Patients with impaired kidney function and increased albuminuria are at risk of developing cardiovascular disease (CVD). Previous research has revealed that a substantial proportion of patients with chronic kidney disease (CKD) do not get a registered diagnosis in the electronic health record of the general practitioner. The aim of this study was to investigate the association between non-registration of CKD and all-cause mortality and cardiovascular outcome.

A retrospective study in primary care.

The analyses were carried out in the INTEGO database, a general practice-based morbidity registration network in Flanders, Belgium. The study used INTEGO data from the year 2018 for all patients ≥18 years old, including 10 551 patients. To assess the risk of mortality and CVD, a time-to-event analysis was performed. Cox proportional hazard model was used to evaluate the association between non-registration and incidence of all-cause mortality and cardiovascular events with mortality as a competing risk. Subgroup analyses were performed for estimated glomerular filtration rate stages (3A, 3B, 4 and 5). Multiple imputation was done following the methodology of Mamouris et al.

Mortality was higher in patients with non-registered CKD compared with patients with registered CKD (HR 1.29, 95% CI 1.19 to 1.41). Non-registration of CKD was not associated with an increased risk for the development of CVD (HR 0.92, 95% CI 0.77 to 1.11).

An association between non-registration and all-cause mortality was identified, although no such association was apparent for CVD.

To assess the impact of tobacco control regulations and policy implementation on smoking cessation tendencies in cigarette users born between 1982 and 1991 in Chile.

Longitudinal cross-sectional study.

National level.

Data from the National Survey of Drug Consumption (Service of Prevention and Rehabilitation for Drug and Alcohol Consumption). A pseudo-cohort of smokers born between 1982 and 1991 (N=17 905) was tracked from 2002 to 2016.

Primary outcome was the tendency to cease smoking conceptualised as the report of using cigarettes 1 month or more ago relative to using cigarettes in the last 30 days. The main exposure variable was the Tobacco Policy Index—tracking tobacco policy changes over time. Logistic regression, controlling for various factors, was applied.

Models suggested a 14% increase in the smoking cessation tendency of individuals using cigarettes 1 month or more ago relative to those using cigarettes in the last 30 days (OR 1.14, CI 95% CI 1.10 to 1.19) for each point increment in the Tobacco Policy index.

Our study contributes to documenting a positive impact of the implementation of interventions considered in the MPOWER strategy in the progression of smoking cessation tendencies in smokers born between 1982 and 1991 in Chile.

Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage.

We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at

This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results.

ClinicalTrials.gov, NCT05968794.

SARS-CoV-2 mainly infects respiratory endothelial cells, which is facilitated through its spike protein binding to heparan sulphate. Calcium dobesilate (CaD) is a well-established, widely available vasoactive and angioprotective drug interacting with heparan sulphate, with the potential to interfere with the uptake of SARS-CoV-2 by epithelial cells. The CADOVID trial aims to evaluate the efficacy and safety of CaD in reducing the SARS-CoV-2 viral load in non-hospitalised adult patients diagnosed with COVID-19, confirmed by a positive SARS-CoV-2 PCR, including its efficacy to reduce the impact of persistent COVID-19 symptoms.

This is a randomised, placebo-controlled, double-blind, monocentric phase II trial. Enrolment began in July 2022. A total of 74 adult patients will be randomly allocated to the CaD arm or the placebo group with a 1:1 ratio, respectively. Participants in the intervention arm will receive two capsules of CaD 500 mg two times per day and the placebo arm will receive two matching capsules of mannitol 312.5 mg two times per day, with a treatment period of 7 days for both arms, followed by a 77-day observational period without treatment administration. Participants will be asked to complete secured online questionnaires using their personal smartphone or other electronic device. These include a COVID-19 questionnaire (assessing symptoms, temperature measurement, reporting of concomitant medication and adverse events), a COVID-19 persistent symptoms’ questionnaire and the Short Form 12-Item (SF-12) survey. SARS-CoV-2 PCR testing will be performed on nasopharyngeal swabs collected on days 1, 4, 8 and 21. The primary endpoint is the reduction from baseline of SARS-CoV-2 viral load determined by RT-PCR at day 4.

This trial has received approval by the Geneva Regional Research Ethics Committee (2022-00613) and Swissmedic (701339). Dissemination of results will be through presentations at scientific conferences and publication in scientific journals.

