Applicability and generalisability of the results of systematic reviews to public health practice and policy: a systematic review

<p>Abstract</p> <p>Background</p> <p>The purpose of the study was to evaluate systematic reviews of research into two public health priorities, tobacco consumption and HIV infection, in terms of the reporting of data related to the applicability of trial results (i.e., whether the results of a trial can be reasonably applied or generalized to a definable group of patients in a particular setting in routine practice, also called external validity or generalisability).</p> <p>Methods</p> <p>All systematic reviews of interventions aimed at reducing or stopping tobacco use and treating or preventing HIV infection published in the Cochrane database of systematic reviews and in journals indexed in MEDLINE between January 1997 and December 2007 were selected. We used a standardized data abstraction form to extract data related to applicability in terms of the context of the trial, (country, centres, settings), participants (recruitment, inclusion and exclusion criteria, baseline characteristics of participants such as age, sex, ethnicity, coexisting diseases or co-morbidities, and socioeconomic status), treatment (duration, intensity/dose of treatment, timing and delivery format), and the outcomes assessment from selected reviews.</p> <p>Results</p> <p>A total of 98 systematic reviews were selected (57 Cochrane reviews and 41 non-Cochrane reviews); 49 evaluated interventions aimed at reducing or stopping tobacco use and 49 treating or preventing HIV infection. The setting of the individual studies was reported in 45 (46%) of the systematic reviews, the number of centres in 21 (21%), and the country where the trial took place in 62 (63%). Inclusion and exclusion criteria of the included studies were reported in 16 (16%) and 13 (13%) of the reviews, respectively. Baseline characteristics of participants in the included studies were described in 59 (60%) of the reviews. These characteristics concerned age in about half of the reviews, sex in 46 (47%), and ethnicity in 9 (9%).</p> <p>Applicability of results was discussed in 13 (13%) of the systematic reviews. The reporting was better in systematic reviews by the Cochrane Collaboration than by non-Cochrane groups.</p> <p>Conclusions</p> <p>Our study highlighted the lack of consideration of applicability of results in systematic reviews of research into 2 public health priorities: tobacco consumption and HIV infection.</p

A cluster randomized trial of standard quality improvement versus patient-centered interventions to enhance depression care for African Americans in the primary care setting: study protocol NCT00243425

<p>Abstract</p> <p>Background</p> <p>Several studies document disparities in access to care and quality of care for depression for African Americans. Research suggests that patient attitudes and clinician communication behaviors may contribute to these disparities. Evidence links patient-centered care to improvements in mental health outcomes; therefore, quality improvement interventions that enhance this dimension of care are promising strategies to improve treatment and outcomes of depression among African Americans. This paper describes the design of the BRIDGE (Blacks Receiving Interventions for Depression and Gaining Empowerment) Study. The goal of the study is to compare the effectiveness of two interventions for African-American patients with depression--a standard quality improvement program and a patient-centered quality improvement program. The main hypothesis is that patients in the patient-centered group will have a greater reduction in their depression symptoms, higher rates of depression remission, and greater improvements in mental health functioning at six, twelve, and eighteen months than patients in the standard group. The study also examines patient ratings of care and receipt of guideline-concordant treatment for depression.</p> <p>Methods/Design</p> <p>A total of 36 primary care clinicians and 132 of their African-American patients with major depressive disorder were recruited into a cluster randomized trial. The study uses intent-to-treat analyses to compare the effectiveness of standard quality improvement interventions (academic detailing about depression guidelines for clinicians and disease-oriented care management for their patients) and patient-centered quality improvement interventions (communication skills training to enhance participatory decision-making for clinicians and care management focused on explanatory models, socio-cultural barriers, and treatment preferences for their patients) for improving outcomes over 12 months of follow-up.</p> <p>Discussion</p> <p>The BRIDGE Study includes clinicians and African-American patients in under-resourced community-based practices who have not been well-represented in clinical trials to improve depression care. The patient-centered and culturally targeted approach to depression care is a relatively new one that has not been tested in most previous studies. The study will provide evidence about whether patient-centered accommodations improve quality of care and outcomes to a greater extent than standard quality improvement strategies for African Americans with depression.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov NCT00243425</p

An occupational therapy intervention for residents with stroke-related disabilities in UK care homes (OTCH):Cluster randomised controlled trial with economic evaluation

