A randomised control trial of experiential learning to promote physical activity

The paucity of training in physical activity (PA) promotion in UK medical schools is a barrier to health professionals' promotion of PA to their patients. Doctors who are more physically active are more likely to counsel patients in this regard. We used a randomised controlled trial (RCT) to examine the effect of an intervention which engaged students in goal-setting, using pedometer step counts, on their PA behaviour and intentions to promote PA in future practice.

SMART Arm with outcome-triggered electrical stimulation:a pilot randomized clinical trial

The SMART (SensoriMotor Active Rehabilitation Training) Arm is a nonrobotic device designed to allow stroke survivors with severe paresis to practice reaching. It can be used with or without outcome-triggered electrical stimulation (OT-stim) to augment movement. The aim of this study was to evaluate the efficacy of SMART Arm training when used with or without OT-stim, in addition to usual care, as compared with usual care alone during inpatient rehabilitation.

The efficacy of SMART Arm training early after stroke for stroke survivors with severe upper limb disability:a protocol for a randomised controlled trial

Recovery of upper limb function after stroke is poor. The acute to subacute phase after stroke is the optimal time window to promote the recovery of upper limb function. The dose and content of training provided conventionally during this phase is however, unlikely to be adequate to drive functional recovery, especially in the presence of severe motor disability. The current study concerns an approach to address this shortcoming, through evaluation of the SMART Arm, a non-robotic device that enables intensive and repetitive practice of reaching by stroke survivors with severe upper limb disability, with the aim of improving upper limb function. The outcomes of SMART Arm training with or without outcome-triggered electrical stimulation (OT-stim) to augment movement and usual therapy will be compared to usual therapy alone.

Using Pedometer Step-Count Goals to Promote Physical Activity in Cardiac Rehabilitation: A Feasibility Study of a Controlled Trial

Background: There is a need to improve the effectiveness of strategies to help cardiac rehabilitation patients achieve recommended levels of physical activity; the use of pedometers requires further research. We aimed to examine the feasibility of a randomised controlled trial, of an intervention using pedometer step-count goals, to promote physical activity for cardiac rehabilitation patients. Methods: We invited patients who completed a supervised cardiac rehabilitation programme to participate in this community-based study. Consenting participants wore a Yamax CW-701 pedometer for one week, blinded to stepcount readings, before being randomly allocated to groups. Intervention groups were told their step-counts; working with a clinical facilitator (nurse or physiotherapist) individually, they set daily step-count goals and reviewed these weekly. Baseline step-counts were hidden from controls, who were not given pedometers but received ongoing weekly facilitator support. After six weeks both groups wore ‘blinded’ pedometers for outcome assessment and participated in semi-structured interviews which explored their experiences of the study. Outcomes included rates of uptake, adherence and completion of measures, including step-counts, quality of life (EQ-5D) and stage of behaviour change. Results: Four programme groups were recruited; two received the intervention. Of 68 invitees, 45 participated (66%) (19 intervention; 26 control). Forty-two (93%) completed the outcomes. Baseline characteristics were comparable between groups. Mean steps/day increased more for intervention participants (2,742; 95%CI 1,169 to 4,315) than controls (-42; 95%CI -1,102 to 1,017) (p=0.004). The intervention and on-going clinical contact were welcomed; participants considered that step-counts, compared to time-related targets, encouraged them to become more active. Conclusion: These findings suggest that an intervention using individually tailored step-count goals may help increase and sustain physical activity following a cardiac rehabilitation programme. A definitive randomised controlled trial using blinded outcome measurements is feasible and of potential value in determining how best to translate physical activity advice into practice.

Clinical trial designs for rare diseases: Studies developed and discussed by the International Rare Cancers Initiative

BACKGROUND: The past three decades have seen rapid improvements in the diagnosis and treatment of most cancers and the most important contributor has been research. Progress in rare cancers has been slower, not least because of the challenges of undertaking research.

SETTINGS: The International Rare Cancers Initiative (IRCI) is a partnership which aims to stimulate and facilitate the development of international clinical trials for patients with rare cancers. It is focused on interventional--usually randomized--clinical trials with the clear goal of improving outcomes for patients. The key challenges are organisational and methodological. A multi-disciplinary workshop to review the methods used in ICRI portfolio trials was held in Amsterdam in September 2013. Other as-yet unrealised methods were also discussed.

RESULTS: The IRCI trials are each presented to exemplify possible approaches to designing credible trials in rare cancers. Researchers may consider these for use in future trials and understand the choices made for each design.

INTERPRETATION: Trials can be designed using a wide array of possibilities. There is no 'one size fits all' solution. In order to make progress in the rare diseases, decisions to change practice will have to be based on less direct evidence from clinical trials than in more common diseases.

