Interventions to improve medicines optimisation in frail older patients in secondary and acute care settings: a systematic review of randomised controlled trials and non-randomised studies

Risk Of Bias ◽

Controlled Trials ◽

High Quality ◽

Older Inpatients ◽

Medicines Optimisation ◽

AbstractBackground: Frailty is a geriatric syndrome in which physiological systems have decreased reserve and resistance against stressors. Frailty is associated with polypharmacy, inappropriate prescribing and unfavourable clinical outcomes. Aim: To identify and evaluate randomised controlled trials (RCTs) and non-randomised studies of interventions designed to optimise the medications of frail older patients, aged 65 years and over, in secondary or acute care settings. Method: Literature searches were conducted across seven electronic databases and three trial registries from the date of inception to October 2021. All types of interventional studies were included. Study selection, data extraction, risk of bias and quality assessment were conducted by two independent reviewers. Results: Three RCTs were eligible for inclusion; two employed deprescribing as the intervention, and one used comprehensive geriatric assessment. All reported significant improvements in prescribing appropriateness. One study investigated the effect of the intervention on clinical outcomes including hospital presentations, falls, fracture, quality of life and mortality, and reported no significant differences in these outcomes, but did report a significant reduction in monthly medication cost. Two of the included studies were assessed as having ‘some concerns’ of bias, and one was judged to be at ‘high risk’ of bias. Conclusion: This systematic review demonstrates that medicines optimisation interventions may improve medication appropriateness in frail older inpatients. However, it highlights the paucity of high-quality evidence that examines the impact of medicines optimisation on quality of prescribing and clinical outcomes for frail older inpatients. High-quality studies are needed to address this gap.

A systematic review of interventions to improve medicines optimisation in frail older patients in secondary and acute care settings

International Journal of Pharmacy Practice ◽

10.1093/ijpp/riab015.026 ◽

2021 ◽

Vol 29 (Supplement_1) ◽

pp. i22-i23

Author(s):

D Saeed ◽

G Carter ◽

C Parsons

Keyword(s):

Systematic Review ◽

Clinical Outcomes ◽

Acute Care ◽

Older Patients ◽

Inappropriate Prescribing ◽

Risk Of Bias ◽

Controlled Trials ◽

Older Inpatients ◽

Medicines Optimisation

Abstract Introduction Frailty is a geriatric syndrome in which physiological systems have decreased reserve and resistance against stressors. Frailty is associated with polypharmacy, inappropriate prescribing and unfavourable clinical outcomes [1,2]. Aim To identify and evaluate studies of interventions designed to optimise the medications of frail older patients, aged 65 years or over, in secondary or acute care settings. Methods The protocol was registered and published on PROSPERO (CRD42019156623). A literature review was conducted across the following databases and trial registries: Medline, Scopus, Embase, Web of Science, Cochrane Library, Cochrane Central Register of Controlled Trials, International Pharmaceutical Abstracts, Cumulative Index to Nursing and Allied Health Literature Plus (CINAHL Plus), ClinicalTrials.gov, International Clinical Trials Registry Platform and Research Registry. All types of randomised controlled trials (RCTs) and non-randomised studies (NRSs) of interventions relating to any aspect of ‘medicines optimisation’, ‘medicines management’ or ‘pharmaceutical care’ to frail older inpatients (aged ≥ 65 years) were included. Eligible studies published in English were identified from the date of inception to October 2020. Screening and selection of titles, abstracts and full texts were followed by data extraction. Risk of bias was assessed using the Cochrane Collaboration ROB 2.0 tool for RCTs and risk of bias in non-randomized studies-of Interventions (ROBINS-I) tool for NRSs. Results 36 articles were identified and of these, three were eligible for inclusion (Figure 1). All included studies were RCTs. Although all included studies examined the effect of different types of interventions on different outcomes, they all concluded that medication optimisation interventions reduced suboptimal prescribing (measured as polypharmacy, inappropriate prescribing, and underuse) among frail older inpatients. The included studies used different tools to assess prescribing appropriateness; one used the STOPP criteria, one used STOPPFrail criteria and one employed inpatient/ outpatient geriatric evaluation and management according to published guidelines and Veterans Affairs (VA) hospital standards. Two of the included studies was assessed as having ‘some concerns’ of bias, and one was judged to be at ‘high risk’ of bias. Due to the heterogeneity of the included studies, a meta-analysis was not possible. Conclusion This systematic review demonstrates that medication optimisation interventions may improve medication appropriateness in frail older inpatients. Limitations include the small number of included studies and the exclusion of non-English language articles. However, this review highlights the paucity of evidence that examines impact of medication optimisation on quality of prescribing and clinical outcomes for frail older inpatients including hospitalisation, falls, quality of life and mortality. High-quality studies are needed to address this gap and to outline the framework of medication optimisation for this vulnerable cohort group. References 1. Clegg A, Young J, Life S, Rikket MO, Rockwood K. Frailty in Older People. Lancet. 2013;381(9868):752–62. 2. Fried, L. P. Tangen, C. M.Walston, J.Newman, A. B.Hirsch, C.Gottdiener et al. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2011; 56(3), 146–M15

