The Hawthorne Effect: a randomised,controlled trial

Background  

The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia.     

Influence of therapist competence and quantity of cognitive behavioural therapy on suicidal behaviour and inpatient hospitalisation in a randomised controlled trial in borderline personality disorder: Further analyses of treatment effects in the BOSCOT study

Objectives

We investigated the treatment effects reported from a high‐quality randomized controlled trial of cognitive behavioural therapy (CBT) for 106 people with borderline personality disorder attending community‐based clinics in the UK National Health Service – the BOSCOT trial. Specifically, we examined whether the amount of therapy and therapist competence had an impact on our primary outcome, the number of suicidal acts ¹ , using instrumental variables regression modelling.

Design

Randomized controlled trial. Participants from across three sites (London, Glasgow, and Ayrshire/Arran) were randomized equally to CBT for personality disorders (CBTpd) plus Treatment as Usual or to Treatment as Usual. Treatment as Usual varied between sites and individuals, but was consistent with routine treatment in the UK National Health Service at the time. CBTpd comprised an average 16 sessions (range 0–35) over 12 months.

Method

We used instrumental variable regression modelling to estimate the impact of quantity and quality of therapy received (recording activities and behaviours that took place after randomization) on number of suicidal acts and inpatient psychiatric hospitalization.

Results

A total of 101 participants provided full outcome data at 2 years post randomization. The previously reported intention‐to‐treat (ITT) results showed on average a reduction of 0.91 (95% confidence interval 0.15–1.67) suicidal acts over 2 years for those randomized to CBT. By incorporating the influence of quantity of therapy and therapist competence, we show that this estimate of the effect of CBTpd could be approximately two to three times greater for those receiving the right amount of therapy from a competent therapist.

Conclusions

Trials should routinely control for and collect data on both quantity of therapy and therapist competence, which can be used, via instrumental variable regression modelling, to estimate treatment effects for optimal delivery of therapy. Such estimates complement rather than replace the ITT results, which are properly the principal analysis results from such trials.

Practitioner points

• Assessing the impact of the quantity and quality of therapy (competence of therapists) is complex.
• More competent therapists, trained in CBTpd, may significantly reduce the number of suicidal act in patients with borderline personality disorder.

     

Design,analysis and presentation of factorial randomised controlled trials

Background  

The evaluation of more than one intervention in the same randomised controlled trial can be achieved using a parallel group design. However this requires increased sample size and can be inefficient, especially if there is also interest in considering combinations of the interventions. An alternative may be a factorial trial, where for two interventions participants are allocated to receive neither intervention, one or the other, or both. Factorial trials require special considerations, however, particularly at the design and analysis stages.     

Assessing methods for dealing with treatment switching in randomised controlled trials: a simulation study

Background  

We investigate methods used to analyse the results of clinical trials with survival outcomes in which some patients switch from their allocated treatment to another trial treatment. These included simple methods which are commonly used in medical literature and may be subject to selection bias if patients switching are not typical of the population as a whole. Methods which attempt to adjust the estimated treatment effect, either through adjustment to the hazard ratio or via accelerated failure time models, were also considered. A simulation study was conducted to assess the performance of each method in a number of different scenarios.     

Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial

Background  

A model for integrative medicine (IM) adapted to Swedish primary care was previously developed. The aim of this study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain. Specific objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial.     

Alternative vs. conventional treatment given on-demand for gastroesophageal reflux disease: a randomised controlled trial

Background  

Alternative treatments are commonly used for various disorders and often taken on-demand. On-demand treatment of gastroesophageal reflux disease (GERD) with pharmaceutical products is an established, cost-effective strategy. Comparisons between alternative medicine and pharmaceutical products are rare. The aim of this trial was to compare on-demand treatment with a pectin-based, raft-forming, natural, anti-reflux agent (PRA) with that of esomeprazole 20 mg (Eso20) in patients with mild/moderate GERD.     

Recruitment difficulties in a primary care cluster randomised trial: investigating factors contributing to general practitioners' recruitment of patients

Background  

Recruitment of patients by health professionals is reported as one of the most challenging steps when undertaking studies in primary care settings. Numerous investigations of the barriers to patient recruitment in trials which recruit patients to receive an intervention have been published. However, we are not aware of any studies that have reported on the recruitment barriers as perceived by health professionals to recruiting patients into cluster randomised trials where patients do not directly receive an intervention. This particular subtype of cluster trial is commonly termed a professional-cluster trial. The aim of this study was to investigate factors that contributed to general practitioners recruitment of patients in a professional-cluster trial which evaluated the effectiveness of an intervention to increase general practitioners adherence to a clinical practice guideline for acute low-back pain.     

