken to inform the design of a definitive cluster randomised controlled trial.\ud \ud \ud \ud Methods: This is a cluster randomised controlled feasibility trial, aiming to recruit at least 12–15 residents at each of 10 care homes across Yorkshire. Care homes will be randomly allocated on a 1:1 basis to receive either the Skilful Care Training Package alongside usual care or to continue to provide usual care alone. Assessments will be undertaken by blinded researchers with participating residents at baseline (before care home randomisation) and at three and six months post randomisation. Data relating to changes in physical activity, mobility, posture, mood and quality of life will be collected. Data at the level of the home will also be collected and will include staff experience of care and changes in the numbers and types of adverse events residents experience (for example, hospital admissions, falls). Details of NHS service usage will be collected to inform the economic analysis. An embedded process evaluation will explore intervention delivery and its acceptability to staff and residents.\ud \ud \ud \ud Discussion: Participant uptake, engagement and retention are key feasibility outcomes. Exploration of barriers and facilitators to intervention delivery will inform intervention optimisation. Study results will inform progression to a definitive trial and add to the body of evidence for good practice in care home research.\ud \ud \ud \ud Trial registration: ISRCTN Registry, ISRCTN50080330. Registered on 27 March 2017.

Since 2010, the World Health Organization has been recommending that all suspected cases of malaria be confirmed with parasite-based diagnosis before treatment. These guidelines represent a paradigm shift away from presumptive antimalarial treatment of fever. Malaria rapid diagnostic tests (mRDTs) are central to implementing this policy, intended to target artemisinin-based combination therapies (ACT) to patients with confirmed malaria and to improve management of patients with nonmalarial fevers. The ACT Consortium conducted ten linked studies, eight in sub-Saharan Africa and two in Afghanistan, to evaluate the impact of mRDT introduction on case management across settings that vary in malaria endemicity and healthcare provider type. This synthesis includes 562,368 outpatient encounters (study size range 2,400–432,513). mRDTs were associated with significantly lower ACT prescription (range 8–69% versus 20–100%). Prescribing did not always adhere to malaria test results; in several settings, ACTs were prescribed to more than 30% of test-negative patients or to fewer than 80% of test-positive patients. Either an antimalarial or an antibiotic was prescribed for more than 75% of patients across most settings; lower antimalarial prescription for malaria test-negative patients was partly offset by higher antibiotic prescription. Symptomatic management with antipyretics alone was prescribed for fewer than 25% of patients across all scenarios. In community health worker and private retailer settings, mRDTs increased referral of patients to other providers. This synthesis provides an overview of shifts in case management that may be expected with mRDT introduction and highlights areas of focus to improve design and implementation of future case management programs.

Background The World Health Organisation (WHO) recommends parasitological diagnosis of malaria before treatment, but use of malaria rapid diagnostic tests (mRDTs) by community health workers (CHWs) has not been fully tested within health services in south and central Asia. mRDTs could allow CHWs to diagnose malaria accurately, improving treatment of febrile illness. Methods A cluster randomised trial in community health services was undertaken in Afghanistan. The primary outcome was the proportion of suspected malaria cases correctly treated for polymerase chain reaction (PCR)-confirmed malaria and PCR negative cases receiving no antimalarial drugs measured at the level of the patient. CHWs from 22 clusters (clinics) received standard training on clinical diagnosis and treatment of malaria; 11 clusters randomised to the intervention arm received additional training and were provided with mRDTs. CHWs enrolled cases of suspected malaria, and the mRDT results and treatments were compared to blind-read PCR diagnosis. Results In total, 256 CHWs enrolled 2400 patients with 2154 (89.8%) evaluated. In the intervention arm, 75.3% (828/1099) were treated appropriately vs. 17.5% (185/1055) in the control arm (cluster adjusted risk ratio: 3.72, 95% confidence interval 2.40–5.77; p

