Resolving Malpractice Disputes: Imaging the Jury’s Shadow

The ability of juries to resolve malpractice suits was studied. Results showed that most of the time, jury outcomes represent a fair resolution of the claim, but the risk that the result will not be fair is real and troubling

Reporting quality of music intervention research in healthcare: A systematic review

INTRODUCTION: Concomitant with the growth of music intervention research, are concerns about inadequate intervention reporting and inconsistent terminology, which limits validity, replicability, and clinical application of findings. OBJECTIVE: Examine reporting quality of music intervention research, in chronic and acute medical settings, using the Checklist for Reporting Music-based Interventions. In addition, describe patient populations and primary outcomes, intervention content and corresponding interventionist qualifications, and terminology. METHODS: Searching MEDLINE, PubMed, CINAHL, HealthSTAR, and PsycINFO we identified articles meeting inclusion/exclusion criteria for a five-year period (2010-2015) and extracted relevant data. Coded material included reporting quality across seven areas (theory, content, delivery schedule, interventionist qualifications, treatment fidelity, setting, unit of delivery), author/journal information, patient population/outcomes, and terminology. RESULTS: Of 860 articles, 187 met review criteria (128 experimental; 59 quasi-experimental), with 121 publishing journals, and authors from 31 countries. Overall reporting quality was poor with <50% providing information for four of the seven checklist components (theory, interventionist qualifications, treatment fidelity, setting). Intervention content reporting was also poor with <50% providing information about the music used, decibel levels/volume controls, or materials. Credentialed music therapists and registered nurses delivered most interventions, with clear differences in content and delivery. Terminology was varied and inconsistent. CONCLUSIONS: Problems with reporting quality impedes meaningful interpretation and cross-study comparisons. Inconsistent and misapplied terminology also create barriers to interprofessional communication and translation of findings to patient care. Improved reporting quality and creation of shared language will advance scientific rigor and clinical relevance of music intervention research

Nutritional labelling for healthier food or non-alcoholic drink purchasing and consumption.