Increasing recruitment to randomised trials: a review of randomised controlled trials

Background  

Poor recruitment to randomised controlled trials (RCTs) is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective.     

The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

Background  

The Breathlessness Intervention Service is a novel service for patients with intractable breathlessness regardless of aetiology. It is being evaluated using the Medical Research Council's framework for the evaluation of complex interventions. This paper describes the feasibility results of Phase II: a single-blinded fast-track pragmatic randomised controlled trial.     

Effectiveness and cost of recruitment strategies for a community-based randomised controlled trial among rainwater drinkers

Background  

Community-based recruitment is challenging particularly if the sampling frame is not easily defined as in the case of people who drink rainwater. Strategies for contacting participants must be carefully considered to maximise generalisability and minimise bias of the results. This paper assesses the recruitment strategies for a 1-year double-blinded randomised trial on drinking untreated rainwater. The effectiveness of the recruitment strategies and associated costs are described.     

Involving users in the design of a randomised controlled trial of an intervention to promote early presentation in breast cancer: qualitative study

Background  

The purpose of this study was to explore women's views of the design of a large pragmatic cost-effectiveness randomised controlled trial of the policy of offering a health professional-delivered intervention to promote early presentation with breast symptoms in older women and thereby improve survival, with a view to informing protocol development. The trial will recruit over 100,000 healthy women aged 67+, and outcome data will be collected on those who develop breast cancer. The scale of the trial and the need for long-term follow-up presented a number of design challenges in relation to obtaining consent, ascertaining and contacting participants who developed breast cancer, and collecting outcome data.     

The fading of reported effectiveness. A meta-analysis of randomised controlled trials

Background  

The "real" effect size of a medical therapy is constant over time. In contrast, the effect size reported in randomised controlled trials (RCTs) may change over time because the sum of all kinds of bias influencing the reported effectiveness is not necessarily constant. As this would affect the validity of meta-analyses, we tested the hypothesis that the reported effect size decreases over time. Furthermore, we tested three hypotheses that would explain a possible change.     

Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials

Background  

Despite treatment recommendations from various organizations, oral rehydration therapy (ORT) continues to be underused, particularly by physicians in high-income countries. We conducted a systematic review of randomised controlled trials (RCTs) to compare ORT and intravenous therapy (IVT) for the treatment of dehydration secondary to acute gastroenteritis in children.     

Acceptability of a novel suicide prevention psychological therapy for people who experience non-affective psychosis

Objectives

Suicide is a leading cause of death worldwide. People experiencing psychosis are at increased risk of death by suicide. Talking therapies can alleviate suicidal thoughts, plans, and attempts. Therapies need to also be acceptable to recipients. The aim of this study was to investigate the views on psychological therapy for people experiencing psychosis and suicidality using the Theoretical Framework of Acceptability.

Design

Qualitative interview study.

Methods

Participants were recruited from a randomised controlled trial comparing suicide prevention psychological therapy with treatment as usual. Individuals had a diagnosis of non-affective psychosis and experience of suicidal thoughts, plans and/or attempts. To assess the acceptability of the therapy, semi-structured interviews were conducted with 20 participants randomised to receive therapy. Data were deductively analysed using an adaptation of the Theoretical Framework of Acceptability.

Results

Interviews (Mean = 45 min) were conducted and audio recorded with 21 participants. Data were organised into six themes: 1. Affective attitude, 2. Burden, 3. Alliance, 4. Intervention coherence, 5. Perceived effectiveness, and 6. Self-efficacy. There was no evidence of issues relating to domains of ethicality and opportunity costs associated with receiving therapy.

Conclusions

Talking about suicide was difficult and, at times, distressing, but it was perceived to be useful for understanding experiences. To be acceptable, it is important for therapists to ensure that clients' understanding of therapy aligns with expectations of effectiveness and to invest in building strong therapeutic alliances. Future research will benefit from examining therapists' experiences of delivering therapy through different modes (e.g. online, telephone).     

A randomised controlled trial of patient led training in medical education: protocol

Background  

Estimates suggest that approximately 1 in 10 patients admitted to hospital experience an adverse event resulting in harm. Methods to improve patient safety have concentrated on developing safer systems of care and promoting changes in professional behaviour. There is a growing international interest in the development of interventions that promote the role of patients preventing error, but limited evidence of effectiveness of such interventions. The present study aims to undertake a randomised controlled trial of patient-led teaching of junior doctors about patient safety.     

A randomised controlled pilot and feasibility study of music therapy for improving the quality of life of hospice inpatients

Background

Evidence about the effectiveness of music therapy for improving the quality of life of palliative care patients is positive but weak in terms of risk of bias.