NCT05305508; Clinicaltrials.gov; Swiss National Clinical Portal Registry (SNCTP 000004938).

To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.

Systematic review.

We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.

Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.

4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.

We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).

Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.

CRD42022282565.

Climate change is a major global issue with significant consequences, including effects on air quality and human well-being. This review investigated the projection of non-communicable diseases (NCDs) attributable to air pollution under different climate change scenarios.

This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 flow checklist. A population-exposure-outcome framework was established. Population referred to the general global population of all ages, the exposure of interest was air pollution and its projection, and the outcome was the occurrence of NCDs attributable to air pollution and burden of disease (BoD) based on the health indices of mortality, morbidity, disability-adjusted life years, years of life lost and years lived with disability.

The Web of Science, Ovid MEDLINE and EBSCOhost databases were searched for articles published from 2005 to 2023.

The eligible articles were evaluated using the modified scale of a checklist for assessing the quality of ecological studies.

Two reviewers searched, screened and selected the included studies independently using standardised methods. The risk of bias was assessed using the modified scale of a checklist for ecological studies. The results were summarised based on the projection of the BoD of NCDs attributable to air pollution.

This review included 11 studies from various countries. Most studies specifically investigated various air pollutants, specifically particulate matter 2.5), nitrogen oxides and ozone. The studies used coupled-air quality and climate modelling approaches, and mainly projected health effects using the concentration–response function model. The NCDs attributable to air pollution included cardiovascular disease (CVD), respiratory disease, stroke, ischaemic heart disease, coronary heart disease and lower respiratory infections. Notably, the BoD of NCDs attributable to air pollution was projected to decrease in a scenario that promotes reduced air pollution, carbon emissions and land use and sustainable socioeconomics. Contrastingly, the BoD of NCDs was projected to increase in a scenario involving increasing population numbers, social deprivation and an ageing population.

The included studies widely reported increased premature mortality, CVD and respiratory disease attributable to PM_2.5. Future NCD projection studies should consider emission and population changes in projecting the BoD of NCDs attributable to air pollution in the climate change era.

CRD42023435288.

To (1) pilot a study of behavioural characterisation based on risk and time preferences in clinically well-characterised individuals, (2) assess the distribution of preferences in this population and (3) explore differences in preferences between individuals with ‘lifestyle-related’ (LS) and ‘non-lifestyle-related’ (NLS) cardiovascular diseases.

Cross-sectional study with an economic online experiment to collect risk and time preferences, a detailed clinical characterisation and a sociodemographic and lifestyle survey. A definition of LS and NLS groups was developed.

Specialist outpatient clinics of the clinic for cardiology and pneumology of the University Hospital Düsseldorf and patients from a cardiology practice in Düsseldorf.

A total of 74 individuals with cardiovascular diseases.

Risk and time preferences.

The implementation of the study process, including participant recruitment and data collection, ran smoothly. The medical checklist, the survey and the time preference instrument were well received. However, the conceptual understanding of the risk preference instrument resulted in inconsistent choices for many participants (47%). The remaining individuals were more risk averse (27%) than risk seeking (16%) and risk neutral (10%). Individuals in our sample were also more impatient (49%) than patient (42%). The participant classification showed that 65% belonged to the LS group, 19% to the NLS group and 16% could not be assigned (unclear allocation to lifestyle (ULS) group). Excluding the ULS group, we show that individuals in the LS group were more risk seeking, and unexpectedly, more patient than those in the NLS group.

The process of the pilot study and its results can be used as a basis for the design of the main study. The differences in risk and time preferences between the LS and NLS groups provide us with a novel hypothesis for unhealthy behaviours: individuals never give up a bad habit, they simply postpone the latter, which can be tested alongside other additional research questions.

The aim of the study was to evaluate mortality and morbidity outcomes following open-heart isolated tricuspid valve surgery (TVSx) with medium to long-term follow-up.

Retrospective cohort study.

New South Wales public and private hospital admissions between 1 January 2002 and 30 June 2018.

A total of 537 patients underwent open isolated TVSx during the study period.

Primary outcome was all-cause mortality tracked from the death registry to 31 December 2018. Secondary morbidity outcomes, including admission for congestive cardiac failure (CCF), new atrial fibrillation (AF), infective endocarditis (IE), pulmonary embolism (PE) and insertion of a permanent pacemaker (PPM) or implantable cardioverter-defibrillator (ICD), were tracked from the Admitted Patient Data Collection database. Independent mortality associations were determined using the Cox regression method.

