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1.
Pain Med ; 2021 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-34480571

RESUMO

INTRODUCTION: There is a common belief that patients presenting to emergency departments have more severe pain levels and functional limitations than those in general practice. The aim of this systematic review was to compare pain and disability levels of patients with acute low back pain presenting to general practice versus those presenting to emergency departments. METHODS: Electronic searches were conducted in MEDLINE, EMBASE and CINAHL from inception to February 2019. Observational studies including patients with acute non-specific low back pain presenting to emergency departments and/or general practice were eligible. Pain and/or disability scores expressed on a 0-100 scale were the primary outcomes. Risk of bias was evaluated using a validated tool for observational studies and the overall quality of evidence was assessed using GRADE. Meta-analysis using random effects and meta-regression were used to test for differences between the two settings. RESULTS: We included 12 records reporting results for 10 unique studies with a total of 6,999 participants from general practice (n = 6) and emergency departments (n = 4). There was low quality evidence (downgraded for indirectness and inconsistency) that patients presenting to emergency departments had higher pain scores than those in general practice with a mean difference of 17.3 points (95%CI: 8.8 to 25.9 on a 0-100 scale). Similarly, there was low quality evidence (downgraded for indirectness and inconsistency) that patients presenting to emergency departments had higher disability scores than those in general practice (mean difference: 21.7, 95%CI: 4.6 to 38.7 on a 0-100 scale). CONCLUSION: Patients with acute non-specific low back pain presenting to emergency departments may report higher levels of pain and disability than those seen in general practice. PROSPERO REGISTRATION NUMBER: CRD42017076806.

2.
BMJ ; 374: n1034, 2021 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-34497047

RESUMO

OBJECTIVE: To determine the benefits and harms of medical cannabis and cannabinoids for chronic pain. DESIGN: Systematic review and meta-analysis. DATA SOURCES: MEDLINE, EMBASE, AMED, PsycInfo, CENTRAL, CINAHL, PubMed, Web of Science, Cannabis-Med, Epistemonikos, and trial registries up to January 2021. STUDY SELECTION: Randomised clinical trials of medical cannabis or cannabinoids versus any non-cannabis control for chronic pain at ≥1 month follow-up. DATA EXTRACTION AND SYNTHESIS: Paired reviewers independently assessed risk of bias and extracted data. We performed random-effects models meta-analyses and used GRADE to assess the certainty of evidence. RESULTS: A total of 32 trials with 5174 adult patients were included, 29 of which compared medical cannabis or cannabinoids with placebo. Medical cannabis was administered orally (n=30) or topically (n=2). Clinical populations included chronic non-cancer pain (n=28) and cancer related pain (n=4). Length of follow-up ranged from 1 to 5.5 months. Compared with placebo, non-inhaled medical cannabis probably results in a small increase in the proportion of patients experiencing at least the minimally important difference (MID) of 1 cm (on a 10 cm visual analogue scale (VAS)) in pain relief (modelled risk difference (RD) of 10% (95% confidence interval 5% to 15%), based on a weighted mean difference (WMD) of -0.50 cm (95% CI -0.75 to -0.25 cm, moderate certainty)). Medical cannabis taken orally results in a very small improvement in physical functioning (4% modelled RD (0.1% to 8%) for achieving at least the MID of 10 points on the 100-point SF-36 physical functioning scale, WMD of 1.67 points (0.03 to 3.31, high certainty)), and a small improvement in sleep quality (6% modelled RD (2% to 9%) for achieving at least the MID of 1 cm on a 10 cm VAS, WMD of -0.35 cm (-0.55 to -0.14 cm, high certainty)). Medical cannabis taken orally does not improve emotional, role, or social functioning (high certainty). Moderate certainty evidence shows that medical cannabis taken orally probably results in a small increased risk of transient cognitive impairment (RD 2% (0.1% to 6%)), vomiting (RD 3% (0.4% to 6%)), drowsiness (RD 5% (2% to 8%)), impaired attention (RD 3% (1% to 8%)), and nausea (RD 5% (2% to 8%)), but not diarrhoea; while high certainty evidence shows greater increased risk of dizziness (RD 9% (5% to 14%)) for trials with <3 months follow-up versus RD 28% (18% to 43%) for trials with ≥3 months follow-up; interaction test P=0.003; moderate credibility of subgroup effect). CONCLUSIONS: Moderate to high certainty evidence shows that non-inhaled medical cannabis or cannabinoids results in a small to very small improvement in pain relief, physical functioning, and sleep quality among patients with chronic pain, along with several transient adverse side effects, compared with placebo. The accompanying BMJ Rapid Recommendation provides contextualised guidance based on this body of evidence. SYSTEMATIC REVIEW REGISTRATION: https://osf.io/3pwn2.


