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Practice Changing Updates from the Medical LiteratureAugust 2019Jim Stevermer, MD, MSPHstevermerj@health.missouri.eduAspirin use in healthy people over 70 does improve disability-free survival, or cardiovascular outcomes.IFdha2UgRm9yZXN0IFNjaG9vbCBvZiBNZWRpY2luZSwgV2luc3Rvbi1TYWxlbSwgTkMgKEouRC5X
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ADDIN EN.CITE.DATA 1-3 SOR:(B)Aspirin is effective in primary prevention of major vascular events in people with diabetes, but that benefit is only slightly higher than the increased risk of major bleeding episodes. ADDIN EN.CITE <EndNote><Cite><Author>ASCEND Study Collaborative Group</Author><Year>2018</Year><RecNum>1215</RecNum><DisplayText><style face="superscript">4</style></DisplayText><record><rec-number>1215</rec-number><foreign-keys><key app="EN" db-id="02020pd9uw52zuew9f9xdpr722wpp9rd9dwx" timestamp="1545419274" guid="a64cc091-4546-4faa-8dc1-7fbd7b1a1e7a">1215</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>ASCEND Study Collaborative Group,</author></authors></contributors><titles><title>Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus</title><secondary-title>New England Journal of Medicine</secondary-title></titles><periodical><full-title>New England Journal of Medicine</full-title><abbr-1>N. Engl. J. Med.</abbr-1><abbr-2>N Engl J Med</abbr-2></periodical><reprint-edition>Not in File</reprint-edition><keywords><keyword>PURL</keyword></keywords><dates><year>2018</year><pub-dates><date>8/26/2018</date></pub-dates></dates><label>1245</label><urls><related-urls><url> SOR:(B)This study did not find any benefit to aspirin for primary prevention of vascular events; primarily due to lower event rates - likely due to contemporary risk management. ADDIN EN.CITE <EndNote><Cite><Author>Gaziano</Author><Year>2018</Year><RecNum>1214</RecNum><DisplayText><style face="superscript">5</style></DisplayText><record><rec-number>1214</rec-number><foreign-keys><key app="EN" db-id="02020pd9uw52zuew9f9xdpr722wpp9rd9dwx" timestamp="1545419274" guid="0a57641b-9f8f-4dea-9ed7-b0b975d52db9">1214</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Gaziano, J.Michael</author><author>Brotons, Carlos</author><author>Coppolecchia, Rosa</author><author>Cricelli, Claudio</author><author>Darius, Harald</author><author>Gorelick, Philip B.</author><author>Howard, George</author><author>Pearson, Thomas A.</author><author>Rothwell, Peter M.</author><author>Ruilope, Luis Miguel</author><author>Tendera, Michal</author><author>Tognoni, Gianni</author></authors></contributors><titles><title>Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial</title><secondary-title>The Lancet</secondary-title></titles><reprint-edition>Not in File</reprint-edition><keywords><keyword>PURL</keyword></keywords><dates><year>2018</year><pub-dates><date>2018</date></pub-dates></dates><label>1244</label><urls><related-urls><url>(18)31924-X</url><url>: 10.1016/S0140-6736(18)31924-X</electronic-resource-num></record></Cite></EndNote>5 SOR:(B)This meta-analysis found no significant benefit in primary prevention by the use of aspirin; there was increased bleeding noted. ADDIN EN.CITE <EndNote><Cite><Author>Mahmoud</Author><Year>2018</Year><RecNum>1241</RecNum><DisplayText><style face="superscript">6</style></DisplayText><record><rec-number>1241</rec-number><foreign-keys><key app="EN" db-id="02020pd9uw52zuew9f9xdpr722wpp9rd9dwx" timestamp="1550615228" guid="c3279a35-5af7-4863-986a-f928f7031cfa">1241</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mahmoud, A. N.</author><author>Gad, M. M.</author><author>Elgendy, A. Y.</author><author>Elgendy, I. Y.</author><author>Bavry, A. A.</author></authors></contributors><titles><title>Efficacy and safety of aspirin for primary prevention of cardiovascular events: a meta-analysis and trial sequential analysis of randomized controlled trials</title><secondary-title>European Heart Journal</secondary-title></titles><periodical><full-title>European Heart Journal</full-title><abbr-1>Eur. Heart J.</abbr-1><abbr-2>Eur Heart J</abbr-2></periodical><pages>17</pages><volume>17</volume><dates><year>2018</year></dates><accession-num>30561620</accession-num><urls><related-urls><url> Technologies</remote-database-provider></record></Cite></EndNote>6 SOR:(A)Statins probably do NOT reduce major outcomes in people over 75 w/o vascular disease.PEVuZE5vdGU+PENpdGUgRXhjbHVkZVllYXI9IjEiPjxBdXRob3I+Q2hvbGVzdGVyb2wgVHJlYXRt
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ADDIN EN.CITE.DATA 7 SOR:(A)Zolendronic acid (5 mg IV) every 18 months reduced fragility fractures in women with osteopenia, but did not reduce hip fractures.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SZWlkPC9BdXRob3I+PFllYXI+MjAxODwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA 8 SOR:(B)Only patients with select circumstances should receive oxygen to get their SpO2 to a target of 97% or higher, most people are at risk of increased mortality (NNH=100). For patients with acute MI or CVA, do not start O2 in patients with SpO2 => 90% (weak recommendation) or =>93% (strong).PEVuZE5vdGU+PENpdGUgRXhjbHVkZVllYXI9IjEiPjxBdXRob3I+U2llbWllbml1azwvQXV0aG9y
