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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.

In response to public concerns and campaigns, some United Kingdom supermarkets have implemented policies to reduce less-healthy food at checkouts. We explored the effects of these policies on purchases of less-healthy foods commonly displayed at checkouts. We used a natural experimental design and two data sources providing complementary and unique information. We analysed data on purchases of small packages of common, less-healthy, checkout foods (sugary confectionary, chocolate, and potato crisps) from 2013 to 2017 from nine UK supermarkets (Aldi, Asda, Co-op, Lidl, M&S, Morrisons, Sainsbury's, Tesco, and Waitrose). Six supermarkets implemented a checkout food policy between 2013 and 2017 and were considered intervention stores; the remainder were comparators. Firstly, we studied the longitudinal association between implementation of checkout policies and purchases taken home. We used data from a large (n ≈ 30,000) household purchase panel of food brought home to conduct controlled interrupted time series analyses of purchases of less-healthy common checkout foods from 12 months before to 12 months after implementation. We conducted separate analyses for each intervention supermarket, using others as comparators. We synthesised results across supermarkets using random effects meta-analyses. Implementation of a checkout food policy was associated with an immediate reduction in four-weekly purchases of common checkout foods of 157,000 (72,700-242,800) packages per percentage market share-equivalent to a 17.3% reduction. This decrease was sustained at 1 year with 185,100 (121,700-248,500) fewer packages purchased per 4 weeks per percentage market share-equivalent to a 15.5% reduction. The immediate, but not sustained, effect was robust to sensitivity analysis. Secondly, we studied the cross-sectional association between checkout food policies and purchases eaten without being taken home. We used data from a smaller (n ≈ 7,500) individual purchase panel of food bought and eaten 'on the go'. We conducted cross-sectional analyses comparing purchases of common checkout foods in 2016-2017 from supermarkets with and without checkout food policies. There were 76.4% (95% confidence interval 48.6%-89.1%) fewer annual purchases of less-healthy common checkout foods from supermarkets with versus without checkout food policies. The main limitations of the study are that we do not know where in the store purchases were selected and cannot determine the effect of changes in purchases on consumption. Other interventions may also have been responsible for the results seen. There is a potential impact of checkout food polices on purchases. Voluntary supermarket-led activities may have public health benefits.

We evaluated the impact of the pharmacist-led Safety Medication dASHboard (SMASH) intervention on medication safety in primary care. SMASH comprised (1) training of clinical pharmacists to deliver the intervention; (2) a web-based dashboard providing actionable, patient-level feedback; and (3) pharmacists reviewing individual at-risk patients, and initiating remedial actions or advising general practitioners on doing so. It was implemented in 43 general practices covering a population of 235,595 people in Salford (Greater Manchester), UK. All practices started receiving the intervention between 18 April 2016 and 26 September 2017. We used an interrupted time series analysis of rates (prevalence) of potentially hazardous prescribing and inadequate blood-test monitoring, comparing observed rates post-intervention to extrapolations from a 24-month pre-intervention trend. The number of people registered to participating practices and having 1 or more risk factors for being exposed to hazardous prescribing or inadequate blood-test monitoring at the start of the intervention was 47,413 (males: 23,073 [48.7%]; mean age: 60 years [standard deviation: 21]). At baseline, 95% of practices had rates of potentially hazardous prescribing (composite of 10 indicators) between 0.88% and 6.19%. The prevalence of potentially hazardous prescribing reduced by 27.9% (95% CI 20.3% to 36.8%, p < 0.001) at 24 weeks and by 40.7% (95% CI 29.1% to 54.2%, p < 0.001) at 12 months after introduction of SMASH. The rate of inadequate blood-test monitoring (composite of 2 indicators) reduced by 22.0% (95% CI 0.2% to 50.7%, p = 0.046) at 24 weeks; the change at 12 months (23.5%) was no longer significant (95% CI -4.5% to 61.6%, p = 0.127). After 12 months, 95% of practices had rates of potentially hazardous prescribing between 0.74% and 3.02%. Study limitations include the fact that practices were not randomised, and therefore unmeasured confounding may have influenced our findings. The SMASH intervention was associated with reduced rates of potentially hazardous prescribing and inadequate blood-test monitoring in general practices. This reduction was sustained over 12 months after the start of the intervention for prescribing but not for monitoring of medication. There was a marked reduction in the variation in rates of hazardous prescribing between practices.