Assuntos
Dor do Câncer/tratamento farmacológico , Canabinoides/efeitos adversos , Dor Crônica/tratamento farmacológico , Maconha Medicinal/administração & dosagem , Adulto , Canabinoides/administração & dosagem , Feminino , Humanos , Masculino , Maconha Medicinal/efeitos adversos , Diferença Mínima Clinicamente Importante , Medição da Dor , Ensaios Clínicos Controlados Aleatórios como Assunto , Sono/efeitos dos fármacos
3.
BMJ ; 374: n2040, 2021 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-34497062

RESUMO

CLINICAL QUESTION: What is the role of medical cannabis or cannabinoids for people living with chronic pain due to cancer or non-cancer causes? CURRENT PRACTICE: Chronic pain is common and distressing and associated with considerable socioeconomic burden globally. Medical cannabis is increasingly used to manage chronic pain, particularly in jurisdictions that have enacted policies to reduce use of opioids; however, existing guideline recommendations are inconsistent, and cannabis remains illegal for therapeutic use in many countries. RECOMMENDATION: The guideline expert panel issued a weak recommendation to offer a trial of non-inhaled medical cannabis or cannabinoids, in addition to standard care and management (if not sufficient), for people living with chronic cancer or non-cancer pain. HOW THIS GUIDELINE WAS CREATED: An international guideline development panel including patients, clinicians with content expertise, and methodologists produced this recommendation in adherence with standards for trustworthy guidelines using the GRADE approach. The MAGIC Evidence Ecosystem Foundation (MAGIC) provided methodological support. The panel applied an individual patient perspective. THE EVIDENCE: This recommendation is informed by a linked series of four systematic reviews summarising the current body of evidence for benefits and harms, as well as patient values and preferences, regarding medical cannabis or cannabinoids for chronic pain. UNDERSTANDING THE RECOMMENDATION: The recommendation is weak because of the close balance between benefits and harms of medical cannabis for chronic pain. It reflects a high value placed on small to very small improvements in self reported pain intensity, physical functioning, and sleep quality, and willingness to accept a small to modest risk of mostly self limited and transient harms. Shared decision making is required to ensure patients make choices that reflect their values and personal context. Further research is warranted and may alter this recommendation.


Assuntos
Canabinoides/administração & dosagem , Dor Crônica/tratamento farmacológico , Maconha Medicinal/administração & dosagem , Adolescente , Adulto , Canabinoides/efeitos adversos , Criança , Humanos , Maconha Medicinal/efeitos adversos , Adulto Jovem
4.
BMJ Open ; 11(9): e049938, 2021 Sep 13.
Artigo em Inglês | MEDLINE | ID: mdl-34518265

RESUMO

OBJECTIVES: To investigate (1) self-reported societal comprehension of common and usually non-serious terms found in lumbar spine imaging reports and (2) its relationship to perceived seriousness, likely persistence of low back pain (LBP), fear of movement, back beliefs and history and intensity of LBP. DESIGN: Cross-sectional online survey of the general public. SETTING: Five English-speaking countries: UK, USA, Canada, New Zealand and Australia. PARTICIPANTS: Adults (age >18 years) with or without a history of LBP recruited in April 2019 with quotas for country, age and gender. PRIMARY AND SECONDARY OUTCOME MEASURES: Self-reported understanding of 14 terms (annular fissure, disc bulge, disc degeneration, disc extrusion, disc height loss, disc protrusion, disc signal loss, facet joint degeneration, high intensity zone, mild canal stenosis, Modic changes, nerve root contact, spondylolisthesis and spondylosis) commonly found in lumbar spine imaging reports. For each term, we also elicited worry about its seriousness, and whether its presence would indicate pain persistence and prompt fear of movement. RESULTS: From 774 responses, we included 677 (87.5%) with complete and valid responses. 577 (85%) participants had a current or past history of LBP of whom 251 (44%) had received lumbar spine imaging. Self-reported understanding of all terms was poor. At best, 235 (35%) reported understanding the term 'disc degeneration', while only 71 (10.5%) reported understanding the term 'Modic changes'. For all terms, a moderate to large proportion of participants (range 59%-71%), considered they indicated a serious back problem, that pain might persist (range 52%-71%) and they would be fearful of movement (range 42%-57%). CONCLUSION: Common and usually non-serious terms in lumbar spine imaging reports are poorly understood by the general population and may contribute to the burden of LBP. TRIAL REGISTRATION NUMBER: ACTRN12619000545167.