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ADDIN EN.CITE.DATA 10 SOR:(B)Adding field therapy (e.g, 5-FU) to cryotheryapy appears to be superior for cryotherapy alone for people with multiple AKs. ADDIN EN.CITE <EndNote><Cite ExcludeYear="1"><Author>Heppt</Author><Year>2019</Year><RecNum>1287</RecNum><DisplayText><style face="superscript">11</style></DisplayText><record><rec-number>1287</rec-number><foreign-keys><key app="EN" db-id="02020pd9uw52zuew9f9xdpr722wpp9rd9dwx" timestamp="1565654310" guid="1a1bf1e6-a692-4d79-bd4b-42e847a1acf7">1287</key><key app="ENWeb" db-id="">0</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Heppt, M. V.</author><author>Steeb, T.</author><author>Ruzicka, T.</author><author>Berking, C.</author></authors></contributors><auth-address>Department of Dermatology and Allergy, University Hospital, LMU Munich, Frauenlobstrasse 9-11, 80337, Munich, Germany.</auth-address><titles><title>Cryosurgery combined with topical interventions for actinic keratosis: a systematic review and meta-analysis</title><secondary-title>Br J Dermatol</secondary-title></titles><periodical><full-title>British Journal of Dermatology</full-title><abbr-1>Br. J. Dermatol.</abbr-1><abbr-2>Br J Dermatol</abbr-2></periodical><pages>740-748</pages><volume>180</volume><number>4</number><edition>2018/11/18</edition><dates><year>2019</year><pub-dates><date>Apr</date></pub-dates></dates><isbn>0007-0963</isbn><accession-num>30447074</accession-num><urls></urls><electronic-resource-num>10.1111/bjd.17435</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>11 SOR:(A)Advance Care Planning (Respecting Choices) did not change patient outcomes or activation, but did increase advance directive completion and surrogate selection in Dutch frail elderly.PEVuZE5vdGU+PENpdGUgRXhjbHVkZVllYXI9IjEiPjxBdXRob3I+T3ZlcmJlZWs8L0F1dGhvcj48
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ADDIN EN.CITE.DATA 14 SOR:(A)Start DAPT within 24 hours of a minor CVA (NIH score <= 3, and no persisting deficit or high risk TIA (ABCD2 >= 4). Continue it for 10-21 days, and then convert to single agent therapy. ADDIN EN.CITE <EndNote><Cite><Author>Hao</Author><Year>2018</Year><RecNum>1249</RecNum><DisplayText><style face="superscript">15</style></DisplayText><record><rec-number>1249</rec-number><foreign-keys><key app="EN" db-id="02020pd9uw52zuew9f9xdpr722wpp9rd9dwx" timestamp="1550615235" guid="86baa69c-de86-421c-9c82-77fc2dcdd87b">1249</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hao, Q.</author><author>Tampi, M.</author><author>O'Donnell, M.</author><author>Foroutan, F.</author><author>Siemieniuk, R. A.</author><author>Guyatt, G.</author></authors></contributors><titles><title>Clopidogrel plus aspirin versus aspirin alone for acute minor ischaemic stroke or high risk transient ischaemic attack: systematic review and meta-analysis</title><secondary-title>BMJ</secondary-title></titles><periodical><full-title>BMJ</full-title><abbr-1>BMJ</abbr-1><abbr-2>BMJ</abbr-2></periodical><pages>k5108</pages><volume>363</volume><dates><year>2018</year></dates><accession-num>30563866</accession-num><urls><related-urls><url> Technologies</remote-database-provider></record></Cite></EndNote>15 SOR:(A)An IM injection of triamcinolone 40 mg provides some pain relief in patients with hip osteoarthritis.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb3JsZWlqbjwvQXV0aG9yPjxZZWFyPjIwMTg8L1llYXI+
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ADDIN EN.CITE.DATA 18 SOR:(A)Strength of recommendation (SOR) Basis for recommendationAConsistent, good-quality patient-oriented evidenceBInconsistent or limited-quality patient-oriented evidenceCConsensus, disease-oriented evidence, usual practice, expert opinion, or case series for studies of diagnosis, treatment, prevention, or screeningReferences ADDIN EN.REFLIST 1.McNeil JJ, Wolfe R, Woods RL, et al. Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly. N Engl J Med. 2018:DOI: 10.1056/NEJMoa1805819. Background Aspirin is a well-established therapy for the secondary prevention of cardiovascular events. However, its role in the primary prevention of cardiovascular disease is unclear, especially in older persons, who have an increased risk. Methods From 2010 through 2014, we enrolled community-dwelling men and women in Australia and the United States who were 70 years of age or older (or >/=65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability. Participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo. The primary end point was a composite of death, dementia, or persistent physical disability; results for this end point are reported in another article in the Journal. Secondary end points included major hemorrhage and cardiovascular disease (defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure). Results Of the 19,114 persons who were enrolled in the trial, 9525 were assigned to receive aspirin and 9589 to receive placebo. After a median of 4.7 years of follow-up, the rate of cardiovascular disease was 10.7 events per 1000 person-years in the aspirin group and 11.3 events per 1000 person-years in the placebo group (hazard ratio, 0.95; 95% confidence interval [CI], 0.83 to 1.08). The rate of major hemorrhage was 8.6 events per 1000 person-years and 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001). Conclusions The use of low-dose aspirin as a primary prevention strategy in older adults resulted in a significantly higher risk of major hemorrhage and did not result in a significantly lower risk of cardiovascular disease than placebo. (Funded by the National Institute on Aging and others; ASPREE number, NCT01038583 .)2.McNeil JJ, Woods RL, Nelson MR, et al. Effect of Aspirin on Disability-free Survival in the Healthy Elderly. N Engl J Med. 2018:DOI: 10.1056/NEJMoa1800722. Background Information on the use of aspirin to increase healthy independent life span in older persons is limited. Whether 5 years of daily low-dose aspirin therapy would extend disability-free life in healthy seniors is unclear. Methods From 2010 through 2014, we enrolled community-dwelling persons in Australia and the United States who were 70 years of age or older (or >/=65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or physical disability. Participants were randomly assigned to receive 100 mg per day of enteric-coated aspirin or placebo orally. The primary end point was a composite of death, dementia, or persistent physical disability. Secondary end points reported in this article included the individual components of the primary end point and major hemorrhage. Results A total of 19,114 persons with a median age of 74 years were enrolled, of whom 9525 were randomly assigned to receive aspirin and 9589 to receive placebo. A