ABSTRACT
OBJECTIVES: To review the findings of studies that have evaluated the design and/or usability of key risk of bias (RoB) tools for the assessment of RoB in primary studies, as categorized by the Library of Assessment Tools and InsTruments Used to assess Data validity in Evidence Synthesis Network (a searchable library of RoB tools for evidence synthesis): Prediction model Risk Of Bias ASessment Tool (PROBAST) , Risk of Bias-2 (RoB2), Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I), Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2), Quality Assessment of Diagnostic Accuracy Studies-Comparative (QUADAS-C), Quality Assessment of Prognostic Accuracy Studies (QUAPAS), Risk Of Bias in Non-randomised Studies of Exposures (ROBINS-E), and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) RoB checklist. STUDY DESIGN AND SETTING: Systematic review of methodological studies. We conducted a forward citation search from the primary report of each tool, to identify primary studies that aimed to evaluate the design and/or usability of the tool. Two reviewers assessed studies for inclusion. We extracted tool features into Microsoft Word and used NVivo for document analysis, comprising a mix of deductive and inductive approaches. We summarized findings within each tool and explored common findings across tools. RESULTS: We identified 13 tool evaluations meeting our inclusion criteria: PROBAST (3), RoB2 (3), ROBINS-I (4), and QUADAS-2 (3). We identified no evaluations for the other tools. Evaluations varied in clinical topic area, methodology, approach to bias assessment, and tool user background. Some had limitations affecting generalizability. We identified common findings across tools for 6/14 themes: (1) challenging items (eg, RoB2/ROBINS-I "deviations from intended interventions" domain), (2) overall RoB judgment (concerns with overall risk calculation in PROBAST/ROBINS-I), (3) tool usability (concerns about complexity), (4) time to complete tool (varying demands on time, eg, depending on number of outcomes assessed), (5) user agreement (varied across tools), and (6) recommendations for future use (eg, piloting) and development (add intermediate domain answer to QUADAS-2/PROBAST; provide clearer guidance for all tools). Of the other eight themes, seven only had findings for the QUADAS-2 tool, limiting comparison across tools, and one ("reorganization of questions") had no findings. CONCLUSION: Evaluations of key RoB tools have posited common challenges and recommendations for tool use and development. These findings may be helpful to people who use or develop RoB tools. Guidance is necessary to support the design and implementation of future RoB tool evaluations.
Subject(s)
Bias , Humans , Research Design/standardsABSTRACT
BACKGROUND: In patients with suspected deep vein thrombosis (DVT), D-dimer thresholds adjusted to age or clinical pretest probability (CPTP) increase the proportion of patients in whom DVT can be safely excluded compared to a standard approach using a fixed D-dimer threshold. Performance of these diagnostic strategies among cancer patients is uncertain. AIM: To compare the performance of age- and CPTP-adjusted D-dimer approaches among cancer outpatients with clinically suspected DVT, and derive a cancer-specific CPTP rule. PATIENTS AND METHODS: Consecutive ambulatory patients with active cancer and clinically suspected DVT of the lower extremity underwent CPTP assessment using the Wells rule, D-dimer testing, and whole-leg compression ultrasonography. Patients with normal ultrasonography were followed-up for 3 months for the occurrence of symptomatic venous thromboembolism. RESULTS: Upon referral, DVT was diagnosed in 48 of 239 (20.1 %) patients. The age-adjusted approach showed higher specificity and efficiency than the standard approach. Compared to the standard and age-adjusted strategies, the CPTP-adjusted approach had 35 % and 21 % higher specificity, and 34 % and 21 % higher efficiency, respectively. Failure rate, sensitivity, and predictive values were similar across strategies. A simplified CPTP score derived from the Wells rule reduced unnecessary imaging with similar accuracy and efficiency, but higher failure rate. CONCLUSIONS: In this prospective cohort of ambulatory cancer patients with clinically suspected DVT, the CPTP-adjusted D-dimer approach held the highest specificity and efficiency, potentially safely reducing unnecessary ultrasonography examinations compared to other approaches. Additional studies are warranted to evaluate the use of a simplified clinical prediction rule in this setting.