BACKGROUND: Nutritional labelling is advocated as a means to promote healthier food purchasing and consumption, including lower energy intake. Internationally, many different nutritional labelling schemes have been introduced. There is no consensus on whether such labelling is effective in promoting healthier behaviour. OBJECTIVES: To assess the impact of nutritional labelling for food and non-alcoholic drinks on purchasing and consumption of healthier items. Our secondary objective was to explore possible effect moderators of nutritional labelling on purchasing and consumption. SEARCH METHODS: We searched 13 electronic databases including CENTRAL, MEDLINE and Embase to 26 April 2017. We also handsearched references and citations and sought unpublished studies through websites and trials registries. SELECTION CRITERIA: Eligible studies: were randomised or quasi-randomised controlled trials (RCTs/Q-RCTs), controlled before-and-after studies, or interrupted time series (ITS) studies; compared a labelled product (with information on nutrients or energy) with the same product without a nutritional label; assessed objectively measured purchasing or consumption of foods or non-alcoholic drinks in real-world or laboratory settings. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies for inclusion and extracted study data. We applied the Cochrane 'Risk of bias' tool and GRADE to assess the quality of evidence. We pooled studies that evaluated similar interventions and outcomes using a random-effects meta-analysis, and we synthesised data from other studies in a narrative summary. MAIN RESULTS: We included 28 studies, comprising 17 RCTs, 5 Q-RCTs and 6 ITS studies. Most (21/28) took place in the USA, and 19 took place in university settings, 14 of which mainly involved university students or staff. Most (20/28) studies assessed the impact of labelling on menus or menu boards, or nutritional labelling placed on, or adjacent to, a range of foods or drinks from which participants could choose. Eight studies provided participants with only one labelled food or drink option (in which labelling was present on a container or packaging, adjacent to the food or on a display board) and measured the amount consumed. The most frequently assessed labelling type was energy (i.e. calorie) information (12/28).Eleven studies assessed the impact of nutritional labelling on purchasing food or drink options in real-world settings, including purchases from vending machines (one cluster-RCT), grocery stores (one ITS), or restaurants, cafeterias or coffee shops (three RCTs, one Q-RCT and five ITS). Findings on vending machines and grocery stores were not interpretable, and were rated as very low quality. A meta-analysis of the three RCTs, all of which assessed energy labelling on menus in restaurants, demonstrated a statistically significant reduction of 47 kcal in energy purchased (MD -46.72 kcal, 95% CI -78.35, -15.10, N = 1877). Assuming an average meal of 600 kcal, energy labelling on menus would reduce energy purchased per meal by 7.8% (95% CI 2.5% to 13.1%). The quality of the evidence for these three studies was rated as low, so our confidence in the effect estimate is limited and may change with further studies. Of the remaining six studies, only two (both ITS studies involving energy labels on menus or menus boards in a coffee shop or cafeteria) were at low risk of bias, and their results support the meta-analysis. The results of the other four studies which were conducted in a restaurant, cafeterias (2 studies) or a coffee shop, were not clearly reported and were at high risk of bias.Seventeen studies assessed the impact of nutritional labels on consumption in artificial settings or scenarios (henceforth referred to as laboratory studies or settings). Of these, eight (all RCTs) assessed the effect of labels on menus or placed on a range of food options. A meta-analysis of these studies did not conclusively demonstrate a reduction in energy consumed during a meal (MD -50 kcal, 95% CI -104.41, 3.88, N = 1705). We rated the quality of the evidence as low, so our confidence in the effect estimate is limited and may change with further studies.Six laboratory studies (four RCTs and two Q-RCTs) assessed the impact of labelling a single food or drink option (such as chocolate, pasta or soft drinks) on energy consumed during a snack or meal. A meta-analysis of these studies did not demonstrate a statistically significant difference in energy (kcal) consumed (SMD 0.05, 95% CI -0.17 to 0.27, N = 732). However, the confidence intervals were wide, suggesting uncertainty in the true effect size. We rated the quality of the evidence as low, so our confidence in the effect estimate is limited and may change with further studies.There was no evidence that nutritional labelling had the unintended harm of increasing energy purchased or consumed. Indirect evidence came from five laboratory studies that involved mislabelling single nutrient content (i.e. placing low energy or low fat labels on high-energy foods) during a snack or meal. A meta-analysis of these studies did not demonstrate a statistically significant increase in energy (kcal) consumed (SMD 0.19, 95% CI -0.14to 0.51, N = 718). The effect was small and the confidence intervals wide, suggesting uncertainty in the true effect size. We rated the quality of the evidence from these studies as very low, providing very little confidence in the effect estimate. AUTHORS' CONCLUSIONS: Findings from a small body of low-quality evidence suggest that nutritional labelling comprising energy information on menus may reduce energy purchased in restaurants. The evidence assessing the impact on consumption of energy information on menus or on a range of food options in laboratory settings suggests a similar effect to that observed for purchasing, although the evidence is less definite and also of low quality.Accordingly, and in the absence of observed harms, we tentatively suggest that nutritional labelling on menus in restaurants could be used as part of a wider set of measures to tackle obesity. Additional high-quality research in real-world settings is needed to enable more certain conclusions.Further high-quality research is also needed to address the dearth of evidence from grocery stores and vending machines and to assess potential moderators of the intervention effect, including socioeconomic status

Enhanced motivational interviewing for reducing weight and increasing physical activity in adults with high cardiovascular risk: the MOVE IT three-arm RCT.