A pilot randomised controlled trial (RCT) investigating the effectiveness of reflexology for managing pregnancy low back and/or pelvic pain.

any pregnant women with low back and/or pelvic pain (LBPP) use pain medications to manage this pain, much of which is self-prescribed and potentially harmful. Therefore, there is a need to find effective nonpharmacological treatments for the condition. Reflexology has previously been shown to help nonspecific low back pain. Therefore; a pilot RCT was conducted investigating reflexology in the management of pregnancy-LBPP. 90 primiparous women were randomised to either usual care, a reflexology or footbath intervention. Primary outcome measures were; the Pain Visual Analogue Scale (VAS). 64 women completed the RCT; retention rates for the reflexology group were 80%, usual care group 83.33% and footbath group 50%. The reflexology group demonstrated a Clinically Important Change (CIC) in pain frequency (1.64 cm). Results indicate it is feasible to conduct an RCT in this area, although a footbath is an unsuitable sham treatment. Reflexology may help manage pregnancy-LBPP; however a fully powered trial is needed to confirm this.

Parents’ and young people’s involvement in designing a trial of ventilator weaning

Consulting with users is considered best practice and is highly recommended in designing new trials. As part of our feasibility work, we undertook a consultation exercise with parents, ex-patients and young people prior to designing a trial of protocol-based ventilator weaning. Our aims were to (1) ascertain views on the relevance and importance of the trial; (2) determine the important parent/patient outcome measures; and (3) ascertain views on informed consent in a cluster randomized controlled trial. We conducted audio-recorded face-to-face, telephone and focus group interviews with parents and young people. Data were content analysed to generate information to address our specific consultation objectives. The setting was the north-western region of England. A total of 16 participants were interviewed: 2 parents of paediatric intensive care unit (PICU) survivors; 1 PICU survivor; and 13 young people from the former Medicines for Children Research Network. The trial objectives were deemed important and relevant, and participants considered the most important outcome measure to be the length of time on ventilation. Parents and young people did not consider written informed consent to be a necessary requirement in the context of this trial, rather awareness of unit participation in the trial was important with the opportunity of opting out of data collection. This consultation provided useful, pragmatic insights to inform trial design. We encountered significant challenges in recruiting parents and young people for this consultation exercise, and novel recruitment methods need to be considered for future work in this field. Patient and public involvement is essential to ensure that future trials answer parent-relevant questions and have meaningful outcome measures, as well as involving parents and young people in the general development of health care services.

Musculoskeletal (MSK) and Sport and Exercise Medicine (SEM) in General Practice (GP): A Novel GP-based clinic

The problem-Musculoskeletal (MSK) symptoms are common within primary care but some GPs are not comfortable managing these; waiting times for hospital appointments are a major cause of patients’ complaints. Current UK healthcare policies emphasise a need for more community-based management. We aimed to pilot an innovative general practice-based clinic to improve the management of MSK and Sport and Exercise Medicine (SEM) symptoms within general practice.

The approach-This project was conducted in an inner-city practice of approximately 9,000 patients and 5 GP partners. The practice commissioned a novel monthly 4-hour clinic staffed by one GP with a specialist interest in MSK and SEM conditions. Each patient was allocated a 20-minute appointment. All primary care staff within the practice could refer any patient for whom they considered hospital referral appropriate, with no specific exclusion criteria. Management plans included injection therapy, exercise prescription and onward referral. After three months (August-October 2014) numbers of consultations, sources of referral, reasons for referral and management outcomes were described; patient satisfaction was assessed by questionnaire, offered to 10 randomly selected patients by reception staff and self-completed by patients. Costs of the clinic were compared to current options.

Findings- All patients (14 males; 21 females; aged 35-77 years), were seen within four weeks of referral (one third of orthopaedic referrals in 2013 waited over 9 weeks for appointment). Most were referred from other GPs; some came from physiotherapy and podiatry. Shoulder problems were the most frequent reason for referral. The commonest management option was steroid injection, with most patients being given advice regarding exercise and analgesia; there were 3 onward referrals (2 physiotherapy; 1 rheumatology).

Comparing August-October data in 2014 and 2013, total, orthopaedic and rheumatology referrals were reduced by 147, 2 and 3, respectively; within the practice MSK presentations and physiotherapy and x-ray referrals were 60, 47 and 90 fewer, respectively.

The cost per attendance at the clinic was £61; initial orthopaedic-ICAT assessments cost £82 and a consultant appointment £213.

Satisfaction questionnaires were returned by all 10 selected participants and provided positive feedback, expressing preference for community-based, rather than hospital, management.

