RESUMO
AIMS: This study aims to understand factors contributing to nonpublication and publication bias in clinical trials in Canada. METHODS: Qualitative interviews were conducted between March 2019 and April 2021 with 34 participants from the Canadian provinces of Alberta, British Columbia and Ontario, including 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators, 3 research ethics board members and 10 clinical trial participants. We conducted a thematic analysis involving coding of interview transcripts and memo-writing to identify key themes. RESULTS: Several factors contribute to nonpublication and publication bias in clinical trial research. A core theme was that reporting practices are shaped by incentives within the research system taht favour publication of positive over negative trials. Investigators are discouraged from reporting by experiences or perceptions of difficulty in publishing negative findings but rewarded for publishing positive findings in various ways. Trial investigators more strongly associated positive clinical trials than negative trials with opportunities for industry and nonindustry funding and with academic promotion, bonuses and recognition. Research institutions and ethics boards tended to lack well-resourced, proactive policies and practices to ensure trial findings are reported in registries or journals. CONCLUSION: Clinical trial reporting practices in Canada are shaped by incentives favouring reporting of positive over negative trials, such as funding opportunities and academic promotion, bonuses and recognition. Research institutions could help change incentives by adopting performance metrics that emphasize full reporting of results in journals or registries.
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Viés de Publicação , Humanos , Pesquisa Qualitativa , Ontário , Sistema de RegistrosRESUMO
OBJECTIVE: To determine the proportions of patients who receive care from family physicians, specialists, and nurse practitioners for the management of common chronic medical conditions. DESIGN: Population-based retrospective cohort study. SETTING: Province of Alberta. PARTICIPANTS: Adults aged 19 years or older who were registered for provincial health services and each had 2 or more interactions with the same provider between January 1, 2013, and December 31, 2017, for any of 7 specified chronic medical conditions: hypertension, diabetes, chronic obstructive pulmonary disease (COPD), asthma, heart failure, ischemic heart disease, and chronic kidney disease. MAIN OUTCOME MEASURES: Numbers of patients being managed for these conditions and which provider types were involved in their care. RESULTS: Albertans receiving care for the chronic medical conditions being studied (n=970,783) had a mean (SD) age of 56.8 (16.3) years and 49.1% were female. Family physicians were the sole providers of care for 85.7% of patients with a diagnosis of hypertension, 70.9% with diabetes, 59.8% with COPD, and 65.5% with asthma. Specialists were sole providers of care for 49.1% of patients with ischemic heart disease, 42.2% with chronic kidney disease, and 35.6% with heart failure. Nurse practitioners were involved in the care of less than 1% of patients with these conditions. CONCLUSION: Family physicians were involved in the care of most patients with any of 7 chronic medical conditions included in this study and were the sole providers of care for the majority of patients with hypertension, diabetes, COPD, and asthma. Guideline working group representation and the setting of clinical trials should reflect this reality.
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Asma , Insuficiência Cardíaca , Hipertensão , Isquemia Miocárdica , Doença Pulmonar Obstrutiva Crônica , Insuficiência Renal Crônica , Adulto , Humanos , Feminino , Masculino , Alberta/epidemiologia , Estudos Retrospectivos , Doença Crônica , Insuficiência Renal Crônica/epidemiologia , Insuficiência Renal Crônica/terapia , Asma/epidemiologia , Asma/terapia , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Hipertensão/epidemiologia , Hipertensão/terapia , Gerenciamento ClínicoRESUMO
OBJECTIVE: To determine the extent of chronic obstructive pulmonary disease (COPD) hospitalization in easily identifiable high-risk subgroups within a typical primary care practice. DESIGN: Prospective cohort analysis of administrative claims data. SETTING: British Columbia. PARTICIPANTS: British Columbia residents who were 50 years or older on December 31, 2014, and received a physician diagnosis of COPD between 1996 and 2014. MAIN OUTCOME MEASURES: Rate of acute exacerbation of COPD (AECOPD) or pneumonia hospitalization in 2015, broken down by risk identifiers including previous AECOPD admission, 2 or more community respirologist consultations, nursing home residence, or none of these. RESULTS: Of the 242,509 identified COPD patients (12.9% of British Columbia residents ≥50 years), 2.8% were hospitalized for AECOPD in 2015 (0.038 AECOPD hospitalizations per patient-year). The 12.0% with prior AECOPD hospitalization accounted for 57.7% of new AECOPD hospitalizations (0.183 hospitalizations per patient-year); the 7.7% with respirologist involvement accounted for 20.4% (0.102 hospitalizations per patient-year); and the 2.2% in nursing homes accounted for 3.6% (0.061 hospitalizations per patient-year). Those with any of the 3 risk identifiers accounted for only 1.5% more COPD hospitalizations (59.2%) than those with prior AECOPD hospitalization, suggesting prior AECOPD hospitalization is the most important indication of risk. A typical primary care practice held a median of 23 (interquartile range=4 to 65) COPD patients, of whom roughly 20 (86.4%) had none of these risk identifiers. This low-risk majority had only 0.018 AECOPD hospitalizations per patient-year. CONCLUSION: Most AECOPD hospitalizations occur in patients with previous such admissions. When time and resources are limited, COPD initiatives targeting primary care practices should focus more on the 2 to 3 patients with prior AECOPD hospitalization or more symptomatic disease, and less on the low-risk majority.