Long-acting reversible contraception (LARC) is among the most effective contraceptive methods, but uptake remains low even in high-income settings. In 2009/2010, a target-based pay-for-performance (P4P) scheme in Britain was introduced for primary care physicians (PCPs) to offer advice about LARC methods to a specified proportion of women attending for contraceptive care to improve contraceptive choice. We examined the impact and equity of this scheme on LARC uptake and abortions. We examined records of 3,281,667 women aged 13 to 54 years registered with a primary care clinic in Britain (England, Wales, and Scotland) using Clinical Practice Research Datalink (CPRD) from 2004/2005 to 2013/2014. We used interrupted time series (ITS) analysis to examine trends in annual LARC and non-LARC hormonal contraception (NLHC) uptake and abortion rates, stratified by age and deprivation groups, before and after the P4P was introduced in 2009/2010. Between 2004/2005 and 2013/2014, crude LARC uptake rates increased by 32.0% from 29.6 per 1,000 women to 39.0 per 1,000 women, compared with 18.0% decrease in NLHC uptake. LARC uptake among women of all ages increased immediately after the P4P with step change of 5.36 per 1,000 women (all values are per 1,000 women unless stated, 95% CI 5.26-5.45, p < 0.001). Women aged 20 to 24 years had the largest step change (8.40, 8.34-8.47, p < 0.001) and sustained trend increase (3.14, 3.08-3.19, p < 0.001) compared with other age groups. NLHC uptake fell in all women with a step change of -22.8 (-24.5 to -21.2, p < 0.001), largely due to fall in combined hormonal contraception (CHC; -15.0, -15.5 to -14.5, p < 0.001). Abortion rates in all women fell immediately after the P4P with a step change of -2.28 (-2.98 to -1.57, p = 0.002) and sustained decrease in trend of -0.88 (-1.12 to -0.63, p < 0.001). The largest falls occurred in women aged 13 to 19 years (step change -5.04, -7.56 to -2.51, p = 0.011), women aged 20 to 24 years (step change -4.52, -7.48 to -1.57, p = 0.030), and women from the most deprived group (step change -4.40, -6.89 to -1.91, p = 0.018). We estimate that by 2013/2014, the P4P scheme resulted in an additional 4.53 LARC prescriptions per 1,000 women (relative increase of 13.4%) more than would have been expected without the scheme. There was a concurrent absolute reduction of -5.31 abortions per 1,000 women, or -38.3% relative reduction. Despite universal coverage of healthcare, some women might have obtained contraception elsewhere or had abortion procedure that was not recorded on CPRD. Other policies aiming to increase LARC use or reduce unplanned pregnancies around the same time could also explain the findings. In this study, we found that LARC uptake increased and abortions fell in the period after the P4P scheme in British primary care, with additional impact for young women aged 20-24 years and those from deprived backgrounds.

Background Cardiovascular disease (CVD) is the main cause of morbidity and mortality in Sweden. This study aims to assess the impact of a CVD intervention implemented in 1993 in northern Sweden on the reduction of premature ischemic heart disease (IHD) morbidity and mortality in women and men during the period 1987–2013. Methods An ecological controlled interrupted time series design, with pre-intervention period defined as 1987–1993 and post-intervention period 1994–2013 was carried out. For each year, IHD events, stratified by sex, were retrieved from national registers. Results Impressive reductions on IHD premature morbidity and mortality were observed to a similar degree in both the intervention county and the other comparison counties across the last 27 years. Significant differences in the pre-post intervention trends indicating the intervention group had smaller reductions than expected from its pre-intervention trend and the trend of control counties were found among men for both IHD morbidity and mortality. A similar pattern was observed among women but without significant differences. Conclusions Taken together, the data do not support that the intervention has contributed to an additional reduction on IHD morbidity and mortality, above and beyond that which is already seen in neighbouring counties without similar programs.