Consequence- Our pilot study indicates that this novel service model has potential for efficient and effective management of MSK and SEM complaints in primary care, reducing the need for hospital referral and the clinical burden on general practices. The innovation deserves further evaluation in a full-scale trial to determine its generalisability to other practice settings and populations.

Six-year follow-up of the SPHERE RCT: secondary prevention of heart disease in general practice.

Objective: To determine the long-term effectiveness of a complex intervention in primary care aimed at improving outcomes for patients with coronary heart disease.

Design: A 6-year follow-up of a cluster randomised controlled trial, which found after 18 months that both total and cardiovascular hospital admissions were significantly reduced in intervention practices (8% absolute reduction).

Setting: 48 general practices in the Republic of Ireland and Northern Ireland.

Participants: 903 patients with established coronary heart disease at baseline in the original trial.

Intervention: The original intervention consisted of tailored practice and patient plans; training sessions for practitioners in medication prescribing and behavioural change; and regular patient recall system. Control practices provided usual care. Following the intervention period, all supports from the research team to intervention practices ceased.

Outcome measures: Primary outcome: hospital admissions, all cause and cardiovascular; secondary outcomes: mortality; blood pressure and cholesterol control.

Results: At 6-year follow-up, data were collected from practice records of 696 patients (77%). For those who had died, we censored their data at the point of death and cause of death was established. There were no significant differences between the intervention and control practices in either total (OR 0.83 (95% CI 0.54 to 1.28)) or cardiovascular hospital admissions (OR 0.91 (95% CI 0.49 to 1.65)). We confirmed mortality status of 886 of the original 903 patients (98%). There were no significant differences in mortality (15% in intervention and 16% in control) or in the proportions of patients above target control for systolic blood pressure or total cholesterol.

Conclusions: Initial significant differences in the numbers of total and cardiovascular hospital admissions were not maintained at 6 years and no differences were found in mortality or blood pressure and cholesterol control. Policymakers need to continue to assess the effectiveness of previously efficacious programmes.

Trial registration number: Current Controlled Trials ISRCTN24081411.

FITS into Practice: Translating Research into Practice in Reducing the Use of Anti-psychotic Medication for People with Dementia Living in Care Homes

Objectives: This paper reports on the acceptability and effectiveness of the FITS (Focussed Intervention Training and Support) into Practice Programme. This intervention was scaled up from an earlier cluster randomised-controlled trial that had proven successful in significantly decreasing antipsychotic prescribing in care homes. Method: An in depth 10-day education course in person-centred care was delivered over a three-month period, followed by six supervision sessions. Participants were care-home staff designated as Dementia Care Coaches (DCCs) responsible for implementing interventions in 1 or 2 care homes. The course and supervision was provided by educators called Dementia Practice Development Coaches (DPDCs). Effectiveness data included monitoring antipsychotic prescriptions, goal attainment, knowledge, attitudes and implementation questionnaires. Qualitative data included case studies and reflective journals to elucidate issues of implementation. Results: Of the 100 DCCs recruited, 66 DCCs completed the programme. Pre-post questionnaires demonstrated increased knowledge and confidence and improved attitudes to dementia. Twenty per cent of residents were prescribed antipsychotics at baseline which reduced to 14% (31% reduction) with additional dose reductions being reported alongside improved personalised goal attainment. Crucial for FITS into Practice to succeed was the allocation and protection of time for the DCC to attend training and supervision and to carry out implementation tasks in addition to their existing job role. Evaluation data showed that this was a substantial barrier to implementation in a small number of homes. Discussion and conclusions: The FITS into practice programme was well evaluated and resulted in reduction in inappropriate anti-psychotic prescribing. Revisions to the intervention are suggested to maximise successful implementation.

Training medical students to conduct motivational interviewing: a randomized controlled trial.

OBJECTIVE: To examine the effectiveness of motivational interviewing (MI) training among medical students. METHODS: All students (n=131) (year 5) at Lausanne Medical School, Switzerland were randomized into an experimental or a control group. After a training in basic communication skills (control condition), an 8-h MI training was completed by 84.8% students in the exprimental group. One week later, students in both groups were invited to meet with two standardized patients. MI skills were coded by blinded research assistants using the Motivational Interviewing Treatment Integrity 3.0. RESULTS: Superior MI performance was shown for trained versus control students, as demonstrated by higher scores for "Empathy" [p<0.001] and "MI Spirit" [p<0.001]. Scores were similar between groups for "Direction", indicating that students in both groups invited the patient to talk about behavior change. Behavior counts assessment demonstrated better performance in MI in trained versus untrained students regarding occurences of MI-adherent behavior [p<0.001], MI non-adherent behavior [p<0.001], Closed questions [p<0.001], Open questions [p=0.001], simple reflections [p=0.03], and Complex reflections [p<0.001]. Occurrences were similar between groups regarding "Giving information". CONCLUSION: An 8-h training workshop was associated with improved MI performance. PRACTICE IMPLICATIONS: These findings lend support for the implementation of MI training in medical schools.