Subject(s)
Neoplasms , Venous Thrombosis , Humans , Prospective Studies , Venous Thrombosis/diagnostic imaging , Fibrin Fibrinogen Degradation Products , Ultrasonography , Probability , Lower Extremity , Neoplasms/complications , Predictive Value of TestsABSTRACT
BACKGROUND: Adverse events (AEs) cause suffering for hospitalised children, a fragile patient group where the delivery of adequate timely care is of great importance. OBJECTIVE: To report the incidence and characteristics of AEs, in paediatric inpatient care, as detected with the Global Trigger Tool (GTT), the Trigger Tool (TT) or the Harvard Medical Practice Study (HMPS) method. METHOD: MEDLINE, Embase, Web of Science and Google Scholar were searched from inception to June 2021, without language restrictions. Studies using manual record review were included if paediatric data were reported separately. We excluded studies reporting: AEs for a specific disease/diagnosis/treatment/procedure, or deceased patients; study protocols with no AE outcomes; conference abstracts, editorials and systematic reviews; clinical incident reports as the primary data source; and studies focusing on specific AEs only. Methodological risk of bias was assessed using a tool based on the Quality Assessment Tool for Diagnostic Accuracy Studies 2. Primary outcome was the percentage of admissions with ≥1 AEs. All statistical analyses were stratified by record review methodology (GTT/TT or HMPS) and by type of population. Meta-analyses, applying random-effects models, were carried out. The variability of the pooled estimates was characterised by 95% prediction intervals (PIs). RESULTS: We included 32 studies from 44 publications, conducted in 15 countries totalling 33 873 paediatric admissions. The total number of AEs identified was 8577. The most common types of AEs were nosocomial infections (range, 6.8%-59.6%) for the general care population and pulmonary-related (10.5%-36.7%) for intensive care. The reported incidence rates were highly heterogeneous. The PIs for the primary outcome were 3.8%-53.8% and 6.9%-91.6% for GTT/TT studies (general and intensive care population). The equivalent PI was 0.3%-33.7% for HMPS studies (general care). The PIs for preventable AEs were 7.4%-96.2% and 4.5%-98.9% for GTT/TT studies (general and intensive care population) and 10.4%-91.8% for HMPS studies (general care). The quality assessment indicated several methodological concerns regarding the included studies. CONCLUSION: The reported incidence of AEs is highly variable in paediatric inpatient care research, and it is not possible to estimate a reliable single rate. Poor reporting standards and methodological differences hinder the comparison of study results.
Subject(s)
Inpatients , Patient Safety , Humans , Child , Incidence , Hospitalization , Risk ManagementABSTRACT
BACKGROUND: Adverse event (AE) detection is a major patient safety priority. However, despite extensive research on AEs, reported incidence rates vary widely. OBJECTIVE: This study aimed: (1) to synthesize available evidence on AE incidence in acute care inpatient settings using Trigger Tool methodology; and (2) to explore whether study characteristics and study quality explain variations in reported AE incidence. DESIGN: Systematic review and meta-analysis. METHODS: To identify relevant studies, we queried PubMed, EMBASE, CINAHL, Cochrane Library and three journals in the patient safety field (last update search 25.05.2022). Eligible publications fulfilled the following criteria: adult inpatient samples; acute care hospital settings; Trigger Tool methodology; focus on specialty of internal medicine, surgery or oncology; published in English, French, German, Italian or Spanish. Systematic reviews and studies addressing adverse drug events or exclusively deceased patients were excluded. Risk of bias was assessed using an adapted version of the Quality Assessment Tool for Diagnostic Accuracy Studies 2. Our main outcome of interest was AEs per 100 admissions. We assessed nine study characteristics plus study quality as potential sources of variation using random regression models. We received no funding and did not register this review. RESULTS: Screening 6,685 publications yielded 54 eligible studies covering 194,470 admissions. The cumulative AE incidence was 30.0 per 100 admissions (95% CI 23.9-37.5; I2 = 99.7%) and between study heterogeneity was high with a prediction interval of 5.4-164.7. Overall studies' risk of bias and applicability-related concerns were rated as low. Eight out of nine methodological study characteristics did explain some variation of reported AE rates, such as patient age and type of hospital. Also, study quality did explain variation. CONCLUSION: Estimates of AE studies using trigger tool methodology vary while explaining variation is seriously hampered by the low standards of reporting such as the timeframe of AE detection. Specific reporting guidelines for studies using retrospective medical record review methodology are necessary to strengthen the current evidence base and to help explain between study variation.