total of 56.4% of the participants were women, 8.7% were nonwhite, and 11.0% reported previous regular aspirin use. The trial was terminated at a median of 4.7 years of follow-up after a determination was made that there would be no benefit with continued aspirin use with regard to the primary end point. The rate of the composite of death, dementia, or persistent physical disability was 21.5 events per 1000 person-years in the aspirin group and 21.2 per 1000 person-years in the placebo group (hazard ratio, 1.01; 95% confidence interval [CI], 0.92 to 1.11; P=0.79). The rate of adherence to the assigned intervention was 62.1% in the aspirin group and 64.1% in the placebo group in the final year of trial participation. Differences between the aspirin group and the placebo group were not substantial with regard to the secondary individual end points of death from any cause (12.7 events per 1000 person-years in the aspirin group and 11.1 events per 1000 person-years in the placebo group), dementia, or persistent physical disability. The rate of major hemorrhage was higher in the aspirin group than in the placebo group (3.8% vs. 2.8%; hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001). Conclusions Aspirin use in healthy elderly persons did not prolong disability-free survival over a period of 5 years but led to a higher rate of major hemorrhage than placebo. (Funded by the National Institute on Aging and others; ASPREE number, NCT01038583 .)3.McNeil JJ, Nelson MR, Woods RL, et al. Effect of Aspirin on All-Cause Mortality in the Healthy Elderly. N Engl J Med. 2018:DOI: 10.1056/NEJMoa1803955. Background In the primary analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, now published in the Journal, we report that the daily use of aspirin did not provide a benefit with regard to the primary end point of disability-free survival among older adults. A numerically higher rate of the secondary end point of death from any cause was observed with aspirin than with placebo. Methods From 2010 through 2014, we enrolled community-dwelling persons in Australia and the United States who were 70 years of age or older (or >/=65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability. Participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo. Deaths were classified according to the underlying cause by adjudicators who were unaware of trial-group assignments. Hazard ratios were calculated to compare mortality between the aspirin group and the placebo group, and post hoc exploratory analyses of specific causes of death were performed. Results Of the 19,114 persons who were enrolled, 9525 were assigned to receive aspirin and 9589 to receive placebo. A total of 1052 deaths occurred during a median of 4.7 years of follow-up. The risk of death from any cause was 12.7 events per 1000 person-years in the aspirin group and 11.1 events per 1000 person-years in the placebo group (hazard ratio, 1.14; 95% confidence interval [CI], 1.01 to 1.29). Cancer was the major contributor to the higher mortality in the aspirin group, accounting for 1.6 excess deaths per 1000 person-years. Cancer-related death occurred in 3.1% of the participants in the aspirin group and in 2.3% of those in the placebo group (hazard ratio, 1.31; 95% CI, 1.10 to 1.56). Conclusions Higher all-cause mortality was observed among apparently healthy older adults who received daily aspirin than among those who received placebo and was attributed primarily to cancer-related death. In the context of previous studies, this result was unexpected and should be interpreted with caution. (Funded by the National Institute on Aging and others; ASPREE number, NCT01038583 .)4.ASCEND Study Collaborative Group. Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus. N Engl J Med. 2018. BACKGROUND: Diabetes mellitus is associated with an increased risk of cardiovascular events.?Aspirin?use reduces the risk of occlusive vascular events but increases the risk of bleeding; the balance of benefits and hazards for the prevention of first cardiovascular events in patients with diabetes is unclear. METHODS: We randomly assigned adults who had diabetes but no evident cardiovascular disease to receive?aspirin?at a dose of 100 mg daily or matching placebo. The primary efficacy outcome was the first serious vascular event (i.e., myocardial infarction, stroke or transient ischemic attack, or death from any vascular cause, excluding any confirmed intracranial hemorrhage). The primary safety outcome was the first major bleeding event (i.e., intracranial hemorrhage, sight-threatening bleeding event in the eye, gastrointestinal bleeding, or other serious bleeding). Secondary outcomes included gastrointestinal tract cancer. RESULTS: A total of 15,480 participants underwent randomization. During a mean follow-up of 7.4 years, serious vascular events occurred in a significantly lower percentage of participants in the?aspirin?group than in the placebo group (658 participants [8.5%] vs. 743 [9.6%]; rate ratio, 0.88; 95% confidence interval [CI], 0.79 to 0.97; P=0.01). In contrast, major bleeding events occurred in 314 participants (4.1%) in the?aspirin?group, as compared with 245 (3.2%) in the placebo group (rate ratio, 1.29; 95% CI, 1.09 to 1.52; P=0.003), with most of the excess being gastrointestinal bleeding and other extracranial bleeding. There was no significant difference between the?aspirin?group and the placebo group in the incidence of gastrointestinal tract cancer (157 participants [2.0%] and 158 [2.0%], respectively) or all cancers (897 [11.6%] and 887 [11.5%]); long-term follow-up for these outcomes is planned. CONCLUSIONS: Aspirin?use prevented serious vascular events in persons who had diabetes and no evident cardiovascular disease at trial entry, but it also caused major bleeding events. The absolute benefits were largely counterbalanced by the bleeding hazard. (Funded by the British Heart Foundation and others;?ASCEND?Current Controlled Trials number, ISRCTN60635500?5.Gaziano JM, Brotons C, Coppolecchia R, et al. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. The Lancet. 2018. BACKGROUND: The use of?aspirin?in the primary prevention of cardiovascular events remains controversial. We aimed to assess the efficacy and safety of?aspirin?versus placebo in patients with a moderate estimated risk of a first cardiovascular event. METHODS: ARRIVE?is a randomised, double-blind, placebo-controlled, multicentre study done in seven countries. Eligible patients were aged 55 years (men) or 60 years (women) and older and had an average cardiovascular risk, deemed to be moderate on the basis of the number of specific risk factors. We excluded patients at high risk of gastrointestinal bleeding or other bleeding, or?diabetes. Patients were randomly assigned (1:1) with a computer-generated randomisation code to receive enteric-coated?aspirin?tablets (100 mg) or placebo tablets, once daily. Patients, investigators, and others involved in treatment or data analysis were masked to treatment allocation. The primary efficacy endpoint was a composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischaemic attack. Safety endpoints were haemorrhagic events and incidence of other adverse events, and were analysed in the intention-to-treat population. This study is registered with , number?NCT00501059. FINDINGS: Between July 5, 2007, and Nov 15, 2016, 12?546 patients were enrolled and randomly assigned to receive?aspirin?(n=6270) or placebo (n=6276) at 501 study sites. Median follow-up was 60 months. In the intention-to-treat analysis, the primary endpoint occurred in 269 (4·29%) patients in the?aspirin?group versus 281 (4·48%) patients in the placebo group (hazard ratio [HR] 0·96; 95% CI 0·81-1·13; p=0·6038). Gastrointestinal bleeding events (mostly mild) occurred in 61 (0·97%) patients in the?aspirin?group versus 29 (0·46%) in the placebo group (HR 2·11; 95% CI 1·36-3·28; p=0·0007). The overall incidence rate of serious adverse events was similar in both treatment groups (n=1266 [20·19%] in the?aspirin?group vs n=1311 [20·89%] in the placebo group. The overall incidence of adverse events was similar in both treatment groups (n=5142 [82·01%] vs n=5129 [81·72%] in the placebo group). The overall incidence of treatment-related adverse events was low (n=1050 [16·75%] vs n=850 [13·54%] in the placebo group; p<0·0001). There were 321 documented deaths in the intention-to-treat population (n=160 [2·55%] vs n=161 [2·57%] of 6276 patients in the placebo group). INTERPRETATION: The event rate was much lower than expected, which is probably reflective of contemporary risk management strategies, making the study more representative of a low-risk population. The role of?aspirin?in primary prevention among patients at moderate risk could therefore not be addressed. Nonetheless, the findings with respect to?aspirin's effects are consistent with those observed in the previously published low-risk primary prevention studies.6.Mahmoud AN, Gad MM, Elgendy AY, Elgendy IY, Bavry AA. Efficacy and safety of aspirin for primary prevention of cardiovascular events: a meta-analysis and trial sequential analysis of randomized controlled trials. Eur Heart J. 2018;17:17. Aims: The role of aspirin in the primary prevention setting is continuously evolving. Recent randomized trials have challenged the role of aspirin in the primary prevention setting. Methods and results: Electronic databases were searched for randomized trials that compared aspirin vs. placebo (or control) in subjects without established atherosclerotic disease. The primary efficacy outcome was all-cause mortality, while the primary safety outcome was major bleeding. Summary estimates were reported using a DerSimonian and Laird random effects model. A total of 11 trials with 157 248 subjects were included. At a mean follow-up of 6.6 years, aspirin was not associated with a lower incidence of all-cause mortality [risk ratio (RR) 0.98, 95% confidence interval (CI) 0.93-1.02; P = 0.30]; however, aspirin was associated with an increased incidence of major bleeding (RR 1.47, 95% CI 1.31-1.65; P < 0.0001) and intracranial haemorrhage (RR 1.33, 95% CI 1.13-1.58; P = 0.001). A similar effect on all-cause mortality and major bleeding was demonstrated in diabetic and high cardiovascular risk patients (i.e. 10-year risk >7.5%). Aspirin was associated with a lower incidence of myocardial infarction (RR 0.82, 95% CI 0.71-0.94; P = 0.006); however, this outcome was characterized by considerable heterogeneity (I2 = 67%), and this effect was no longer evident upon limiting the analysis to the more recent trials. Trial sequential analysis confirmed the lack of benefit of aspirin for all-cause mortality up to a relative risk reduction of 5%. Conclusion: Among adults without established cardiovascular disease, aspirin was not associated with a reduction in the incidence of all-cause mortality; however, it was associated with an increased incidence of major bleeding. The routine use of aspirin for primary prevention needs to be reconsidered.7.Cholesterol Treatment Trialists' Collaboration. Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trials. Lancet. 