Design considerations in a clinical trial of a cognitive behavioural intervention for the management of low back pain in primary care : Back Skills Training Trial

Background Low back pain (LBP) is a major public health problem. Risk factors for the development and persistence of LBP include physical and psychological factors. However, most research activity has focused on physical solutions including manipulation, exercise training and activity promotion. Methods/Design This randomised controlled trial will establish the clinical and cost-effectiveness of a group programme, based on cognitive behavioural principles, for the management of sub-acute and chronic LBP in primary care. Our primary outcomes are disease specific measures of pain and function. Secondary outcomes include back beliefs, generic health related quality of life and resource use. All outcomes are measured over 12 months. Participants randomised to the intervention arm are invited to attend up to six weekly sessions each of 90 minutes; each group has 6–8 participants. A parallel qualitative study will aid the evaluation of the intervention. Discussion In this paper we describe the rationale and design of a randomised evaluation of a group based cognitive behavioural intervention for low back pain

Mapping poverty using mobile phone and satellite data

Poverty is one of the most important determinants of adverse health outcomes globally, a major cause of societal instability and one of the largest causes of lost human potential. Traditional approaches to measuring and targeting poverty rely heavily on census data, which in most low- and middle-income countries (LMICs) are unavailable or out-of-date. Alternate measures are needed to comp- lement and update estimates between censuses. This study demonstrates how public and private data sources that are commonly available for LMICs can be used to provide novel insight into the spatial distribution of poverty. We evalu- ate the relative value of modelling three traditional poverty measures using aggregate data from mobile operators and widely available geospatial data. Taken together, models combining these data sources providethebest predictive power (highest r 2 ¼ 0.78) and lowest error, but generally models employing mobile data only yield comparable results, offering the potential to measure poverty more frequently and at finer granularity. Stratifying models into urban and rural areas highlights the advantage of using mobile data in urban areas and different data in different contexts. The findings indicate the possibility to estimate and continually monitor poverty rates at high spatial resolution in countries with limited capacity to support traditional methods of datacollection

The combined diabetes and renal control trial (C-DIRECT) - a feasibility randomised controlled trial to evaluate outcomes in multi-morbid patients with diabetes and on dialysis using a mixed methods approach

Background: This cluster randomised controlled trial set out to investigate the feasibility and acceptability of the “Combined Diabetes and Renal Control Trial” (C-DIRECT) intervention, a nurse-led intervention based on motivational interviewing and self-management in patients with coexisting end stage renal diseases and diabetes mellitus (DM ESRD). Its efficacy to improve glycaemic control, as well as psychosocial and self-care outcomes were also evaluated as secondary outcomes. Methods: An assessor-blinded, clustered randomised-controlled trial was conducted with 44 haemodialysis patients with DM ESRD and ≥ 8% glycated haemoglobin (HbA1c), in dialysis centres across Singapore. Patients were randomised according to dialysis shifts. 20 patients were assigned to intervention and 24 were in usual care. The C-DIRECT intervention consisted of three weekly chair-side sessions delivered by diabetes specialist nurses. Data on recruitment, randomisation, and retention, and secondary outcomes such as clinical endpoints, emotional distress, adherence, and self-management skills measures were obtained at baseline and at 12 weeks follow-up. A qualitative evaluation using interviews was conducted at the end of the trial. Results: Of the 44 recruited at baseline, 42 patients were evaluated at follow-up. One patient died, and one discontinued the study due to deteriorating health. Recruitment, retention, and acceptability rates of C-DIRECT were generally satisfactory HbA1c levels decreased in both groups, but C-DIRECT had more participants with HbA1c < 8% at follow up compared to usual care. Significant improvements in role limitations due to physical health were noted for C-DIRECT whereas levels remained stable in usual care. No statistically significant differences between groups were observed for other clinical markers and other patient-reported outcomes. There were no adverse effects. Conclusions: The trial demonstrated satisfactory feasibility. A brief intervention delivered on bedside as part of routine dialysis care showed some benefits in glycaemic control and on QOL domain compared with usual care, although no effect was observed in other secondary outcomes. Further research is needed to design and assess interventions to promote diabetes self-management in socially vulnerable patients

A randomised controlled trial of a lengthened and multi-disciplinary consultation model in a socially deprived community: a study protocol