BACKGROUND: Malaria rapid diagnostic tests (RDTs) are a valid alternative to malaria testing with microscopy and are recommended for the testing of febrile patients before prescribing an antimalarial. There is a need for interventions to support the uptake of RDTs by health workers. OBJECTIVE: To evaluate the cost-effectiveness of introducing RDTs with basic or enhanced training in health facilities in which microscopy was available, compared with current practice. METHODS: A three-arm cluster randomized trial was conducted in 46 facilities in central and northwest Cameroon. Basic training had a practical session on RDTs and lectures on malaria treatment guidelines. Enhanced training included small-group activities designed to change health workers' practice and reduce the consumption of antimalarials among test-negative patients. The primary outcome was the proportion of febrile patients correctly treated: febrile patients should be tested for malaria, artemisinin combination therapy should be prescribed for confirmed cases, and no antimalarial should be prescribed for patients who are test-negative. Individual patient data were obtained from facility records and an exit survey. Costs were estimated from a societal perspective using project reports and patient exit data. The analysis used bivariate multilevel modeling and adjusted for imbalance in baseline covariates. RESULTS: Incremental cost per febrile patient correctly treated was $8.40 for the basic arm and $3.71 for the enhanced arm. On scale-up, it was estimated that RDTs with enhanced training would save $0.75 per additional febrile patient correctly treated. CONCLUSIONS: Introducing RDTs with enhanced training was more cost-effective than RDTs with basic training when each was compared with current practice.

Rigorous evidence of "what works" to improve health care is in demand, but methods for the development of interventions have not been scrutinized in the same ways as methods for evaluation. This article presents and examines intervention development processes of eight malaria health care interventions in East and West Africa. A case study approach was used to draw out experiences and insights from multidisciplinary teams who undertook to design and evaluate these studies. Four steps appeared necessary for intervention design: (1) definition of scope, with reference to evaluation possibilities; (2) research to inform design, including evidence and theory reviews and empirical formative research; (3) intervention design, including consideration and selection of approaches and development of activities and materials; and (4) refining and finalizing the intervention, incorporating piloting and pretesting. Alongside these steps, projects produced theories, explicitly or implicitly, about (1) intended pathways of change and (2) how their intervention would be implemented.The work required to design interventions that meet and contribute to current standards of evidence should not be underestimated. Furthermore, the process should be recognized not only as technical but as the result of micro and macro social, political, and economic contexts, which should be acknowledged and documented in order to infer generalizability. Reporting of interventions should go beyond descriptions of final intervention components or techniques to encompass the development process. The role that evaluation possibilities play in intervention design should be brought to the fore in debates over health care improvement.

In Uganda, as in many parts of Africa, the majority of the population seek treatment for malaria in drug shops as their first point of care; however, parasitological diagnosis is not usually offered in these outlets. Rapid diagnostic tests (RDTs) for malaria have attracted interest in recent years as a tool to improve malaria diagnosis, since they have proved accurate and easy to perform with minimal training. Although RDTs could feasibly be performed by drug shop vendors, it is not known how much customers would be willing to pay for an RDT if offered in these settings. We conducted a contingent valuation survey among drug shop customers in Mukono District, Uganda. Exit interviews were undertaken with customers aged 15 years and above after leaving a drug shop having purchased an antimalarial and/or paracetamol. The bidding game technique was used to elicit the willingness-to-pay (WTP) for an RDT and a course of artemisinin-based combination therapy (ACT) with and without RDT confirmation. Factors associated with WTP were investigated using linear regression. The geometric mean WTP for an RDT was US$0.53, US$1.82 for a course of ACT and US$2.05 for a course of ACT after a positive RDT. Factors strongly associated with a higher WTP for these commodities included having a higher socio-economic status, no fever/malaria in the household in the past 2 weeks and if a malaria diagnosis had been obtained from a qualified health worker prior to visiting the drug shop. The findings further suggest that the WTP for an RDT and a course of ACT among drug shop customers is considerably lower than prevailing and estimated end-user prices for these commodities. Increasing the uptake of ACTs in drug shops and restricting the sale of ACTs to parasitologically confirmed malaria will therefore require additional measures.