2019;393(10170):407-415. BACKGROUND: Statin therapy has been shown to reduce major vascular events and vascular mortality in a wide range of individuals, but there is uncertainty about its efficacy and safety among older people. We undertook a meta-analysis of data from all large statin trials to compare the effects of statin therapy at different ages. METHODS: In this meta-analysis, randomised trials of statin therapy were eligible if they aimed to recruit at least 1000 participants with a scheduled treatment duration of at least 2 years. We analysed individual participant data from 22 trials (n=134 537) and detailed summary data from one trial (n=12 705) of statin therapy versus control, plus individual participant data from five trials of more intensive versus less intensive statin therapy (n=39 612). We subdivided participants into six age groups (55 years or younger, 56-60 years, 61-65 years, 66-70 years, 71-75 years, and older than 75 years). We estimated effects on major vascular events (ie, major coronary events, strokes, and coronary revascularisations), cause-specific mortality, and cancer incidence as the rate ratio (RR) per 1.0 mmol/L reduction in LDL cholesterol. We compared proportional risk reductions in different age subgroups by use of standard chi(2) tests for heterogeneity when there were two groups, or trend when there were more than two groups. FINDINGS: 14 483 (8%) of 186 854 participants in the 28 trials were older than 75 years at randomisation, and the median follow-up duration was 4.9 years. Overall, statin therapy or a more intensive statin regimen produced a 21% (RR 0.79, 95% CI 0.77-0.81) proportional reduction in major vascular events per 1.0 mmol/L reduction in LDL cholesterol. We observed a significant reduction in major vascular events in all age groups. Although proportional reductions in major vascular events diminished slightly with age, this trend was not statistically significant (ptrend=0.06). Overall, statin or more intensive therapy yielded a 24% (RR 0.76, 95% CI 0.73-0.79) proportional reduction in major coronary events per 1.0 mmol/L reduction in LDL cholesterol, and with increasing age, we observed a trend towards smaller proportional risk reductions in major coronary events (ptrend=0.009). We observed a 25% (RR 0.75, 95% CI 0.73-0.78) proportional reduction in the risk of coronary revascularisation procedures with statin therapy or a more intensive statin regimen per 1.0 mmol/L lower LDL cholesterol, which did not differ significantly across age groups (ptrend=0.6). Similarly, the proportional reductions in stroke of any type (RR 0.84, 95% CI 0.80-0.89) did not differ significantly across age groups (ptrend=0.7). After exclusion of four trials which enrolled only patients with heart failure or undergoing renal dialysis (among whom statin therapy has not been shown to be effective), the trend to smaller proportional risk reductions with increasing age persisted for major coronary events (ptrend=0.01), and remained non-significant for major vascular events (ptrend=0.3). The proportional reduction in major vascular events was similar, irrespective of age, among patients with pre-existing vascular disease (ptrend=0.2), but appeared smaller among older than among younger individuals not known to have vascular disease (ptrend=0.05). We found a 12% (RR 0.88, 95% CI 0.85-0.91) proportional reduction in vascular mortality per 1.0 mmol/L reduction in LDL cholesterol, with a trend towards smaller proportional reductions with older age (ptrend=0.004), but this trend did not persist after exclusion of the heart failure or dialysis trials (ptrend=0.2). Statin therapy had no effect at any age on non-vascular mortality, cancer death, or cancer incidence. INTERPRETATION: Statin therapy produces significant reductions in major vascular events irrespective of age, but there is less direct evidence of benefit among patients older than 75 years who do not already have evidence of occlusive vascular disease. This limitation is now being addressed by further trials. FUNDING: Australian National Health and Medical Research Council, National Institute for Health Research Oxford Biomedical Research Centre, UK Medical Research Council, and British Heart Foundation.8.Reid IR, Horne AM, Mihov B, et al. Fracture prevention with zoledronate in older women with osteopenia. N Engl J Med. 2018;379(25):2407-2416. BACKGROUND: Bisphosphonates prevent fractures in patients with osteoporosis, but their efficacy in women with osteopenia is unknown. Most fractures in postmenopausal women occur in those with osteopenia, so therapies that are effective in women with osteopenia are needed. METHODS: We conducted a 6-year, double-blind trial involving 2000 women with osteopenia (defined by a T score of -1.0 to -2.5 at either the total hip or the femoral neck on either side) who were 65 years of age or older. Participants were randomly assigned to receive four infusions of either zoledronate at a dose of 5 mg (zoledronate group) or normal saline (placebo group) at 18-month intervals. A dietary calcium intake of 1 g per day was advised, but calcium supplements were not provided. Participants who were not already taking vitamin D supplements received cholecalciferol before the trial began (a single dose of 2.5 mg) and during the trial (1.25 mg per month). The primary end point was the time to first occurrence of a nonvertebral or vertebral fragility fracture. RESULTS: At baseline, the mean (+/-SD) age was 71+/-5 years, the T score at the femoral neck was -1.6+/-0.5, and the median 10-year risk of hip fracture was 2.3%. A fragility fracture occurred in 190 women in the placebo group and in 122 women in the zoledronate group (hazard ratio with zoledronate, 0.63; 95% confidence interval, 0.50 to 0.79; P<0.001). The number of women that would need to be treated to prevent the occurrence of a fracture in 1 woman was 15. As compared with the placebo group, women who received zoledronate had a lower risk of nonvertebral fragility fractures (hazard ratio, 0.66; P=0.001), symptomatic fractures (hazard ratio, 0.73; P=0.003), vertebral fractures (odds ratio, 0.45; P=0.002), and height loss (P<0.001). CONCLUSIONS: The risk of nonvertebral or vertebral fragility fractures was significantly lower in women with osteopenia who received zoledronate than in women who received placebo. (Funded by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12609000593235 .).9.Siemieniuk RAC, Chu DK, Kim LH, et al. Oxygen therapy for acutely ill medical patients: a clinical practice guideline. BMJ. 2018;363:k4169.It is a longstanding cultural norm to provide supplemental oxygen to sick patients regardless of their blood oxygen saturationA recent