5.
Cochrane Database Syst Rev ; 9: CD010951, 2021 09 30.
Artigo em Inglês | MEDLINE | ID: mdl-34590307

RESUMO

BACKGROUND: Autologous whole blood or platelet-rich plasma (PRP) injections are commonly used to treat lateral elbow pain (also known as tennis elbow or lateral epicondylitis or epicondylalgia). Based on animal models and observational studies, these injections may modulate tendon injury healing, but randomised controlled trials have reported inconsistent results regarding benefit for people with lateral elbow pain. OBJECTIVES: To review current evidence on the benefit and safety of autologous whole blood or platelet-rich plasma (PRP) injection for treatment of people with lateral elbow pain. SEARCH METHODS: We searched CENTRAL, MEDLINE, and Embase for published trials, and Clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal for ongoing trials, on 18 September 2020. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) and quasi-RCTs comparing autologous whole blood or PRP injection therapy to another therapy (placebo or active treatment, including non-pharmacological therapies, and comparison between PRP and autologous blood) for lateral elbow pain. The primary comparison was PRP versus placebo. Major outcomes were pain relief (≥ 30% or ≥ 50%), mean pain, mean function, treatment success, quality of life, withdrawal due to adverse events, and adverse events; the primary time point was three months. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 32 studies with 2337 participants; 56% of participants were female, mean age varied between 36 and 53 years, and mean duration of symptoms ranged from 1 to 22 months. Seven trials had three intervention arms. Ten trials compared autologous blood or PRP injection to placebo injection (primary comparison). Fifteen trials compared autologous blood or PRP injection to glucocorticoid injection. Four studies compared autologous blood to PRP. Two trials compared autologous blood or PRP injection plus tennis elbow strap and exercise versus tennis elbow strap and exercise alone. Two trials compared PRP injection to surgery, and one trial compared PRP injection and dry needling to dry needling alone. Other comparisons include autologous blood versus extracorporeal shock wave therapy; PRP versus arthroscopic surgery; PRP versus laser; and autologous blood versus polidocanol. Most studies were at risk of selection, performance, and detection biases, mainly due to inadequate allocation concealment and lack of participant blinding. We found moderate-certainty evidence (downgraded for bias) to show that autologous blood or PRP injection probably does not provide clinically significant improvement in pain or function compared with placebo injection at three months. Further, low-certainty evidence (downgraded for bias and imprecision) suggests that PRP may not increase risk for adverse events. We are uncertain whether autologous blood or PRP injection improves treatment success (downgraded for bias, imprecision, and indirectness) or withdrawals due to adverse events (downgraded for bias and twice for imprecision). No studies measured health-related quality of life, and no studies reported pain relief (> 30% or 50%) at three months. At three months, mean pain was 3.7 points (0 to 10; 0 is best) with placebo and 0.16 points better (95% confidence interval (CI) 0.60 better to 0.29 worse; 8 studies, 523 participants) with autologous blood or PRP injection, for absolute improvement of 1.6% better (6% better to 3% worse). At three months, mean function was 27.5 points (0 to 100; 0 is best) with placebo and 1.86 points better (95% CI 4.9 better to 1.25 worse; 8 studies, 502 participants) with autologous blood or PRP injection, for absolute benefit of 1.9% (5% better to 1% worse), and treatment success was 121 out of 185 (65%) with placebo versus 125 out of 187 (67%) with autologous blood or PRP injection (risk ratio (RR) 1.00; 95% CI 0.83 to 1.19; 4 studies, 372 participants), for absolute improvement of 0% (11.1% lower to 12.4% higher). Regarding harm, we found very low-certainty evidence to suggest that we are uncertain whether withdrawal rates due to adverse events differed. Low-certainty evidence suggests that autologous blood or PRP injection may not increase adverse events compared with placebo injection. Withdrawal due to adverse events occurred in 3 out of 39 (8%) participants treated with placebo versus 1 out of 41 (2%) treated with autologous blood or PRP injection (RR 0.32, 95% CI 0.03 to 2.92; 1 study), for an absolute difference of 5.2% fewer (7.5% fewer to 14.8% more). Adverse event rates were 35 out of 208 (17%) with placebo versus 41 out of 217 (19%) with autologous blood or PRP injection (RR 1.14, 95% CI 0.76 to 1.72; 5 studies; 425 participants), for an absolute difference of 2.4% more (4% fewer to 12% more). At six and twelve months, no clinically important benefit for mean pain or function was observed with autologous blood or PRP injection compared with placebo injection. AUTHORS' CONCLUSIONS: Data in this review do not support the use of autologous blood or PRP injection for treatment of lateral elbow pain. These injections probably provide little or no clinically important benefit for pain or function (moderate-certainty evidence), and it is uncertain (very low-certainty evidence) whether they improve treatment success and pain relief > 50%, or increase withdrawal due to adverse events. Although risk for harm may not be increased compared with placebo injection (low-certainty evidence), injection therapies cause pain and carry a small risk of infection. With no evidence of benefit, the costs and risks are not justified.

6.
Health Technol Assess ; 25(53): 1-52, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34505829

RESUMO

BACKGROUND: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. OBJECTIVES: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. DESIGN: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. SETTING: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. RESULTS: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. CONCLUSIONS: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. LIMITATIONS: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. FUTURE WORK: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. FUNDING: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research programme.

7.
BMJ Open ; 11(9): e055528, 2021 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-34561264

RESUMO

INTRODUCTION: General practice is integral to the Australian healthcare system. Outcome Health's POpulation Level Analysis and Reporting (POLAR) database uses de-identified electronic health records to analyse general practice data in Australia. Previous studies using routinely collected health data for research have not consistently reported the codes and algorithms used to describe the population, exposures, interventions and outcomes in sufficient detail to allow replication. This paper reports a study protocol investigating patterns of care for people presenting with musculoskeletal conditions to general practice in Victoria, Australia. Its focus is on the systematic approach used to classify and select eligible records from the POLAR database to facilitate replication. This will be useful for other researchers using routinely collected health data for research. METHODS AND ANALYSIS: This is a retrospective cohort study. Patient-related data will be obtained through electronic health records from a subset of general practices across three primary health networks (PHN) in southeastern Victoria. Data for patients with a low back, neck, shoulder and/or knee condition and who received at least one general practitioner (GP) face-to-face consultation between 1 January 2014 and 31 December 2018 will be included. Data quality checks will be conducted to exclude patients with poor data recording and/or non-continuous follow-up. Relational data files with eligible and valid records will be merged to select the study cohort and the GP care received (consultations, imaging requests, prescriptions and referrals) between diagnosis and 31 December 2018. Number and characteristics of patients and GPs, and number, type and timing of imaging requests, prescriptions for pain relief and referrals to other health providers will be investigated. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Cabrini and Monash University Human Research Ethics Committees (Reference Numbers 02-21-01-19 and 16975, respectively). Study findings will be reported to Outcome Health, participating PHNs, disseminated in academic journals and presented in conferences.