Assuntos
Hospitalização , Doença Pulmonar Obstrutiva Crônica , Humanos , Estudos Prospectivos , Colúmbia Britânica/epidemiologia , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Doença Pulmonar Obstrutiva Crônica/terapia , Atenção Primária à SaúdeRESUMO
OBJECTIVE: To assess the benefits and harms of lipid-lowering therapies used to prevent or manage cardiovascular disease including bile acid sequestrants (BAS), ezetimibe, fibrates, niacin, omega-3 supplements, proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, and statins. DATA SOURCES: MEDLINE, the Cochrane Database of Systematic Reviews, and a grey literature search. STUDY SELECTION: Systematic reviews of randomized controlled trials published between January 2017 and March 2022 looking at statins, ezetimibe, PCSK9 inhibitors, fibrates, BAS, niacin, and omega-3 supplements for preventing cardiovascular outcomes were selected. Outcomes of interest included major adverse cardiovascular events (MACE), cardiovascular mortality, all-cause mortality, and adverse events. SYNTHESIS: A total of 76 systematic reviews were included. Four randomized controlled trials were also included for BAS because no efficacy systematic review was identified. Statins significantly reduced MACE (6 systematic reviews; median risk ratio [RR]=0.74; interquartile range [IQR]=0.71 to 0.76), cardiovascular mortality (7 systematic reviews; median RR=0.85, IQR=0.83 to 0.86), and all-cause mortality (8 systematic reviews; median RR=0.91, IQR=0.88 to 0.92). Major adverse cardiovascular events were also significantly reduced by ezetimibe (3 systematic reviews; median RR=0.93, IQR=0.93 to 0.94), PCSK9 inhibitors (14 systematic reviews; median RR=0.84, IQR=0.83 to 0.87), and fibrates (2 systematic reviews; mean RR=0.86), but these interventions had no effect on cardiovascular or all-cause mortality. Fibrates had no effect on any cardiovascular outcomes when added to a statin. Omega-3 combination supplements had no effect on MACE or all-cause mortality but significantly reduced cardiovascular mortality (5 systematic reviews; median RR=0.93, IQR=0.93 to 0.94). Eicosapentaenoic acid ethyl ester alone significantly reduced MACE (1 systematic review, RR=0.78) and cardiovascular mortality (2 systematic reviews; RRs of 0.82 and 0.82). In primary cardiovascular prevention, only statins showed consistent benefits on MACE (6 systematic reviews; median RR=0.75, IQR=0.73 to 0.78), cardiovascularall-cause mortality (7 systematic reviews, median RR=0.83, IQR=0.81 to 0.90), and all-cause mortality (8 systematic reviews; median RR=0.91, IQR=0.87 to 0.91). CONCLUSION: Statins have the most consistent evidence for the prevention of cardiovascular complications with a relative risk reduction of about 25% for MACE and 10% to 15% for mortality. The addition of ezetimibe, a PCSK9 inhibitor, or eicosapentaenoic acid ethyl ester to a statin provides additional MACE risk reduction but has no effect on all-cause mortality.
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Anticolesterolemiantes , Doenças Cardiovasculares , Inibidores de Hidroximetilglutaril-CoA Redutases , Niacina , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Pró-Proteína Convertase 9 , Doenças Cardiovasculares/prevenção & controle , Inibidores de PCSK9 , Revisões Sistemáticas como Assunto , Ezetimiba/uso terapêutico , Lipídeos , Ácidos Fíbricos , Atenção Primária à Saúde , Anticolesterolemiantes/efeitos adversosRESUMO
OBJECTIVE: To update the 2015 clinical practice guideline and provide a simplified approach to lipid management in the prevention of cardiovascular disease (CVD) for primary care. METHODS: Following the Institute of Medicine's Clinical Practice Guidelines We Can Trust, a multidisciplinary, pan-Canadian guideline panel was formed. This panel was represented by primary care providers, free from conflicts of interest with industry, and included the patient perspective. A separate scientific evidence team performed evidence reviews on statins, ezetimibe, proprotein convertase subtilisin-kexin type 9 inhibitors, fibrates, bile acid sequestrants, niacin, and omega-3 supplements (docosahexaenoic acid with eicosapentaenoic acid [EPA] or EPA ethyl ester alone [icosapent]), as well as on 11 supplemental questions. Recommendations were finalized by the guideline panel through use of the Grading of Recommendations Assessment, Development and Evaluation methodology. RECOMMENDATIONS: All recommendations are presented in a patient-centred manner designed with the needs of family physicians and other primary care providers in mind. Many recommendations are similar to those published in 2015. Statins remain first-line therapy for both primary and secondary CVD prevention, and the Mediterranean diet and physical activity are recommended to reduce cardiovascular risk (primary and secondary prevention). The guideline panel recommended against using lipoprotein a, apolipoprotein B, or coronary artery calcium levels when assessing cardiovascular risk, and recommended against targeting specific lipid levels. The team also reviewed new evidence pertaining to omega-3 fatty acids (including EPA ethyl ester [icosapent]) and proprotein convertase subtilisin-kexin type 9 inhibitors, and outlined when to engage in informed shared decision making with patients on interventions to lower cardiovascular risk. CONCLUSION: These updated evidence-based guidelines provide a simplified approach to lipid management for the prevention and management of CVD. These guidelines were created by and for primary health care professionals and their patients.