systematic review and meta-analysis has shown that too much supplemental oxygen increases mortality for medical patients in hospitalFor patients receiving oxygen therapy, aim for peripheral capillary oxygen saturation (SpO2) of ≤96% (strong recommendation)For patients with acute myocardial infarction or stroke, do not initiate oxygen therapy in patients with SpO2≥90% (for ≥93% strong recommendation, for 90-92% weak recommendation)A target SpO2?range of 90-94% seems reasonable for most patients and 88-92% for patients at risk of hypercapnic respiratory failure; use the minimum amount of oxygen necessary10.Jansen MHE, Kessels J, Nelemans PJ, et al. Randomized trial of four treatment approaches for actinic keratosis. N Engl J Med. 2019;380(10):935-946. BACKGROUND: Actinic keratosis is the most frequent premalignant skin disease in the white population. In current guidelines, no clear recommendations are made about which treatment is preferred. METHODS: We investigated the effectiveness of four frequently used field-directed treatments (for multiple lesions in a continuous area). Patients with a clinical diagnosis of five or more actinic keratosis lesions on the head, involving one continuous area of 25 to 100 cm(2), were enrolled at four Dutch hospitals. Patients were randomly assigned to treatment with 5% fluorouracil cream, 5% imiquimod cream, methyl aminolevulinate photodynamic therapy (MAL-PDT), or 0.015% ingenol mebutate gel. The primary outcome was the proportion of patients with a reduction of 75% or more in the number of actinic keratosis lesions from baseline to 12 months after the end of treatment. Both a modified intention-to-treat analysis and a per-protocol analysis were performed. RESULTS: A total of 624 patients were included from November 2014 through March 2017. At 12 months after the end of treatment, the cumulative probability of remaining free from treatment failure was significantly higher among patients who received fluorouracil (74.7%; 95% confidence interval [CI], 66.8 to 81.0) than among those who received imiquimod (53.9%; 95% CI, 45.4 to 61.6), MAL-PDT (37.7%; 95% CI, 30.0 to 45.3), or ingenol mebutate (28.9%; 95% CI, 21.8 to 36.3). As compared with fluorouracil, the hazard ratio for treatment failure was 2.03 (95% CI, 1.36 to 3.04) with imiquimod, 2.73 (95% CI, 1.87 to 3.99) with MAL-PDT, and 3.33 (95% CI, 2.29 to 4.85) with ingenol mebutate (P</=0.001 for all comparisons). No unexpected toxic effects were documented. CONCLUSIONS: At 12 months after the end of treatment in patients with multiple actinic keratosis lesions on the head, 5% fluorouracil cream was the most effective of four field-directed treatments. (Funded by the Netherlands Organization for Health Research and Development; number, NCT02281682.).11.Heppt MV, Steeb T, Ruzicka T, Berking C. Cryosurgery combined with topical interventions for actinic keratosis: a systematic review and meta-analysis. Br J Dermatol. 2019;180(4):740-748. BACKGROUND: Actinic keratoses (AKs) are early in situ carcinomas of the skin caused by cumulative sun exposure. Cryosurgery is an easy and practicable lesion-directed approach for treatment of isolated lesions. OBJECTIVES: To investigate whether an upfront combination of cryosurgery with a topical intervention is superior to cryosurgery alone for treatment of AK. METHODS: We performed a systematic literature search in MEDLINE, Embase and CENTRAL and hand searched pertinent trial registers for eligible randomized controlled trials until 17 July 2018. Results from individual studies were pooled using a random effects model. The risk of bias was estimated with the Cochrane Risk of Bias Tool and the quality of evidence of the outcomes with the GRADE approach. RESULTS: Out of 1758 records initially identified, nine studies with a total sample size of 1644 patients were included. Cryosurgery in combination with a topical approach showed significantly higher participant complete clearance rates than monotherapy [risk ratio (RR) 1.74, 95% confidence interval (CI) 1.25-2.43, I(2) = 73%, eight studies]. The participant partial clearance rate was not statistically different (RR 1.64, 95% CI 0.88-3.03, I(2) = 77%, three studies). The number of patients who completed the study protocol and did not withdraw due to adverse events was equal in both groups (RR 0.98, 95% CI 0.95-1.01, I(2) = 75%, seven studies). The studies were estimated to have high risk for selective reporting bias. CONCLUSIONS: Our results suggest the superiority of a combination regimen for AK clearance, with equal tolerability. This study highlights the importance of a field-directed approach in patients with multiple AKs or field cancerization.12.Overbeek A, Korfage IJ, Jabbarian LJ, et al. Advance care planning in frail older adults: A cluster randomized controlled trial. J Am Geriatr Soc. 2018;66(6):1089-1095. OBJECTIVES: To determine the effectiveness of advance care planning (ACP) in frail older adults. DESIGN: Cluster randomized controlled trial. SETTING: Residential care homes in the Netherlands (N=16). PARTICIPANTS: Care home residents and community-dwelling adults receiving home care (N=201; n=101 intervention; n=100 control). Participants were 75 years and older, frail, and capable of consenting to participation. INTERVENTION: Adjusted Respecting Choices ACP program. MEASUREMENTS: The primary outcome was change in patient activation (Patient Activation Measure, PAM-13) between baseline and 12-month follow-up. Secondary outcomes included change in quality of life (SF-12), advance directive (AD) completion, and surrogate decision-maker appointment. Use of medical care in the 12 months after inclusion was also assessed. Multilevel analyses were performed, controlling for clustering effects and differences in demographics. RESULTS: Seventy-seven intervention participants and 83 controls completed the follow-up assessment. There were no statistically significant differences between the intervention (-0.26+/-11.2) and control group (-1.43+/-10.6) in change scores of the PAM (p=.43) or the SF-12. Of intervention group participants, 93% completed an AD, and 94% appointed a decision-maker. Of control participants, 34% completed an AD, and 67% appointed a decision-maker (p<.001). No differences in the use of medical care were found. CONCLUSIONS: ACP did not increase levels of patient activation or quality of life but did increase completion of ADs and appointment of surrogate decision-makers. It did not affect use of medical care.13.Wylie G, Torrens C, Campbell P, et al. Podiatry interventions to prevent falls in older people: a systematic review and meta-analysis. Age Ageing. 