8.
Trials ; 22(1): 564, 2021 Aug 24.
Artigo em Inglês | MEDLINE | ID: mdl-34429127

RESUMO

BACKGROUND: This a priori statistical analysis plan describes the analysis for CRISTAL. METHODS: CRISTAL (cluster-randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study) aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic venous thromboembolism (VTE) following hip arthroplasty (HA) or knee arthroplasty (KA). The study is nested within the Australian Orthopaedic Association National Joint Replacement Registry. The trial was commenced in April 2019 and after an unplanned interim analysis, recruitment was stopped (December 2020), as the stopping rule was met for the primary outcome. The clusters comprised hospitals performing > 250 HA and/or KA procedures per annum, whereby all adults (> 18 years) undergoing HA or KA were recruited. Each hospital was randomised to commence with aspirin, orally, 85-150 mg daily or LMWH (enoxaparin), 40 mg, subcutaneously, daily within 24 h postoperatively, for 35 days after HA and 14 days after KA. Crossover was planned once the registration target was met for the first arm. The primary end point is symptomatic VTE within 90 days. Secondary outcomes include readmission, reoperation, major bleeding and death within 90 days, and reoperation and patient-reported pain, function and health status at 6 months. The main analyses will focus on the primary and secondary outcomes for patients undergoing elective primary total HA and KA for osteoarthritis. The analysis will use an intention-to-treat approach with cluster summary methods to compare treatment arms. As the trial stopped early, analyses will account for incomplete cluster crossover and unequal cluster sizes. CONCLUSIONS: This paper provides a detailed statistical analysis plan for CRISTAL. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12618001879257 . Registered on 19/11/2018.


Assuntos
Artroplastia do Joelho , Tromboembolia Venosa , Adulto , Artroplastia do Joelho/efeitos adversos , Aspirina/efeitos adversos , Austrália , Heparina de Baixo Peso Molecular/efeitos adversos , Humanos , Sistema de Registros , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle
9.
Pain ; 2021 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-34382608

RESUMO

ABSTRACT: The number of placebo surgical trials on musculoskeletal conditions is increasing, but little is known about the quality of their design and methods. This review aimed to (1) assess the level of placebo fidelity (ie, degree to which the placebo control mimicked the index procedure) in placebo trials of musculoskeletal surgery, (2) describe the trials' methodological features using the adapted Applying Surgical Placebo in Randomised Evaluations (ASPIRE) checklist, and (3) describe each trial's characteristics. We searched 4 electronic databases from inception until February 18, 2021, for randomised trials of surgery that included a placebo control for any musculoskeletal condition. Protocols and full text were used to assess placebo fidelity (categorised as minimal, low, or high fidelity). The adapted 26-item ASPIRE checklist was also completed on each trial. PROSPERO registration number: CRD42021202131. A total of 30,697 studies were identified in the search, and 22 placebo-controlled surgical trials of 2045 patients included. Thirteen trials (59%) included a high-fidelity placebo control, 7 (32%) used low fidelity, and 2 (9%) minimal fidelity. According to the ASPIRE checklist, included trials had good reporting of the "rationale and ethics" (68% overall) and "design" sections (42%), but few provided enough information on the "conduct" (13%) and "interpretation and translation" (11%) of the placebo trials. Most trials sufficiently reported their rationale and ethics, but interpretation and translation are areas for improvement, including greater stakeholder involvement. Most trials used a high-fidelity placebo procedure suggesting an emphasis on blinding and controlling for nonspecific effects.

10.
Soc Sci Med ; 285: 114255, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34391966

RESUMO

RATIONALE: The public should be informed about overtesting and overdiagnosis. Diverse qualitative studies have examined public understandings of this information. A synthesis was needed to systematise the body of evidence and yield new, generalisable insights. AIM: Synthesise data from qualitative studies exploring patient and public understanding of overtesting and overdiagnosis. METHODS: We searched Scopus, CINAHL, Ovid MEDLINE and PsycINFO databases from inception to March 18, 2020. We included published English-language primary studies exploring the perspectives of patients/the public about overtesting/overdiagnosis from any setting, year and relating to any condition. Only qualitative parts of mixed-methods studies were synthesised. We excluded studies that only examined overtreatment or sampled people with specialised medical knowledge. Two authors independently selected studies, extracted data, assessed the methodological quality of included studies using the CASP tool, and assessed confidence in the synthesis findings using the GRADE-CERQual approach. Data was analysed using thematic meta-synthesis, utilising descriptive and interpretive methods. RESULTS: We synthesised data from 21 studies, comprising 1638 participants, from 2754 unique records identified. We identified six descriptive themes, all graded as moderate confidence (indicating they are likely to reasonably represent the available evidence): i) high confidence in screening and testing; ii) difficulty in understanding overuse; iii) acceptance that overuse can be harmful; iv) rejection or problematisation of overuse; v) limited impacts of overuse information on intended test and screening uptake; vi) desire for information and shared decision-making regarding overuse. The descriptive themes were underpinned by two analytic themes: i) perceived intrinsic value of information and information gathering, and; ii) differences in comprehension and acceptance of overuse concepts. CONCLUSIONS: This study identified novel and important insights about how lay people interpret overuse concepts. It will guide the development of more effective public messages about overuse, highlighting the importance of interpretative frameworks in these communications.

