Ruairidh Milne

Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.

LITERATURE SEARCHING FOR RANDOMIZED CONTROLLED TRIALS USED IN COCHRANE REVIEWS: RAPID VERSUS EXHAUSTIVE SEARCHES

OBJECTIVES To analyze sources searched in Cochrane reviews, to determine the proportion of trials included in reviews that are indexed in major databases, and to compare the quality of these trials with those from other sources. METHODS All new systematic reviews in the Cochrane Library, Issue1 2001, that were restricted to randomized controlled trials (RCTs) or quasi-RCTs were selected. The sources searched in the reviews were recorded, and the trials included were checked to see whether they were indexed in four major databases. Trials not indexed were checked to determine how they could be identified. The quality of trials found in major databases was compared with those found from other sources. RESULTS The range in the number of databases searched per review ranged between one and twenty-seven. The proportion of the trials in the four databases were Cochrane Controlled Trials Register = 78.5%, MEDLINE = 68.8%, Embase = 65.0%, and Science/Social Sciences Citation Index = 60.7%. Searching another twenty-six databases after Cochrane Controlled Trials Register (CCTR), MEDLINE, and Embase only found 2.4% additional trials. There was no significant difference between trials found in the CCTR, MEDLINE, and Embase compared with other trials, with respect to adequate allocation concealment or sample size. CONCLUSIONS There was a large variation between reviews in the exhaustiveness of the literature searches. CCTR was the single best source of RCTs. Additional database searching retrieved only a small percentage of extra trials. Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials.

A multidimensional conceptual framework for analysing public involvement in health services research

Objective To describe the development of a multidimensional conceptual framework capable of drawing out the implications for policy and practice of what is known about public involvement in research agenda setting.

Involving consumers in a needs-led research programme: a pilot project

Objectives To describe the methods used for involving consumers in a needs‐led health research programme, and to discuss facilitators, barriers and goals.

Smoking, Alcohol And The Risk Of Dupuytren's Contracture

We investigated the association of Dupuytrens contracture with smoking and with alcohol by a case-control study in which 222 patients having an operation for this condition were matched for age, operation date and gender with control patients having other orthopaedic operations. Fifty of the cases were also each matched with four community controls. Data were collected by postal questionnaire. Dupuytrens contracture needing operation was strongly associated with current cigarette smoking (adjusted odds ratio 2.8 (95% confidence interval (CI) 1.5 to 5.2)). The mean lifetime cigarette consumption was 16.7 pack-years for the cases compared with 12.0 pack-years for the controls (p = 0.016). Dupuytrens contracture was also associated with an Alcohol Use Disorders Test score greater than 7 (adjusted odds ratio 1.9 (95% CI 1.02 to 3.57)). Mean weekly alcohol consumption was 7.3 units for cases and 5.4 units for controls (p = 0.016). The excess risk associated with alcohol did not appear to be due to a confounding effect of smoking, or vice versa. Smoking increases the risk of developing Dupuytrens contracture and may contribute to its prevalence in alcoholics, who tend to smoke heavily.

Health technology assessment in England and Wales

In this study, we describe the current state of the Health Technology Assessment (HTA) system in England and Wales. This system rests on a distinction between assessment and appraisal and has three main strands: researcher-led HTA, the research and development program, and the HTA-NICE (National Institute for Clinical Excellence) process. We outline the pressures for HTA and how it has evolved in the British National Health Service. We discuss how HTA priorities are chosen, how HTA information is collected and assessed, how HTA evidence is used, and we make some observations about its impact. In our discussion, we consider some limitations of the HTA system, its possible divergence from evidence-based health care, its centralization, and some of the key challenges for managing HTA-driven policy. But we remain hopeful that HTA can contribute to better and more explicit decision-making within England and Wales.

