A brief intervention for weight control based on habit-formation theory delivered through primary care: results from a randomised controlled trial

Background: Primary care is the 'first port of call' for weight control advice, creating a need for simple, effective interventions that can be delivered without specialist skills. Ten Top Tips (10TT) is a leaflet based on habit-formation theory that could fill this gap. The aim of the current study was to test the hypothesis that 10TT can achieve significantly greater weight loss over 3 months than ‘usual care’. Methods: A two-arm, individually randomised, controlled trial in primary care. Adults with obesity were identified from 14 primary care providers across England. Patients were randomised to either 10TT or 'usual care' and followed up at 3, 6, 12, 18 and 24 months. The primary outcome was weight loss at 3 months, assessed by a health professional blinded to group allocation. Difference between arms was assessed using a mixed-effect linear model taking into account the health professionals delivering 10TT, and adjusted for baseline weight. Secondary outcomes included body mass index, waist circumference, the number achieving a 5% weight reduction, clinical markers for potential comorbidities, weight loss over 24 months and basic costs. Results: Five-hundred and thirty-seven participants were randomised to 10TT (n=267) or to ‘usual care' (n=270). Data were available for 389 (72%) participants at 3 months and for 312 (58%) at 24 months. Participants receiving 10TT lost significantly more weight over 3 months than those receiving usual care (mean difference =−0.87kg; 95% confidence interval: −1.47 to −0.27; P=0.004). At 24 months, the 10TT group had maintained their weight loss, but the ‘usual care’ group had lost a similar amount. The basic cost of 10TT was low, that is, around £23 ($32) per participant. Conclusions: The 10TT leaflet delivered through primary care is effective in the short-term and a low-cost option over the longer term. It is the first habit-based intervention to be used in a health service setting and offers a low-intensity alternative to ‘usual care’

Do screening tools assess palliative care needs and 12-month mortality in patients admitted to hepatology in-patient wards?

BACKGROUND: Many liver patients have unmet palliative care needs, but liver clinicians are unclear whom to refer to specialist palliative care (SPC). The Supportive and Palliative Care Indicator Tool (SPICT) and the Bristol Prognostic Screening Tool (BPST) could help identify suitable patients, but neither has been tested for this role. This study evaluated their role as screening tools for palliative care needs and for predicting 12-month mortality. METHODS: A case note review of hepatology in-patients, who were not peritransplant and post-transplant status, was conducted in one tertiary unit. Main outcomes were clinical judgement of need for SPC referral, BPST scores, SPICT attribution of caseness and 12-month survival status. Discriminatory ability of tools was assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and area under the receiver operating characteristic (AUROC) curve. RESULTS: 117 medical notes were reviewed for survival analysis, 47 of which were additionally assessed for suitability for SPC referral, using clinical judgement. SPICT (sensitivity=93%; PPV=93%; AUROC=0.933) and BPST (sensitivity=59%, PPV=79%, AUROC=0.693) demonstrated excellent and good performance, respectively, in predicting patients’ need for SPC referral. SPICT and BPST only had moderate ability at predicting death at 12 months (PPV: 54% and 56%, respectively). CONCLUSION: SPICT and BPST show potential as screening tools for identifying patients for referral to SPC. Further work is needed to determine how to implement these tools in a clinical setting

Study recruitment factors in advanced cancer: the Prognosis in Palliative care Study II (PiPS2) - a multicentre, prospective, observational cohort project.

Objectives: The Prognosis in Palliative care Study II (PiPS2) was a large multicentre observational study validating prognostic tools in patients with advanced cancer. Many palliative care studies fail to reach their recruitment target. To inform future studies, PiPS2 rigorously monitored and identified any potential recruitment barriers. / Methods: Key recruitment stages (ie, whether patients were eligible for the study, approached by the researchers and whether consent was obtained for enrolment) were monitored via comprehensive screening logs at participating sites (inpatient hospices, hospitals and community palliative care teams). The reasons for patients’ ineligibility, inaccessibility or decision not to consent were documented. / Results: 17 014 patients were screened across 27 participating sites over a 20-month recruitment period. Of those, 4642 (27%) were ineligible for participation in the study primarily due to non-cancer diagnoses. Of 12 372 eligible patients, 9073 (73%) were not approached, the most common reason being a clinical decision not to do so. Other reasons included patients’ death or discharge before they were approached by the researchers. Of the 3299 approached patients, 1458 (44%) declined participation mainly because of feeling too unwell, experiencing severe distress or having other competing priorities. 11% (n=1841/17 014) of patients screened were enrolled in the study, representing 15% (n=1841/12 372) of eligible patients. Different recruitment patterns were observed across inpatient hospice, hospital and community palliative care teams. / Conclusions: The main barrier to recruitment was ‘accessing’ potentially eligible patients. Monitoring key recruitment stages may help to identify barriers and facilitators to enrolment and allow results to be put into better context