11.
BMJ Open ; 11(8): e054032, 2021 08 30.
Artigo em Inglês | MEDLINE | ID: mdl-34462283

RESUMO

OBJECTIVE: To develop and user test a patient decision aid for people with subacromial pain syndrome that presents evidence-based information on the benefits and harms of subacromial decompression surgery and rotator cuff repair surgery. DESIGN: Mixed-methods study outlining the development of a patient decision aid. SETTING: We assembled a multidisciplinary steering group, and used existing decision aids and decision science to draft the decision aid. Participants were recruited through social media (not restricted by country nor setting), local hospitals and the authors' collaboration network. PARTICIPANTS: People with shoulder pain and health professionals who manage people with shoulder pain. PRIMARY AND SECONDARY OUTCOMES: We interviewed participants to gather feedback on the decision aid, assessed useability and acceptability (using qualitative and quantitative methods) and performed iterative cycles of redrafting the decision aid and reinterviewing participants as necessary. Interview data were analysed using thematic analysis. Quantitative data were summarised descriptively. RESULTS: We interviewed 26 health professionals (11 physiotherapists, 7 orthopaedic surgeons, 4 general practitioners, 3 chiropractors and 1 osteopath) and 14 people with shoulder pain. Most health professionals and people with shoulder pain rated all aspects of decision aid acceptability as adequate-to-excellent (eg, length, presentation, comprehensibility). Interviews highlighted agreement among health professionals and people with shoulder pain on most aspects of the decision aid (eg, treatment options, summary of benefits, harms and practical issues, questions to ask a health professional, graphics, formatting). However, some aspects of the decision aid elicited divergent views among health professionals (eg, causes and symptoms of shoulder pain, evidence on benefits and harms). CONCLUSION: This decision aid could be an acceptable and valuable tool for helping people with subacromial pain syndrome make informed treatment choices. A randomised controlled trial evaluating whether this decision aid reduces people's intentions to undergo shoulder surgery and facilitates informed treatment choices is underway.Trial registration number ACTRN12621000992808.


Assuntos
Manguito Rotador , Dor de Ombro , Técnicas de Apoio para a Decisão , Descompressão Cirúrgica , Humanos , Dor de Ombro/cirurgia , Resultado do Tratamento
12.
Cochrane Database Syst Rev ; 8: CD009147, 2021 08 26.
Artigo em Inglês | MEDLINE | ID: mdl-34435661