Assuntos
Anticolesterolemiantes , Doenças Cardiovasculares , Inibidores de Hidroximetilglutaril-CoA Redutases , Humanos , Doenças Cardiovasculares/prevenção & controle , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Anticolesterolemiantes/uso terapêutico , Ácido Eicosapentaenoico , Canadá , Pró-Proteína Convertases , Atenção Primária à Saúde , Subtilisinas , Ésteres , Prevenção PrimáriaRESUMO
OBJECTIVE: To develop a clinical practice guideline to support the management of chronic pain, including low back, osteoarthritic, and neuropathic pain in primary care. METHODS: The guideline was developed with an emphasis on best available evidence and shared decision-making principles. Ten health professionals (4 generalist family physicians, 1 pain management-focused family physician, 1 anesthesiologist, 1 physical therapist, 1 pharmacist, 1 nurse practitioner, and 1 psychologist), a patient representative, and a nonvoting pharmacist and guideline methodologist comprised the Guideline Committee. Member selection was based on profession, practice setting, and lack of financial conflicts of interest. The guideline process was iterative in identification of key questions, evidence review, and development of guideline recommendations. Three systematic reviews, including a total of 285 randomized controlled trials, were completed. Randomized controlled trials were included only if they reported a responder analysis (eg, how many patients achieved a 30% or greater reduction in pain). The committee directed an Evidence Team (composed of evidence experts) to address an additional 11 complementary questions. Key recommendations were derived through committee consensus. The guideline and shared decision-making tools underwent extensive review by clinicians and patients before publication. RECOMMENDATIONS: Physical activity is recommended as the foundation for managing osteoarthritis and chronic low back pain; evidence of benefit is unclear for neuropathic pain. Cognitive-behavioural therapy or mindfulness-based stress reduction are also suggested as options for managing chronic pain. Treatments for which there is clear, unclear, or no benefit are outlined for each condition. Treatments for which harms likely outweigh benefits for all or most conditions studied include opioids and cannabinoids. CONCLUSION: This guideline for the management of chronic pain, including osteoarthritis, low back pain, and neuropathic pain, highlights best available evidence including both benefits and harms for a number of treatment interventions. A strong recommendation for exercise as the primary treatment for chronic osteoarthritic and low back pain is made based on demonstrated long-term evidence of benefit. This information is intended to assist with, not dictate, shared decision making with patients.
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Dor Crônica , Dor Lombar , Neuralgia , Dor Crônica/terapia , Guias como Assunto , Humanos , Dor Lombar/terapia , Neuralgia/terapia , Manejo da Dor , Atenção Primária à SaúdeRESUMO
OBJECTIVE: To determine the proportion of patients with neuropathic pain who achieve a clinically meaningful improvement in their pain with the use of different pharmacologic and nonpharmacologic treatments. DATA SOURCES: MEDLINE, EMBASE, the Cochrane Library, and a gray literature search. STUDY SELECTION: Randomized controlled trials that reported a responder analysis of adults with neuropathic pain-specifically diabetic neuropathy, postherpetic neuralgia, or trigeminal neuralgia-treated with any of the following 8 treatments: exercise, acupuncture, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), topical rubefacients, opioids, anticonvulsant medications, and topical lidocaine. SYNTHESIS: A total of 67 randomized controlled trials were included. There was moderate certainty of evidence that anticonvulsant medications (risk ratio of 1.54; 95% CI 1.45 to 1.63; number needed to treat [NNT] of 7) and SNRIs (risk ratio of 1.45; 95% CI 1.33 to 1.59; NNT = 7) might provide a clinically meaningful benefit to patients with neuropathic pain. There was low certainty of evidence for a clinically meaningful benefit for rubefacients (ie, capsaicin; NNT = 7) and opioids (NNT = 8), and very low certainty of evidence for TCAs. Very low-quality evidence demonstrated that acupuncture was ineffective. All drug classes, except TCAs, had a greater likelihood of deriving a clinically meaningful benefit than having withdrawals due to adverse events (number needed to harm between 12 and 15). No trials met the inclusion criteria for exercise or lidocaine, nor were any trials identified for trigeminal neuralgia. CONCLUSION: There is moderate certainty of evidence that anticonvulsant medications and SNRIs provide a clinically meaningful reduction in pain in those with neuropathic pain, with lower certainty of evidence for rubefacients and opioids, and very low certainty of evidence for TCAs. Owing to low-quality evidence for many interventions, future high-quality trials that report responder analyses will be important to strengthen understanding of the relative benefits and harms of treatments in patients with neuropathic pain.
