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BACKGROUND: IgA nephropathy (IgAN) is the most common primary glomerular disease, with approximately 20% to 40% of patients progressing to kidney failure within 25 years. Non-immunosuppressive treatment has become a mainstay in the management of IgAN by improving blood pressure (BP) management, decreasing proteinuria, and avoiding the risks of long-term immunosuppressive management. Due to the slowly progressive nature of the disease, clinical trials are often underpowered, and conflicting information about management with non-immunosuppressive treatment is common. This is an update of a Cochrane review, first published in 2011. OBJECTIVES: To assess the benefits and harms of non-immunosuppressive treatment for treating IgAN in adults and children. We aimed to examine all non-immunosuppressive therapies (e.g. anticoagulants, antihypertensives, dietary restriction and supplementation, tonsillectomy, and herbal medicines) in the management of IgAN. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Register of Studies up to December 2023 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs of non-immunosuppressive agents in adults and children with biopsy-proven IgAN were included. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed search results, extracted data and assessed study quality. Results were expressed as mean differences (MD) for continuous outcomes and risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CI) using random-effects meta-analysis. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. MAIN RESULTS: This review includes 80 studies (4856 participants), of which 24 new studies (2018 participants) were included in this review update. The risk of bias within the included studies was mostly high or unclear for many of the assessed methodological domains, with poor reporting of important key clinical trial methods in most studies. Antihypertensive therapies were the most examined non-immunosuppressive therapy (37 studies, 1799 participants). Compared to placebo or no treatment, renin-angiotensin system (RAS) inhibition probably decreases proteinuria (3 studies, 199 participants: MD - 0.71 g/24 h, 95% CI -1.04 to -0.39; moderate certainty evidence) but may result in little or no difference to kidney failure or doubling of serum creatinine (SCr), or complete remission of proteinuria (low certainty evidence). Death, remission of haematuria, relapse of proteinuria or > 50% increase in SCr were not reported. Compared to symptomatic treatment, RAS inhibition (3 studies, 168 participants) probably decreases proteinuria (MD -1.16 g/24 h, 95% CI -1.52 to -0.81) and SCr (MD -9.37 µmol/L, 95% CI -71.95 to -6.80) and probably increases creatinine clearance (2 studies, 127 participants: MD 23.26 mL/min, 95% CI 10.40 to 36.12) (all moderate certainty evidence); however, the risk of kidney failure is uncertain (1 study, 34 participants: RR 0.20, 95% CI 0.01 to 3.88; very low certainty evidence). Death, remission of proteinuria or haematuria, or relapse of proteinuria were not reported. The risk of adverse events may be no different with RAS inhibition compared to either placebo or symptomatic treatment (low certainty evidence). In low certainty evidence, tonsillectomy in people with IgAN in addition to standard care may increase remission of proteinuria compared to standard care alone (2 studies, 143 participants: RR 1.90, 95% CI 1.45 to 2.47) and remission of microscopic haematuria (2 studies, 143 participants: RR 1.93, 95% CI 1.47 to 2.53) and may decrease relapse of proteinuria (1 study, 73 participants: RR 0.70, 95% CI 0.57 to 0.85) and relapse of haematuria (1 study, 72 participants: RR 0.70, 95% CI 0.51 to 0.98). Death, kidney failure and a > 50% increase in SCr were not reported. These trials have only been conducted in Japanese people with IgAN, and the findings' generalisability is unclear. Anticoagulant therapy, fish oil, and traditional Chinese medicines exhibited small benefits to kidney function in patients with IgAN when compared to placebo or no treatment. However, compared to standard care, the kidney function benefits are no longer evident. Antimalarial therapy compared to placebo in one study reported an increase in a > 50% reduction of proteinuria (53 participants: RR 3.13 g/24 h, 95% CI 1.17 to 8.36; low certainty evidence). Although, there was uncertainty regarding adverse events from this study due to very few events. AUTHORS' CONCLUSIONS: Available RCTs focused on a diverse range of interventions. They were few, small, and of insufficient duration to determine potential long-term benefits on important kidney and cardiovascular outcomes and harms of treatment. Antihypertensive agents appear to be the most beneficial non-immunosuppressive intervention for IgAN. The antihypertensives examined were predominantly angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. The benefits of RAS inhibition appear to outweigh the harms in patients with IgAN. The certainty of the evidence of RCTs demonstrating a benefit of tonsillectomy to patients with Japanese patients with IgAN was low. In addition, these findings are inconsistent across observational studies in people with IgAN of other ethnicities; hence, tonsillectomy is not widely recommended, given the potential harm of therapy. The RCT evidence is insufficiently robust to demonstrate efficacy for the other non-immunosuppressive treatments evaluated here.