A rapid and systematic review of the effectiveness of temozolomide for the treatment of recurrent malignant glioma

A rapid and systematic review of the effectiveness and cost-effectiveness of temozolomide in the treatment of recurrent malignant glioma was commissioned by the NHS HTA Programme on behalf of NICE. The full report has been published elsewhere. This paper summarizes the results for the effectiveness of temozolomide in people with recurrent glioblastoma multiforme and anaplastic astrocytoma. The review was conducted using standard systematic review methodology involving a systematic literature search, quality assessment of included studies with systematic data extraction and data synthesis. One randomized controlled trial and four uncontrolled studies were identified for inclusion. The key results were that temozolomide may increase progression-free survival but has no significant impact on overall length of survival. The main effect from temozolomide may have been in those patients who had not received any prior chemotherapy regimens, however further randomized controlled trials are required to confirm this suggestion. Temozolomide appears to produce few serious adverse effects and may also have a positive impact on health-related quality of life. Overall the evidence-base is weak and few strong conclusions can be drawn regarding the effectiveness of temozolomide. Large, well-designed randomized controlled trails conducted in a wider patient population are needed.

Impact of the NHS reforms on English hospital productivity: an analysis of the first three years.

Abstract Objectives: To evaluate the effect of purchaser mix, market competition, and trust status on hospital productivity within the NHS internal market. Methods: Hospital cost and activity data were taken from routinely collected data for acute NHS hospitals in England for 1991–2 to 1993-4. Cross sectional and longitudinal regression methods were used to estimate the effect of trust status, competition, and purchaser mix on average hospital costs per inpatient, after adjusting for outpatient activity levels, casemix, teaching activity, regional salary variation, hospital size, scale of activity, and scope of cases treated. Results: Real productivity gains were apparent across the study period for NHS hospitals on average. Casemix adjustment drastically improved cross sectional comparisons between hospitals. Gaining trust status and increasing host district purchaser share were associated with productivity increases after adjustment for casemix, regional salary differences, and hospital size and scope. Hospitals that became trusts during the study period were on average less productive at the beginning of the period than those that did not, and there were no significant productivity differences between trust waves at the end of the period in 1993-4. Market concentration was not associated with productivity differences. Conclusion: Further analysis is needed to determine whether overall and trust associated productivity gains are transient effects, one off shifts, or self perpetuating reorientations of organisational behaviour. Hospitals may have chosen to become trusts because they anticipated being able to increase productivity. Increases in the proportions of small purchasers were associated with increasing costs. Importantly, this study could not adjust for changes in the quality of care. Key messages Comparisons of performance between hospitals should take casemix into account, as failure to do so could significantly bias results Gaining independent trust status was associated with significant productivity gains for NHS hospitals, although some of the effect may have been due to self selection; and at the end of the study period productivity differences between trust waves were non-significant Competition between hospitals had no significant effect on productivity during the first three years of the internal market Hospitals that contract with many smaller purchasers other than their host district are more costly, other factors being equal

European network for Health Technology Assessment, EUnetHTA: Planning, development, and implementation of a sustainable European network for Health Technology Assessment

OBJECTIVES The European network on Health Technology Assessment (EUnetHTA) aimed to produce tangible and practical results to be used in the various phases of health technology assessment and to establish a framework and processes to support this. This article presents the background, objectives, and organization of EUnetHTA, which involved a total of sixty-four partner organizations. METHODS Establishing an effective and sustainable structure for a transnational network involved many managerial, policy, and methodological tools, according to the objective of each task or Work Package. Transparency in organization, financial transactions, and decision making was a key principle in the management of the Project as was the commitment to appropriately involve stakeholders. RESULTS EUnetHTA activities resulted in a clear management and governance structure, efficient partnership, and transnational cooperation. The Project developed a model for sustainable continuation of the EUnetHTA Collaboration. CONCLUSIONS The EUnetHTA Project achieved its goals by producing a suite of practical tools, a strong network, and plans for continuing the work in a sustainable EUnetHTA Collaboration that facilitates and promotes the use of HTA at national and regional levels. Responsiveness to political developments in Europe should be balanced with maintaining a high level of ambition to promote independent, evidence-based information and well-tested tools for best practice based on a strong network of HTA institutions.

Growth hormone replacement in adults and bone mineral density: a systematic review and meta-analysis

background  The effect of GH replacement on bone mineral density (BMD) in adults with GH deficiency (GHD) is uncertain. We carried out a systematic review of randomized trials that compared GH to no active treatment, with BMD as an outcome.