SUMMARYThis study quantifies the rate and intensity of re-infection with human hookworm and Schistosoma mansoni infection 12 months following successful treatment, and investigates the influence of socio-economic, geographical and environmental factors. A longitudinal study of 642 individuals aged over 5 years was conducted in Minas Gerais State, Brazil from June 2004 to March 2006. Risk factors were assessed using interval censored regression for the rate and negative binomial regression for intensity. The crude rate and intensity of hookworm re-infection was 0·21 per year (95% confidence interval (CI) 0·15–0·29) and 70·9 epg (95% CI 47·2–106·6). For S. mansoni the rate was 0·06 per year (95% CI 0·03–0·10) and intensity 6·51 epg (95% CI 3·82–11·11). Rate and intensity of re-infection with hookworm were highest among males and positively associated with previous infection status, absence of a toilet and house structure. Rate and intensity of S. mansoni re-infection were associated with previous infection status as well as geographical, environmental and socio-economic factors. The implications of findings for the design of anti-helminth vaccine trials are discussed.

Vaccines against human helminths are being developed but the choice of optimal parasitological endpoints and effect measures to assess their efficacy has received little attention. Assuming negative binomial distributions for the parasite counts, we rank the statistical power of three measures of efficacy: ratio of mean parasite intensity at the end of the trial, the odds ratio of infection at the end of the trial, and the rate ratio of incidence of infection during the trial. We also use a modelling approach to estimate the likely impact of trial interventions on the force of infection, and hence statistical power. We conclude that (1) final mean parasite intensity is a suitable endpoint for later phase vaccine trials, and (2) mass effects of trial interventions are unlikely to appreciably reduce the force of infection in the community – and hence statistical power – unless there is a combination of high vaccine efficacy and a large proportion of the population enrolled.

Background. Predisposition to heavy or light human hookworm infection is consistently reported in treatment-reinfection studies. A significant role for host genetics in determining hookworm infection intensity has also been shown, but the relationship between host genetics and predisposition has not been investigated. Methods. A treatment-reinfection study was conducted among 1302 individuals in Brazil. Bivariate variance components analysis was used to estimate heritability for pretreatment and reinfection intensity and to estimate the contribution of genetic and household correlations between phenotypes to the overall phenotypic correlation (ie, predisposition). Results. Heritability for hookworm egg count was 17% before treatment and 25% after reinfection. Predisposition to heavy or light hookworm infection was observed, with a phenotypic correlation of 0.34 between pretreatment and reinfection intensity. This correlation was reduced to 0.23 after including household and environmental covariates. Genetic and household correlations were 0.41 and 1, respectively, and explained 88% of the adjusted phenotypic correlation. Conclusions. Predisposition to human hookworm infection in this area results from a combination of host genetics and consistent differences in exposure, with the latter explained by household and environmental factors. Unmeasured individual-specific differences in exposure did not contribute to predisposition.

UNLABELLED: The World Health Organization recommends that malaria be confirmed by parasitological diagnosis before treatment using Artemisinin-based Combination Therapy (ACT). Despite this, many health workers in malaria endemic countries continue to diagnose malaria based on symptoms alone. This study evaluates interventions to help bridge this gap between guidelines and provider practice. A stratified cluster-randomized trial in 42 communities in Enugu state compared 3 scenarios: Rapid Diagnostic Tests (RDTs) with basic instruction (control); RDTs with provider training (provider arm); and RDTs with provider training plus a school-based community intervention (provider-school arm). The primary outcome was the proportion of patients treated according to guidelines, a composite indicator requiring patients to be tested for malaria and given treatment consistent with the test result. The primary outcome was evaluated among 4946 (93%) of the 5311 patients invited to participate. A total of 40 communities (12 in control, 14 per intervention arm) were included in the analysis. There was no evidence of differences between the three arms in terms of our composite indicator (p = 0.36): stratified risk difference was 14% (95% CI -8.3%, 35.8%; p = 0.26) in the provider arm and 1% (95% CI -21.1%, 22.9%; p = 0.19) in the provider-school arm, compared with control. The level of testing was low across all arms (34% in control; 48% provider arm; 37% provider-school arm; p = 0.47). Presumptive treatment of uncomplicated malaria remains an ingrained behaviour that is difficult to change. With or without extensive supporting interventions, levels of testing in this study remained critically low. Governments and researchers must continue to explore alternative ways of encouraging providers to deliver appropriate treatment and avoid the misuse of valuable medicines. TRIAL REGISTRATION: ClinicalTrials.gov NCT01350752.

