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No short-cut in assessing trial quality: a case study.

ABSTRACT: BACKGROUND: Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke et al., BMJ, 1991, as the case study, this paper illustrates some limitations of the check-list approach to trial quality assessment. RESULTS: The general verdict from the check list type evaluations in nine relevant systematic reviews was that Burke et al. (1991) is a good quality trial. All relevant meta-analyses extensively used its data to formulate therapeutic evidence. My comprehensive evaluation, on the other hand, brought to the surface a series of serious problems in the design, conduct, analysis and report of this trial that were missed by the earlier evaluations. CONCLUSION: A check-list or instrument based approach, if used as a short-cut, may at times rate deeply flawed trials as good quality trials. Check lists are crucial but they need to be augmented with an in-depth review, and where possible, a scrutiny of the protocol, trial records, and original data. The extent and severity of the problems I uncovered for this particular trial warrant an independent audit before it is included in a systematic review.

SUBMITTER: Hirji KF

PROVIDER: S-EPMC2636799 | biostudies-other | 2009

REPOSITORIES: biostudies-other

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No short-cut in assessing trial quality: a case study.

Hirji Karim F KF

Trials 20090107

<h4>Background</h4>Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke et al., BMJ, 1991, as the case study, this paper illustrates some limitations of the check-list approach to trial quality assessment.<h4>Results</h4>The general verdict from the check list type evaluations in nine relevant systematic reviews was that Burke et al. (1991) i ...[more]

PMID: 19128475

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Project description:Birth centres are described as settings where women with uncomplicated pregnancies can give birth in a home-like environment assisted by midwives and maternity care assistants. If complications arise or threaten, the woman is referred to a maternity unit of a hospital where an obstetrician will take over responsibility. In the last decade, a number of new birth centres have been established in the Netherlands, based on the assumption that birth centres provide better quality of care since they offer a better opportunity for more integrated care than the existing system with independent primary and secondary care providers. At present, there is no evidence for this assumption. The Dutch Birth Centre Study is designed to present evidence-based recommendations for organization and functioning of future birth centres in the Netherlands. A necessary first step in this evaluation is the development of indicators for measuring the quality of the care delivered in birth centres in the Netherlands. The aim of this study is to identify a comprehensive set of structure and process indicators to assess quality of birth centre care.We used mixed methods to develop a set of structure and process quality indicators for evaluating birth centre care. Beginning with a literature review, we developed an exhaustive list of determinants. We then used a Delphi study to narrow this list, calling on experts to rate the determinants for relevance and feasibility. A multidisciplinary expert panel of 63 experts, directly or indirectly involved with birth centre care, was invited to participate.A panel of 42 experts completed two Delphi rounds rating determinants of the quality of birth centre care based on their relevance (to the setting) and feasibility (of use). A set of 30 determinants for structure and process quality indicators was identified to assess the quality of birth centre care in the Netherlands.We identified 30 determinants for structure and process quality indicators concerning birth centre care. This set will be validated during the evaluation of birth centres in the Dutch Birth Centre Study.

Project description:Electrical coupling between retinal neurons contributes to the functional complexity of visual circuits. "Cut-loading" methods allow simultaneous assessment of cell-coupling between multiple retinal cell-types, but existing analysis methods impede direct comparison with gold standard direct dye injection techniques. In the current study, we both improved an existing method and developed two new approaches to address observed limitations. Each method of analysis was applied to cut-loaded dark-adapted Guinea pig retinae (n = 29) to assess coupling strength in the axonless horizontal cell type ('a-type', aHCs). Method 1 was an improved version of the standard protocol and described the distance of dye-diffusion (space constant). Method 2 adjusted for the geometric path of dye-transfer through cut-loaded cells and extracted the rate of dye-transfer across gap-junctions in terms of the coupling coefficient (kj). Method 3 measured the diffusion coefficient (De) perpendicular to the cut-axis. Dye transfer was measured after one of five diffusion times (1-20 mins), or with a coupling inhibitor, meclofenamic acid (MFA) (50-500μM after 20 mins diffusion). The standard protocol fits an exponential decay function to the fluorescence profile of a specified retina layer but includes non-specific background fluorescence. This was improved by measuring the fluorescence of individual cell soma and excluding from the fit non-horizontal cells located at the cut-edge (p<0.001) (Method 1). The space constant (Method 1) increased with diffusion time (p<0.01), whereas Methods 2 (p = 0.54) and 3 (p = 0.63) produced consistent results across all diffusion times. Adjusting distance by the mean cell-cell spacing within each tissue reduced the incidence of outliers across all three methods. Method 1 was less sensitive to detecting changes induced by MFA than Methods 2 (p<0.01) and 3 (p<0.01). Although the standard protocol was easily improved (Method 1), Methods 2 and 3 proved more sensitive and generalisable; allowing for detailed assessment of the tracer kinetics between different populations of gap-junction linked cell networks and direct comparison to dye-injection techniques.

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No short-cut in assessing trial quality: a case study.

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No short-cut in assessing trial quality: a case study.

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