Subject(s)
Drug-Related Side Effects and Adverse Reactions , Adult , Drug-Related Side Effects and Adverse Reactions/epidemiology , Hospitalization , Humans , Inpatients , Patient Safety , Retrospective StudiesABSTRACT
Comparative diagnostic test accuracy studies assess and compare the accuracy of 2 or more tests in the same study. Although these studies have the potential to yield reliable evidence regarding comparative accuracy, shortcomings in the design, conduct, and analysis may bias their results. The currently recommended quality assessment tool for diagnostic test accuracy studies, QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies-2), is not designed for the assessment of test comparisons. The QUADAS-C (Quality Assessment of Diagnostic Accuracy Studies-Comparative) tool was developed as an extension of QUADAS-2 to assess the risk of bias in comparative diagnostic test accuracy studies. Through a 4-round Delphi study involving 24 international experts in test evaluation and a face-to-face consensus meeting, an initial version of the tool was developed that was revised and finalized following a pilot study among potential users. The QUADAS-C tool retains the same 4-domain structure of QUADAS-2 (Patient Selection, Index Test, Reference Standard, and Flow and Timing) and comprises additional questions to each QUADAS-2 domain. A risk-of-bias judgment for comparative accuracy requires a risk-of-bias judgment for the accuracy of each test (resulting from QUADAS-2) and additional criteria specific to test comparisons. Examples of such additional criteria include whether participants either received all index tests or were randomly assigned to index tests, and whether index tests were interpreted with blinding to the results of other index tests. The QUADAS-C tool will be useful for systematic reviews of diagnostic test accuracy addressing comparative questions. Furthermore, researchers may use this tool to identify and avoid risk of bias when designing a comparative diagnostic test accuracy study.
Subject(s)
Bias , Diagnosis , Quality Assurance, Health Care , Review Literature as Topic , Surveys and Questionnaires , Evidence-Based Medicine , HumansABSTRACT
OBJECTIVE: To compare the effectiveness of single, multiple, and multifactorial interventions to prevent falls and fall-related fractures in community-dwelling older persons. METHODS: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were systematically searched for randomized controlled trials (RCTs) evaluating the effectiveness of fall prevention interventions in community-dwelling adults aged ≥65 years, from inception until February 27, 2019. Two large RCTs (published in 2020 after the search closed) were included in post hoc analyses. Pairwise meta-analysis and network meta-analysis (NMA) were conducted. RESULTS: NMA including 192 studies revealed that the following single interventions, compared with usual care, were associated with reductions in number of fallers: exercise (risk ratio [RR] 0.83; 95% confidence interval [CI] 0.77-0.89) and quality improvement strategies (e.g., patient education) (RR 0.90; 95% CI 0.83-0.98). Exercise as a single intervention was associated with a reduction in falls rate (RR 0.79; 95% CI 0.73-0.86). Common components of multiple interventions significantly associated with a reduction in number of fallers and falls rate were exercise, assistive technology, environmental assessment and modifications, quality improvement strategies, and basic falls risk assessment (e.g., medication review). Multifactorial interventions were associated with a reduction in falls rate (RR 0.87; 95% CI 0.80-0.95), but not with a reduction in number of fallers (RR 0.95; 95% CI 0.89-1.01). The following single interventions, compared with usual care, were associated with reductions in number of fall-related fractures: basic falls risk assessment (RR 0.60; 95% CI 0.39-0.94) and exercise (RR 0.62; 95% CI 0.42-0.90). CONCLUSIONS: In keeping with Tricco et al. (2017), several single and multiple fall prevention interventions are associated with fewer falls. In addition to Tricco, we observe a benefit at the NMA-level of some single interventions on preventing fall-related fractures.