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Glomerulonefrite por IGA , Insuficiência Renal , Humanos , Anti-Hipertensivos/uso terapêutico , População do Leste Asiático , Glomerulonefrite por IGA/tratamento farmacológico , Hematúria/tratamento farmacológico , Proteinúria/tratamento farmacológico , RecidivaRESUMO
INTRODUCTION: Long term opioids are commonly prescribed to manage pain. Dose reduction or discontinuation (deprescribing) can be challenging, even when the potential harms of continuation outweigh the perceived benefits. The Evidence-based clinical practice guideline for deprescribing opioid analgesics was developed using robust guideline development processes and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology, and contains deprescribing recommendations for adults prescribed opioids for pain. MAIN RECOMMENDATIONS: Eleven recommendations provide advice about when, how and for whom opioid deprescribing should be considered, while noting the need to consider each person's goals, values and preferences. The recommendations aim to achieve: implementation of a deprescribing plan at the point of opioid initiation; initiation of opioid deprescribing for persons with chronic non-cancer or chronic cancer-survivor pain if there is a lack of overall and clinically meaningful improvement in function, quality of life or pain, a lack of progress towards meeting agreed therapeutic goals, or the person is experiencing serious or intolerable opioid-related adverse effects; gradual and individualised deprescribing, with regular monitoring and review; consideration of opioid deprescribing for individuals at high risk of opioid-related harms; avoidance of opioid deprescribing for persons nearing the end of life unless clinically indicated; avoidance of opioid deprescribing for persons with a severe opioid use disorder, with the initiation of evidence-based care, such as medication-assisted treatment of opioid use disorder; and use of evidence-based co-interventions to facilitate deprescribing, including interdisciplinary, multidisciplinary or multimodal care. CHANGES IN MANAGEMENT AS A RESULT OF THESE GUIDELINES: To our knowledge, these are the first evidence-based guidelines for opioid deprescribing. The recommendations intend to facilitate safe and effective deprescribing to improve the quality of care for persons taking opioids for pain.
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Dor Crônica , Desprescrições , Transtornos Relacionados ao Uso de Opioides , Adulto , Humanos , Analgésicos Opioides/efeitos adversos , Dor Crônica/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Qualidade de VidaRESUMO
Clostridioides (Clostridium) difficile infection (CDI) places a burden on healthcare facilities worldwide. Most research studies have been concentrated in high-income countries in North America, Europe, Asia and Australia, where C. difficile is the leading cause of diarrhoea associated with antimicrobial use. This narrative review summarises African CDI studies, focussing on reports published in the last 20 years. Although relatively sparse, the data suggest that CDI is an important cause of diarrhoea on the continent. African CDI patient populations are often younger than in European and North American settings, probably due to the high prevalence of co-morbid conditions such as tuberculosis, particularly in sub-Saharan Africa. Strain typing data are rare and where reported generally limited to single sites and institutions. Despite challenges, including a lack of facilities and awareness, there is a need for further investigation to more accurately determine the true burden of disease caused by C. difficile in Africa.
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Clostridioides difficile , Infecções por Clostridium , Antibacterianos/uso terapêutico , Clostridioides , Infecções por Clostridium/tratamento farmacológico , Infecções por Clostridium/epidemiologia , Diarreia/tratamento farmacológico , Diarreia/epidemiologia , HumanosRESUMO
OF RECOMMENDATIONS AND LEVELS OF EVIDENCE: Chapter 2: Screening and assessment for unhealthy alcohol use Screening Screening for unhealthy alcohol use and appropriate interventions should be implemented in general practice (Level A), hospitals (Level B), emergency departments and community health and welfare settings (Level C). Quantity-frequency measures can detect consumption that exceeds levels in the current Australian guidelines (Level B). The Alcohol Use Disorders Identification Test (AUDIT) is the most effective screening tool and is recommended for use in primary care and hospital settings. For screening in the general community, the AUDIT-C is a suitable alternative (Level A). Indirect biological markers should be used as an adjunct to screening (Level A), and direct measures of alcohol in breath and/or blood can be useful markers of recent use (Level B). Assessment Assessment should include evaluation of alcohol use and its effects, physical examination, clinical investigations and collateral history taking (Level C). Assessment for alcohol-related physical problems, mental health problems and social support should be undertaken routinely (GPP). Where there are concerns regarding the safety of the patient or others, specialist consultation is recommended (Level C). Assessment should lead to a clear, mutually acceptable treatment plan which specifies interventions to meet the patient's needs (Level D). Sustained abstinence is the optimal outcome for most patients with alcohol dependence (Level C). Chapter 3: Caring for and managing patients with alcohol problems: interventions, treatments, relapse prevention, aftercare, and long term follow-up Brief interventions Brief motivational interviewing interventions are more effective than no treatment for people who consume alcohol at risky levels (Level A). Their effectiveness compared with standard care or alternative psychosocial interventions varies by treatment setting. They are most effective in primary care settings (Level A). Psychosocial interventions Cognitive behaviour therapy should be a first-line psychosocial intervention for alcohol dependence. Its clinical benefit is enhanced when it is combined with pharmacotherapy for alcohol dependence or an additional psychosocial intervention (eg, motivational interviewing) (Level A). Motivational interviewing