<p>Abstract</p> <p>Background</p> <p>There has been little development of the general practice consultation over the years, and many aspects of the present consultation do not serve communities with multiple health and social problems well. Many of the problems presenting to general practitioners in socio-economically disadvantaged areas are not amenable to a purely medical solution, and would particularly benefit from a multidisciplinary approach. Socio-economic deprivation is also associated with those very factors (more psychosocial problems, greater need for health promotion, more chronic diseases, more need for patient enablement) that longer consultations have been shown to address. This paper describes our study protocol, which aims to evaluate whether a lengthened multidisciplinary primary care team consultation with families in a socially deprived area can improve the psychological health of mothers in the families.</p> <p>Methods/Design</p> <p>In a randomised controlled trial, families with a history of social problems, substance misuse or depression are randomly allocated to an intervention or control group. The study is based in three general practices in a highly deprived area of North Dublin. Primary health care teams will be trained in conducting a multidisciplinary lengthened consultation. Families in the intervention group will participate in the new style multidisciplinary consultation. Outcomes of families receiving the intervention will be compared to the control group who will receive only usual general practitioner care. The primary outcome is the psychological health of mothers of the families and secondary outcomes include general health status, quality of life measures and health service usage.</p> <p>Discussion</p> <p>The main aim of this study is to evaluate the effectiveness of a lengthened multidisciplinary team consultation in primary care. The embedded nature of this study in general practices in a highly deprived area ensures generalisability to other deprived communities, but more particularly it promises relevance to primary care.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN70578736</p

Effects of a 1-Week Inpatient Course Including Information, Physical Activity, and Group Sessions for Prostate Cancer Patients

This study aims to explore the effects of a 1-week inpatient course including information, physical activity (PA), and group sessions on physical and mental health-related outcomes for prostate cancer (PCa) patients. Further to assess the patients’ satisfaction with the course. PCa patients completed a questionnaire assessing PA, fatigue, mental distress, and quality of life 1 month before (T0) and 3 months after (T1) the course. Total fatigue, physical fatigue, and PSA anxiety decreased significantly from T0 to T1. No significant changes were observed in the other measures. The majority of the participants were satisfied with the course. In spite of minor reductions in fatigue and PSA anxiety and satisfied patients, the findings indicate that a 1-week inpatient course does not influence substantially on most of the health-related outcomes in PCa patients 3 months after the course

Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial

Background: Knee replacement surgery reduces pain for many people with osteoarthritis (OA). However, surgical outcomes are partly dependent on patients’ moods, and those with depression or anxiety have worse outcomes. Approximately one-third of people with OA have mood problems. Cognitive behavioural therapy (CBT), a psychological therapy, is recommended by the National Institute for Health and Care Excellence for improving mood. However, evidence for the effectiveness of CBT before knee surgery in improving pain, mood, and quality of life following this surgery for people with knee OA is lacking. Methods/Design: This is a multi-centre, mixed-methods feasibility randomised controlled trial to compare treatment as usual (TAU) plus a brief CBT-based intervention with a TAU-only control, for people with knee OA. We will recruit 50 patients with knee OA, listed for knee replacement surgery, with high levels of distress (assessed using a mood questionnaire), and who consent to take part. Participants will be randomly allocated to receive TAU plus intervention or TAU. Up to 10 sessions of CBT will be offered on an individual basis by a psychologist. The assessments and interventions will be completed before surgery. Repeat assessments at 4 and 6 months after randomisation will be sent and received by post. Two patient-partners will conduct feedback interviews with some participants to assess what aspects of the intervention were helpful or unhelpful, the acceptability of randomisation, the experience of being in a control group, and the appropriateness of the measures used. Interviews will be audio-recorded, transcribed, and analysed using the framework approach. We will examine the feasibility and acceptability of patient-partners conducting the interviews by also interviewing the patient-partners. Discussion: Findings from this study will be used to design a definitive study that will examine the clinical and cost-effectiveness of the CBT intervention in improving patient outcomes following knee surgery

Health problems and help-seeking in a nationwide sample of operational Norwegian ambulance personnel