Subject(s)
Accidental Falls/prevention & control , Accidents, Home/prevention & control , Fractures, Bone/prevention & control , Aged , Aged, 80 and over , Environment Design , Exercise Therapy , Female , Humans , Independent Living , Male , Network Meta-Analysis , Randomized Controlled Trials as Topic , Risk Assessment , Self-Help DevicesABSTRACT
BACKGROUND: Venous thromboembolism (VTE) may complicate the course of Coronavirus Disease 2019 (COVID-19). OBJECTIVES: To evaluate the incidence of VTE in patients with COVID-19. METHODS: MEDLINE, EMBASE, and PubMed were searched up to 24th June 2020 for studies that evaluated the incidence of VTE, including pulmonary embolism (PE) and/or deep vein thrombosis (DVT), in patients with COVID-19. Pooled proportions with corresponding 95% confidence intervals (CI) and prediction intervals (PI) were calculated by random-effect meta-analysis. RESULTS: 3487 patients from 30 studies were included. Based on very low-quality evidence due to heterogeneity and risk of bias, the incidence of VTE was 26% (95% PI, 6%-66%). PE with or without DVT occurred in 12% of patients (95% PI, 2%-46%) and DVT alone in 14% (95% PI, 1%-75%). Studies using standard algorithms for clinically suspected VTE reported PE in 13% of patients (95% PI, 2%-57%) and DVT in 6% (95% PI, 0%-60%), compared to 11% (95% PI, 2%-46%) and 24% (95% PI, 2%-85%) in studies using other diagnostic strategies or patient sampling. In patients admitted to intensive care units, VTE occurred in 24% (95% PI, 5%-66%), PE in 19% (95% PI, 6%-47%), and DVT alone in 7% (95% PI, 0%-69%). Corresponding values in general wards were respectively 9% (95% PI, 0%-94%), 4% (95% PI, 0%-100%), and 7% (95% CI, 1%-49%). CONCLUSIONS: VTE represents a frequent complication in hospitalized COVID-19 patients and often occurs as PE. The threshold for clinical suspicion should be low to trigger prompt diagnostic testing.
Subject(s)
COVID-19/complications , SARS-CoV-2 , Venous Thromboembolism/epidemiology , Aged , Female , Humans , Incidence , Male , Middle Aged , Pulmonary Embolism/epidemiology , Venous Thrombosis/epidemiologyABSTRACT
BACKGROUND: The incidence of acute complications and mortality associated with COVID-19 remains poorly characterized. The aims of this systematic review and meta-analysis were to summarize the evidence on clinically relevant outcomes in hospitalized patients with COVID-19. METHODS: MEDLINE, EMBASE, PubMed, and medRxiv were searched up to April 20, 2020, for studies including hospitalized symptomatic adult patients with laboratory-confirmed COVID-19. The primary outcomes were all-cause mortality and acute respiratory distress syndrome (ARDS). The secondary outcomes included acute cardiac or kidney injury, shock, coagulopathy, and venous thromboembolism. The main analysis was based on data from peer-reviewed studies. Summary estimates and the corresponding 95% prediction intervals (PIs) were obtained through meta-analyses. RESULTS: A total of 44 peer-reviewed studies with 14,866 COVID-19 patients were included. In general, risk of bias was high. All-cause mortality was 10% overall (95% PI, 2 to 39%; 1687/14203 patients; 43 studies), 34% in patients admitted to intensive care units (95% PI, 8 to 76%; 659/2368 patients; 10 studies), 83% in patients requiring invasive ventilation (95% PI, 1 to 100%; 180/220 patients; 6 studies), and 75% in patients who developed ARDS (95% PI, 35 to 94%; 339/455 patients; 11 studies). On average, ARDS occurred in 14% of patients (95% PI, 2 to 59%; 999/6322 patients; 23 studies), acute cardiac injury in 15% (95% PI, 5 to 38%; 452/2389 patients; 10 studies), venous thromboembolism in 15% (95% PI, 0 to 100%; patients; 3 studies), acute kidney injury in 6% (95% PI, 1 to 41%; 318/4682 patients; 15 studies), coagulopathy in 6% (95% PI, 1 to 39%; 223/3370 patients; 9 studies), and shock in 3% (95% PI, 0 to 61%; 203/4309 patients; 13 studies). CONCLUSIONS: Mortality was very high in critically ill patients based on very low-quality evidence due to striking heterogeneity and risk of bias. The incidence of clinically relevant outcomes was substantial, although reported by only one third of the studies suggesting considerable underreporting. TRIAL REGISTRATION: PROSPERO registration ID for this study is CRD42020177243 ( https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=177243 ).