Assuntos
Dor Crônica , Neuralgia Pós-Herpética , Neuralgia , Adulto , Analgésicos , Dor Crônica/tratamento farmacológico , Humanos , Neuralgia/tratamento farmacológico , Neuralgia Pós-Herpética/tratamento farmacológico , Atenção Primária à Saúde , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVE: To determine the proportion of chronic low back pain patients who achieve a clinically meaningful response from different pharmacologic and nonpharmacologic treatments. DATA SOURCES: MEDLINE, EMBASE, Cochrane Library, and gray literature search. STUDY SELECTION: Published randomized controlled trials (RCTs) that reported a responder analysis of adults with chronic low back pain treated with any of the following 15 interventions: oral or topical nonsteroidal anti-inflammatory drugs (NSAIDs), exercise, acupuncture, spinal manipulation therapy, corticosteroid injections, acetaminophen, oral opioids, anticonvulsants, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors, cannabinoids, oral muscle relaxants, or topical rubefacients. SYNTHESIS: A total of 63 RCTs were included. There was moderate certainty that exercise (risk ratio [RR] of 1.71; 95% CI 1.37 to 2.15; number needed to treat [NNT] of 7), oral NSAIDs (RR = 1.44; 95% CI 1.17 to 1.78; NNT = 6), and SNRIs (duloxetine; RR = 1.25; 95% CI 1.13 to 1.38; NNT = 10) provide clinically meaningful benefits to patients with chronic low back pain. Exercise was the only intervention with sustained benefit (up to 48 weeks). There was low certainty that spinal manipulation therapy and topical rubefacients benefit patients. The benefit of acupuncture disappeared in higher-quality, longer (> 4 weeks) trials. Very low-quality evidence demonstrated that corticosteroid injections are ineffective. Patients treated with opioids had a greater likelihood of discontinuing treatment owing to an adverse event (number needed to harm of 5) than continuing treatment to derive any clinically meaningful benefit (NNT = 16), while those treated with SNRIs (duloxetine) had a similar likelihood of continuing treatment to attain benefit (NNT = 10) as those discontinuing the medication owing to an adverse event (number need to harm of 11). One trial each of anticonvulsants and topical NSAIDs found similar benefit to that of placebo. No RCTs of acetaminophen, cannabinoids, muscle relaxants, selective serotonin reuptake inhibitors, or tricyclic antidepressants met the inclusion criteria. CONCLUSION: Exercise, oral NSAIDs, and SNRIs (duloxetine) provide a clinically meaningful reduction in pain, with exercise being the only intervention that demonstrated sustained benefit after the intervention ended. Future high-quality trials that report responder analyses are required to provide a better understanding of the benefits and harms of interventions for patients with chronic low back pain.
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Dor Lombar , Adulto , Anti-Inflamatórios não Esteroides , Humanos , Dor Lombar/tratamento farmacológico , Atenção Primária à Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Inibidores Seletivos de Recaptação de Serotonina/uso terapêuticoRESUMO
PURPOSE: Without supporting evidence, clinicians commonly recommend that warfarin be taken in the evening. We conducted a randomized controlled trial to evaluate the effect of administration time (morning vs evening) on the stability of warfarin's anticoagulant effect. METHODS: A total of 236 primary care physicians serving 54 western Canadian communities mailed letters of invitation to all their warfarin-using patients. Eligible patients were community-dwelling warfarin users (any indication) with at least 3 months of evening warfarin use and no plans for discontinuation. Participants were randomized (by web-based allocation) to morning vs continued evening warfarin ingestion. We used the Rosendaal method to determine the proportion of time within therapeutic range (TTR) of the international normalized ratio (INR) blood test month 2 to 7 postrandomization vs the 6 months prerandomization. The primary outcome was the percent change in proportion of time outside target INR range (with an a priori minimum clinically important difference of ±20%). All analyses were intention to treat. RESULTS: Between March 8, 2015 and September 30, 2016, we randomized 109 participants to morning and 108 to evening warfarin use. TTR rose from 71.8% to 74.7% in the morning group, and from 72.6% to 75.6% in the evening group, for a change in TTR of 2.9% in the former vs 3.0% in the latter (difference, -0.1%; P = .97; 95% CI for the difference, -6.1% to 5.9%). The difference in percent change in proportion of time outside the therapeutic INR range (obtained via Hodges-Lehmann estimation of the difference in medians) was 4.4% (P = .62; 95% CI for the difference, -17.6% to 27.3%). CONCLUSIONS: Administration time has no statistically significant nor clinically important impact on the stability of warfarin's anticoagulant effect. Patients should take warfarin whenever regular compliance would be easiest.