RESUMO

BACKGROUND: Despite widespread use, our 2012 Cochrane review did not confirm that use of imaging to guide glucocorticoid injection for people with shoulder pain improves its efficacy. OBJECTIVES: To update our review and assess the benefits and harms of image-guided glucocorticoid injection compared to non-image-guided injection for patients with shoulder pain. SEARCH METHODS: We updated the search of the Cochrane Central Register of Controlled Trials (CENTRAL, via Ovid), MEDLINE (Ovid), Embase (Ovid) and clinicaltrials.gov to 15 Feb 2021, and the World Health Organisation International Clinical Trials Registry Platform (http://www.who.int/trialsearch/Default.aspx) to 06 July 2020. We also screened reference lists of retrieved review articles and trials to identify potentially relevant studies. SELECTION CRITERIA: We included randomised or quasi-randomised controlled trials that compared image-guided glucocorticoid injection to injection without image guidance (either landmark-guided or intramuscular) injection in patients with shoulder pain (rotator cuff disease, adhesive capsulitis or mixed or undefined shoulder pain). Major outcomes were pain, function, proportion of participants with treatment success, quality of life, adverse events, serious adverse events and withdrawals due to adverse events. Minor outcomes were shoulder range of motion and proportion of participants requiring surgery or additional injections. There were no restrictions on language or date of publication. DATA COLLECTION AND ANALYSIS: We used standard methodologic procedures expected by Cochrane. MAIN RESULTS: Nineteen trials were included (1035 participants). Fourteen trials included participants with rotator cuff disease, four with adhesive capsulitis, and one with mixed or undefined shoulder pain. Trial size varied from 28 to 256 participants, most participants were female, mean age ranged between 31 and 60 years, and mean symptom duration varied from 2 to 23 months. Two trials were at low risk of bias for all criteria. The most notable sources of bias in the remaining trials included performance bias and detection bias. Moderate-certainty evidence (downgraded for bias) indicates that ultrasound-guided injection probably provides little or no clinically important benefits compared with injection without guidance with respect to pain (15 trials) or function (14 trials) at three to six weeks follow-up. It may not improve quality of life (2 trials, low-certainty evidence, downgraded due to potential for bias and imprecision) and we are uncertain about the effect of ultrasound-guided injection on participant-rated treatment success due to very low-certainty evidence (downgraded for bias, inconsistency and imprecision). Mean pain (scale range 0 to 10, higher scores indicate more pain) was 3.1 points with injection without image guidance and 0.5 points better (0.2 points better to 0.8 points better; 1003 participants, 15 trials) with an ultrasound-guided injection. This represents a slight difference for pain (0.5 to 1.0 points on a 0 to 10 scale). Mean function (scale range 0 to 100, higher scores indicate better function) was 68 points with injection without image guidance and 2.4 points better (0.2 points worse to 5.1 points better; 895 participants, 14 trials) with an ultrasound-guided injection. Mean quality of life (scale range 0 to 100, higher scores indicate better quality of life) was 65 with injection without image guidance and 2.8 points better (0.7 worse to 6.4 better; 220 participants, 2 trials) with an ultrasound-guided injection. In five trials (350 participants), 101/175 (or 606 per 1000) people in the ultrasound-guided group reported treatment success compared with 68/175 (or 389 per 1000) people in the group injected without image guidance (RR 1.56 (95% CI 0.89 to 2.75)), an absolute difference of 22% more reported success (4% fewer to 62% more). Low-certainty evidence (downgraded for bias and imprecision) indicates that ultrasound-guided injections may not reduce the risk of adverse events compared to injections without image guidance. In five trials (402 participants), 38/200 (or 181 per 1000) people in the ultrasound-guided group reported adverse events compared with 51/202 (or 252 per 1000) in the non-image-guided injection group (RR 0.72 (95% CI 0.4 to 1.28)), an absolute difference of 7% fewer adverse events (15% fewer to 7% more). Five trials reported that there were no serious adverse events. The remaining trials did not report serious adverse events. One trial reported that 1/53 (or 19 per 1000) in the injection without image guidance group and 0/53 in the ultrasound-guided group withdrew due to adverse events. Sensitivity analyses indicate that the effects for pain and function may have been influenced by selection bias, and the effects for function may have been influenced by detection bias. The test for subgroup differences indicated there were unlikely to be differences in pain and function across different shoulder conditions. AUTHORS' CONCLUSIONS: Our updated review does not support use of image guidance for injections in the shoulder. Moderate-certainty evidence indicates that ultrasound-guided injection in the treatment of shoulder pain probably provides little or no benefit over injection without imaging in terms of pain or function and low-certainty evidence indicates there may be no difference in quality of life. We are uncertain if ultrasound-guided injection improves participant-rated treatment success, due to very low-certainty evidence. Low-certainty evidence also suggests ultrasound-guided injection may not reduce the risk of adverse events compared with non-image-guided injection. No serious adverse events were reported in any trial. The lack of significant benefit of image guidance over injection without image guidance to improve patient-relevant outcomes or reduce harms, suggests that any added cost of image guidance appears unjustified.