2019;48(3):327-336. BACKGROUND: foot problems are independent risk factors for falls in older people. Podiatrists diagnose and treat a wide range of problems affecting the feet, ankles and lower limbs. However, the effectiveness of podiatry interventions to prevent falls in older people is unknown. This systematic review examined podiatry interventions for falls prevention delivered in the community and in care homes. METHODS: systematic review and meta-analysis. We searched multiple electronic databases with no language restrictions. Randomised or quasi-randomised-controlled trials documenting podiatry interventions in older people (aged 60+) were included. Two reviewers independently applied selection criteria and assessed methodological quality using the Cochrane Risk of Bias tool. TiDieR guidelines guided data extraction and where suitable statistical summary data were available, we combined the selected outcome data in pooled meta-analyses. RESULTS: from 35,857 titles and 5,201 screened abstracts, nine studies involving 6,502 participants (range 40-3,727) met the inclusion criteria. Interventions were single component podiatry (two studies), multifaceted podiatry (three studies), or multifactorial involving other components and referral to podiatry component (four studies). Seven studies were conducted in the community and two in care homes. Quality assessment showed overall low risk for selection bias, but unclear or high risk of detection bias in 4/9 studies. Combining falls rate data showed significant effects for multifaceted podiatry interventions compared to usual care (falls rate ratio 0.77 [95% CI 0.61, 0.99]); and multifactorial interventions including podiatry (falls rate ratio: 0.73 [95% CI 0.54, 0.98]). Single component podiatry interventions demonstrated no significant effects on falls rate. CONCLUSIONS: multifaceted podiatry interventions and multifactorial interventions involving referral to podiatry produce significant reductions in falls rate. The effect of multi-component podiatry interventions and of podiatry within multifactorial interventions in care homes is unknown and requires further trial data. PROSPERO REGISTRATION NUMBER: CRD42017068300.14.Travers J, Romero-Ortuno R, Bailey J, Cooney MT. Delaying and reversing frailty: a systematic review of primary care interventions. Br J Gen Pract. 2019;69(678):e61-e69. BACKGROUND: Recommendations for routine frailty screening in general practice are increasing as frailty prevalence grows. In England, frailty identification became a contractual requirement in 2017. However, there is little guidance on the most effective and practical interventions once frailty has been identified. AIM: To assess the comparative effectiveness and ease of implementation of frailty interventions in primary care. DESIGN AND SETTING: A systematic review of frailty interventions in primary care. METHOD: Scientific databases were searched from inception to May 2017 for randomised controlled trials or cohort studies with control groups on primary care frailty interventions. Screening methods, interventions, and outcomes were analysed in included studies. Effectiveness was scored in terms of change of frailty status or frailty indicators and ease of implementation in terms of human resources, marginal costs, and time requirements. RESULTS: A total of 925 studies satisfied search criteria and 46 were included. There were 15 690 participants (median study size was 160 participants). Studies reflected a broad heterogeneity. There were 17 different frailty screening methods. Of the frailty interventions, 23 involved physical activity and other interventions involved health education, nutrition supplementation, home visits, hormone supplementation, and counselling. A significant improvement of frailty status was demonstrated in 71% (n = 10) of studies and of frailty indicators in 69% (n=22) of studies where measured. Interventions with both muscle strength training and protein supplementation were consistently placed highest for effectiveness and ease of implementation. CONCLUSION: A combination of muscle strength training and protein supplementation was the most effective intervention to delay or reverse frailty and the easiest to implement in primary care. A map of interventions was created that can be used to inform choices for managing frailty.15.Hao Q, Tampi M, O'Donnell M, Foroutan F, Siemieniuk RA, Guyatt G. Clopidogrel plus aspirin versus aspirin alone for acute minor ischaemic stroke or high risk transient ischaemic attack: systematic review and meta-analysis. BMJ. 2018;363:k5108. OBJECTIVE: To assess the effectiveness and safety of dual agent antiplatelet therapy combining clopidogrel and aspirin to prevent recurrent thrombotic and bleeding events compared with aspirin alone in patients with acute minor ischaemic stroke or transient ischaemic attack (TIA). DESIGN: Systematic review and meta-analysis of randomised, placebo controlled trials. DATA SOURCES: Medline, Embase, Cochrane Central Register of Controlled Trials, Cochrane Library, , WHO website, PsycINFO, and grey literature up to 4 July 2018. ELIGIBILITY CRITERIA FOR SELECTING STUDIES AND METHODS: Two reviewers independently screened potentially eligible studies according to predefined selection