Worldwide nearly 3 million people die from chronic obstructive pulmonary disease (COPD) every year. Integrated disease management (IDM) improves quality of life for COPD patients and can reduce hospitalization. Self-management of COPD through eHealth is an effective method to improve IDM and clinical outcomes. The objective of this implementation study was to investigate the effect of 3 chronic obstructive pulmonary disease eHealth programs applied in primary care on health status. The e-Vita COPD study compares different levels of integration of Web-based self-management platforms in IDM in 3 primary care settings. Patient health status is examined using the Clinical COPD Questionnaire (CCQ). The parallel cohort design includes 3 levels of integration in IDM (groups 1, 2, 3) and randomization of 2 levels of personal assistance for patients (group A, high assistance, group B, low assistance). Interrupted time series (ITS) design was used to collect CCQ data at multiple time points before and after intervention, and multilevel linear regression modeling was used to analyze CCQ data. Of the 702 invited patients, 215 (30.6%) registered to a platform. Of these, 82 participated in group 1 (high integration IDM), 36 in group 1A (high assistance), and 46 in group 1B (low assistance); 96 participated in group 2 (medium integration IDM), 44 in group 2A (high assistance) and 52 in group 2B (low assistance); also, 37 participated in group 3 (no integration IDM). In the total group, no significant difference was found in change in CCQ trend (P=.334) before (-0.47% per month) and after the intervention (-0.084% per month). Also, no significant difference was found in CCQ changes before versus after the intervention between the groups with high versus low personal assistance. In all subgroups, there was no significant change in the CCQ trend before and after the intervention (group 1A, P=.237; 1B, P=.991; 2A, P=.120; 2B, P=.166; 3, P=.945). The e-Vita eHealth-supported COPD programs had no beneficial impact on the health status of COPD patients. Also, no differences were found between the patient groups receiving different levels of personal assistance. Netherlands Trial Registry NTR4098; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4098 (Archived by WebCite at http://www.webcitation.org/6sbM5PayG).

ObjectivesHead injury is a common reason for emergency department (ED) attendance. Around 1% of patients have life-threatening injuries, while 80% of patients are discharged. National guidelines (Scottish Intercollegiate Guidelines Network (SIGN)) were introduced in Scotland with the aim of achieving early identification of those with acute intracranial lesions yet safely reducing hospital admissions.This study aims to assess the impact of these guidelines and any effect the national 4-hour ED performance target had on hospital admissions for head injury.SettingAll Scottish hospitals between April 1998 and March 2016.ParticipantsPatients admitted to hospital for head injury or traumatic brain injury (TBI) diagnosed by CT imaging identified using administrative Scottish Information Services Division data. There are 275 hospitals in Scotland. In 2015/2016, there were 571 221 emergency hospital admissions in Scotland.InterventionsThe SIGN head injury guidelines introduced in 2000 and 2009. The 4-hour ED target introduced in 2004.OutcomesThe monthly rate of hospital admissions for head injury and traumatic brain injury.Study designAn interrupted time series analysis.ResultsThe first guideline was associated with a reduction in monthly admissions of 0.14 (95% CI 0.09 to 4.83) per 100 000 population. The 4-hour target was associated with a monthly increase in admissions of 0.13 (95% CI 0.06 to 0.20) per 100 000 population. The second guideline reduced monthly admissions by 0.09 (95% CI−0.13 to −0.05) per 100 000 population. These effects varied between age groups.The guidelines were associated with increased admissions for patients with injuries identified by CT imaging—guideline 1: 0.06 (95% CI 0.004 to 0.12); guideline 2: 0.05 (95% CI 0.04 to 0.06) per 100 000 population.ConclusionIncreased CT imaging of head injured patients recommended by SIGN guidelines reduced hospital admissions. The 4-hour ED target and the increased identification of TBI by CT imaging acted to undermine this effect.

