David R. Ellard

Whole home exercise intervention for depression in older care home residents (the OPERA study): a process evaluation

BackgroundThe ‘Older People’s Exercise intervention in Residential and nursing Accommodation’ (OPERA) cluster randomised trial evaluated the impact of training for care home staff together with twice-weekly, physiotherapist-led exercise classes on depressive symptoms in care home residents, but found no effect. We report a process evaluation exploring potential explanations for the lack of effect.MethodsThe OPERA trial included over 1,000 residents in 78 care homes in the UK. We used a mixed methods approach including quantitative data collected from all homes. In eight case study homes, we carried out repeated periods of observation and interviews with residents, care staff and managers. At the end of the intervention, we held focus groups with OPERA research staff. We reported our first findings before the trial outcome was known.ResultsHomes showed large variations in activity at baseline and throughout the trial. Overall attendance rate at the group exercise sessions was low (50%). We considered two issues that might explain the negative outcome: whether the intervention changed the culture of the homes, and whether the residents engaged with the intervention. We found low levels of staff training, few home champions for the intervention and a culture that prioritised protecting residents from harm over encouraging activity. The trial team delivered 3,191 exercise groups but only 36% of participants attended at least 1 group per week and depressed residents attended significantly fewer groups than those who were not depressed. Residents were very frail and therefore most groups only included seated exercises.ConclusionsThe intervention did not change the culture of the homes and, in the case study homes, activity levels did not change outside the exercise groups. Residents did not engage in the exercise groups at a sufficient level, and this was particularly true for those with depressive symptoms at baseline. The physical and mental frailty of care home residents may make it impossible to deliver a sufficiently intense exercise intervention to impact on depressive symptoms.

A systematic review of the effects of physical activity on physical functioning, quality of life and depression in older people with dementia

Depression is common in older people with dementia. Physical activity is effective in reducing depression in adults but there is limited evidence about its effectiveness in people with dementia.

Information and self‐management needs of people living with bleeding disorders: a survey

Summary.  The aim of the study was to conduct a survey of information and self‐management needs among members of the UK Haemophilia Society (HS). Of 1082 members mailed, 307 took part in the survey, the mean age was 52.4 years (SD 14.8), 85% were male, 96% white and 66% were living with haemophilia A. 90% felt that there is a lack of understanding amongst the public regarding bleeding disorders, 76% felt that health professionals understood their health and information needs and 32% had experienced problems managing anxiety and or depression. Results suggest that there was a ‘stigma’ attached to having a bleeding disorder and almost half are very careful about informing others that they have a bleeding disorder. Self‐efficacy was relatively high within the sample. Many respondents wanted to be kept informed about current research and the opportunity to participate in research. Women experienced a greater need for more information than men, particularly in the area of the ‘medical management’ and ‘emotional’ topics. Men appeared to need more information and or training on ‘physical’ aspects such as physiotherapy and joint replacement. The study provides an insight into the educational and self‐management needs of those affected by bleeding disorders and highlights the importance of providing accessible information.

Fidelity in complex behaviour change interventions: a standardised approach to evaluate intervention integrity

Objectives The aim of this study was to (1) demonstrate the development and testing of tools and procedures designed to monitor and assess the integrity of a complex intervention for chronic pain (COping with persistent Pain, Effectiveness Research into Self-management (COPERS) course); and (2) make recommendations based on our experiences. Design Fidelity assessment of a two-arm randomised controlled trial intervention, assessing the adherence and competence of the facilitators delivering the intervention. Setting The intervention was delivered in the community in two centres in the UK: one inner city and one a mix of rural and urban locations. Participants 403 people with chronic musculoskeletal pain were enrolled in the intervention arm and 300 attended the self-management course. Thirty lay and healthcare professionals were trained and 24 delivered the courses (2 per course). We ran 31 courses for up to 16 people per course and all were audio recorded. Interventions The course was run over three and a half days; facilitators delivered a semistructured manualised course. Outcomes We designed three measures to evaluate fidelity assessing adherence to the manual, competence and overall impression. Results We evaluated a random sample of four components from each course (n=122). The evaluation forms were reliable and had good face validity. There were high levels of adherence in the delivery: overall adherence was two (maximum 2, IQR 1.67–2.00), facilitator competence exhibited more variability, and overall competence was 1.5 (maximum 2, IQR 1.25–2.00). Overall impression was three (maximum 4, IQR 2.00–3.00). Conclusions Monitoring and assessing adherence and competence at the point of intervention delivery can be realised most efficiently by embedding the principles of fidelity measurement within the design stage of complex interventions and the training and assessment of those delivering the intervention. More work is necessary to ensure that more robust systems of fidelity evaluation accompany the growth of complex interventions. Trial Registration ISRCTN No ISRCTN24426731.