Subject(s)
Coronavirus Infections/complications , Coronavirus Infections/mortality , Pneumonia, Viral/complications , Pneumonia, Viral/mortality , COVID-19 , Coronavirus Infections/therapy , Hospitalization , Humans , Observational Studies as Topic , Pandemics , Pneumonia, Viral/therapy , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
Introduction: Obesity is associated with a higher risk of abortion in women undergoing in vitro fertilization (IVF). Whether thrombophilia amplifies this risk is currently unclear. The aim of this study was to evaluate the effects of thrombophilia on the risk of abortion in obese women treated with IVF. Methods: Patient characteristics, presence of inherited or acquired thrombophilia, and comorbidities were prospectively collected before the procedure in consecutive women undergoing IVF. The primary outcome was the incidence of abortion among women who achieved a clinical pregnancy. Results: A total of 633 non-obese and 49 obese Caucasian women undergoing IVF were included. 204 (32%) women achieved clinical pregnancy, of whom six had an ectopic pregnancy and 63 experienced an abortion. The incidence of abortion was higher in obese women compared to non-obese women after adjusting for age (64.3% vs. 29.3%, odds ratio [OR] 4.41; 95% CI 1.41 to 13.81). Women with one or more thrombophilia were at increased risk of abortion relative to those without thrombophilia (OR 2.70; 95% CI 1.34 to 5.45), and the risk seemed to be higher with hereditary (OR 5.12; 95% CI 1.77 to 14.8) than acquired thrombophilia (OR 1.92; 95% CI 0.52 to 5.12; p for interaction 0.194). Among obese women, the presence of one or more thrombophilia seemed associated with a substantially increased risk of abortion (unadjusted OR 14.00; 95% CI 0.94 to 207.6). Conclusions: Obese women undergoing IVF have a high risk of abortion which seems further amplified by the concomitant presence of thrombophilia.
Subject(s)
Abortion, Spontaneous/epidemiology , Fertilization in Vitro/adverse effects , Infertility, Female/therapy , Obesity/complications , Thrombophilia/complications , Abortion, Spontaneous/etiology , Adult , Case-Control Studies , Female , Humans , Incidence , Italy/epidemiology , Pregnancy , Pregnancy Outcome , Prospective Studies , Risk FactorsABSTRACT
BACKGROUND: The use of systematic review methods are widely recognized to be essential in the development of recommendations in clinical practice guidelines to prove their trustworthiness. The objective of this study was to assess the use of systematic search methods by authors of guidelines published in the oncology field. METHODS: We analyzed 590 guidance documents identified in PubMed, NGC, GIN and web sites for guidelines in 2009-2015 in oncology. The main outcome measure used was incidence of guidance documents supported by a systematic search of the literature. In addition to descriptive analyses, logistic regression was used to evaluate if adequate search methods were explained by guideline characteristics. RESULTS: Of 590 guidance documents included in the study, 305 (51.7%) declared the use of systematic search methods but only 168 (28.5%) applied methods meeting minimum standards for quality and provided sufficient details to allow classification. 164 (27.8%) guidance documents did not report any use of literature evaluation. Guidance documents produced by a Government Agency in North America (OR 2.16, 95% CI 1.16-4.17) and those with a focused scope (OR 2.35, 95% CI 0.97-5.56) were positively associated with the use of systematic search methods. We found no association between the year of publication and use of systematic search methods. CONCLUSIONS: A relatively small number of guidance documents was informed by scientific evidence identified through adequate systematic search methods. We observed substantial room for improvement of applied methods and reporting, especially in documents with a broad focus, or those produced by professional societies or independent expert panels in other continents than North America.