A total of 537 patients underwent open isolated TVSx (46% male): median age (IQR) was 63.5 years (43.9–73.8 years) with median length of stay of 16 days (10–31 days). Main cardiovascular comorbidities were AF (54%) and CCF (42%); 67% had rheumatic tricuspid valve. In-hospital and total mortality were 7.4% and 39.3%, respectively (mean follow-up: 4.8 years). Cause-specific deaths were evenly split between cardiovascular and non-cardiovascular causes. Predictors of mortality included a history of CCF (HR=1.78, 95% CI 1.33 to 2.38, p

Open isolated TVSx carries significant mortality risk, with decompensated CCF and new AF the most common morbidities encountered after surgery. This report forms a benchmark to compare outcomes with newer percutaneous tricuspid interventions.

The 68th World Health Assembly, in 2015, called for surgical and anaesthesia services strengthening. Acknowledging the healthcare staff shortages, they referred to task sharing, among others, as a more effective use of the healthcare workforce. While task sharing has been increasingly proposed as an important strategy to increase the reach and safety of anaesthesia as well as a means of supporting the workforce in low-resource settings, most data on task sharing relate to non-anaesthetic healthcare contexts. The aim of this study was to understand anaesthetic task sharing as currently experienced and/or envisaged by non-physician anaesthesia providers in Zambia and Somaliland.

An exploratory qualitative research methodology was used. Participants were recruited initially via contacts of the research team, then through snowballing using a purposive sampling strategy. There were 13 participants: 7 from Somaliland and 6 from Zambia. Semistructured interviews took place synchronously, then were recorded, anonymised, transcribed and analysed thematically. Triangulation and respondents’ validation were used to maximise data validity.

Four major themes were identified in relation to task sharing practices: (1) participants recognised variable components of task sharing in their practice; (2) access to task sharing depends both on sources and resources; (3) implicit barriers may inhibit task sharing practices; (4) there is an appetite among participants for amelioration of current task sharing practices.

Empowering task sharing practices can be achieved only by understanding how these practices work, by identifying gaps and areas of improvement, and by addressing them. The findings from this exploratory study could help the global community understand how anaesthetic task sharing in low-resource settings works and inspire further research on the field. This could inform future modelling of workforce planning strategies in low-resource settings to maximise the effectiveness and professional well-being of the workforce.

Decisions about nurse staffing models are a concern for health systems globally due to workforce retention and well-being challenges. Nurse staffing models range from all Registered Nurse workforce to a mix of differentially educated nurses and aides (regulated and unregulated), such as Licensed Practical or Vocational Nurses and Health Care Aides. Systematic reviews have examined relationships between specific nurse staffing models and client, staff and health system outcomes (eg, mortality, adverse events, retention, healthcare costs), with inconclusive or contradictory results. No evidence has been synthesised and consolidated on how, why and under what contexts certain staffing models produce different outcomes. We aim to describe how we will (1) conduct a realist review to determine how nurse staffing models produce different client, staff and health system outcomes, in which contexts and through what mechanisms and (2) coproduce recommendations with decision-makers to guide future research and implementation of nurse staffing models.

Using an integrated knowledge translation approach with researchers and decision-makers as partners, we are conducting a three-phase realist review. In this protocol, we report on the final two phases of this realist review. We will use Citation tracking, tracing Lead authors, identifying Unpublished materials, Google Scholar searching, Theory tracking, ancestry searching for Early examples, and follow-up of Related projects (CLUSTER) searching, specifically designed for realist searches as the review progresses. We will search empirical evidence to test identified programme theories and engage stakeholders to contextualise findings, finalise programme theories document our search processes as per established realist review methods.

Ethical approval for this study was provided by the Health Research Ethics Board of the University of Alberta (Study ID Pro00100425). We will disseminate the findings through peer-reviewed publications, national and international conference presentations, regional briefing sessions, webinars and lay summary.

To follow SARS-CoV-2-infected persons up to 18 months after a positive test in order to assess the burden and nature of post acute symptoms and health problems.

Persons in Denmark above 15 years of age, who were tested positive for SARS-CoV-2 during 1 September 2020 to 21 February 2023 using a RT-PCR test. As a reference group, three test-negative individuals were selected for every two test-positive individuals by matching on test date.