BACKGROUND: Motivational interviewing (MI) enhanced with behaviour change techniques (BCTs) and deployed by health trainers targeting multiple risk factors for cardiovascular disease (CVD) may be more effective than interventions targeting a single risk factor. OBJECTIVES: The clinical effectiveness and cost-effectiveness of an enhanced lifestyle motivational interviewing intervention for patients at high risk of CVD in group settings versus individual settings and usual care (UC) in reducing weight and increasing physical activity (PA) were tested. DESIGN: This was a three-arm, single-blind, parallel randomised controlled trial. SETTING: A total of 135 general practices across all 12 South London Clinical Commissioning Groups were recruited. PARTICIPANTS: A total of 1742 participants aged 40-74 years with a ≥ 20.0% risk of a CVD event in the following 10 years were randomised. INTERVENTIONS: The intervention was designed to integrate MI and cognitive-behavioural therapy (CBT), delivered by trained healthy lifestyle facilitators in 10 sessions over 1 year, in group or individual format. The control group received UC. RANDOMISATION: Simple randomisation was used with computer-generated randomisation blocks. In each block, 10 participants were randomised to the group, individual or UC arm in a 4 : 3 : 3 ratio. Researchers were blind to the allocation. MAIN OUTCOME MEASURES: The primary outcomes are change in weight (kg) from baseline and change in PA (average number of steps per day over 1 week) from baseline at the 24-month follow-up, with an interim follow-up at 12 months. An economic evaluation estimates the relative cost-effectiveness of each intervention. Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. RESULTS: The mean age of participants was 69.75 years (standard deviation 4.11 years), 85.5% were male and 89.4% were white. At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI) -288 to 147.9 steps, and mean 7.24 steps, 95% CI -224.01 to 238.5 steps, respectively] or in reducing weight (mean -0.03 kg, 95% CI -0.49 to 0.44 kg, and mean -0.42 kg, 95% CI -0.93 to 0.09 kg, respectively). At the 12-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA (mean 131.1 steps, 95% CI -85.28 to 347.48 steps, and mean 210.22 steps, 95% CI -19.46 to 439.91 steps, respectively), but there were reductions in weight for the group and individual intervention arms compared with UC (mean -0.52 kg, 95% CI -0.90 to -0.13 kg, and mean -0.55 kg, 95% CI -0.95 to -0.14 kg, respectively). The group intervention arm was not more effective than the individual intervention arm in improving outcomes at either follow-up point. The group and individual interventions were not cost-effective. CONCLUSIONS: Enhanced MI, in group or individual formats, targeted at members of the general population with high CVD risk is not effective in reducing weight or increasing PA compared with UC. Future work should focus on ensuring objective evidence of high competency in BCTs, identifying those with modifiable factors for CVD risk and improving engagement of patients and primary care. TRIAL REGISTRATION: Current Controlled Trials ISRCTN84864870. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 69. See the NIHR Journals Library website for further project information. This research was part-funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London

Strategies to improve retention in randomised trials

Acknowledgements We thank Jayne Tierney, Sally Stenning, Seeromanie Harding, Sarah Meredith, and Irwin Nazareth for their contributions to earlier versions of this review. We also thank all authors of included published studies who provided additional or unreported data and Principal investigators for data on studies in progress or completed and unpublished. This update was funded by a National Institute for Health Research (NIHR) Incentive Award Scheme 2019 Reference 130660. The Health Services Research Unit, University of Aberdeen receives core funding from the Chief Scientist Office of the Scottish Government Health Directorates. The views expressed in this review are those of the authors and do not necessarily reflect those of the NIHR, the Department of Health and Social Care or these other funders. Sources of support Internal sources: No sources of support supplied External sources: National Institue for Health Research Incentive Award, UK; This update was funded by a National Institue for Health Research Incentive Award [NIHR IA 130660].Peer reviewedPublisher PD

The Evaluation of Enhanced Academic Instruction in After-School Programs: Findings After the First Year of Implementation

This report presents one-year implementation and impact findings on two supplemental academic instruction approaches developed for after-school settings -- one for math and one for reading. Compared with regular after-school programming, the supplemental math program had impacts on student SAT 10 test scores and the supplemental reading program did not --although the reading program had some effect on reading fluency

The effectiveness and cost-effectiveness of hospital-based specialist palliative care for adults with advanced illness and their caregivers