Inclusion of older patients with cancer in randomised controlled trials with patient-reported outcomes: a systematic review

BMJ Supportive & Palliative Care ◽

10.1136/bmjspcare-2019-001902 ◽

2019 ◽

pp. bmjspcare-2019-001902

Author(s):

Francesco Sparano ◽

Neil K Aaronson ◽

Mirjam A G Sprangers ◽

Peter Fayers ◽

Andrea Pusic ◽

...

Keyword(s):

Systematic Review ◽

Older Patients ◽

Patient Reported Outcomes ◽

Controlled Trials ◽

High Quality ◽

Quality Of Life Research ◽

Patient Reported ◽

ObjectivesInclusion of patient-reported outcomes (PROs) in cancer randomised controlled trials (RCTs) may be particularly important for older patients. The objectives of this systematic review were to quantify the frequency with which older patients are included in RCTs with PROs and to evaluate the quality of PRO reporting in those trials.MethodsAll RCTs with PRO endpoints, published between January 2004 and February 2019, which included a patient sample with a mean/median age ≥70 years, were considered for this systematic review. The following cancer malignancies were considered: breast, colorectal, lung, prostate, gynaecological and bladder cancer.Quality of PRO reporting was evaluated using the International Society for Quality of Life Research–PRO standards. Studies meeting at least two-thirds of these criteria were considered to have high-quality PRO reporting.ResultsOf 649 RCTs identified with a PRO endpoint, only 72 (11.1%) included older patients. Of these, 35 trials (48.6%) were conducted in patients with metastatic/advanced disease. PROs were primary endpoints in 20 RCTs (27.8%). Overall survival was the most frequently reported clinical outcome in studies of patients with metastatic/advanced cancer (n=28, 80%). One-third of the RCTs (n=24, 33.3%) were considered to have high-quality PRO reporting. Overall, the largest prevalence of RCTs with high-quality PRO reporting was observed in prostate and colorectal cancers.ConclusionsOur review indicates not only that PRO–RCT-based studies in oncology rarely include older patients but also that completeness of PRO reporting of many of them is often suboptimal.

Treating depression with physical activity in adolescents and young adults: a systematic review and meta-analysis of randomised controlled trials

Psychological Medicine ◽

10.1017/s0033291717002653 ◽

2017 ◽

Vol 48 (7) ◽

pp. 1068-1083 ◽

Cited By ~ 70

Author(s):

A. P. Bailey ◽

S. E. Hetrick ◽

S. Rosenbaum ◽

R. Purcell ◽

A. G. Parker

Keyword(s):

Physical Activity ◽

Young Adults ◽

Treatment Effect ◽

Meta Analysis ◽

Risk Of Bias ◽

Adolescents And Young Adults ◽

Controlled Trials ◽

AbstractWe aimed to establish the treatment effect of physical activity for depression in young people through meta-analysis. Four databases were searched to September 2016 for randomised controlled trials of physical activity interventions for adolescents and young adults, 12–25 years, experiencing a diagnosis or threshold symptoms of depression. Random-effects meta-analysis was used to estimate the standardised mean difference (SMD) between physical activity and control conditions. Subgroup analysis and meta-regression investigated potential treatment effect modifiers. Acceptability was estimated using dropout. Trials were assessed against risk of bias domains and overall quality of evidence was assessed using GRADE criteria. Seventeen trials were eligible and 16 provided data from 771 participants showing a large effect of physical activity on depression symptoms compared to controls (SMD = −0.82, 95% CI = −1.02 to −0.61, p < 0.05, I2 = 38%). The effect remained robust in trials with clinical samples (k = 5, SMD = −0.72, 95% CI = −1.15 to −0.30), and in trials using attention/activity placebo controls (k = 7, SMD = −0.82, 95% CI = −1.05 to −0.59). Dropout was 11% across physical activity arms and equivalent in controls (k = 12, RD = −0.01, 95% CI = −0.04 to 0.03, p = 0.70). However, the quality of RCT-level evidence contributing to the primary analysis was downgraded two levels to LOW (trial-level risk of bias, suspected publication bias), suggesting uncertainty in the size of effect and caution in its interpretation. While physical activity appears to be a promising and acceptable intervention for adolescents and young adults experiencing depression, robust clinical effectiveness trials that minimise risk of bias are required to increase confidence in the current finding. The specific intervention characteristics required to improve depression remain unclear, however best candidates given current evidence may include, but are not limited to, supervised, aerobic-based activity of moderate-to-vigorous intensity, engaged in multiple times per week over eight or more weeks. Further research is needed. (Registration: PROSPERO-CRD 42015024388).

Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?

BMC Medical Research Methodology ◽

10.1186/1471-2288-6-44 ◽

2006 ◽

Vol 6 (1) ◽

Cited By ~ 70

Author(s):

Rudolf W Poolman ◽

Peter AA Struijs ◽

Rover Krips ◽

Inger N Sierevelt ◽

Kristina H Lutz ◽

...

Keyword(s):

Controlled Trials ◽

Quality Of Reporting ◽

High Quality ◽

Evidence Rating ◽

Level I ◽

Acupuncture for Vascular Mild Cognitive Impairment: A Systematic Review of Randomised Controlled Trials

Acupuncture in Medicine ◽

10.1136/acupmed-2013-010363 ◽

2013 ◽

Vol 31 (4) ◽

pp. 368-374 ◽

Cited By ~ 22

Author(s):

Huijuan Cao ◽

Yuyi Wang ◽

Dennis Chang ◽

Li Zhou ◽

Jianping Liu

Keyword(s):

Cognitive Impairment ◽

Mild Cognitive Impairment ◽

Meta Analysis ◽

Vascular Cognitive Impairment ◽

Risk Of Bias ◽

Controlled Trials ◽

Randomised Controlled ◽

State Examination

Background Vascular mild cognitive impairment (VMCI) is the most common type of vascular cognitive impairment induced by cerebrovascular disease. No effective medicines are currently available for VMCI. Objective To assess the effectiveness and safety of acupuncture for VMCI. Methods Seven electronic databases were searched for randomised controlled trials which investigated the effects of acupuncture compared with no treatment, placebo or conventional therapies on cognitive function or other clinical outcomes in patients with VMCI. The quality of the trials selected was evaluated according to the ‘risk of bias’ assessment provided by the Cochrane Handbook for Systematic Reviews of Interventions. RevMan V.5.1 software was employed for data analysis. Results Twelve trials with 691 participants were included. The methodological quality of all included trials was unclear and/or they had a high risk of bias. Meta-analysis showed acupuncture in conjunction with other therapies could significantly improve Mini-Mental State Examination scores (mean difference 1.99, 95% CI 1.09 to 2.88, random model, p<0.0001, 6 trials). No included trials mentioned any adverse events of the treatment. Conclusions The current clinical evidence is not of sufficient quality for wider application of acupuncture to be recommended for the treatment of VMCI, and further large, rigorously designed trials are warranted.

A meta-analysis of the effects of therapeutic hypothermia in adult patients with traumatic brain injury

Critical Care ◽

10.1186/s13054-019-2667-3 ◽

2019 ◽

Vol 23 (1) ◽

Author(s):

Hanbing Chen ◽

Fei Wu ◽

Penglei Yang ◽

Jun Shao ◽

Qihong Chen ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Therapeutic Hypothermia ◽

Meta Analysis ◽

Risk Of Bias ◽

Controlled Trials ◽

High Quality ◽

Hypothermia Group ◽

Abstract Purpose Therapeutic hypothermia management remains controversial in patients with traumatic brain injury. We conducted a meta-analysis to evaluate the risks and benefits of therapeutic hypothermia management in patients with traumatic brain injury. Methods We searched the Web of Science, PubMed, Embase, Cochrane (Central) and Clinical Trials databases from inception to January 17, 2019. Eligible studies were randomised controlled trials that investigated therapeutic hypothermia management versus normothermia management in patients with traumatic brain injury. We collected the individual data of the patients from each included study. Meta-analyses were performed for 6-month mortality, unfavourable functional outcome and pneumonia morbidity. The risk of bias was evaluated using the Cochrane Risk of Bias tool. Results Twenty-three trials involving a total of 2796 patients were included. The randomised controlled trials with a high quality show significantly more mortality in the therapeutic hypothermia group [risk ratio (RR) 1.26, 95% confidence interval (CI) 1.04 to 1.53, p = 0.02]. Lower mortality in the therapeutic hypothermia group occurred when therapeutic hypothermia was received within 24 h (RR 0.83, 95% CI 0.71 to 0.96, p = 0.01), when hypothermia was received for treatment (RR 0.66, 95% CI 0.49 to 0.88, p = 0.006) or when hypothermia was combined with post-craniectomy measures (RR 0.69, 95% CI 0.48 to 1.00, p = 0.05). The risk of unfavourable functional outcome following therapeutic hypothermia management appeared to be significantly reduced (RR 0.78, 95% CI 0.67 to 0.91, p = 0.001). The meta-analysis suggested that there was a significant increase in the risk of pneumonia with therapeutic hypothermia management (RR 1.48, 95% CI 1.11 to 1.97, p = 0.007). Conclusions Our meta-analysis demonstrated that therapeutic hypothermia did not reduce but might increase the mortality rate of patients with traumatic brain injury in some high-quality studies. However, traumatic brain injury patients with elevated intracranial hypertension could benefit from hypothermia in therapeutic management instead of prophylaxis when initiated within 24 h.