In total, 2 427 913 invitations to baseline questionnaires have been sent out and 839 528 baseline questionnaires (34.5%) have been completed. Females, the age group 50–69 years, Danish-born and persons, who had received at least one SARS-CoV-2 vaccination booster dose were more likely to participate. Follow-up questionnaires were sent at 2, 4, 6, 9, 12 and 18 months after the test, with response rates at 42%–54%.

New participants have been recruited on a daily basis from 1 August 2021 to 23 March 2023. Data collection will continue until the last follow-up questionnaires (at 18 months after test) have been distributed in August 2024.

Bacterial infection and Modic changes (MCs) as causes of low back pain (LBP) are debated. Results diverged between two randomised controlled trials examining the effect of amoxicillin with and without clavulanic acid versus placebo on patients with chronic LBP (cLBP) and MCs. Previous biopsy studies have been criticised with regard to methods, few patients and controls, and insufficient measures to minimise perioperative contamination. In this study, we minimise contamination risk, include a control group and optimise statistical power. The main aim is to compare bacterial growth between patients with and without MCs.

This multicentre, case–control study examines disc and vertebral body biopsies of patients with cLBP. Cases have MCs at the level of tissue sampling, controls do not. Previously operated patients are included as a subgroup. Tissue is sampled before antibiotic prophylaxis with separate instruments. We will apply microbiological methods and histology on biopsies, and predefine criteria for significant bacterial growth, possible contamination and no growth. Microbiologists, surgeons and pathologist are blinded to allocation of case or control. Primary analysis assesses significant growth in MC1 versus controls and MC2 versus controls separately. Bacterial disc growth in previously operated patients, patients with large MCs and growth from the vertebral body in the fusion group are all considered exploratory analyses.

The Regional Committees for Medical and Health Research Ethics in Norway (REC South East, reference number 2015/697) has approved the study. Study participation requires written informed consent. The study is registered at ClinicalTrials.gov (NCT03406624). Results will be disseminated in peer-reviewed journals, scientific conferences and patient fora.

NCT03406624.

Overweight and obesity are excessive fat accumulations linked with many health problems, including heart diseases, type 2 diabetes and cancer. Multiple studies have demonstrated that beliefs about overweight, obesity and self-efficacy play essential roles in the success of interventions for obesity management.

This study aimed to identify the perceptions of university students of overweight and obesity using the health belief model (HBM) and to analyse their association with the body mass index (BMI) categories of the students.

A cross-sectional questionnaire-based study and a multistage sampling technique were used to ensure the recruitment of students from selected colleges of Jazan University—Saudi Arabia.

Six colleges of Jazan University were randomly selected to ensure equal representation of health sciences, sciences and humanities colleges.

A total of 579 students completed an online survey between January and April 2023.

The primary outcome measures were demographic characteristics and HBM constructs. Secondary outcome measures were behavioural intentions relating to obesity management.

This study demonstrated that gender and self-reported family history of obesity were significantly correlated with the BMI categories of the students (p

This study underscores the need for tailored health promotion strategies that consider the perceptions and beliefs of people about the management of obesity.

The increasing elderly population has led to a growing demand for healthcare services. A hospital at home treatment model offers an alternative to standard hospital admission, with the potential to reduce readmission and healthcare consumption while improving patients’ quality of life. However, there is little evidence regarding hospital at home treatment in a Danish setting. This article describes the protocol for a randomised controlled trial (RCT) comparing standard hospital admission to hospital at home treatment. The main aim of the intervention is to reduce 30-day acute readmission after discharge and improve the quality of life of elderly acute patients.

A total of 849 elderly acute patients will be randomised in a 1:2 ratio to either the control or intervention group in the trial. The control group will receive standard hospital treatment in a hospital emergency department while the intervention group will receive treatment at home. The primary outcomes of the trial are the rate of 30-day acute readmission and quality of life, assessed using the European Quality of Life-5 Dimensions-5-Level instrument. Primary analyses are based on the intention-to-treat principle. Secondary outcomes are basic functional mobility, resource use in healthcare, primary and secondary healthcare cost, incremental cost-effectiveness ratio, and the mortality rate 3 months after discharge.