The COVID-19 pandemic affected healthcare worldwide. This study analysed age-standardised incidence rates (ASIR) of colorectal cancer (CRC) in Bavaria to assess the COVID-19 pandemic’s impact. We modelled CRC ASIR, overall and in the subgroups (sex, age group, site and stage), in the pre-pandemic (01/2007 to 02/2020) and pandemic (03/2020 to 02/2022) periods using interrupted time-series analyses. Predictions for the third year of the pandemic (03/2022 to 02/2023) were compared to expected ASIR. Comparing expected and observed CRC ASIR during the first year of the pandemic showed a significant relative change of -8.8% (95% CI: -12.7% to -4.6%), improving to 1.4% (95% CI: -4.5% to 7.2%) in the third year of the pandemic. Likewise, ASIR significantly decreased across almost all subgroups during the first year of the pandemic, recovering during the second and the third year of the pandemic. Early stages showed a significant estimated reduction, persisting until the third year of the pandemic (-4.7%; 95% CI: -8.6% to -0.9%). In contrast, for women aged 70 years and above and women with colon cancer, ASIR experienced a significant excess. In the first year of the pandemic, estimated CRC ASIR experienced significant decline, returning to the expected rates during the third year of the pandemic, for most, but not all subgroups. The relative difference remained significantly negative for early stages. A significant catch-up effect occurred in the subgroups of women aged 70 years and above and women with colon cancer. Overall, estimations indicate a recovery of CRC ASIR.

Background: In April 2016, Japan mandated higher-level hospitals (ie, Special Functioning Hospitals [SFHs] and Regional Medical Care Support Hospitals [RMCSHs] with ≥500 beds) to charge additional fees for non-referral first visits to facilitate hospital function differentiation. The mandate expanded to RMCSHs with 400–499 beds and 200–399 beds in April 2018 and April 2020, respectively. We investigated changes in referral rates (proportion of referred to first-visit patients) before and after the fee’s implementation.Methods: Using a community-based insurance claims database from a single prefecture in Japan, we extracted claims for first visits to hospitals with ≥200 beds between April 2014 and March 2022 and calculated monthly referral rates to five hospital groups (SFHs, RMCSHs with ≥500, 400–499, and 200–399 beds, and non-designated hospitals with ≥200 beds). We conducted a controlled interrupted time-series analysis by hospital category, treating non-designated hospitals as controls.Results: Of 405,087 first-visit patients (mean age 54.9; standard deviation, 20.2 years; 53.2% female), 157,734 (38.9%) had a referral. The average referral rate to SFHs was high pre-mandate and did not increase. With the mandate, referral rates to RMSCHs with ≥500 beds and 400–499 beds rose by 5.10% points (95% confidence interval [CI], 1.84–8.35) in 2016 and 4.49% points (95% CI, 0.28–8.70) in 2018, respectively, and stabilized afterward. Referral rates to RMCSHs with 200–399 beds remained unchanged.Conclusion: Average referral rates increased when the additional fee was mandated for RMCSHs with ≥400 beds, although the influence on health outcomes remains unclear.

Background Limited information is available regarding the changes in blood culture utilization following the COVID-19 pandemic. Blood culture utilization rate is a critical indicator of diagnostic efficiency for infectious diseases. This study aims to describe the impact of the COVID-19 pandemic on blood culture utilization rate in Shanghai. Methods We conducted an interrupted time-series analysis based on electronic health records from the Shanghai Changzheng hospital from January 2014 to October 2023. The outcome measure was the rate of blood culture utilization among inpatients with a temperature of ≥ 39.4 °C. The impact of the COVID-19 pandemic on blood culture utilization was quantified by fitting linear segmented regression models and modelling the relative cumulative effect by the end of the study. The pandemic period was defined from February 2020, following the implementation of strict containment measures in Shanghai. Results A total of 23,761 inpatients with a temperature of ≥ 39.4 °C were included in the analysis. From 2014 to 2023, the utilization rate of hospital blood cultures increased initially and then declined, with a significant change point following the onset of the COVID-19 pandemic (Cochran-Armitage trend test, P  < 0.001). The COVID-19 pandemic was associated with a significant change in the slope of the blood culture utilization rate (pre-COVID-19 vs. during-COVID-19: 0.31% per month vs. -0.30% per month, P  < 0.001), resulting in a relative cumulative effect of -12.55% at the end of the study (95% confidence interval, -19.08 to -6.03). This corresponds to 407 inpatients who did not have blood cultures taken during-pandemic, which represents a significant deviation from pre-pandemic trends. Conclusions The upward trend in blood culture utilization rate among inpatients stalled during the COVID-19 pandemic and did not return to pre-pandemic levels following the pandemic. These findings suggest that the pandemic had a lasting impact on diagnostic practices. More targeted intervention measures are needed to promote appropriate utilization of blood cultures.