Ivermectin for the prevention of COVID-19: addressing potential bias and medical fraud

10.21203/rs.3.rs-1090102/v1 ◽

2021 ◽

Author(s):

Andrew Hill ◽

Manya Mirchandani ◽

Leah Ellis ◽

Victoria Pilkington

Keyword(s):

Meta Analysis ◽

Group Analysis ◽

Poor Quality ◽

Risk Of Bias ◽

Controlled Trials ◽

Quality Of Data ◽

Randomised Controlled ◽

Post Hoc

Abstract Background Ivermectin is an antiparasitic drug being investigated in clinical trials for the prevention of COVID-19. However, there are concerns about the quality of some of these trials. Objectives To conduct a meta-analysis with randomised controlled trials of ivermectin for the prevention of COVID-19, while controlling for the quality of data. Methods We conducted a sub-group analysis based on the quality of randomised controlled trials evaluating ivermectin for the prevention of COVID-19. Quality was assessed using the Cochrane Risk of Bias measures (RoB 2) and additional checks on raw data, where possible. Results Four studies were included in the meta-analysis. One was rated as being potentially fraudulent, two as having a high risk of bias and one as having some concerns for bias. Ivermectin did not have a significant effect on preventing RT-PCR confirmed COVID-19 infection. Ivermectin had a significant effect on preventing symptomatic COVID-19 infection in one trial with some concerns of bias, but this result was based on post-hoc analysis of a multi-arm study. Conclusions This meta-analysis demonstrates that the currently available randomised trials evaluating ivermectin for the prevention of COVID-19 are insufficient and of poor quality.

The Extent and Quality of Evidence in Neurological Physiotherapy: An Analysis of the Physiotherapy Evidence Database (PEDro)

Brain Impairment ◽

10.1375/brim.1.2.130 ◽

2000 ◽

Vol 1 (2) ◽

pp. 130-140 ◽

Cited By ~ 17

Author(s):

Anne Moseley ◽

Catherine Sherrington ◽

Robert Herbert ◽

Christopher Maher

Keyword(s):

Systematic Reviews ◽

Controlled Trials ◽

Evidence Based ◽

High Quality ◽

Quality Of Evidence ◽

Quality Rating ◽

Evidence Database ◽

AbstractEvidence-based practice involves the use of evidence from systematic reviews and randomised controlled trials. The extent of this evidence in neurological physiotherapy has not previously been surveyed. The aim of this study was to describe the quantity and quality of randomised controlled trials, and the quantity and scope of systematic reviews relevant to neurological physiotherapy. PEDro (the Physiotherapy Evidence Database) was searched for trials and reviews relevant to neurological physiotherapy (adult and paediatric). The quality and quantity of trials were analysed, and the topics and conclusions of reviews were synthesised. The search revealed a total of 265 records, consisting of 238 randomised controlled trials and 27 systematic reviews. Since the first trial was published in 1958, the number of trials has expanded exponentially. Fifty-four percent of trials were categorised as being of moderate to high quality, rating five or more out of ten. The first review was published in 1991. Many of the reviews have been unable to reach firm conclusions due to the paucity of available trials. The results show that there is a substantial body of evidence relevant to neurological physiotherapy. However, there remains scope for improvements in the quality of the conduct and reporting of clinical trials. There is an urgent need for more randomised controlled trials and systematic reviews.