The RCT was approved by the Ethical Committee, Central Denmark Region (no. 1-10-72-67-20). Results will be presented at relevant national and international meetings and conferences and will be published in international peer-reviewed journals. Furthermore, we plan to communicate the results to relevant stakeholders in the Danish healthcare system.

NCT05360914.

The burden of malaria has persistently been high in Ebonyi state and Nigeria despite long-standing collaborations with international partners with huge and increased amounts of financial investments. We explored the system-wide governance challenges of the Ebonyi State Malaria Elimination Programme (SMEP) and the factors responsible in order to make recommendations for malaria health system strengthening.

We did a qualitative study informed by the health system governance framework by Mikkelsen-Lopez et al and Savedoff’s concept of governance.

Between 18 October 2022 and 8 November 2022, 25 semistructured face-to-face in-depth interviews were conducted in English with purposively selected key stakeholders in the Ebonyi SMEP aged 18 years or older with at least 2 years of involvement in the SMEP and who gave consent.

Data were analysed deductively and the analytical strategy was informed by the framework method for the analysis of qualitative data by Gale et al.

Many system-wide governance challenges of the SMEP were identified including the absence of state’s strategic vision and plans for malaria elimination; very weak primary and secondary healthcare systems; inadequate financial allocation and untimely release of budgeted funds by the state government; lack of human resources for health and very poor mosquito net distribution system. Other challenges were inadequate stakeholders’ participation; poor accountability culture; impaired transparency and corruption and impaired ability to address corruption. The fundamental responsible factors were the lack of state government’s concern for people’s welfare and lack of interest and commitment to the malaria elimination effort, chronic non-employment of staff and lack of human resources in the entire health sector including SMEP, and nepotism and godfatherism.

The system-wide governance challenges and the responsible factors call for changing the ‘business as usual’ and refocusing on strengthening malaria health system governance in addressing the persisting malaria health problems in Ebonyi state (and Nigeria).

Telemedicine, a method of healthcare service delivery bridging geographic distances between patients and providers, has gained prominence. This modality is particularly advantageous for outpatient consultations, addressing inherent barriers of travel time and cost.

We aim to describe economical outcomes towards the implementation of a multidisciplinary telemedicine service in a high-complexity hospital in Latin America, from the perspective of patients.

A cross-sectional study was conducted, analysing the institutional data obtained over a period of 9 months, between April 2020 and December 2020.

A high-complexity teaching hospital located in Cali, Colombia.

Individuals who received care via telemedicine. The population was categorised into three groups based on their place of residence: Cali, Valle del Cauca excluding Cali and Outside of Valle del Cauca.

Travel distance, time, fuel and public round-trip cost savings, and potential loss of productivity were estimated from the patient’s perspective.

A total of 62 258 teleconsultations were analysed. Telemedicine led to a total distance savings of 4 514 903 km, and 132 886 hours. The estimated cost savings were US$680 822 for private transportation and US$1 087 821 for public transportation. Patients in the Outside of Valle del Cauca group experienced an estimated average time savings of 21.2 hours, translating to an average fuel savings of US$149.02 or an average savings of US$156.62 in public transportation costs. Areas with exclusive air access achieved a mean cost savings of US$362.9 per teleconsultation, specifically related to transportation costs.

Telemedicine emerges as a powerful tool for achieving substantial travel savings for patients, especially in regions confronting geographical and socioeconomic obstacles. These findings underscore the potential of telemedicine to bridge healthcare accessibility gaps in low-income and middle-income countries, calling for further investment and expansion of telemedicine services in such areas.

Falls are common in older people and individuals with neurological conditions. Parkinson’s disease (PD) is known for postural instability causing mobility disabilities, falls and reduced quality of life. The fear of falling (FOF), a natural response to unstable balance, can worsen postural control problems. Evaluating FOF relies largely on affected persons’ subjective accounts due to limited objective assessment methods available. The aim of this mixed-methods feasibility study is to develop an assessment method for FOF while in motion and walking within virtual environments. This study will assess a range of FOF-related responses, including cognitive factors, neuromuscular response and postural stability.