Methods

This study aimed to determine the feasibility of a randomised controlled trial to evaluate the effectiveness of music therapy for improving the quality of life of hospice inpatients, as measured by the McGill Quality of Life questionnaire. Objectives included recruitment of 52 participants over 12?months and provision of data to support the calculation of the required sample size for a definitive randomised trial, taking into account the retention rates of recruited participants; and evaluation of the viability of the intervention and the acceptability of the assessment tool. The design was a single-centre, researcher-blinded randomised pilot and feasibility study involving two parallel groups. Participants were recruited from one inpatient hospice unit in Northern Ireland. Eligibility criteria were an Eastern Cooperative Oncology Group performance status of two or lower and an Abbreviated Mental Test score of seven or more. Consenting patients were randomly allocated to the intervention or control group using a 1:1 allocation ratio. The intervention group received up to six individual music therapy sessions over 3 weeks in addition to usual care. The control group received usual care only.

Results

Fifty one participants were recruited over 12?months. Twenty five were allocated to the intervention group and 26 to the control group. Seventy one percent of participants were lost to follow up by week 3, the proposed primary endpoint. The primary endpoint was moved from week 3, when 71% were lost to follow up to week 1, when 33% were lost. The McGill Quality of Life questionnaire was generally acceptable to participants. In order to detect a small to moderate effect size of 0.3, a fully powered study would require the recruitment of 698 participants.

Conclusions

A Phase III randomised controlled trial to evaluate the effectiveness of music therapy in improving the quality of life of hospice inpatients is feasible.

Trial registration

ClinicalTrials.gov: NCT02791048. Registered 6 June 2016.

     

Weight-management interventions in primary care: a pilot randomised controlled trial

Background

There is a paucity of randomised controlled trials of weight management in primary care.

Aim

To ascertain the feasibility of a full trial of a nurse-led weight-management programme in general practice.

Design of study

Factorial randomised control trial.

Setting

Primary care, UK.

Method

A total of 123 adults (80.3% women, mean age 47.2 years) with body mass index ≥27 kg/m², recruited from eight practices, were randomised to receive structured lifestyle support (n = 30), structured lifestyle support plus pedometer (n = 31), usual care (n = 31), or usual care plus pedometer (n = 31) for a 12-week period.

Results

A total of 103 participants were successfully followed up. The adjusted mean difference in weight in structured support compared to usual care groups was −2.63 kg (95% confidence interval [CI] = −4.06 to −1.20 kg), and for pedometer compared to no pedometer groups it was −0.11 kg (95% CI = −1.52 to 1.30 kg). One in three participants in the structured-support groups (17/50, 34.0%) lost 5% or more of their initial weight, compared to less than one in five (10/53, 18.9%) in usual-care groups; provision of a pedometer made little difference (14/48, 29.2% pedometer; 13/55, 23.6% no pedometer). Difference in waist circumference change between structured-support and usual-care groups was −1.80 cm (95% CI = −3.39 to −0.20 cm), and between the pedometer and no pedometer groups it was −0.84 cm (95% CI = −2.42 to 0.73 cm). When asked about their experience of study participation, most participants found structured support helpful.

Conclusion

The structured lifestyle support package could make substantial contributions to improving weight-management services. A trial of the intervention in general practice is feasible and practicable.     

A brief compassion focused therapy intervention can help self-critical parents and their children: A randomised controlled trial

Background

Parents can be highly self-critical of their own parenting, which can negatively impact parenting style and child outcomes.

Aims

The aim of this randomised controlled trial (RCT) was to examine the efficacy of a brief 2-hour Compassion Focused Therapy intervention (CFT) for parents to determine if it can reduce self-criticism, improve parenting and improve child social, emotional and behavioural outcomes.

Materials & Methods

In total, 102 parents (87 mothers) were randomised to either a CFT intervention (n = 48) or waitlist control group (n = 54). Participants were measured at pre-, 2-week post-intervention and the CFT group again at 3-month follow-up.

Results

At 2-week post-intervention parents in the CFT group compared to waitlist control had significantly reduced levels of self-criticism, significant reductions in child emotional and peer problems, but no changes in parental style. At 3-month follow-up, these outcomes improved, with self-criticism further decreasing, parental hostility and verbosity decreasing, as well as a range of childhood improvements.

Conclusion

The results from this first RCT evaluation of a brief 2-hour CFT intervention for parents show promise for not only improving how parents relate to themselves with self-criticism and self-reassurance, but also for improving parenting styles and child outcomes.     

Successful Reach and Adoption of a workplace health promotion RCT targeting a group of high-risk workers

Background  

Cleaners are rarely introduced to workplace health promotion programs. The study's objective was to evaluate the reach and adoption of a workplace randomized controlled trial (RCT) among cleaners in Denmark.