Dataset Information

Methodology and reporting characteristics of studies using interrupted time series design in healthcare.

ABSTRACT:

Background

Randomised controlled trials (RCTs) are considered the gold standard when evaluating the causal effects of healthcare interventions. When RCTs cannot be used (e.g. ethically difficult), the interrupted time series (ITS) design is a possible alternative. ITS is one of the strongest quasi-experimental designs. The aim of this methodological study was to describe how ITS designs were being used, the design characteristics, and reporting in the healthcare setting.

Methods

We searched MEDLINE for reports of ITS designs published in 2015 which had a minimum of two data points collected pre-intervention and one post-intervention. There was no restriction on participants, language of study, or type of outcome. Data were summarised using appropriate summary statistics.

Results

One hundred and sixteen studies were included in the study. Interventions evaluated were mainly programs 41 (35%) and policies 32 (28%). Data were usually collected at monthly intervals, 74 (64%). Of the 115 studies that reported an analysis, the most common method was segmented regression (78%), 55% considered autocorrelation, and only seven reported a sample size calculation. Estimation of intervention effects were reported as change in slope (84%) and change in level (70%) and 21% reported long-term change in levels.

Conclusions

This methodological study identified problems in the reporting of design features and results of ITS studies, and highlights the need for future work in the development of formal reporting guidelines and methodological work.

SUBMITTER: Hudson J

PROVIDER: S-EPMC6609377 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

Methodology and reporting characteristics of studies using interrupted time series design in healthcare.

Hudson Jemma J Fielding Shona S Ramsay Craig R CR

BMC medical research methodology 20190704 1

<h4>Background</h4>Randomised controlled trials (RCTs) are considered the gold standard when evaluating the causal effects of healthcare interventions. When RCTs cannot be used (e.g. ethically difficult), the interrupted time series (ITS) design is a possible alternative. ITS is one of the strongest quasi-experimental designs. The aim of this methodological study was to describe how ITS designs were being used, the design characteristics, and reporting in the healthcare setting.<h4>Methods</h4>W ...[more]

PMID: 31272382

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Project description:INTRODUCTION:An interrupted time series (ITS) design is an important observational design used to examine the effects of an intervention or exposure. This design has particular utility in public health where it may be impracticable or infeasible to use a randomised trial to evaluate health system-wide policies, or examine the impact of exposures (such as earthquakes). There have been relatively few studies examining the design characteristics and statistical methods used to analyse ITS designs. Further, there is a lack of guidance to inform the design and analysis of ITS studies.This is the first study in a larger project that aims to provide tools and guidance for researchers in the design and analysis of ITS studies. The objectives of this study are to (1) examine and report the design characteristics and statistical methods used in a random sample of contemporary ITS studies examining public health interventions or exposures that impact on health-related outcomes, and (2) create a repository of time series data extracted from ITS studies. Results from this study will inform the remainder of the project which will investigate the performance of a range of commonly used statistical methods, and create a repository of input parameters required for sample size calculation. METHODS AND ANALYSIS:We will collate 200 ITS studies evaluating public health interventions or the impact of exposures. ITS studies will be identified from a search of the bibliometric database PubMed between the years 2013 and 2017, combined with stratified random sampling. From eligible studies, we will extract study characteristics, details of the statistical models and estimation methods, effect metrics and parameter estimates. Further, we will extract the time series data when available. We will use systematic review methods in the screening, application of inclusion and exclusion criteria, and extraction of data. Descriptive statistics will be used to summarise the data. ETHICS AND DISSEMINATION:Ethics approval is not required since information will only be extracted from published studies. Dissemination of the results will be through peer-reviewed publications and presentations at conferences. A repository of data extracted from the published ITS studies will be made publicly available.