Background To estimate the prevalence of anxiety and depression symptoms, and their association with professional help-seeking, among operational ambulance personnel and a general working population, and to study the symptoms of musculoskeletal pain and disturbed sleep among ambulance personnel. Methods The results of a comprehensive nationwide questionnaire survey of operational ambulance personnel (n = 1180) were compared with the findings of a population-based Norwegian health study of working people (n = 31,987). The questionnaire included measures of help-seeking, the Hospital Anxiety and Depression Scale, the Subjective Health Complaints Questionnaire, the Karolinska Sleep Questionnaire and the Need for Recovery after Work Scale. Results Compared with those in the reference population, the mean of level anxiety symptoms in the ambulance sample was lower for men (3.5 vs. 3.9, P < 0.001) and women (4.0 vs. 4.4, P < 0.05), and the mean level of depression symptoms in ambulance workers was lower for men (2.3 vs. 2.8, P < 0.05) but not for women (2.9 vs. 3.1, P = 0.22). A model adjusted for anxiety and depression symptoms indicated that ambulance personnel had lower levels of help-seeking except for seeing a chiropractor (12% vs. 5%, P < 0.01). In the ambulance sample, symptoms of musculoskeletal pain were most consistently associated with help-seeking. In the adjusted model, only symptoms of disturbed sleep were associated with help-seeking from a psychologist/psychiatrist (total sample = 2.3%). Help-seeking was more often reported by women but was largely unaffected by age. Conclusion The assumption that ambulance personnel have more anxiety and depression symptoms than the general working population was not supported. The level of musculoskeletal pain and, accordingly, the level of help-seeking from a chiropractor were higher for ambulance workers. More research should address the physical strains among ambulance personnel

Anxiety and depressive symptoms related to parenthood in a large Norwegian community sample: the HUNT2 study

The study compared anxiety and depression prevalence between parents and non-parents in a society with family- and parenthood-friendly social politics, controlling for family status and family history, age, gender, education and social class. All participants aged 30–49 (N&nbsp;=&nbsp;24,040) in the large, non-sampled Norwegian HUNT2 community health study completed the Hospital Anxiety and Depression Scales. The slightly elevated anxiety and depression among non-parents compared to parents in the complete sample was not confirmed as statistically significant within any subgroups. Married parents and (previously unmarried) cohabiting parents did not differ in portraying low anxiety and depression prevalence. Anxiety was associated with single parenthood, living alone or being divorced, while elevated depression was found only among those living alone. Burdening selection and cultural/political context are suggested as interpretative perspectives on the contextual and personal influences on the complex relationship between parenthood and mental health

Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol

Background: Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Fragmentation of care, inadequate pain communication, and reluctance towards pain medication contribute to difficulties in optimizing outcomes. Integration of patient self-management and professional care by means of healthcare technology provides new opportunities in the outpatient setting. Methods/Design: This study protocol outlines a two-armed multicenter randomized controlled trial that compares a technology based multicomponent self-management support intervention with care as usual and includes an effect, economic and process evaluation. Patients will be recruited consecutively via the outpatient oncology clinics and inpatient oncology wards of one academic hospital and one regional hospital in the south of the Netherlands. Irrespective of the stage of disease, patients are eligible when they are diagnosed with cancer and have uncontrolled moderate to severe cancer (treatment) related pain defined as NRS ≥ 4 for more than two weeks. Randomization (1:1) will assign patients to either the intervention or control group; patients in the intervention group receive self-management support and patients in the control group receive care as usual. The intervention will be delivered by registered nurses specialized in pain and palliative care. Important components include monitoring of pain, adverse effects and medication as well as graphical feedback, education, and nurse support. Effect measurements for both groups will be carried out with questionnaires at baseline (T0), after 4 weeks (T1) and after 12 weeks (T2). Pain intensity and quality of life are the primary outcomes. Secondary outcomes include self-efficacy, knowledge, anxiety, depression and pain medication use. The final questionnaire contains also questions for the economic evaluation that includes both cost-effectiveness and cost-utility analysis. Data for the process evaluation will be gathered continuously over the study period and focus on recruitment, reach, dose delivered and dose received. Discussion: The proposed study will provide insight into the effectiveness of the self-management support intervention delivered by nurses to outpatients with uncontrolled cancer pain. Study findings will be used to empower patients and health professionals to improve cancer pain control. Trial registration: NCT02333968 December 29, 201