Subject(s)
Guideline Adherence/standards , Medical Oncology/methods , Medical Oncology/standards , Practice Guidelines as Topic/standards , Guideline Adherence/statistics & numerical data , Humans , Logistic Models , Medical Oncology/statistics & numerical data , Periodicals as Topic/standards , Periodicals as Topic/statistics & numerical data , Publications/standards , Publications/statistics & numerical dataABSTRACT
AIMS: Deprescribing interventions safely and effectively optimize medication use in older people. However, questions remain about which components of interventions are key to effectively reduce inappropriate medication use. This systematic review examines the behaviour change techniques (BCTs) of deprescribing interventions and summarizes intervention effectiveness on medication use and inappropriate prescribing. METHODS: MEDLINE, EMBASE, Web of Science and Academic Search Complete and grey literature were searched for relevant literature. Randomized controlled trials (RCTs) were included if they reported on interventions in people aged ≥65 years. The BCT taxonomy was used to identify BCTs frequently observed in deprescribing interventions. Effectiveness of interventions on inappropriate medication use was summarized in meta-analyses. Medication appropriateness was assessed in accordance with STOPP criteria, Beers' criteria and national or local guidelines. Between-study heterogeneity was evaluated by I-squared and Chi-squared statistics. Risk of bias was assessed using the Cochrane Collaboration Tool for randomized controlled studies. RESULTS: Of the 1561 records identified, 25 studies were included in the review. Deprescribing interventions were effective in reducing number of drugs and inappropriate prescribing, but a large heterogeneity in effects was observed. BCT clusters including goals and planning; social support; shaping knowledge; natural consequences; comparison of behaviour; comparison of outcomes; regulation; antecedents; and identity had a positive effect on the effectiveness of interventions. CONCLUSIONS: In general, deprescribing interventions effectively reduce medication use and inappropriate prescribing in older people. Successful deprescribing is facilitated by the combination of BCTs involving a range of intervention components.
Subject(s)
Behavior Therapy/methods , Deprescriptions , Bias , Humans , Inappropriate Prescribing , Potentially Inappropriate Medication ListABSTRACT
Importance: Systematic reviews of diagnostic test accuracy synthesize data from primary diagnostic studies that have evaluated the accuracy of 1 or more index tests against a reference standard, provide estimates of test performance, allow comparisons of the accuracy of different tests, and facilitate the identification of sources of variability in test accuracy. Objective: To develop the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagnostic test accuracy guideline as a stand-alone extension of the PRISMA statement. Modifications to the PRISMA statement reflect the specific requirements for reporting of systematic reviews and meta-analyses of diagnostic test accuracy studies and the abstracts for these reviews. Design: Established standards from the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network were followed for the development of the guideline. The original PRISMA statement was used as a framework on which to modify and add items. A group of 24 multidisciplinary experts used a systematic review of articles on existing reporting guidelines and methods, a 3-round Delphi process, a consensus meeting, pilot testing, and iterative refinement to develop the PRISMA diagnostic test accuracy guideline. The final version of the PRISMA diagnostic test accuracy guideline checklist was approved by the group. Findings: The systematic review (produced 64 items) and the Delphi process (provided feedback on 7 proposed items; 1 item was later split into 2 items) identified 71 potentially relevant items for consideration. The Delphi process reduced these to 60 items that were discussed at the consensus meeting. Following the meeting, pilot testing and iterative feedback were used to generate the 27-item PRISMA diagnostic test accuracy checklist. To reflect specific or optimal contemporary systematic review methods for diagnostic test accuracy, 8 of the 27 original PRISMA items were left unchanged, 17 were modified, 2 were added, and 2 were omitted. Conclusions and Relevance: The 27-item PRISMA diagnostic test accuracy checklist provides specific guidance for reporting of systematic reviews. The PRISMA diagnostic test accuracy guideline can facilitate the transparent reporting of reviews, and may assist in the evaluation of validity and applicability, enhance replicability of reviews, and make the results from systematic reviews of diagnostic test accuracy studies more useful.