Project description:BackgroundIn uncontrolled before-after studies, CONSORT was shown to improve the reporting of randomised trials. Before-after studies ignore underlying secular trends and may overestimate the impact of interventions. Our aim was to assess the impact of the 2007 STROBE statement publication on the quality of observational study reporting, using both uncontrolled before-after analyses and interrupted time series.MethodsFor this quasi-experimental study, original articles reporting cohort, case-control, and cross-sectional studies published between 2004 and 2010 in the four dermatological journals having the highest 5-year impact factors (? 4) were selected. We compared the proportions of STROBE items (STROBE score) adequately reported in each article during three periods, two pre STROBE period (2004-2005 and 2006-2007) and one post STROBE period (2008-2010). Segmented regression analysis of interrupted time series was also performed.ResultsOf the 456 included articles, 187 (41%) reported cohort studies, 166 (36.4%) cross-sectional studies, and 103 (22.6%) case-control studies. The median STROBE score was 57% (range, 18%-98%). Before-after analysis evidenced significant STROBE score increases between the two pre-STROBE periods and between the earliest pre-STROBE period and the post-STROBE period (median score2004-05 48% versus median score2008-10 58%, p<0.001) but not between the immediate pre-STROBE period and the post-STROBE period (median score2006-07 58% versus median score2008-10 58%, p?=?0.42). In the pre STROBE period, the six-monthly mean STROBE score increased significantly, by 1.19% per six-month period (absolute increase 95%CI, 0.26% to 2.11%, p?=?0.016). By segmented analysis, no significant changes in STROBE score trends occurred (-0.40%; 95%CI, -2.20 to 1.41; p?=?0.64) in the post STROBE statement publication.InterpretationThe quality of reports increased over time but was not affected by STROBE. Our findings raise concerns about the relevance of uncontrolled before-after analysis for estimating the impact of guidelines.

Project description:OBJECTIVE:To evaluate the 2017 implementation of China's 2009 healthcare price reforms on Beijing's secondary and tertiary traditional Chinese medicine (TCM) hospitals. DESIGN:We employed a panel-interrupted time-series model with hospital fixed effects to estimate the impact of the price reforms. SETTING:Beijing, April 2014 to April 2018. PARTICIPANTS:All TCM hospitals in Beijing. OUTCOME MEASURES:Our dependent variables comprised the monthly outpatient and inpatient revenues, the number of monthly outpatient visits and inpatient admissions, the average total expenditures per outpatient visit and per inpatient admission, the average drug expenditures (except herbal medicines) per outpatient visit and per inpatient admission and the average medical service expenditures per outpatient visit and per inpatient admission. RESULTS:In tertiary hospitals, the price reforms led to significant reductions in the number of outpatient visits (23.1%), inpatients admission (4.6%) and drug expenditures (except herbal medicines) per inpatient admission (14.0%), and an instant raise in average total expenditure per outpatient (22.0%), medical service expenditures per outpatient visit (58.2%) and inpatient admission (19.0%). There was no significant association between the price reforms and the monthly outpatient and inpatient revenues. After the price reforms, the previous upward trend in medical service expenditures per outpatient visit rose more sharply (from 0.5% to 1.6%). In secondary hospitals, the price reforms decreased the level of drug expenditures (except herbal medicines) per outpatient visit (13.0%) and per inpatient admission (20.8%), but increased medical service expenditures per inpatient admission by 19.0%. CONCLUSION:The Beijing price reforms adjusted the cost structures in secondary and tertiary TCM hospitals without negatively impacting the operation of the hospitals, and through the increased hierarchical medical service fee, shifted patient choices away from tertiary to other health facilities, especially for patients with minor illnesses.

Project description:ObjectiveTo investigate the effect of the CONSORT for Abstracts guidelines, and different editorial policies used by five leading general medical journals to implement the guidelines, on the reporting quality of abstracts of randomised trials.DesignInterrupted time series analysis.SampleWe randomly selected up to 60 primary reports of randomised trials per journal per year from five high impact, general medical journals in 2006-09, if indexed in PubMed with an electronic abstract. We excluded reports that did not include an electronic abstract, and any secondary trial publications or economic analyses. We classified journals in three categories: those not mentioning the guidelines in their instructions to authors (JAMA and New England Journal of Medicine), those referring to the guidelines in their instructions to authors but with no specific policy to implement them (BMJ), and those referring to the guidelines in their instructions to authors with an active policy to implement them (Annals of Internal Medicine and Lancet). Two authors extracted data independently using the CONSORT for Abstracts checklist.Main outcomeMean number of CONSORT items reported in selected abstracts, among nine items reported in fewer than 50% of the abstracts published across the five journals in 2006.ResultsWe assessed 955 reports of abstracts of randomised trials. Journals with an active policy to enforce the guidelines showed an immediate increase in the level of mean number of items reported (increase of 1.50 items; P=0.0037). At 23 months after publication of the guidelines, the mean number of items reported per abstract for the primary outcome was 5.41 of nine items, a 53% increase compared with the expected level estimated on the basis of pre-intervention trends. The change in level or trend did not increase in journals with no policy to enforce the guidelines (BMJ, JAMA, and New England Journal of Medicine).ConclusionActive implementation of the CONSORT for Abstracts guidelines by journals can lead to improvements in the reporting of abstracts of randomised trials.

Dataset Information

Methodology and reporting characteristics of studies using interrupted time series design in healthcare.

Background

Methods

Results

Conclusions

Publications

Methodology and reporting characteristics of studies using interrupted time series design in healthcare.

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