BackgroundSerious illness is often characterised by physical/psychological problems, family support needs, and high healthcare resource use. Hospital‐based specialist palliative care (HSPC) has developed to assist in better meeting the needs of patients and their families and potentially reducing hospital care expenditure. There is a need for clarity on the effectiveness and optimal models of HSPC, given that most people still die in hospital and also to allocate scarce resources judiciously.ObjectivesTo assess the effectiveness and cost‐effectiveness of HSPC compared to usual care for adults with advanced illness (hereafter patients) and their unpaid caregivers/families.Search methodsWe searched CENTRAL, CDSR, DARE and HTA database via the Cochrane Library; MEDLINE; Embase; CINAHL; PsycINFO; CareSearch; National Health Service Economic Evaluation Database (NHS EED) and two trial registers to August 2019, together with checking of reference lists and relevant systematic reviews, citation searching and contact with experts to identify additional studies.Selection criteriaWe included randomised controlled trials (RCTs) evaluating the impact of HSPC on outcomes for patients or their unpaid caregivers/families, or both. HSPC was defined as specialist palliative care delivered by a palliative care team that is based in a hospital providing holistic care, co‐ordination by a multidisciplinary team, and collaboration between HSPC providers and generalists. HSPC was provided to patients while they were admitted as inpatients to acute care hospitals, outpatients or patients receiving care from hospital outreach teams at home. The comparator was usual care, defined as inpatient or outpatient hospital care without specialist palliative care input at the point of entry into the study, community care or hospice care provided outside of the hospital setting.Data collection and analysisWe used standard methodological procedures expected by Cochrane. We assessed risk of bias and extracted data. To account for use of different scales across studies, we calculated standardised mean differences (SMDs) with 95% confidence intervals (CIs) for continuous data. We used an inverse variance random‐effects model. For binary data, we calculated odds ratio (ORs) with 95% CIs. We assessed the evidence using GRADE and created a 'Summary of findings' table.Our primary outcomes were patient health‐related quality of life (HRQoL) and symptom burden (a collection of two or more symptoms). Key secondary outcomes were pain, depression, satisfaction with care, achieving preferred place of death, mortality/survival, unpaid caregiver burden, and cost‐effectiveness. Qualitative data was analysed where available.Main resultsWe identified 42 RCTs involving 7779 participants (6678 patients and 1101 caregivers/family members). Twenty‐one studies were with cancer populations, 14 were with non‐cancer populations (of which six were with heart failure patients), and seven with mixed cancer and non‐cancer populations (mixed diagnoses).HSPC was offered in different ways and included the following models: ward‐based, inpatient consult, outpatient, hospital‐at‐home or hospital outreach, and service provision across multiple settings which included hospital. For our main analyses, we pooled data from studies reporting adjusted endpoint values. Forty studies had a high risk of bias in at least one domain.Compared with usual care, HSPC improved patient HRQoL with a small effect size of 0.26 SMD over usual care (95% CI 0.15 to 0.37; I2 = 3%, 10 studies, 1344 participants, low‐quality evidence, higher scores indicate better patient HRQoL). HSPC also improved other person‐centred outcomes. It reduced patient symptom burden with a small effect size of ‐0.26 SMD over usual care (95% CI ‐0.41 to ‐0.12; I2 = 0%, 6 studies, 761 participants, very low‐quality evidence, lower scores indicate lower symptom burden). HSPC improved patient satisfaction with care with a small effect size of 0.36 SMD over usual care (95% CI 0.41 to 0.57; I2 = 0%, 2 studies, 337 participants, low‐quality evidence, higher scores indicate better patient satisfaction with care). Using home death as a proxy measure for achieving patient's preferred place of death, patients were more likely to die at home with HSPC compared to usual care (OR 1.63, 95% CI 1.23 to 2.16; I2 = 0%, 7 studies, 861 participants, low‐quality evidence). Data on pain (4 studies, 525 participants) showed no evidence of a difference between HSPC and usual care (SMD ‐0.16, 95% CI ‐0.33 to 0.01; I2 = 0%, very low‐quality evidence). Eight studies (N = 1252 participants) reported on adverse events and very low‐quality evidence did not demonstrate an effect of HSPC on serious harms. Two studies (170 participants) presented data on caregiver burden and both found no evidence of effect of HSPC (very low‐quality evidence). We included 13 economic studies (2103 participants). Overall, the evidence on cost‐effectiveness of HSPC compared to usual care was inconsistent among the four full economic studies. Other studies that used only partial economic analysis and those that presented more limited resource use and cost information also had inconsistent results (very low‐quality evidence).Quality of the evidenceThe quality of the evidence assessed using GRADE was very low to low, downgraded due to a high risk of bias, inconsistency and imprecision.Authors' conclusionsVery low‐ to low‐quality evidence suggests that when compared to usual care, HSPC may offer small benefits for several person‐centred outcomes including patient HRQoL, symptom burden and patient satisfaction with care, while also increasing the chances of patients dying in their preferred place (measured by home death). While we found no evidence that HSPC causes serious harms, the evidence was insufficient to draw strong conclusions. Although these are only small effect sizes, they may be clinically relevant at an advanced stage of disease with limited prognosis, and are person‐centred outcomes important to many patients and families. More well conducted studies are needed to study populations with non‐malignant diseases and mixed diagnoses, ward‐based models of HSPC, 24 hours access (out‐of‐hours care) as part of HSPC, pain, achieving patient preferred place of care, patient satisfaction with care, caregiver outcomes (satisfaction with care, burden, depression, anxiety, grief, quality of life), and cost‐effectiveness of HSPC. In addition, research is needed to provide validated person‐centred outcomes to be used across studies and populations