Subject(s)
Checklist , Diagnostic Techniques and Procedures , Guidelines as Topic , Meta-Analysis as Topic , Systematic Reviews as Topic , Consensus Development Conferences as Topic , Delphi Technique , Diagnostic Techniques and Procedures/standards , Reproducibility of ResultsABSTRACT
AIM: Medication review has been advocated as one of the measures to tackle the challenge of polypharmacy in older patients, yet there is no consensus on how best to evaluate its efficacy. This study aimed to assess outcome reporting in trials of medication review in older patients. METHODS: Randomized controlled trials (RCTs), prospective studies and RCT protocols involving medication review performed in patients aged 65 years or older in any setting of care were identified from: (1) a recent systematic review; (2) RCT registries of ongoing studies; (3) the Cochrane library. The type, definition, and frequency of all outcomes reported were extracted independently by two researchers. RESULTS: Forty-seven RCTs or prospective published studies and 32 RCT protocols were identified. A total of 327 distinct outcomes were identified in the 47 published studies. Only one fifth (21%) of the studies evaluated the impact of medication reviews on adverse events such as drug reactions or drug-related hospital admissions. Most of the outcomes were related to medication use (n = 114, 35%) and healthcare use (n = 74, 23%). Very few outcomes were patient-related (n = 24, 7%). A total of 248 distinct outcomes were identified in the 32 RCT protocols. Overall, the number of outcomes and the number and type of health domains covered by the outcomes varied largely. CONCLUSION: Outcome reporting from RCTs concerning medication review in older patients is heterogeneous. This review highlights the need for a standardized core outcome set for medication review in older patients, to improve outcome reporting and evidence synthesis.
Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Medication Therapy Management , Outcome Assessment, Health Care/methods , Aged , Humans , Polypharmacy , Randomized Controlled Trials as Topic , Research DesignABSTRACT
OBJECTIVES: The aim was to analyze the data about the effects on marginal bone resorption and implant failure rates between implants inserted with high or low insertion torque values. MATERIALS AND METHODS: A systematic literature search until July 2015 was conducted. Data were summarized qualitatively in descriptive tables and quantitatively by performing random effects meta-analyses of effect sizes (ESs) for bone resorption and bone-to-implant contact (BIC) and relative risks (RRs) for implant failures. Risk of bias assessments were performed using the Cochrane tool for human studies and the SYRCLE's tool for animal studies. RESULTS: Four studies in humans and 6 quasirandomized animal studies were included. A total of 591 implants were evaluated qualitatively: 348 installed with high insertion torque (>25 Ncm, up to 176 Ncm) and 243 implants inserted with low torque values (<30-35 Ncm). No significant differences were detected for bone resorption (ES, 0.13; 95% confidence interval [CI], -0.12 to 0.38 in human studies; ES predictive interval from 35.03 to 34.50 in animal studies), implant failure (RR, 0.39; 95% CI, 0.01-20.77 in human studies; RR, 2.05; 95% CI, 0.19-21.71 in animal studies), or BIC (ES predictive interval from -3.84 to 5.13 in animal studies). CONCLUSION: The current review indicated that there is no significant difference in marginal bone resorption and implant failure rate between implants inserted with high or low insertion torque values.