The OPERA trial: a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation

BackgroundThe OPERA trial is large cluster randomised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people. A process evaluation was commissioned alongside the trial and we report the protocol for this process evaluation. Challenges included the cognitive and physical ability of the participants, the need to respect the privacy of all home residents, including study non-participants, and the physical structure of the homes. Evaluation activity had to be organised around the structured timetable of homes, leaving limited opportunities for data collection. The aims of this process evaluation are to provide findings that will assist in the interpretation of the clinical trial results, and to inform potential implementation of the physical activity intervention on a wider scale.Methods/designQuantitative data on recruitment of homes and individuals is being collected. For homes in the intervention arm, data on dose and fidelity of the intervention delivered; including individual rates of participation in exercise classes are collected. In the control homes, uptake and delivery of depression awareness training is monitored. These data will be combined with qualitative data from an in-depth study of a purposive sample of eight homes (six intervention and two control).DiscussionAlthough process evaluations are increasingly funded alongside trials, it is still rare to see the findings published, and even rarer to see the protocol for such an evaluation published. Process evaluations have the potential to assist in interpreting and understanding trial results as well as informing future roll-outs of interventions. If such evaluations are funded they should also be reported and reviewed in a similar way to the trial outcome evaluation.Trial RegistrationISRCTN No: ISRCTN43769277

Can training in advanced clinical skills in obstetrics, neonatal care and leadership, of non-physician clinicians in Malawi impact on clinical services improvements (the ETATMBA project): a process evaluation

Objectives The ‘enhancing human resources and the use of appropriate technologies for maternal and perinatal survival in sub-Saharan Africa’ (ETATMBA) project is training emergency obstetric and new-born care (EmONC) non-physician clinicians (NPCs) as advanced clinical leaders. Our objectives were to evaluate the implementation and changes to practice. Design A mixed methods process evaluation with the predominate methodology being qualitative. Setting Rural and urban hospitals in 8 of the 14 districts of northern and central Malawi. Participants 54 EmONC NPCs with 3 years’ plus experience. Intervention Training designed and delivered by clinicians from the UK and Malawi; it is a 2-year plus package of training (classroom, mentorship and assignments). Results We conducted 79 trainee interviews over three time points during the training, as well as a convenience sample of 10 colleagues, 7 district officers and 2 UK obstetricians. Trainees worked in a context of substantial variation in the rates of maternal and neonatal deaths between districts. Training reached trainees working across the target regions. For 46 trainees (8 dropped out of the course), dose delivered in terms of attendance was high and all 46 spent time working alongside an obstetrician. In early interviews trainees recalled course content unprompted indicating training had been received. Colleagues and district officers reported cascading of knowledge and initial changes in practice indicating early implementation. By asking trainees to describe actual cases we found they had implemented new knowledge and skills. These included life-saving interventions for postpartum haemorrhage and eclampsia. Trainees identified the leadership training as enabling them to confidently change their own practice and initiate change in their health facility. Conclusions This process evaluation suggests that trainees have made positive changes in their practice. Clear impacts on maternal and perinatal mortality are yet to be elucidated.

Identifying potential moderators for response to treatment in low back pain: A systematic review

BACKGROUND Identifying which patients with non-specific low back pain are likely to gain the greatest benefit from different treatments is an important research priority. Few studies are large enough to produce data on sub-group effects from different treatments. Data from existing large studies may help identify potential moderators to use in future individual patient data meta-analyses. OBJECTIVE To systematically review papers of therapist delivered interventions for low back pain to identify potential moderators to inform an individual patient data meta-analysis. DATA SOURCES We searched MEDLINE, EMBASE, Web of Science and Citation Index and Cochrane Register of Controlled Trials (CENTRALhttp://www.cochrane.org/editorial-and-publishing-policy-resource/cochrane-central-register-controlled-trials-central) for relevant papers. DATA EXTRACTION AND DATA SYNTHESIS We screened for randomised controlled trials with ≥500 or more participants, and cohort studies of ≥1000 or more participants. We examined all publications related to these studies for any reported moderator analyses. Two reviewers independently did risk of bias assessment of main results and quality assessment of any moderator analyses. RESULTS We included four randomised trials (n=7208). Potential moderators with strong evidence (p<0.05) in one or more studies were age, employment status and type, back pain status, narcotic medication use, treatment expectations and education. Potential moderators with weaker evidence (0.05<p≤0.20) included gender, psychological distress, pain/disability and quality of life. CONCLUSION There are insufficient robust data on moderators to be useful in clinical practice. This review has identified some important potential moderators of treatment effect worthy of testing in future confirmatory analyses.

Primary outcome measure use in back pain trials may need radical reassessment.