Background Sample size calculations should correspond to the intended method of analysis. Nevertheless, for non-normal distributions, they are often done on the basis of normal approximations, even when the data are to be analysed using generalized linear models (GLMs). Methods For the case of comparison of two means, we use GLM theory to derive sample size formulae, with particular cases being the negative binomial, Poisson, binomial, and gamma families. By simulation we estimate the performance of normal approximations, which, via the identity link, are special cases of our approach, and for common link functions such as the log. The negative binomial and gamma scenarios are motivated by examples in hookworm vaccine trials and insecticide-treated materials, respectively. Results Calculations on the link function (log) scale work well for the negative binomial and gamma scenarios examined and are often superior to the normal approximations. However, they have little advantage for the Poisson and binomial distributions. Conclusions The proposed method is suitable for sample size calculations for comparisons of means of highly skewed outcome variables. Electronic supplementary material The online version of this article (doi:10.1186/s12874-015-0023-0) contains supplementary material, which is available to authorized users.

OBJECTIVE: To examine the impact of providing rapid diagnostic tests for malaria on fever management in private drug retail shops where most poor rural people with fever present, with the aim of reducing current massive overdiagnosis and overtreatment of malaria. DESIGN: Cluster randomized trial of 24 clusters of shops. SETTING: Dangme West, a poor rural district of Ghana. PARTICIPANTS: Shops and their clients, both adults and children. INTERVENTIONS: Providing rapid diagnostic tests with realistic training. MAIN OUTCOME MEASURES: The primary outcome was the proportion of clients testing negative for malaria by a double-read research blood slide who received an artemisinin combination therapy or other antimalarial. Secondary outcomes were use of antibiotics and antipyretics, and safety. RESULTS: Of 4603 clients, 3424 (74.4%) tested negative by double-read research slides. The proportion of slide-negative clients who received any antimalarial was 590/1854 (32%) in the intervention arm and 1378/1570 (88%) in the control arm (adjusted risk ratio 0.41 (95% CI 0.29 to 0.58), P

BACKGROUND: Inappropriate treatment of malaria is widely reported particularly in areas where there is poor access to health facilities and self-treatment of fevers with anti-malarial drugs bought in shops is the most common form of care-seeking. The main objective of the study was to examine the impact of introducing rapid diagnostic tests for malaria (mRDTs) in registered drug shops in Uganda, with the aim to increase appropriate treatment of malaria with artemisinin-based combination therapy (ACT) in patients seeking treatment for fever in drug shops.METHODS: A cluster-randomized trial of introducing mRDTs in registered drug shops was implemented in 20 geographical clusters of drug shops in Mukono district, central Uganda. Ten clusters were randomly allocated to the intervention (diagnostic confirmation of malaria by mRDT followed by ACT) and ten clusters to the control arm (presumptive treatment of fevers with ACT). Treatment decisions by providers were validated by microscopy on a reference blood slide collected at the time of consultation. The primary outcome was the proportion of febrile patients receiving appropriate treatment with ACT defined as: malaria patients with microscopically-confirmed presence of parasites in a peripheral blood smear receiving ACT or rectal artesunate, and patients with no malaria parasites not given ACT.FINDINGS: A total of 15,517 eligible patients (8672 intervention and 6845 control) received treatment for fever between January-December 2011. The proportion of febrile patients who received appropriate ACT treatment was 72·9% versus 33·7% in the control arm; a difference of 36·1% (95% CI: 21·3 - 50·9), pCONCLUSION: Diagnostic testing with mRDTs compared to presumptive treatment of fevers implemented in registered drug shops substantially improved appropriate treatment of malaria with ACT.TRIAL REGISTRATION: ClinicalTrials.gov NCT01194557.

