Differential associations of risk factors with severe and non-severe hypoglycaemia: the Hypoglycaemia Assessment Tool prospective observational study in people with insulin-treated type 1 diabetes and type 2 diabetes.

AIM: To assess the differential association of risk factors with severe and non-severe hypoglycaemia. MATERIALS AND METHODS: The Hypoglycaemia Assessment Tool study evaluated the risk of hypoglycaemia over a 4-week period in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D) on insulin in 24 countries. Negative binomial regressions were applied to examine the associations of several risk factors with severe and non-severe hypoglycaemia. RESULTS: The median age was 41 years in 5949 patients with T1D and 62 years in 12 914 patients with T2D. The 4-week rates of non-severe hypoglycaemic were 5.57 and 1.40 episodes per person in T1D and T2D, respectively; the corresponding rates for severe hypoglycaemia were 0.94 and 0.30. The excess risk was 42% higher for severe than non-severe hypoglycaemia in females versus males with T2D; 27% higher in patients with T2D with versus without a continuous glucose monitoring (CGM); and 47% lower in patients with T1D with versus without an insulin pump. The excess risk also differed across geographical areas and was marginally lower for severe than non-severe hypoglycaemia for higher values of HbA1c in patients with T2D. Associations with severity of hypoglycaemia were not different for age, diabetes and insulin therapy duration, previous hypoglycaemic episodes and insulin regimen. CONCLUSIONS: The risk of severe versus non-severe hypoglycaemia differs in patients with T1D and T2D; sex, the use of a CGM and insulin pump, and geographical areas were differently associated with one type of hypoglycaemia than the other.

Sex disparities in physical activity domains and hypertension prevalence.

BACKGROUND: This study aimed to examine the associations of leisure time physical activity (LTPA) and occupational physical activity (OPA) with the prevalence of hypertension, while exploring the sex disparities in these associations. METHODS: A cross-sectional study was conducted using data from the Korea National Health and Nutrition Examination Survey between 2014 and 2019 (n = 26,534). Hypertension was defined as the use of antihypertensive drugs or systolic and diastolic blood pressure ≥ 140/90 mm Hg. Self-reported physical activity (PA), assessed by the global PA questionnaire, was categorized into three domains: total PA, LTPA and OPA. Each PA domain was classified based on METs-min/wk and intensity. RESULTS: In a multivariable adjusted model, the odds ratio (OR) with 95% confidence intervals (CIs) for the prevalence of hypertension in the active versus inactive group, based on METs, was 0.92 (95% CI 0.85-0.99) for total PA, 0.90 (95% CI 0.83-0.98) for LTPA and 1.21 (95% CI 1.05-1.38) for OPA. Compared to the inactive group, moderate to vigorous intensity was associated with a lower odds of hypertension for total PA and LTPA (total PA: OR 0.95, 95% CI 0.89-1.00 and LTPA: OR 0.92, 95% CI 0.86-0.98), but a higher odd for OPA (OR 1.17, 95% CI 1.05-1.30). Subgroup analyses showed significant evidence of effect modification by sex on the associations of total PA and LTPA (METs and intensity) with hypertension prevalence (p-values for interaction < 0.01); the associations were generally stronger for women. OPA was associated with a higher prevalence of hypertension in women, but not in men (p-value for interaction > 0.05). CONCLUSIONS: Higher levels of total PA and LTPA were associated with lower prevalence of hypertension in both men and women, with slightly stronger associations for women. However, higher OPA was associated with a higher prevalence of hypertension in women. These findings support the PA health paradox hypothesis and highlight the sex disparities in the association between OPA and hypertension prevalence.

Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial.