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Anticoagulantes/administração & dosagem , Coagulação Sanguínea/efeitos dos fármacos , Coeficiente Internacional Normatizado , Varfarina/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Esquema de Medicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Atenção Primária à Saúde , Estudos Prospectivos , Método Simples-CegoRESUMO
BACKGROUND: Skeletal muscle cramps are common and often occur in association with pregnancy, advanced age, exercise or motor neuron disorders (such as amyotrophic lateral sclerosis). Typically, such cramps have no obvious underlying pathology, and so are termed idiopathic. Magnesium supplements are marketed for the prophylaxis of cramps but the efficacy of magnesium for this purpose remains unclear. This is an update of a Cochrane Review first published in 2012, and performed to identify and incorporate more recent studies. OBJECTIVES: To assess the effects of magnesium supplementation compared to no treatment, placebo control or other cramp therapies in people with skeletal muscle cramps. SEARCH METHODS: On 9 September 2019, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, CINAHL Plus, AMED, and SPORTDiscus. We also searched WHO-ICTRP and ClinicalTrials.gov for registered trials that might be ongoing or unpublished, and ISI Web of Science for studies citing the studies included in this review. SELECTION CRITERIA: Randomized controlled trials (RCTs) of magnesium supplementation (in any form) to prevent skeletal muscle cramps in any patient group (i.e. all clinical presentations of cramp). We considered comparisons of magnesium with no treatment, placebo control, or other therapy. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion and extracted data. Two review authors assessed risk of bias. We attempted to contact all study authors when questions arose and obtained participant-level data for four of the included trials, one of which was unpublished. We collected all data on adverse effects from the included RCTs. MAIN RESULTS: We identified 11 trials (nine parallel-group, two cross-over) enrolling a total of 735 individuals, amongst whom 118 cross-over participants additionally served as their own controls. Five trials enrolled women with pregnancy-associated leg cramps (408 participants) and five trials enrolled people with idiopathic cramps (271 participants, with 118 additionally crossed over to control). Another study enrolled 29 people with liver cirrhosis, only some of whom suffered muscle cramps. All trials provided magnesium as an oral supplement, except for one trial which provided magnesium as a series of slow intravenous infusions. Nine trials compared magnesium to placebo, one trial compared magnesium to no treatment, calcium carbonate or vitamin B, and another trial compared magnesium to vitamin E or calcium. We judged the single trial in people with liver cirrhosis and all five trials in participants with pregnancy-associated leg cramps to be at high risk of bias. In contrast, we rated the risk of bias high in only one of five trials in participants with idiopathic rest cramps. For idiopathic cramps, largely in older adults (mean age 61.6 to 69.3 years) presumed to have nocturnal leg cramps (the commonest presentation), differences in measures of cramp frequency when comparing magnesium to placebo were small, not statistically significant, and showed minimal heterogeneity (I² = 0% to 12%). This includes the primary endpoint, percentage change from baseline in the number of cramps per week at four weeks (mean difference (MD) -9.59%, 95% confidence interval (CI) -23.14% to 3.97%; 3 studies, 177 participants; moderate-certainty evidence); and the difference in the number of cramps per week at four weeks (MD -0.18 cramps/week, 95% CI -0.84 to 0.49; 5 studies, 307 participants; moderate-certainty evidence). The percentage of individuals experiencing a 25% or better reduction in cramp rate from baseline was also no different (RR 1.04, 95% CI 0.84 to 1.29; 3 studies, 177 participants; high-certainty evidence). Similarly, no statistically significant difference was found at four weeks in measures of cramp intensity or cramp duration. This includes the number of participants rating their cramps as moderate or severe at four weeks (RR 1.33, 95% CI 0.81 to 2.21; 2 studies, 91 participants; moderate-certainty evidence); and the percentage of participants with the majority of cramp durations of one minute or more at four weeks (RR 1.83, 95% CI 0.74 to 4.53, 1 study, 46 participants; low-certainty evidence). We were unable to perform meta-analysis for trials of pregnancy-associated leg cramps. The single study comparing magnesium to no treatment failed to find statistically significant benefit on a three-point ordinal scale of overall treatment efficacy. Of the three trials comparing magnesium to placebo, one found no benefit on frequency or intensity measures, another found benefit for both, and a third reported inconsistent results for frequency that could not be reconciled. The single study in people with liver cirrhosis was small and had limited reporting of cramps, but found no difference in terms of cramp frequency or cramp intensity. Our analysis of adverse events pooled all studies, regardless of the setting in which cramps occurred. Major adverse events (occurring in 2 out of 72 magnesium recipients and 3 out of 68 placebo recipients), and withdrawals due to adverse events, were not significantly different from placebo. However, in the four studies for which it could be determined, more participants experienced minor adverse events in the magnesium group than in the placebo group (RR 1.51, 95% CI 0.98 to 2.33; 4 studies, 254 participants; low-certainty evidence). Overall, oral magnesium was associated with mostly gastrointestinal adverse events (e.g. diarrhoea), experienced by 11% (10% in control) to 37% (14% in control) of participants. AUTHORS' CONCLUSIONS: It is unlikely that magnesium supplementation provides clinically meaningful cramp prophylaxis to older adults experiencing skeletal muscle cramps. In contrast, for those experiencing pregnancy-associated rest cramps the literature is conflicting and further research in this population is needed. We found no RCTs evaluating magnesium for exercise-associated muscle cramps or disease-state-associated muscle cramps (for example amyotrophic lateral sclerosis/motor neuron disease) other than a single small (inconclusive) study in people with liver cirrhosis, only some of whom suffered cramps.