Staff training in positive behaviour support for behaviour that challenges in people with intellectual disability: cost-utility analysis of a cluster randomised controlled trial

BACKGROUND: Behaviour that challenges in people with intellectual disability is associated with higher healthcare, social care and societal costs. Although behavioural therapies are widely used, there is limited evidence regarding the cost and quality-adjusted life-years (QALYs). AIMS: We aimed to assess the incremental cost per QALY gained of therapist training in positive behaviour support (PBS) and treatment as usual (TAU) compared with TAU using data from a cluster randomised controlled trial (Clinical Trials.gov registration: NCT01680276). METHOD: We conducted a cost-utility analysis (cost per QALY gained) of 23 teams randomised to PBS or TAU, with a total of 246 participants followed up over 36 months. The primary analysis was from a healthcare cost perspective with a secondary analysis from a societal cost perspective. RESULTS: Over 36 months the intervention resulted in an additional 0.175 QALYs (discounted and adjusted 95% CI -0.068 to 0.418). The total cost of training in and delivery of PBS is £1598 per participant plus an additional cost of healthcare of £399 (discounted and adjusted 95% CI -603 to 1724). From a healthcare cost perspective there is an 85% probability that the intervention is cost-effective compared with TAU at a £30 000 willingness to pay for a QALY threshold. CONCLUSIONS: There was a high probability that training in PBS is cost-effective as the cost of training and delivery of PBS is balanced out by modest improvements in quality of life. However, staff training in PBS is not supported given we found no evidence for clinical effectiveness

Positive behaviour support training for staff for treating challenging behaviour in people with intellectual disabilities: a cluster RCT

BACKGROUND: Preliminary studies have indicated that training staff in Positive Behaviour Support (PBS) may help to reduce challenging behaviour among people with intellectual disability (ID). OBJECTIVE: To evaluate whether or not such training is clinically effective in reducing challenging behaviour in routine care. The study also included longer-term follow-up (approximately 36 months). DESIGN: A multicentre, single-blind, two-arm, parallel-cluster randomised controlled trial. The unit of randomisation was the community ID service using an independent web-based randomisation system and random permuted blocks on a 1 : 1 allocation stratified by a staff-to-patient ratio for each cluster. SETTING: Community ID services in England. PARTICIPANTS: Adults (aged > 18 years) across the range of ID with challenging behaviour [≥ 15 Aberrant Behaviour Checklist - Community total score (ABC-CT)]. INTERVENTIONS: Manual-assisted face-to-face PBS training to therapists and treatment as usual (TAU) compared with TAU only in the control arm. MAIN OUTCOME MEASURES: Carer-reported changes in challenging behaviour as measured by the ABC-CTover 12 months. Secondary outcomes included psychopathology, community participation, family and paid carer burden, family carer psychopathology, costs of care and quality-adjusted life-years (QALYs). Data on main outcome, service use and health-related quality of life were collected for the 36-month follow-up. RESULTS: A total of 246 participants were recruited from 23 teams, of whom 109 were in the intervention arm (11 teams) and 137 were in the control arm (12 teams). The difference in ABC-CTbetween the intervention and control arms [mean difference -2.14, 95% confidence interval (CI) -8.79 to 4.51;p = 0.528] was not statistically significant. No treatment effects were found for any of the secondary outcomes. The mean cost per participant in the intervention arm was £1201. Over 12 months, there was a difference in QALYs of 0.076 in favour of the intervention (95% CI 0.011 to 0.140 QALYs) and a 60% chance that the intervention is cost-effective compared with TAU from a health and social care cost perspective at the threshold of £20,000 per QALY gained. Twenty-nine participants experienced 45 serious adverse events (intervention arm,n = 19; control arm,n = 26). PBS plans were available for 33 participants. An independent assessment of the quality of these plans found that all were less than optimal. Forty-six qualitative interviews were conducted with service users, family carers, paid carers and service managers as part of the process evaluation. Service users reported that they had learned to manage difficult situations and had gained new skills, and carers reported a positive relationship with therapists. At 36 months' follow-up (n = 184), the mean ABC-CTdifference between arms was not significant (-3.70, 95% CI -9.25 to 1.85;p = 0.191). The initial cost-effectiveness of the intervention dissipated over time. LIMITATIONS: The main limitations were low treatment fidelity and reach of the intervention. CONCLUSIONS: Findings from the main study and the naturalistic follow-up suggest that staff training in PBS as delivered in this study is insufficient to achieve significant clinical gains beyond TAU in community ID services. Although there is an indication that training in PBS is potentially cost-effective, this is not maintained in the longer term. There is increased scope to develop new approaches to challenging behaviour as well as optimising the delivery of PBS in routine clinical practice. TRIAL REGISTRATION: This study is registered as NCT01680276. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 15. See the NIHR Journals Library website for further project information