OBJECTIVES: To determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures. DESIGN: Pragmatic, parallel group, open label, randomised controlled trial. SETTING: High volume tertiary referral centres or orthopaedic units in the UK (n=12) and in Sweden (n=3), recruiting from 1 March 2015 to 19 December 2018. PARTICIPANTS: 140 adults (aged ≥18 years) with a prosthetic joint infection of the hip who required revision (65 randomly assigned to single stage and 75 to two stage revision). INTERVENTIONS: A computer generated 1:1 randomisation list stratified by hospital was used to allocate participants with prosthetic joint infection of the hip to a single stage or a two stage revision procedure. MAIN OUTCOME MEASURES: The primary intention-to-treat outcome was pain, stiffness, and functional limitations 18 months after randomisation, measured by the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes included surgical complications and joint infection. The economic evaluation (only assessed in UK participants) compared quality adjusted life years and costs between the randomised groups. RESULTS: The mean age of participants was 71 years (standard deviation 9) and 51 (36%) were women. WOMAC scores did not differ between groups at 18 months (mean difference 0.13 (95% confidence interval -8.20 to 8.46), P=0.98); however, the single stage procedure was better at three months (11.53 (3.89 to 19.17), P=0.003), but not from six months onwards. Intraoperative events occurred in five (8%) participants in the single stage group and 20 (27%) in the two stage group (P=0.01). At 18 months, nine (14%) participants in the single stage group and eight (11%) in the two stage group had at least one marker of possible ongoing infection (P=0.62). From the perspective of healthcare providers and personal social services, single stage revision was cost effective with an incremental net monetary benefit of £11 167 (95% confidence interval £638 to £21 696) at a £20 000 per quality adjusted life years threshold (£1.0; $1.1; €1.4). CONCLUSIONS: At 18 months, single stage revision compared with two stage revision for prosthetic joint infection of the hip showed no superiority by patient reported outcome. Single stage revision had a better outcome at three months, fewer intraoperative complications, and was cost effective. Patients prefer early restoration of function, therefore, when deciding treatment, surgeons should consider patient preferences and the cost effectiveness of single stage surgery. TRIAL REGISTRATION: ISRCTN registry ISRCTN10956306.

Are remote clinical assessments a feasible and acceptable method of assessment? A systematic review.

The COVID-19 pandemic presented an enormous and immediate challenge to assessing clinical skills in healthcare professionals. Many institutions were unable to deliver established face-to-face assessment methods such as Objective Structured Clinical Examinations (OSCEs). Assessors needed to rapidly institute alternative assessment methods to ensure that candidates met the clinical competences required for progression. Using a systematic review, we aimed to evaluate the feasibility, and acceptability of remote methods of clinical skills assessment, including remote structured clinical assessments and the submission of video recordings. We searched for studies reporting on Remote Clinical Assessments or its variants in MEDLINE, Embase and The Cochrane library from 2000 to March 2021. Twenty eight studies were included in the review; 20 studies related to remote structured clinical examinations or OSCEs and 8 reported the use of video submissions. The participants of the different studies included medical students, nursing students, dental students and doctors in training. A variety of different online platforms were utilised including Zoom, Skype, webcams, and Adobe Connect online. The studies found that delivery of remote clinical assessments is possible and provides an alternative method of assessing many clinical skills, but most also acknowledge limitations and challenges. They are acceptable to both candidates and examiners, and where measured, show moderate agreement with on-site clinical assessments. Current evidence is based on studies with low methodological quality and for the most part, small sample sizes.

High fitness levels offset the increased risk of chronic obstructive pulmonary disease due to low socioeconomic status: A cohort study.

OBJECTIVE: Evidence suggests that higher cardiorespiratory fitness (CRF) levels can offset the increased risk of adverse outcomes due to other risk factors. The impact of high CRF levels on the increased risk of chronic obstructive pulmonary disease (COPD) due to low socioeconomic status (SES) is unknown. We aimed to assess the combined effects of SES and CRF on the future risk of COPD. METHODS: We employed a prospective cohort of 2312 Finnish men aged 42-61 years at study entry. Socioeconomic status was self-reported and CRF was objectively assessed using respiratory gas exchange analyzers. Both exposures were categorized as low and high based on median cutoffs. Multivariable-adjusted hazard ratios (HRs) with confidence intervals (CIs) were estimated. RESULTS: During 26.0 years median follow-up, 120 COPD cases occurred. Low SES was associated with increased COPD risk and high CRF was associated with reduced COPD risk. Compared with high SES-low CRF, low SES-low CRF was associated with an increased COPD risk 2.36 (95% CI: 1.44-3.87), with no evidence of an association for low SES-high CRF and COPD risk 1.46 (95% CI:0.82-2.60). CONCLUSION: In middle-aged Finnish men, SES and CRF are each independently associated with COPD risk. However, high CRF levels offset the increased COPD risk related to low SES.