Assuntos
Magnésio/uso terapêutico , Cãibra Muscular/tratamento farmacológico , Músculo Esquelético , Complicações na Gravidez/tratamento farmacológico , Adulto , Fatores Etários , Idoso , Estudos Cross-Over , Feminino , Humanos , Magnésio/efeitos adversos , Masculino , Pessoa de Meia-Idade , Cãibra Muscular/etiologia , Placebos/uso terapêutico , Gravidez , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVE: To determine the effect of mask use on viral respiratory infection risk. DATA SOURCES: MEDLINE and the Cochrane Library. STUDY SELECTION: Randomized controlled trials (RCTs) included in at least 1 published systematic review comparing the use of masks with a control group, either in community or health care settings, on the risk of viral respiratory infections. SYNTHESIS: In total, 11 systematic reviews were included and 18 RCTs of 26 444 participants were found, 12 in the community and 6 in health care workers. Included studies had limitations and were deemed at high risk of bias. Overall, the use of masks in the community did not reduce the risk of influenza, confirmed viral respiratory infection, influenzalike illness, or any clinical respiratory infection. However, in the 2 trials that most closely aligned with mask use in real-life community settings, there was a significant risk reduction in influenzalike illness (risk ratio [RR] = 0.83; 95% CI 0.69 to 0.99). The use of masks in households with a sick contact was not associated with a significant infection risk reduction in any analysis, no matter if masks were used by the sick individual, the healthy family members, or both. In health care workers, surgical masks were superior to cloth masks for preventing influenzalike illness (RR = 0.12; 95% CI 0.02 to 0.98), and N95 masks were likely superior to surgical masks for preventing influenzalike illness (RR = 0.78; 95% CI 0.61 to 1.00) and any clinical respiratory infections (RR = 0.95; 95% CI 0.90 to 1.00). CONCLUSION: This systematic review found limited evidence that the use of masks might reduce the risk of viral respiratory infections. In the community setting, a possible reduced risk of influenzalike illness was found among mask users. In health care workers, the results show no difference between N95 masks and surgical masks on the risk of confirmed influenza or other confirmed viral respiratory infections, although possible benefits from N95 masks were found for preventing influenzalike illness or other clinical respiratory infections. Surgical masks might be superior to cloth masks but data are limited to 1 trial.
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Influenza Humana/prevenção & controle , Dispositivos de Proteção Respiratória , Infecções Respiratórias/prevenção & controle , Pessoal de Saúde , Humanos , Controle de Infecções , Equipamento de Proteção IndividualRESUMO
OBJECTIVE: To determine how many patients with chronic osteoarthritis pain respond to various non-surgical treatments. DATA SOURCES: PubMed and the Cochrane Library. STUDY SELECTION: Published systematic reviews of randomized controlled trials (RCTs) that included meta-analysis of responder outcomes for at least 1 of the following interventions were included: acetaminophen, oral nonsteroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, cannabinoids, counseling, exercise, platelet-rich plasma, viscosupplementation, glucosamine, chondroitin, intra-articular corticosteroids, rubefacients, or opioids. SYNTHESIS: In total, 235 systematic reviews were included. Owing to limited reporting of responder meta-analyses, a post hoc decision was made to evaluate individual RCTs with responder analysis within the included systematic reviews. New meta-analyses were performed where possible. A total of 155 RCTs were included. Interventions that led to more patients attaining meaningful pain relief compared with control included exercise (risk ratio [RR] of 2.36; 95% CI 1.79 to 3.12), intra-articular corticosteroids (RR = 1.74; 95% CI 1.15 to 2.62), SNRIs (RR = 1.53; 95% CI 1.25 to 1.87), oral NSAIDs (RR = 1.44; 95% CI 1.36 to 1.52), glucosamine (RR = 1.33; 95% CI 1.02 to 1.74), topical NSAIDs (RR = 1.27; 95% CI 1.16 to 1.38), chondroitin (RR = 1.26; 95% CI 1.13 to 1.41), viscosupplementation (RR = 1.22; 95% CI 1.12 to 1.33), and opioids (RR = 1.16; 95% CI 1.02 to 1.32). Preplanned subgroup analysis demonstrated no effect with glucosamine, chondroitin, or viscosupplementation in studies that were only publicly funded. When trials longer than 4 weeks were analyzed, the benefits of opioids were not statistically significant. CONCLUSION: Interventions that provide meaningful relief for chronic osteoarthritis pain might include exercise, intra-articular corticosteroids, SNRIs, oral and topical NSAIDs, glucosamine, chondroitin, viscosupplementation, and opioids. However, funding of studies and length of treatment are important considerations in interpreting these data.
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Gerenciamento Clínico , Osteoartrite/diagnóstico , Osteoartrite/terapia , Atenção Primária à Saúde/métodos , Dor Crônica/etiologia , Nível de Saúde , Humanos , Osteoartrite/complicações , Manejo da Dor/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisões Sistemáticas como AssuntoRESUMO
OBJECTIVE: To summarize high-quality studies for 10 topics from 2018 that have strong relevance to primary care practice. QUALITY OF EVIDENCE: Study selection involved routine literature surveillance by a group of primary care health professionals. This included screening abstracts of important journals and Evidence Alerts, as well as searching ACP Journal Club. MAIN MESSAGE: Topics of the 2018 articles include whether low-dose acetylsalicylic acid improves health outcomes like cardiovascular disease (CVD); whether a low-carbohydrate diet is better than a low-fat diet for weight loss (and whether genetics matter); whether vaginal estradiol is superior to placebo for vulvovaginal symptoms of menopause; whether opioid management is better than nonopioid management for chronic back or osteoarthritis pain; whether additional water intake will decrease recurrent urinary tract infections; whether omega-3 fatty acids prevent CVD or reduce dry eyes; whether the new drug icosapent improves CVD; whether bath additives help eczema; whether acetaminophen can prevent recurrent febrile seizures; and recommendations for glycemic targets in diabetes based on reviews of evidence and other guidelines. Five "runner-up" studies are also briefly reviewed. CONCLUSION: Research from 2018 produced several high-quality studies in CVD but also spanned the breadth of primary care including pediatrics, women's health, and pain management, among other areas.