Pharmacological interventions for pain in children and adolescents with life-limiting conditions

BACKGROUND: Pain is one of the most common symptoms in children and young people (CYP) with life-limiting conditions (LLCs) which include a wide range of diagnoses including cancer. The current literature indicates that pain is not well managed, however the evidence base to guide clinicians is limited. There is a clear need for evidence from a systematic review to inform prescribing. OBJECTIVES: To evaluate the evidence on the effectiveness of different pharmacological interventions used for pain in CYP with LLCs. SEARCH METHODS: The following electronic databases were searched up to December 2014: CENTRAL (in the Cochrane Library), MEDLINE, EMBASE, PsycINFO and CINAHL. In addition, we searched conference proceedings and reference lists of included studies. For completeness, we also contacted experts in the field. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials (RCTs), quasi-randomised studies and other studies that included a clearly defined comparator group were included. The studies investigated pharmacological treatments for pain associated with LLCs in CYP. The treatment included those specifically developed to treat pain and those that acted as an adjuvant, where the treatment was not primarily developed to treat pain but has pain relieving properties. The LLC was identified by its inclusion in the Richard Hain Directory of LLCs. DATA COLLECTION AND ANALYSIS: Citations were screened by five review authors. Data were extracted by one review author and checked by a second. Two review authors assessed the risk of bias of included studies. A sufficient number of studies using homogeneous outcomes was not identified so a meta-analysis was not possible. MAIN RESULTS: We identified 24,704 citations from our database search. Nine trials with 379 participants fulfilled our inclusion criteria. Participants had cerebral palsy (CP) in five of the studies and osteogenesis imperfecta (OI) in the other four. Participants across the trials ranged in age from 2 to 19 years. All studies, apart from one cross-over trial, were parallel designed RCTs. Three of the trials on CP evaluated intrathecal baclofen (ITB) and two botulinum toxin A (BoNT-A). All of the OI trials evaluated the use of bisphosphonates (two alendronate and one pamidronate). No trials were identified that evaluated a commonly used analgesic in this patient group. Pain was a secondary outcome in five of the eight identified studies. Overall the quality of the trials was mixed. Only one study involved over 100 participants.For the two ITB studies for pain in CP, in the same study population but assessed at different time points in their disease, both found an effect on pain favouring the intervention compared to the control group (standard care or placebo) (mean difference (MD) 4.20, 95% confidence interval (CI) 2.15 to 6.25; MD 26.60, 95% CI 2.61 to 50.59, respectively). In these studies most of the adverse events related to the procedure or device for administration rather than the drug, such as swelling at the pump site. In one trial there were also eight serious adverse effects; these included difficulty swallowing and an epileptic seizure. The trial did not state if these occurred in the intervention group. At follow-up in both BoNT-A trials there was no evidence of a difference in pain between the trial arms among CP participants. The adverse events in the BoNT-A trials mostly involved those who received the intervention drug and involved seizures. Gastrointestinal problems were the most frequent adverse event in those who received alendronate. The trial investigating pamidronate found no evidence of a difference in pain compared to the control group. No adverse events were reported in this trial. AUTHORS' CONCLUSIONS: Published, controlled evidence on the pharmacological interventions for pain in CYP with LLCs is limited. The evidence that is currently available evaluated pain largely as a secondary outcome and the drugs used were all adjuvants and not always commonly used in general paediatric palliative care for pain. Based on current data this systematic review is unable to determine the effects of pharmacological interventions for pain for CYP with LLCs. Future trials with larger populations should examine the effects of the drugs commonly used as analgesics; with the rising prevalence of many LLCs this becomes more necessary

Prognostic evaluation in patients with advanced cancer in the last months of life:ESMO Clinical Practice Guideline

: • This ESMO Clinical Practice Guideline provides key recommendations for using prognostic estimates in advanced cancer. • The guideline covers recommendations for patients with cancer and an expected survival of months or less. • An algorithm for use of clinical predictions, prognostic factors and multivariable risk prediction models is presented. • The author group encompasses a multidisciplinary group of experts from different institutions in Europe, USA and Asia. • Recommendations are based on available scientific data and the authors’ collective expert opinion