Background Intimate partner violence (IPV) and HIV are important and interconnected public health concerns. While it is recognized that they share common social drivers, there is limited evidence surrounding the potential of community interventions to reduce violence and HIV risk at the community level. The SASA! study assessed the community-level impact of SASA!, a community mobilization intervention to prevent violence and reduce HIV-risk behaviors. Methods From 2007 to 2012 a pair-matched cluster randomized controlled trial (CRT) was conducted in eight communities (four intervention and four control) in Kampala, Uganda. Cross-sectional surveys of a random sample of community members, 18- to 49-years old, were undertaken at baseline (n = 1,583) and four years post intervention implementation (n = 2,532). Six violence and HIV-related primary outcomes were defined a priori. An adjusted cluster-level intention-to-treat analysis compared outcomes in intervention and control communities at follow-up. Results The intervention was associated with significantly lower social acceptance of IPV among women (adjusted risk ratio 0.54, 95% confidence interval (CI) 0.38 to 0.79) and lower acceptance among men (0.13, 95% CI 0.01 to 1.15); significantly greater acceptance that a woman can refuse sex among women (1.28, 95% CI 1.07 to 1.52) and men (1.31, 95% CI 1.00 to 1.70); 52% lower past year experience of physical IPV among women (0.48, 95% CI 0.16 to 1.39); and lower levels of past year experience of sexual IPV (0.76, 95% CI 0.33 to 1.72). Women experiencing violence in intervention communities were more likely to receive supportive community responses. Reported past year sexual concurrency by men was significantly lower in intervention compared to control communities (0.57, 95% CI 0.36 to 0.91). Conclusions This is the first CRT in sub-Saharan Africa to assess the community impact of a mobilization program on the social acceptability of IPV, the past year prevalence of IPV and levels of sexual concurrency. SASA! achieved important community impacts, and is now being delivered in control communities and replicated in 15 countries. Trial registration ClinicalTrials.gov #NCT00790959, Study protocol available at http://www.trialsjournal.com/content/13/1/96 Electronic supplementary material The online version of this article (doi:10.1186/s12916-014-0122-5) contains supplementary material, which is available to authorized users.

BACKGROUND: An intervention was designed to introduce rapid diagnostics tests for malaria (mRDTs) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy (ACT). We conducted participatory training of drug shop vendors and implemented supporting interventions to orientate local communities (patients) and the public sector (health facility staff and district officials) to the behavioral changes in diagnosis, treatment and referral being introduced in drug shops. The intervention was designed to be evaluated through a cluster randomized trial. In this paper, we present detailed design, implementation and evaluation experiences in order to help inform future studies of a complex nature.METHODS: Three preparatory studies (formative, baseline and willingness-to-pay) were conducted to explore perceptions on diagnosis and treatment of malaria at drug shops, and affordable prices for mRDTs and ACTs in order to inform the design of the intervention and implementation modalities. The intervention required careful design with the intention to be acceptable, sustainable and effective. Critical components of intervention were: community sensitization and creating awareness, training of drug shop vendors to diagnose malaria with mRDTs, treat and refer customers to formal health facilities, giving pre-referral rectal artesunate and improved record-keeping. The primary outcome was the proportion of patients receiving appropriately-targeted treatment with ACT, evaluated against microscopy on a research blood slide.RESULTS: Introducing mRDTs in drug shops may seem simple, but our experience of intervention design, conduct and evaluation showed this to be a complex process requiring multiple interventions and evaluation components drawing from a combination of epidemiological, social science and health economics methodologies. The trial was conducted in phases sequenced such that each benefited from the other.CONCLUSIONS: The main challenges in designing this trial were maintaining a balance between a robust intervention to support effective behaviour change and introducing practices that would be sustainable in a real-life situation in tropical Africa; as well as achieving a detailed evaluation without inadvertently influencing prescribing behaviour.Trial registration: Trial registration: NCT01194557 registered with ClinicalTrials.gov 2 September 2010.