Assuntos
Atenção Primária à Saúde/métodos , Doenças Cardiovasculares/terapia , Humanos , Manejo da Dor/métodos , Pediatria/métodos , Saúde da MulherRESUMO
OBJECTIVE: To determine the stability of warfarin anticoagulation using a nationally representative sample of Canadian primary care patients and providers. DESIGN: Prospective cohort study. SETTING: Primary care practices associated with the Canadian Primary Care Sentinel Surveillance Network. PARTICIPANTS: Adult warfarin users with 7 or more evaluable international normalized ratio (INR) readings. MAIN OUTCOMES MEASURES: International normalized ratio time in therapeutic range (TTR) determined using the Rosendaal method; TTR above 75% was considered good INR control and TTR below 60% was considered poor INR control. The primary outcome was the proportion of all warfarin users (using an INR target range of 2.0 to 3.5) with good INR control during their first year taking warfarin who have poor INR control the following year. Secondary outcomes included the TTR using an INR target of 2.0 to 3.0 when restricted to patients with known atrial fibrillation (AF) or venous thromboembolism (VTE); and the proportion of INR values below the target of 2.0 and above the targets of 3.0 and 3.5 in the year before the availability of other oral anticoagulants. RESULTS: Among 18 303 adult warfarin users (mean age of 71.0 years, 46.6% female), the median TTR (INR target range of 2.0 to 3.5) was 77.4% (interquartile range of 64.6% to 86.4%). The TTR was above 75% in 56.0% of patients and below 60% in 19.3% of patients. Of those exhibiting good INR control in year 1 of anticoagulation therapy, only 10.2% had poor control the following year. When restricted to patients with known AF or VTE (89.7% with AF and 13.5% with VTE), and assuming an INR target range of 2.0 to 3.0, the TTR was 67.8% (interquartile range of 54.8% to 77.9%). Of these patients, 27.9% had INR values below 2.0, and 19.4% and 8.6% had values above 3.0 and 3.5, respectively. CONCLUSION: Primary care warfarin management produces a TTR comparable to that in randomized trials, with out-of-range INR values 3 times more likely to predispose to thrombosis (INR of < 2.0) than to hemorrhage (INR of > 3.5). A history of good INR control does predict future INR stability and meaningfully informs decisions to switch established warfarin users onto newer agents.
Assuntos
Anticoagulantes/administração & dosagem , Hemorragia/prevenção & controle , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Varfarina/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/complicações , Canadá , Feminino , Hemorragia/etiologia , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Prevalência , Atenção Primária à Saúde , Estudos Prospectivos , Tromboembolia Venosa/complicaçõesRESUMO
OBJECTIVE: To use the best available evidence and principles of shared, informed decision making to develop a clinical practice guideline for a simplified approach to managing opioid use disorder (OUD) in primary care. METHODS: Eleven health care and allied health professionals representing various practice settings, professions, and locations created a list of key questions relevant to the management of OUD in primary care. These questions related to the treatment setting, diagnosis, treatment, and management of comorbidities in OUD. The questions were researched by a team with expertise in evidence evaluation using a series of systematic reviews of randomized controlled trials. The Guideline Committee used the systematic reviews to create recommendations. RECOMMENDATIONS: Recommendations outline the role of primary care in treating patients with OUD, as well as pharmacologic and psychotherapy treatments and various prescribing practices (eg, urine drug testing and contracts). Specific recommendations could not be made for management of comorbidities in patients with OUD owing to limited evidence. CONCLUSION: The recommendations will help simplify the complex management of patients with OUD in primary care. They will aid clinicians and patients in making informed decisions regarding their care.
Assuntos
Tratamento de Substituição de Opiáceos/normas , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Atenção Primária à Saúde/normas , Tomada de Decisões , Gerenciamento Clínico , HumanosRESUMO
OBJECTIVE: To summarize the best available evidence regarding various topics related to primary care management of opioid use disorder (OUD). DATA SOURCES: MEDLINE, Cochrane Library, Google, and the references of included studies and relevant guidelines. STUDY SELECTION: Published systematic reviews and newer randomized controlled trials from the past 5 to 10 years that investigated patient-oriented outcomes related to managing OUD in primary care, diagnosis, pharmacotherapies (including buprenorphine, methadone, and naltrexone), tapering strategies, psychosocial interventions, prescribing practices, and management of comorbidities. SYNTHESIS: From 8626 articles, 39 systematic reviews and an additional 26 randomized controlled trials were included. New meta-analyses were performed where possible. One cohort study suggests 1 case-finding tool might be reasonable to assist with diagnosis (positive likelihood ratio of 10.3). Meta-analysis demonstrated that retention in treatment improves when buprenorphine or methadone are used (64% to 73% vs 22% to 39% for control), when OUD is treated in primary care (86% vs 67% in specialty care, risk ratio [RR] of 1.25, 95% CI 1.07 to 1.47), and when counseling is added to pharmacotherapy (74% vs 62% for controls, RR = 1.20, 95% CI 1.06 to 1.36). Retention was also improved with naltrexone (33% vs 25% for controls, RR = 1.35, 95% CI 1.11 to 1.64) and reduced with medication-related contingency management (eg, loss of take-home doses as a punitive measure; 68% vs 77% for no contingency, RR = 0.86, 95% CI 0.76 to 0.99). CONCLUSION: There is reasonable evidence that patients with OUD should be managed in the primary care setting. Diagnostic criteria for OUD remain elusive, with 1 reasonable case-finding tool. Methadone and buprenorphine improve treatment retention, while medication-related contingency methods could worsen retention. Counseling is beneficial when added to pharmacotherapy.