Indirect impact of the COVID-19 pandemic on hospitalisations for cardiometabolic conditions and their management: A systematic review.

BACKGROUND: The Coronavirus disease 2019 (COVID-19) pandemic has led to a dramatic crisis in health care systems worldwide. These may have significant implications for the management of cardiometabolic diseases. We conducted a systematic review of published evidence to assess the indirect impact of the COVID-19 pandemic on hospitalisations for cardiovascular diseases and their management. METHODS: Studies that evaluated volume of hospitalisations for cardiometabolic conditions and their management with comparisons between the COVID-19 and pre-COVID periods were identified from MEDLINE, Embase and the reference list of relevant studies from January 2020 to 25 February 2021. RESULTS: We identified 103 observational studies, with most studies assessing hospitalisations for acute cardiovascular conditions such as acute coronary syndrome, ischemic strokes and heart failure. About 89% of studies reported a decline in hospitalisations during the pandemic compared to pre-pandemic times, with reductions ranging from 20.2 to 73%. Severe presentation, less utilization of cardiovascular procedures, and longer patient- and healthcare-related delays were common during the pandemic. Most studies reported shorter length of hospital stay during the pandemic than before the pandemic (1-8 vs 2-12 days) or no difference in length of stay. Most studies reported no change in in-hospital mortality among hospitalised patients. CONCLUSION: Clinical care of patients for acute cardiovascular conditions, their management and outcomes have been adversely impacted by the COVID-19 pandemic. Patients should be educated via population-wide approaches on the need for timely medical contact and health systems should put strategies in place to provide timely care to patients at high risk. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2021: CRD42021236102.

Ideal cardiovascular health and risk of acute myocardial infarction among Finnish men.

BACKGROUND AND AIMS: Acute myocardial infarction (AMI) is associated with high mortality globally and remains a public health burden. We sought to investigate the relation between the American Heart Association's cardiovascular health metrics (CVH) and the risk of AMI among middle-aged Finnish men. METHODS: We used the ongoing population-based Kuopio Ischaemic Heart Disease cohort study comprising men aged 40-62 years at baseline. The CVH metrics was computed among 2584 participants at baseline with health scores ranging from 0 to 7. This was categorized into three groups of CVH metrics as poor (0-2), intermediate (3-4) and ideal (≥5). Multivariate Cox regression models were used to estimate the hazard ratios (HR) and 95% confidence intervals (CIs) of CVH metrics for AMI. RESULTS: During a median follow-up period of 25.2 years, 513 cases of AMI were recorded. Only one participant was able to achieve all the seven ideal health metrics. The risk of AMI decreased continuously with the increasing number of CVH metrics across the range 2-7 (for non-linearity, p = 0.07). Men with ideal CVH metrics had a HR (95% CI) for AMI of 0.28 (CI 0.15-0.55, p < 0.001) compared to those with poor CVH metrics after adjustment for age, alcohol intake and socioeconomic status. The associations remained consistent following further adjustment for history of coronary heart disease and history of type 2 diabetes. CONCLUSIONS: Ideal CVH metrics was strongly and linearly associated with reduced risk of AMI among middle-aged Finnish men.

Health Care Needs and Support for Patients Undergoing Treatment for Prosthetic Joint Infection following Hip or Knee Arthroplasty: A Systematic Review.