13.
Cochrane Database Syst Rev ; 8: CD006190, 2021 08 26.
Artigo em Inglês | MEDLINE | ID: mdl-34438469

RESUMO

BACKGROUND: This is an updated Cochrane Review, first published in 2006 and updated in 2014. Gout is one of the most common rheumatic diseases worldwide. Despite the use of colchicine as one of the first-line therapies for the treatment of acute gout, evidence for its benefits and harms is relatively limited. OBJECTIVES: To update the available evidence of the benefits and harms of colchicine for the treatment of acute gout. SEARCH METHODS: We updated the search of CENTRAL, MEDLINE, Embase, Clinicaltrials.gov and WHO ICTRP registries to 28 August 2020. We did not impose any date or language restrictions in the search. SELECTION CRITERIA: We considered published randomised controlled trials (RCTs) and quasi-randomised controlled trials (quasi-RCTs) evaluating colchicine therapy compared with another therapy (placebo or active) in acute gout; low-dose colchicine at clinically relevant doses compared with placebo was the primary comparison. The major outcomes were pain, participant global assessment of treatment success (proportion with 50% or greater decrease in pain from baseline up to 32 to 36 hours), reduction of inflammation, function of target joint, serious adverse events, total adverse events and withdrawals due to adverse events. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as expected by Cochrane in this review update. MAIN RESULTS: We included four trials (803 randomised participants), including two new trials, in this updated review. One three-arm trial compared high-dose colchicine (52 participants), low-dose colchicine (74 participants) and placebo (59 participants); one trial compared high-dose colchicine with placebo (43 participants); one trial compared low-dose colchicine with non-steroidal anti-inflammatory drugs (NSAIDs) (399 participants); and one trial compared low-dose colchicine with Chuanhu anti-gout mixture (traditional Chinese Medicine compound) (176 participants). We did not identify any trials comparing colchicine to glucocorticoids (by any route). The mean age of participants ranged from 51.2 to 70 years, and trial duration from 48 hours to 12 weeks. Two trials were at low risk of bias, one was possibly susceptible to selection bias (random sequence generation), reporting bias and other bias, and one open-label trial was at high risk of performance and detection bias. For the primary comparison, low-quality evidence from one trial (103 participants, downgraded for imprecision and bias) suggests low-dose colchicine may improve treatment outcome compared to placebo with little or no increased risk of adverse events. The number of people who reported treatment success (50% or greater pain reduction) at 32 to 36 hours was slightly larger with low-dose colchicine (418 per 1000) compared with placebo (172 per 1000; risk ratio (RR) 2.43, 95% confidence interval (CI) 1.05 to 5.64; absolute improvement 25% more reported success (7% more to 42% more, the 95% CIs include both a clinically important and unimportant benefit); relative change of 143% more people reported treatment success (5% more to 464% more). The incidence of total adverse events was 364 per 1000 with low-dose colchicine compared with 276 per 1000 with placebo: RR 1.32, 95% CI 0.68 to 2.56; absolute difference 9% more events with low-dose colchicine (9% fewer to 43% more, the 95% CIs include both a clinically important effect and no effect); relative change of 32% more events (32% fewer to 156% more). No participants withdrew due to adverse events or reported any serious adverse events. Pain, inflammation and function were not reported. Low-quality evidence (downgraded for imprecision and bias) from two trials (124 participants) suggests that high-dose colchicine compared to placebo may improve symptoms, but with increased risk of harms. More participants reported treatment success at 32 to 36 hours with high-dose colchicine (518 per 1000) compared with placebo (240 per 1000): RR 2.16, 95% CI 1.28 to 3.65, absolute improvement 28% (8% more to 46% more); more also had reduced inflammation at this time point with high-dose colchicine (504 per 1000) compared with placebo (48 per 1000): RR 10.50, 95% CI 1.48 to 74.38; absolute improvement 45% greater (22% greater to 68% greater); but more adverse events were reported with high-dose colchicine (829 per 1000 compared with 260 per 1000): RR 3.21, 95% CI 2.01 to 5.11, absolute difference 57% (26% more to 74% more). Pain and function were not reported. Low-quality evidence from a single trial comparing high-dose to low-dose colchicine indicates there may be little or no difference in benefit in terms of treatment success at 32 to 36 hours but more adverse events associated with the higher dose. Similarly, low-quality evidence from a single trial indicates there may also be little or no benefit of low-dose colchicine over NSAIDs in terms of treatment success and pain reduction at seven days, with a similar number of adverse events reported at four weeks follow-up. Reduction of inflammation, function of target joint and withdrawals due to adverse events were not reported in either of these trials, and pain was not reported in the high-dose versus low-dose colchicine trial. We were unable to estimate the risk of serious adverse events for most comparisons as there were few events reported in the trials. One trial (399 participants) reported three serious adverse (one in a participant receiving low-dose colchicine and two in participants receiving NSAIDs), due to reasons unrelated to the trial (low-quality evidence downgraded for bias and imprecision). AUTHORS' CONCLUSIONS: We found low-quality evidence that low-dose colchicine may be an effective treatment for acute gout when compared to placebo and low-quality evidence that its benefits may be similar to NSAIDs. We downgraded the evidence for bias and imprecision. While both high- and low-dose colchicine improve pain when compared to placebo, low-quality evidence suggests that high-dose (but not low-dose) colchicine may increase the number of adverse events compared to placebo, while low-quality evidence indicates that the number of adverse events may be similar with low-dose colchicine and NSAIDs. Further trials comparing colchicine to placebo or other treatment will likely have an important impact on our confidence in the effect estimates and may change the conclusions of this review. There are no trials reporting the effect of colchicine in populations with comorbidities or in comparison with other commonly used treatments, such as glucocorticoids.

14.
Lancet ; 398(10298): 369-370, 2021 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-34265254
15.
Artigo em Inglês | MEDLINE | ID: mdl-34129832

RESUMO

OBJECTIVE: To summarize the proportion of consumer webpages on subacromial decompression and rotator cuff repair surgery that make an accurate portrayal of the evidence for these operations (primary outcome), mention the benefits and harms of surgery, outline alternatives to surgery, and make various surgical recommendations. DESIGN: Content analysis. SETTING: Online consumer information about subacromial decompression and rotator cuff repair surgery. Webpages were identified through (1) Google searches using terms synonymous with "shoulder pain" and "shoulder surgery" and searching "orthopedic surgeon" linked to each Australian capital city and (2) websites of relevant professional associations (eg, Australian Orthopaedic Association). Two reviewers independently identified webpages and extracted data. PARTICIPANTS: Not applicable. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Whether the webpage made an accurate portrayal of the evidence for subacromial decompression or rotator cuff repair surgery (primary outcome), mentioned benefits and harms of surgery, outlined alternatives to surgery, and made various surgical recommendations (eg, delay surgery). Outcome data were summarized using counts and percentages. RESULTS: A total of 155 webpages were analyzed (n=89 on subacromial decompression, n=90 on rotator cuff repair, n=24 on both). Only 18% (n=16) and 4% (n=4) of webpages made an accurate portrayal of the evidence for subacromial decompression and rotator cuff repair surgery, respectively. For subacromial decompression and rotator cuff repair, respectively, 85% (n=76) and 80% (n=72) of webpages mentioned benefits, 38% (n=34) and 47% (n=42) mentioned harms, 94% (n=84) and 92% (n=83) provided alternatives to surgery, and 63% (n=56) and 62% (n=56) recommended delayed surgery (the most common recommendation). CONCLUSIONS: Most online information about subacromial decompression and rotator cuff repair surgery does not accurately portray the best available evidence for surgery and may be inadequate to inform patient decision making.