Assuntos
Antagonistas de Entorpecentes/uso terapêutico , Tratamento de Substituição de Opiáceos/métodos , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Atenção Primária à Saúde/métodos , Analgésicos Opioides/efeitos adversos , Buprenorfina/uso terapêutico , Aconselhamento , Humanos , Metadona/uso terapêutico , Naltrexona/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisões Sistemáticas como AssuntoRESUMO
OBJECTIVE: To identify the most commonly presenting conditions in primary care globally, and to compare common reasons for visits (RFVs) as reported by clinicians and patients, as well as among countries of different economic classifications. DATA SOURCES: Twelve scientific databases were searched up to January 2016, and a dual independent review was performed to select primary care studies. STUDY SELECTION: Studies were included if they contained 20 000 visits or more (or equivalent volume by patient-clinician interactions) and listed 10 or more RFVs. Dual independent data extraction of study characteristics and RFV rankings was performed. Data analysis was descriptive, with pooled rankings of RFVs across studies. SYNTHESIS: Eighteen studies met inclusion criteria (median 250 000 patients or 83 161 visits). Data were from 12 countries across 5 continents. The 10 most common clinician-reported RFVs were upper respiratory tract infection, hypertension, routine health maintenance, arthritis, diabetes, depression or anxiety, pneumonia, acute otitis media, back pain, and dermatitis. The 10 most common patient-reported RFVs were symptomatic conditions including cough, back pain, abdominal symptoms, pharyngitis, dermatitis, fever, headache, leg symptoms, unspecified respiratory concerns, and fatigue. Globally, upper respiratory tract infection and hypertension were the most common clinician-reported RFVs. In developed countries the next most common RFVs were depression or anxiety and back pain, and in developing countries they were pneumonia and tuberculosis. There was a paucity of available data, particularly from developing countries. CONCLUSION: There are differences between clinician-reported and patient-reported RFVs to primary care, as well as between developed and developing countries. The results of our review are useful for the development of primary care guidelines, the allocation of resources, and the design of training programs and curricula.
Assuntos
Países Desenvolvidos , Países em Desenvolvimento , Atenção Primária à Saúde/estatística & dados numéricos , Abdome/fisiopatologia , Dor nas Costas/epidemiologia , Tosse/epidemiologia , Humanos , Hipertensão/epidemiologia , Infecções Respiratórias/epidemiologiaRESUMO
OBJECTIF: Actualiser le guide de pratique clinique de 2015 et présenter une approche simplifiée de la prise en charge des lipides dans la prévention des maladies cardiovasculaires (MCV) en première ligne. MÉTHODES: Conformément aux recommandations de l'Institute of Medicine dans Clinical Practice Guidelines We Can Trust, un panel pancanadien d'experts multidisciplinaires en lignes directrices a été formé. Ce panel était représentatif des cliniciens en soins primaires, libre de tout conflit d'intérêts avec l'industrie, et il tenait compte des points de vue des patients. Une équipe distincte, responsable des données probantes scientifiques, a passé en revue l'information sur les statines, l'ézétimibe, les inhibiteurs de la proprotéine convertase subtilisine-kexine de type 9, les fibrates, les chélateurs des acides biliaires, la niacine et les suppléments d'omega-3 (acide docosahexaénoïque avec acide eicosapentaénoïque [EPA] ou ester éthylique de l'EPA seul [icosapent]), ainsi que sur la réponse à 11 questions supplémentaires. Le panel des lignes directrices a finalisé les recommandations en utilisant la méthodologie GRADE (Grading of Recommendations Assessment, Development and Evaluation). RECOMMANDATIONS: Toutes les recommandations sont présentées de manière à être centrées sur le patient et conçues en ayant à l'esprit les besoins des médecins de famille et des autres cliniciens des soins primaires. De nombreuses recommandations sont semblables à celles publiées en 2015. Les statines demeurent le traitement de première intention pour la prévention tant primaire que secondaire des MCV, et le régime méditerranéen et l'activité physique sont recommandés pour réduire le risque cardiovasculaire (en prévention primaire et secondaire). Le panel des lignes directrices a recommandé de ne pas utiliser le dosage des lipoprotéines a, des apolipoprotéines B ou le score calcique coronarien (SCC) dans l'évaluation du risque cardiovasculaire, et de ne pas cibler de seuils précis de taux lipidiques. L'équipe a aussi passé en revue de nouvelles données concernant les acides gras omega-3 (y compris l'ester éthylique d'EAP [icosapent]) et les inhibiteurs de la proprotéine convertase subtilisine-kexine de type 9, et a précisé les moments où il convient de procéder à une prise de décision partagée avec les patients sur les interventions pour diminuer le risque cardiovasculaire. CONCLUSION: Ces lignes directrices actualisées et fondées sur des données probantes présentent une approche simplifiée de la prise en charge des lipides pour la prévention et le traitement des MCV. Ce guide de pratique clinique a été conçu par et pour des professionnels de la santé en soins primaires et leurs patients.