Biologics in rheumatoid arthritis - recommendations for Swiss practice.

The new paradigm of therapy in rheumatoid arthritis is to aim toward early and complete remission, using a larger use of conventional DMARDs and biologic agents. The present recommendations were established through a consensus to help practitioners in their daily use of those agents, to reflect the current "best practice" in Switzerland.

Verbal ability, previous practice and load on short-term memory as determiners of differences in a complex learning task: an experimental study

Traditional psychometric theory and practice classify people according to broad ability dimensions but do not examine how these mental processes occur. Hunt and Lansman (1975) proposed a 'distributed memory' model of cognitive processes with emphasis on how to describe individual differences based on the assumption that each individual possesses the same components. It is in the quality of these components ~hat individual differences arise. Carroll (1974) expands Hunt's model to include a production system (after Newell and Simon, 1973) and a response system. He developed a framework of factor analytic (FA) factors for : the purpose of describing how individual differences may arise from them. This scheme is to be used in the analysis of psychometric tes ts . Recent advances in the field of information processing are examined and include. 1) Hunt's development of differences between subjects designated as high or low verbal , 2) Miller's pursuit of the magic number seven, plus or minus two, 3) Ferguson's examination of transfer and abilities and, 4) Brown's discoveries concerning strategy teaching and retardates . In order to examine possible sources of individual differences arising from cognitive tasks, traditional psychometric tests were searched for a suitable perceptual task which could be varied slightly and administered to gauge learning effects produced by controlling independent variables. It also had to be suitable for analysis using Carroll's f ramework . The Coding Task (a symbol substitution test) found i n the Performance Scale of the WISe was chosen. Two experiments were devised to test the following hypotheses. 1) High verbals should be able to complete significantly more items on the Symbol Substitution Task than low verbals (Hunt, Lansman, 1975). 2) Having previous practice on a task, where strategies involved in the task may be identified, increases the amount of output on a similar task (Carroll, 1974). J) There should be a sUbstantial decrease in the amount of output as the load on STM is increased (Miller, 1956) . 4) Repeated measures should produce an increase in output over trials and where individual differences in previously acquired abilities are involved, these should differentiate individuals over trials (Ferguson, 1956). S) Teaching slow learners a rehearsal strategy would improve their learning such that their learning would resemble that of normals on the ,:same task. (Brown, 1974). In the first experiment 60 subjects were d.ivided·into high and low verbal, further divided randomly into a practice group and nonpractice group. Five subjects in each group were assigned randomly to work on a five, seven and nine digit code throughout the experiment. The practice group was given three trials of two minutes each on the practice code (designed to eliminate transfer effects due to symbol similarity) and then three trials of two minutes each on the actual SST task . The nonpractice group was given three trials of two minutes each on the same actual SST task . Results were analyzed using a four-way analysis of variance . In the second experiment 18 slow learners were divided randomly into two groups. one group receiving a planned strategy practioe, the other receiving random practice. Both groups worked on the actual code to be used later in the actual task. Within each group subjects were randomly assigned to work on a five, seven or nine digit code throughout. Both practice and actual tests consisted on three trials of two minutes each. Results were analyzed using a three-way analysis of variance . It was found in t he first experiment that 1) high or low verbal ability by itself did not produce significantly different results. However, when in interaction with the other independent variables, a difference in performance was noted . 2) The previous practice variable was significant over all segments of the experiment. Those who received previo.us practice were able to score significantly higher than those without it. J) Increasing the size of the load on STM severely restricts performance. 4) The effect of repeated trials proved to be beneficial. Generally, gains were made on each successive trial within each group. S) In the second experiment, slow learners who were allowed to practice randomly performed better on the actual task than subjeots who were taught the code by means of a planned strategy. Upon analysis using the Carroll scheme, individual differences were noted in the ability to develop strategies of storing, searching and retrieving items from STM, and in adopting necessary rehearsals for retention in STM. While these strategies may benef it some it was found that for others they may be harmful . Temporal aspects and perceptual speed were also found to be sources of variance within individuals . Generally it was found that the largest single factor i nfluencing learning on this task was the repeated measures . What e~ables gains to be made, varies with individuals . There are environmental factors, specific abilities, strategy development, previous learning, amount of load on STM , perceptual and temporal parameters which influence learning and these have serious implications for educational programs .