Changing practice in dementia care in the community: developing and testing evidence-based interventions, from timely diagnosis to end of life (EVIDEM)

Background Dementia has an enormous impact on the lives of individuals and families, and on health and social services, and this will increase as the population ages. The needs of people with dementia and their carers for information and support are inadequately addressed at all key points in the illness trajectory. Methods The Unit is working specifically on an evaluation of the impact of the Mental Capacity Act 2005, and will develop practice guidance to enhance concordance with the Act. Phase One of the study has involved baseline interviews with practitioners across a wide range of services to establish knowledge and expectations of the Act, and to consider change processes when new policy and legislation are implemented. Findings Phase 1, involving baseline interviews with 115 practitioners, identified variable knowledge and understanding about the principles of the Act. Phase 2 is exploring everyday decision-making by people with memory problems and their carers

Text messaging to help women with overweight or obesity lose weight after childbirth:the intervention adaptation and SMS feasibility RCT

Background There is a need to develop weight management interventions that fit seamlessly into the busy lives of women during the postpartum period. Objective The objective was to develop and pilot-test an evidence- and theory-based intervention, delivered by short message service, which supported weight loss and weight loss maintenance in the postpartum period. Design Stage 1 involved the development of a library of short message service messages to support weight loss and weight loss maintenance, with personal and public involvement, focusing on diet and physical activity with embedded behaviour change techniques, and the programming of a short message service platform to allow fully automated intervention delivery. Stage 2 comprised a 12-month, single-centre, two-arm, pilot, randomised controlled trial with an active control. Setting This study was set in Northern Ireland; women were recruited via community-based approaches. Participants A total of 100 women with overweight or obesity who had given birth in the previous 24 months were recruited. Interventions The intervention group received an automated short message service intervention about weight loss and weight loss maintenance for 12 months. The active control group received automated short message service messages about child health and development for 12 months. Main outcome measures The main outcomes measured were the feasibility of recruitment and retention, acceptability of the intervention and trial procedures, and evidence of positive indicative effects on weight. Weight, waist circumference and blood pressure were measured by the researchers; participants completed a questionnaire booklet and wore a sealed pedometer for 7 days at baseline, 3, 6, 9 and 12 months. Outcome assessments were collected during home visits and women received a voucher on completion of each of the assessments. Qualitative interviews were conducted with women at 3 and 12 months, to gather feedback on the intervention and active control and the study procedures. Quantitative and qualitative data were used to inform the process evaluation and to assess fidelity, acceptability, dose, reach, recruitment, retention, contamination and context. Results The recruitment target of 100 participants was achieved (intervention, n = 51; control, n = 49); the mean age was 32.5 years (standard deviation 4.3 years); 28 (28%) participants had a household income o