BackgroundThe answers to patient reported outcome measures and global transition questions for back pain can be discordant. For example, the most commonly used outcome measure in back pain trials, the Roland Morris Disability Questionnaire (RMDQ), can show improvement even though participants say that their back pain is worse. This gives cause for concern as transition questions are used as anchors to estimate minimally important change (MIC) thresholds on patient reported outcome measures such as the RMDQ. We aimed to explore and compare what people with back pain think when they respond to a transition question and when they complete the RMDQ.MethodsWe purposively sampled people enrolled on a back pain randomised controlled trial who completed the RMDQ and two transition questions. One enquired about change in ability to perform tasks, the other about change in back pain. We sampled participants with discordance (in both directions), and participants with concordant scores. We explored participants’ thought processes using in-depth interviews.ResultsWe completed 35 in-depth interviews. People with discordant RMDQ change and transition question responses attend to different factors when responding to transition questions compared to people with concordant scores. In particular, those for whom the RMDQ change indicated greater improvement than transition questions, prioritised their pain ahead of functional disability. When completing the RMDQ, participants’ thought processes were comparatively more objective, and specific to each statement.ConclusionApproaches to primary outcome assessment in back pain needs re-assessment. The RMDQ may be unsuitable for use as a primary outcome measure since patients may not attend to thinking about their back pain when completing it: patients’ abilities to cope with tasks can be independent of the change in their back pain. Some participants who improve on the RMDQ consider themselves globally worse. As transition questions can be driven by pain and other physical factors, transition questions should not be used to anchor minimally important change thresholds on the RMDQ.

The impact of training non-physician clinicians in Malawi on maternal and perinatal mortality: a cluster randomised controlled evaluation of the enhancing training and appropriate technologies for mothers and babies in Africa (ETATMBA) project

BackgroundMaternal mortality in much of sub-Saharan Africa is very high whereas there has been a steady decline in over the past 60 years in Europe. Perinatal mortality is 12 times higher than maternal mortality accounting for about 7 million neonatal deaths; many of these in sub-Saharan countries. Many of these deaths are preventable. Countries, like Malawi, do not have the resources nor highly trained medical specialists using complex technologies within their healthcare system. Much of the burden falls on healthcare staff other than doctors including non-physician clinicians (NPCs) such as clinical officers, midwives and community health-workers. The aim of this trial is to evaluate a project which is training NPCs as advanced leaders by providing them with skills and knowledge in advanced neonatal and obstetric care. Training that will hopefully be cascaded to their colleagues (other NPCs, midwives, nurses).Methods/designThis is a cluster randomised controlled trial with the unit of randomisation being the 14 districts of central and northern Malawi (one large district was divided into two giving an overall total of 15). Eight districts will be randomly allocated the intervention. Within these eight districts 50 NPCs will be selected and will be enrolled on the training programme (the intervention). Primary outcome will be maternal and perinatal (defined as until discharge from health facility) mortality. Data will be harvested from all facilities in both intervention and control districts for the lifetime of the project (3–4 years) and comparisons made. In addition a process evaluation using both quantitative and qualitative (e.g. interviews) will be undertaken to evaluate the intervention implementation.DiscussionEducation and training of NPCs is a key to improving healthcare for mothers and babies in countries like Malawi. Some of the challenges faced are discussed as are the potential limitations. It is hoped that the findings from this trial will lead to a sustainable improvement in healthcare and workforce development and training.Trial registrationISRCTN63294155

Can training non-physician clinicians/associate clinicians (NPCs/ACs) in emergency obstetric, neonatal care and clinical leadership make a difference to practice and help towards reductions in maternal and neonatal mortality in rural Tanzania? The ETATMBA project

Objectives During late 2010, 36 trainees including 19 assistant medical officers (AMOs) 1 senior clinical officer (CO) and 16 nurse midwives/nurses were recruited from districts across rural Tanzania and invited to join the Enhancing Human Resources and Use of Appropriate Technologies for Maternal and Perinatal Survival in the sub-Saharan Africa (ETATMBA) training programme. The ETATMBA project was training associate clinicians (ACs) as advanced clinical leaders in emergency obstetric care. The trainees returned to health facilities across the country with the hope of being able to apply their new skills and knowledge. The main aim of this study was to explore the impact of the ETATMBA training on health outcomes including maternal and neonatal morbidity and mortality in their facilities. Secondly, to explore the challenges faced in working in these health facilities. Design The study is a pre-examination/postexamination of maternal and neonatal health indicators and a survey of health facilities in rural Tanzania. The facilities surveyed were those in which ETATMBA trainees were placed post-training. The maternal and neonatal indicators were collected for 2011 and 2013 and the survey of the facilities was in early 2014. Results 16 of 17 facilities were surveyed. Maternal deaths show a non-significant downward trend over the 2 years (282–232 cases/100 000 live births). There were no significant differences in maternal, neonatal and birth complication variables across the time-points. The survey of facilities revealed shortages in key areas and some are a serious concern. Conclusions This study represents a snapshot of rural health facilities providing maternal and neonatal care in Tanzania. Enhancing knowledge, practical skills, and clinical leadership of ACs may have a positive impact on health outcomes. However, any impact may be confounded by the significant challenges in delivering a service in terms of resources. Thus, training may be beneficial, but it requires an infrastructure that supports it.