BACKGROUND: Hip and knee arthroplasty are common interventions for the treatment of joint conditions, most notably osteoarthritis. Although many patients benefit from surgery, approximately 1% of patients develop infection afterwards known as deep prosthetic joint infection (PJI), which often requires further major surgery. OBJECTIVE: To assess support needs of patients undergoing treatment for PJI following hip or knee arthroplasty and to identify and evaluate what interventions are routinely offered to support such patients. DESIGN: Systematic review. DATA SOURCES: MEDLINE, EMBASE, Web of Science, PsycINFO, Cinahl, Social Science Citation Index, The Cochrane Library, and reference lists of relevant studies from January 01, 1980 to October 05, 2016. SELECTION CRITERIA: Observational (prospective or retrospective cohort, nested case-control or case-control) studies, qualitative studies, or clinical trials conducted in patients treated for PJI and/or other major adverse occurrences following hip or knee arthroplasty. REVIEW METHODS: Data were extracted by two independent investigators and consensus was reached with involvement of a third. Given the heterogeneous nature of study designs, methods, and limited number of studies, a narrative synthesis is presented. RESULTS: Of 4,213 potentially relevant citations, we identified one case-control, one prospective cohort and two qualitative studies for inclusion in the synthesis. Patients report that PJI and treatment had a profoundly negative impact affecting physical, emotional, social and economic aspects of their lives. No study evaluated support interventions. CONCLUSION: The findings demonstrate that patients undergoing treatment for PJI have extensive physical, psychological, social and economic support needs. The interpretation of study results is limited by variation in study design, outcome measures and the small number of relevant eligible studies. However, our review highlights a lack of evidence about support strategies for patients undergoing treatment for PJI and other adverse occurrences following hip or knee arthroplasty. There is a need to design, implement and evaluate interventions to support these patients. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2015: CRD42015027175.

Paying for Performance to Improve the Delivery and Uptake of Family Planning in Low and Middle Income Countries: A Systematic Review.

Paying for performance is a strategy to meet the unmet need for family planning in low and middle income countries; however, rigorous evidence on effectiveness is lacking. Scientific databases and grey literature were searched from 1994 to May 2016. Thirteen studies were included. Payments were linked to units of targeted services, usually modified by quality indicators. Ancillary components and payment indicators differed between studies. Results were mixed for family planning outcome measures. Paying for performance was associated with improved modern family planning use in one study, and increased user and coverage rates in two more. Paying for performance with conditional cash transfers increased family planning use in another. One study found increased use in the upper wealth group only. However, eight studies reported no impact on modern family planning use or prevalence. Secondary outcomes of equity, financial risk protection, satisfaction, quality, and service organization were mixed. Available evidence is inconclusive and limited by the scarcity of studies and by variation in intervention, study design, and outcome measures. Further studies are warranted.

One-stage or two-stage revision surgery for prosthetic hip joint infection--the INFORM trial: a study protocol for a randomised controlled trial.

BACKGROUND: Periprosthetic joint infection (PJI) affects approximately 1% of patients following total hip replacement (THR) and often results in severe physical and emotional suffering. Current surgical treatment options are debridement, antibiotics and implant retention; revision THR; excision of the joint and amputation. Revision surgery can be done as either a one-stage or two-stage operation. Both types of surgery are well-established practice in the NHS and result in similar rates of re-infection, but little is known about the impact of these treatments from the patient's perspective. The main aim of this randomised controlled trial is to determine whether there is a difference in patient-reported outcome measures 18 months after randomisation for one-stage or two-stage revision surgery. METHODS/DESIGN: INFORM (INFection ORthopaedic Management) is an open, two-arm, multi-centre, randomised, superiority trial. We aim to randomise 148 patients with eligible PJI of the hip from approximately seven secondary care NHS orthopaedic units from across England and Wales. Patients will be randomised via a web-based system to receive either a one-stage revision or a two-stage revision THR. Blinding is not possible due to the nature of the intervention. All patients will be followed up for 18 months. The primary outcome is the WOMAC Index, which assesses hip pain, function and stiffness, collected by questionnaire at 18 months. Secondary outcomes include the following: cost-effectiveness, complications, re-infection rates, objective hip function assessment and quality of life. A nested qualitative study will explore patients' and surgeons' experiences, including their views about trial participation and randomisation. DISCUSSION: INFORM is the first ever randomised trial to compare two widely accepted surgical interventions for the treatment of PJI: one-stage and two-stage revision THR. The results of the trial will benefit patients in the future as the main focus is on patient-reported outcomes: pain, function and wellbeing in the long term. Patients state that these outcomes are more important than those that are clinically derived (such as re-infection) and have been commonly used in previous non-randomised studies. Results from the INFORM trial will also benefit clinicians and NHS managers by enabling the comparison of these key interventions in terms of patients' complication rates, health and social resource use and their overall cost-effectiveness. TRIAL REGISTRATION: Current controlled trials ISRCTN10956306 (registered on 29 January 2015); UKCRN ID 18159.