Antibiotic therapy for pelvic inflammatory disease: an abridged version of a Cochrane systematic review and meta-analysis of randomised controlled trials

Sexually Transmitted Infections ◽

10.1136/sextrans-2018-053693 ◽

2018 ◽

Vol 95 (1) ◽

pp. 21-27 ◽

Cited By ~ 6

Author(s):

Ricardo F Savaris ◽

Daniele G Fuhrich ◽

Rui V Duarte ◽

Sebastian Franik ◽

Jonathan D C Ross

Keyword(s):

Systematic Review ◽

Pelvic Inflammatory Disease ◽

Inflammatory Disease ◽

Meta Analysis ◽

Risk Of Bias ◽

Controlled Trials ◽

Quality Of Evidence ◽

ObjectiveTo assess the effectiveness and safety of antibiotic regimens used to treat pelvic inflammatory disease (PID).DesignThis is a systematic review and meta-analysis of randomised controlled trials (RCTs). Risk of bias was assessed using the criteria outlined in the Cochrane guidelines. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation.Data sourcesEight electronic databases were searched from date of inception up to July 2016. Database searches were complemented by screening of reference lists of relevant studies, trial registers, conference proceeding abstracts and grey literature.Eligibility criteriaRCTs comparing the use of antibiotics with placebo or other antibiotics for the treatment of PID in women of reproductive age, either as inpatient or outpatient treatment.ResultsWe included 37 RCTs (6348 women). The quality of evidence ranged from very low to high, the main limitations being serious risk of bias (due to poor reporting of study methods and lack of blinding), serious inconsistency and serious imprecision. There was no clear evidence of a difference in the rates of cure for mild-moderate or for severe PID for the comparisons of azithromycin versus doxycycline, quinolone versus cephalosporin, nitroimidazole versus no use of nitroimidazole, clindamycin plus aminoglycoside versus quinolone, or clindamycin plus aminoglycoside versus cephalosporin. No clear evidence of a difference between regimens in antibiotic-related adverse events leading to discontinuation of therapy was observed.ConclusionsWe found no conclusive evidence that one regimen of antibiotics was safer or more effective than any other for the treatment of PID, and there was no clear evidence for the use of nitroimidazoles (metronidazole) compared with the use of other drugs with activity against anaerobes. More evidence is needed to assess treatments for women with PID, particularly comparing regimens with or without the addition of nitroimidazoles and the efficacy of azithromycin compared with doxycycline.

Effects of traditional Chinese exercise on cardiac rehabilitation after percutaneous coronary intervention: study protocol for network meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2018-023096 ◽

2019 ◽

Vol 9 (2) ◽

pp. e023096 ◽

Cited By ~ 2

Author(s):

Chuanjin Luo ◽

Junmao Wen ◽

Weipeng Sun ◽

Ting Li ◽

Xiaojiang Yu ◽

...

Keyword(s):

Quality Of Life ◽

Tai Chi ◽

Meta Analysis ◽

Coronary Intervention ◽

Risk Of Bias ◽

Controlled Trials ◽

Percutaneous Coronary ◽

IntroductionCoronary heart disease (CHD) is the most common cause of death worldwide. Percutaneous coronary intervention (PCI) has been shown to reduce mortality in patients with CHD. However, there are still recurrences of cardiovascular events after PCI. Cardiac rehabilitation (CR) in patients with established CHD is associated with reductions in cardiovascular mortality and hospital admissions, as well as improved quality of life. More and more clinical trials suggest that traditional Chinese exercise (TCE) plays a positive role in patients post-PCI. The primary purposes of the current study are to conduct a network meta-analysis of randomised trials to determine the effects of TCE in patients after PCI, and to separately compare the effects of tai chi, baduanjin and yijinjing on CR after PCI.Methods and analysisStudies will be retrieved from the following databases: PubMed, Embase, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Data, Chinese BioMedical Database and Chinese Science and Technology Periodicals Database, from inception to December 2018. We will include randomised controlled trials that are related to the effects of TCE therapies in patients after PCI. The primary outcomes will be all-cause mortality, revascularisations, health-related quality of life and hospitalisations. Two reviewers will independently select eligible articles. For each included article, two reviewers will independently extract the data and assess the risk of bias by using the Cochrane risk of bias tool. Bayesian network meta-analyses will be conducted to pool all treatment effects. The ranking probabilities for the optimal intervention of various treatments (tai chi, baduanjin or yijinjing) will be estimated by the mean ranks and surface under the cumulative ranking curve. The Grading of Recommendations Assessment, Development and Evaluation System will be used to assess the quality of evidence.Ethics and disseminationThe results will be disseminated through peer-reviewed publications. They will provide consolidated evidence to inform clinicians on the potential functions of TCE in CR, and to provide reliable evidence for the application of TCE.Trial registration numberCRD42018088415.