Background: Care home residents with stroke-related disabilities have significant activity limitations. Phase II trial results suggested a potential benefit of occupational therapy (OT) in maintaining residents’ capacity to engage in functional activity. Objective: Evaluate clinical and cost effectiveness of a targeted course of OT in maintaining functional activity and reducing further health risks from inactivity for UK care home residents living with stroke-related disabilities. Design: Pragmatic, parallel-group, cluster randomised controlled trial with economic evaluation. Cluster randomisation occurred at the care home level. Homes were stratified according to trial administrative centre, and type of care provided (nursing or residential) and randomised 1:1 to either the intervention or control arm. Setting: 228 care homes local to 11 trial administrative centres across England and Wales. Participants: 1042 care home residents with a history of stroke or transient ischaemic attack, including residents with communication and cognitive impairments, not receiving end of life care. 114 care homes (n=568 residents) were allocated to the intervention arm; 114 homes (n=474 residents) to the control arm. Randomisation of participating homes occurred between May 2010 and March 2012. Intervention: Personalised three-month course of OT delivered by qualified therapists. Care workers participated in training workshops to support personal activities of daily living. The control condition consisted of usual care for residents. Main outcome measures: Primary outcome at the participant level: Barthel Index of Activities of Daily Living at three months. Secondary outcomes at the participant level: Barthel Index scores at six and twelve months post-randomisation, and the Rivermead Mobility Index, Geriatric Depression Scale-15, and EuroQol EQ-5D-3L questionnaire at all time-points. An economic evaluation examined the incremental cost per quality-adjusted life year (QALY) gain, costs were estimated from the perspective of the NHS and personal social services. Results: Participants mean age= 82.9 years, 665/1042 (64%) were female. 2538 OT sessions were delivered to 498 participants in the intervention group (mean visits/participant =5.1, SD=3.0). No adverse events attributable to the intervention were recorded. The primary outcome showed no significant differences between groups. The adjusted mean difference in the Barthel Index score between groups was 0.19 points higher in the intervention arm (95% CI -0.33 to 0.70, p=0.48, adjusted ICC 0.09). Secondary outcome measures showed no significant differences at all time-points. Mean incremental cost of the OTCH intervention was £438.78 (CI £-360.89 to £1238.46), and the incremental QALY gain was 0.009 (CI -0.030 to 0.048). Conclusion: A three-month individualised course of OT, showed no benefit in maintaining functional activity in an older care home population with stroke-related disabilities. Limitations: A high proportion of participants with very severe activity-based limitations and cognitive impairment have limited capacity to engage in therapy. Future work: There is an urgent need to reduce health-related complications caused by inactivity, and create more of an enabling built environment within care homes. Trial registration: Current controlled trials ISRCTN00757750

NMR-based metabolomics and fluxomics: developments and future prospects

International audienceNMR spectroscopy is an essential analytical technique in metabolomics and fluxomics workflows, owing to its high structural elucidation capabilities combined with its intrinsic quantitative nature. However, routine NMR "omic" analytical methods suffer from several drawbacks that may have limited its use as a tool of choice, in particular when compared to another widely used technique, mass spectrometry. This review describes, in a critical and perspective discussion, how some of the most recent developments emerging from the NMR community could act as real game changers for metabolomics and fluxomics in the near future. Advanced developments to make NMR metabolomics more resolutive, more sensitive and more accessible are described, as well as new approaches to improve the identification of biomarkers. We hope that this review will convince a broad end-users community of the increasing role of NMR in the "omic" world at the beginning of the 2020s

Fast and Ultrafast Quantitative 2D NMR: Vital Tools for Efficient Metabolomic Approaches

International audienceNuclear magnetic resonance (NMR) offers great potential for quantitative analysis of metabolic samples, but accurate and precise quantitative analysis is often made difficult by a high degree of spectral overlap. Multi-dimensional NMR offers an interesting alternative, as it provides a much better discrimination of resonances. However, its use for quantitative analysis is limited by its long acquisition duration and its multi-impulsional character. Nevertheless, numerous improvements in the quantitative performance of 2D NMR have been made during the past decade, facilitating a wide range of applications. This review assesses the recent contributions brought to the field of quantitative 2D NMR, and provides a survey of recent studies of metabolic samples using this methodology. The ongoing need for developing and optimizing powerful tools is first examined. It highlights the necessity of reducing the experimental duration, resulting in a fast 2D NMR approach. This methodology is then described, relying on recent applications to metabolic samples. The last section of the chapter describes a more recent approach, ultrafast 2D NMR, which makes it possible to record multi-dimensional spectra in a single scan. The principles and the analytical performances of this novel methodology are described, as well as its perspectives in terms of quantitative analysis