This feasibility study will consist of four phases: the first two phases will include people without PD, while the other two will include people diagnosed with PD. Participants will be assessed for direct and indirect responses to real life, as well as virtual environment walking scenarios that may induce FOF. Data from questionnaires, different neurophysiological assessments, movement and gait parameters, alongside evaluations of usability and acceptability, will be collected. Semistructured interviews involving both participants and research assistants shall take place to elicit their experiences throughout different phases of the assessments undertaken. Demographic data, the scores of assessment scales, as well as feasibility, usability and acceptability of the measurement methods, will be illustrated via descriptive statistics. Movement and gait outcomes, together with neurophysiological data, will be extracted and calculated. Exploring relationships between different factors in the study will be achieved using a regression model. Thematic analysis will be the approach used to manage qualitative data.

This feasibility study was approved by the Ethics Committee of the Faculty of Physical Therapy, Kafr El Sheikh University, Egypt (number: P.T/NEUR/3/2023/46). The results of this study will be published in a peer-reviewed journal.

ClinicalTrials.gov Registry (NCT05931692).

To compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls.

Meta-epidemiological study.

Randomised controlled trials were identified from an electronic search of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials from their inception date to 21 November 2018.

Placebo control trials evaluating efficacy of any surgical intervention and non-operative control trials of the same surgical intervention were included in this study. 25 730 records were retrieved from our systemic search, identifying 61 placebo control and 38 non-operative control trials for inclusion in analysis.

Primary outcome measures were recruitment and attrition. These were assessed in terms of recruitment rate (number of participants enrolled, as a proportion of those eligible) and overall attrition rate (composite of dropout, loss to follow-up and cross-overs, expressed as proportion of total sample size). Secondary outcome measures included participant cross-over rate, dropout and loss to follow-up.

Unadjusted pooled recruitment and attrition rates were similar between placebo and non-operative control trials. Study characteristics were not significantly different apart from time to primary timepoint which was shorter in studies with placebo controls (365 vs 274 days, p=0.006). After adjusting for covariates (follow-up duration and number of timepoints), the attrition rate of placebo control trials was almost twice as high compared with non-operative controlled-trials (incident rate ratio (IRR) (95% CI) 1.8 (1.1 to 3.0), p=0.032). The incorporation of one additional follow-up timepoint (regardless of follow-up duration) was associated with reduced attrition in placebo control surgical trials (IRR (95% CI) 0.64 (0.52 to 0.79), p

Placebo control trials of surgery have similar recruitment issues but higher attrition compared with non-operative (non-placebo) control trials. Study design should incorporate strategies such as increased timepoints for given follow-up duration to mitigate losses to follow-up and dropout.

CRD42019117364.

Potentially harmful non-steroidal anti-inflammatory drugs (NSAIDs) utilisation persists at undesirable rates worldwide. The purpose of this paper is to review the literature on interventions to de-implement potentially harmful NSAIDs in healthcare settings and to suggest directions for future research.

Scoping review.

PubMed, CINAHL, Embase, Cochrane Central and Google Scholar (1 January 2000 to 31 May 2022).

Studies reporting on the effectiveness of interventions to systematically reduce potentially harmful NSAID utilisation in healthcare settings.

Using Covidence systematic review software, we extracted study and intervention characteristics, including the effectiveness of interventions in reducing NSAID utilisation.

From 7818 articles initially identified, 68 were included in the review. Most studies took place in European countries (45.6%) or the USA (35.3%), with randomised controlled trial as the most common design (55.9%). Interventions were largely clinician-facing (76.2%) and delivered in primary care (60.2%) but were rarely (14.9%) guided by an implementation model, framework or theory. Academic detailing, clinical decision support or electronic medical record interventions, performance reports and pharmacist review were frequent approaches employed. NSAID use was most commonly classified as potentially harmful based on patients’ age (55.8%), history of gastrointestinal disorders (47.1%), or history of kidney disease (38.2%). Only 7.4% of interventions focused on over-the-counter (OTC) NSAIDs in addition to prescription. The majority of studies (76.2%) reported a reduction in the utilisation of potentially harmful NSAIDs. Few studies (5.9%) evaluated pain or quality of life following NSAIDs discontinuation.

Many varied interventions to de-implement potentially harmful NSAIDs have been applied in healthcare settings worldwide. Based on these findings and identified knowledge gaps, further efforts to comprehensively evaluate the effectiveness of interventions and the combination of intervention characteristics associated with effective de-implementation are needed. In addition, future work should be guided by de-implementation theory, focus on OTC NSAIDs and incorporate patient-focused strategies and outcomes, including the evaluation of unintended consequences of the intervention.