16.
Semin Arthritis Rheum ; 51(4): 919-924, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34134892

RESUMO

OBJECTIVE: To inform a research plan for future studies by obtaining stakeholder input on the application of preference-based methods to clinical trial design. METHODS: We conducted a virtual OMERACT session to encourage stakeholder engagement. We developed materials for the session to facilitate discussion based on identified case examples and feedback sessions. RESULTS: Participants prioritized incorporating patient preferences in all aspects of trial design with an emphasis on outcome selection. Participants highlighted the need for careful consideration around preference heterogeneity and equity factors. CONCLUSION: Including patient preferences in trial design was considered a priority requiring further exploration to develop comprehensive guidance.

17.
Emerg Med Australas ; 2021 Jun 23.
Artigo em Inglês | MEDLINE | ID: mdl-34164911

RESUMO

OBJECTIVE: Recent studies suggest many patients with non-specific low back pain presenting to public hospital EDs receive low-value care. The primary aim was to describe management of patients presenting with low back pain to the ED of a private hospital in Melbourne, Australia, and received a final ED diagnosis of non-specific low back pain. We also determined predictors of hospital admission. METHODS: Retrospective review of patients who presented with low back pain and received a final ED diagnosis of non-specific low back pain to Cabrini Malvern ED in 2015. Demographics, lumbar spinal imaging, pathology tests and medications were extracted from hospital records. Multivariate logistic regression was used to determine independent predictors of hospital admission. RESULTS: Four hundred and fifty presentations were included (60% female); 238 (52.9%) were admitted to hospital. One hundred and seventy-seven (39.3%) patients received lumbar spine imaging. Two hundred and eighty (62.2%) patients had pathology tests and 391 (86.9%) received medications, which included opioids (n = 298, 66.2%), paracetamol (n = 219, 48.7%), NSAIDs (n = 161, 35.8%), benzodiazepines (n = 118, 26.2%) and pregabalin (n = 26, 5.8%). Predictors of hospital admission included older age (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.02-1.05), arrival by ambulance (OR 2.03, 95% CI 1.06-3.90) and receipt of pathology tests (OR 3.32, 95% CI 2.01-5.49) or computed tomography scans (OR 1.86, 95% CI 1.12-3.11). CONCLUSION: We observed high rates of imaging, pathology tests and hospital admissions compared with previous public hospital studies, while medication use was similar. Implementation of strategies to optimise evidence-based ED care is needed to reduce low-value care and improve patient outcomes.

18.
Intern Med J ; 51(5): 788-792, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-34047040

RESUMO

Community restrictions due to COVID-19 have changed healthcare, including increased telehealth use. During the early pandemic phase, a cohort of Australian patients with inflammatory arthritis was surveyed. Self-reported access to healthcare was maintained and physical health was more likely to be self-rated poorly than mental health. There was a high level of support for telehealth during and after the pandemic.


Assuntos
Artrite , COVID-19 , Telemedicina , Artrite/epidemiologia , Atitude , Austrália/epidemiologia , Humanos , Pandemias , SARS-CoV-2
19.
J Orthop Sports Phys Ther ; 51(8): 401-411, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33789444

RESUMO

OBJECTIVE: To investigate whether different labels for rotator cuff disease influence people's perceived need for surgery. DESIGN: Randomized controlled experiment. METHODS: Participants with and without shoulder pain read a vignette describing a patient with rotator cuff disease and were randomized to 1 of 6 terms describing rotator cuff disease: subacromial impingement syndrome, rotator cuff tear, bursitis, rotator cuff-related shoulder pain, shoulder sprain, and episode of shoulder pain. Perceived need for shoulder surgery was the primary outcome. Secondary outcomes included perceived need for imaging, an injection, a second opinion, and to see a specialist; perceived seriousness of the condition; recovery expectations; and perceived impact on work attendance. Using a Bonferroni correction (significance, P<.003), adjusted between-group mean differences and 99.67% confidence intervals (CIs) were obtained using a 1-way analysis of covariance. RESULTS: One thousand three hundred eight (80% of 1626) responses were analyzed. Participants' mean ± SD age was 40.3 ± 16.0 years, and 59% were women. Mean perceived need for surgery (0-10 scale) was low and slightly higher among those assigned to the rotator cuff tear label compared to the bursitis label (2.6 versus 2.1; adjusted mean difference, 0.7; 99.67% CI: 0.0, 1.4). Mean perceived need for imaging (0-10) was moderate and slightly higher among those assigned to the rotator cuff tear (4.7 versus 3.7; adjusted mean difference, 1.0; 99.67% CI: 0.2, 1.9) and subacromial impingement syndrome labels (4.7 versus 3.7; adjusted mean difference, 1.0; 99.7% CI: 0.1, 1.9) compared to the bursitis label. CONCLUSION: There were small differences in the perceived need for surgery and imaging between some labels, which could be important at the population level. J Orthop Sports Phys Ther 2021;51(8):401-411. Epub 31 Mar 2021. doi:10.2519/jospt.2021.10375.


Assuntos
Conhecimentos, Atitudes e Prática em Saúde , Lesões do Ombro/cirurgia , Dor de Ombro/cirurgia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Lesões do Ombro/diagnóstico por imagem , Dor de Ombro/diagnóstico por imagem , Inquéritos e Questionários
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