criteria and assessed the risk of bias using a modified version of the Cochrane risk of bias tool. A third team member reviewed all final decisions, and the team resolved disagreements through discussion. When reports omitted data that were considered important, clarification and additional information was sought from the authors. The analysis was conducted in RevMan 5.3 and MAGICapp based on GRADE methodology. RESULTS: Three eligible trials involving 10 447 participants were identified. Compared with aspirin alone, dual antiplatelet therapy with clopidogrel and aspirin that was started within 24 hours of symptom onset reduced the risk of non-fatal recurrent stroke (relative risk 0.70, 95% confidence interval 0.61 to 0.80, I<sup>2</sup>=0%, absolute risk reduction 1.9%, high quality evidence), without apparent impact on all cause mortality (1.27, 0.73 to 2.23, I<sup>2</sup>=0%, moderate quality evidence) but with a likely increase in moderate or severe extracranial bleeding (1.71, 0.92 to 3.20, I<sup>2</sup>=32%, absolute risk increase 0.2%, moderate quality evidence). Most stroke events, and the separation in incidence curves between dual and single therapy arms, occurred within 10 days of randomisation; any benefit after 21 days is extremely unlikely. CONCLUSIONS: Dual antiplatelet therapy with clopidogrel and aspirin given within 24 hours after high risk TIA or minor ischaemic stroke reduces subsequent stroke by about 20 in 1000 population, with a possible increase in moderate to severe bleeding of 2 per 1000 population. Discontinuation of dual antiplatelet therapy within 21 days, and possibly as early as 10 days, of initiation is likely to maximise benefit and minimise harms.16.Dorleijn DMJ, Luijsterburg PAJ, Reijman M, et al. Intramuscular glucocorticoid injection versus placebo injection in hip osteoarthritis: a 12-week blinded randomised controlled trial. Ann Rheum Dis. 2018;77(6):875-882. OBJECTIVES: Guidelines recommend intra-articular glucocorticoid injection in patients with painful hip osteoarthritis. However, intra-articular hip injection is an invasive procedure. The efficacy of systemic glucocorticoid treatment for pain reduction in hip osteoarthritis is unknown. This randomised, double-blind, trial assessed effectiveness in hip pain reduction of an intramuscular glucocorticoid injection compared with a placebo injection in patients with hip osteoarthritis. METHODS: Patients with painful hip osteoarthritis were randomised to either 40 mg triamcinolone acetate or placebo with an intramuscular injection into the gluteus muscle. The primary outcomes were severity of hip pain at rest, during walking (0-10) and WOMAC pain at 2-week postinjection. We used linear mixed models for repeated measurements at 2, 4, 6 and 12 weeks for the intention-to-treat data analysis. RESULTS: Of the 107 patients randomised, 106 could be analysed (52 in the glucocorticoid group, 54 in the placebo group). At 2-week follow-up, compared with placebo injection, the intramuscular glucocorticoid injection showed a significant and clinically relevant difference in hip pain reduction at rest (difference -1.3, 95% CI -2.3 to -0.3). This effect persisted for the entire 12-week follow-up. For hip pain during walking, the effect was present at 4-week, 6-week and 12-week follow-ups, and for WOMAC pain the effect was present at 6-week and 12-week follow-up. CONCLUSIONS: An intramuscular glucocorticoid injection showed effectiveness in patients with hip osteoarthritis on one of the three primary outcomes at 2-week postinjection. All primary outcomes showed effectiveness from 4 to 6 weeks, up to a 12-week follow-up. TRIAL REGISTRATION NUMBER: NTR2966.17.Siemieniuk RAC, Harris IA, Agoritsas T, et al. Arthroscopic surgery for degenerative knee arthritis and meniscal tears: a clinical practice guideline. BMJ. 2017;357:j1982.We make a strong recommendation against the use of arthroscopy in nearly all patients with degenerative knee disease, based on linked systematic reviews; further research is unlikely to alter this recommendationThis recommendation applies to patients with or without imaging evidence of osteoarthritis, mechanical symptoms, or sudden symptom onsetHealthcare administrators and funders may use the number of arthroscopies performed in patients with degenerative knee disease as an indicator of quality care.Knee arthroscopy is the most common orthopaedic procedure in countries with available dataThis Rapid Recommendation package was triggered by a randomised controlled trial published in?The BMJ?in June 2016 which found that, among patients with a degenerative medial meniscus tear, knee arthroscopy was no better than exercise therapy18.Tikkinen KAO, Dahm P, Lytvyn L, et al. Prostate cancer screening with prostate-specific antigen (PSA) test: a clinical practice guideline. BMJ. 2018;362:k3581.PSA testing has increased the number of men diagnosed with and treated for prostate cancer, but many of these men would never have experienced any symptoms or death from prostate cancerThis guideline makes a weak recommendation against offering systematic PSA screening based on an updated systematic review. The recommendation is weak because there may be a small, though uncertain, benefit of screening on prostate cancer mortalityMen who place more value on avoiding complications from biopsies and cancer treatment are likely to decline screening. In contrast, men who put more value in even a small reduction of prostate cancer mortality (such as men at high baseline risk because of family history or African descent, or those concerned to rule out the diagnosis) may opt for screeningShared decision making is needed for men considering screening to make a decision consistent with their individual values and preferences. However, clinicians need not feel obligated to systematically raise the issue of PSA screening with their patients ................
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