is effective in the short term and in patients with less severe alcohol dependence (Level A). Residential rehabilitation may be of benefit to patients who have moderate-to-severe alcohol dependence and require a structured residential treatment setting (Level D). Alcohol withdrawal management Most cases of withdrawal can be managed in an ambulatory setting with appropriate support (Level B). Tapering diazepam regimens (Level A) with daily staged supply from a pharmacy or clinic are recommended (GPP). Pharmacotherapies for alcohol dependence Acamprosate is recommended to help maintain abstinence from alcohol (Level A). Naltrexone is recommended for prevention of relapse to heavy drinking (Level A). Disulfiram is only recommended in close supervision settings where patients are motivated for abstinence (Level A). Some evidence for off-label therapies baclofen and topiramate exists, but their side effect profiles are complex and neither should be a first-line medication (Level B). Peer support programs Peer-led support programs such as Alcoholics Anonymous and SMART Recovery are effective at maintaining abstinence or reductions in drinking (Level A). Relapse prevention, aftercare and long-term follow-up Return to problematic drinking is common and aftercare should focus on addressing factors that contribute to relapse (GPP). A harm-minimisation approach should be considered for patients who are unable to reduce their drinking (GPP). Chapter 4: Providing appropriate treatment and care to people with alcohol problems: a summary for key specific populations Gender-specific issues Screen women and men for domestic abuse (Level C). Consider child protection assessments for caregivers with alcohol use disorder (GPP). Explore contraceptive options with women of reproductive age who regularly consume alcohol (Level B). Pregnant and breastfeeding women Advise pregnant and breastfeeding women that there is no safe level of alcohol consumption (Level B). Pregnant women who are alcohol dependent should be admitted to hospital for treatment in an appropriate maternity unit that has an addiction specialist (GPP). Young people Perform a comprehensive HEEADSSS assessment for young people with alcohol problems (Level B). Treatment should focus on tangible benefits of reducing drinking through psychotherapy and engagement of family and peer networks (Level B). Aboriginal and Torres Strait Islander peoples Collaborate with Aboriginal or Torres Strait Islander health workers, organisations and communities, and seek guidance on patient engagement approaches (GPP). Use validated screening tools and consider integrated mainstream and Aboriginal or Torres Strait Islander-specific approaches to care (Level B). Culturally and linguistically diverse groups Use an appropriate method, such as the "teach-back" technique, to assess the need for language and health literacy support (Level C). Engage with culture-specific agencies as this can improve treatment access and success (Level C). Sexually diverse and gender diverse populations Be mindful that sexually diverse and gender diverse populations experience lower levels of satisfaction, connection and treatment completion (Level C). Seek to incorporate LGBTQ-specific treatment and agencies (Level C). Older people All new patients aged over 50 years should be screened for harmful alcohol use (Level D). Consider alcohol as a possible cause for older patients presenting with unexplained physical or psychological symptoms (Level D). Consider shorter acting benzodiazepines for withdrawal management (Level D). Cognitive impairment Cognitive impairment may impair engagement with treatment (Level A). Perform cognitive screening for patients who have alcohol problems and refer them for neuropsychological assessment if significant impairment is suspected (Level A). SUMMARY OF KEY RECOMMENDATIONS AND LEVELS OF EVIDENCE: Chapter 5: Understanding and managing comorbidities for people with alcohol problems: polydrug use and dependence, co-occurring mental disorders, and physical comorbidities Polydrug use and dependence Active alcohol use disorder, including dependence, significantly increases the risk of overdose associated with the administration of opioid drugs. Specialist advice is recommended before treatment of people dependent on both alcohol and opioid drugs (GPP). Older patients requiring management of alcohol withdrawal should have their use of pharmaceutical medications reviewed, given the prevalence of polypharmacy in this age group (GPP). Smoking cessation can be undertaken in patients with alcohol dependence and/or polydrug use problems; some evidence suggests varenicline may help support reduction of both tobacco and alcohol consumption (Level C). Co-occurring mental disorders More intensive interventions are needed for people with comorbid conditions, as this population tends to have more severe problems and carries a worse prognosis than those with single pathology (GPP). The Kessler Psychological Distress Scale (K10 or K6) is recommended for screening for comorbid mental disorders in people presenting for alcohol use disorders (Level A). People with alcohol use disorder and comorbid mental disorders should be offered treatment for both disorders; care should be taken to coordinate intervention (Level C). Physical comorbidities Patients should be advised that alcohol use has no beneficial health effects. There is no clear risk-free threshold for alcohol intake. The safe dose for alcohol intake is dependent on many factors such as underlying liver disease, comorbidities, age and sex (Level A). In patients with alcohol use disorder, early recognition of the risk for liver cirrhosis is critical. Patients with cirrhosis should abstain from alcohol and should be offered referral to a hepatologist for liver disease management and to an addiction physician for management of alcohol use disorder (Level A). Alcohol abstinence reduces the risk of cancer and improves outcomes after a diagnosis of cancer (Level A).
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Alcoolismo/diagnóstico , Alcoolismo/terapia , Austrália , Humanos , Guias de Prática Clínica como Assunto , AutorrelatoRESUMO
AIM: To investigate hepatitis C virus (HCV) testing patterns and engagement with health care for women positive for HCV antibodies (anti-HCV) in pregnancy and their children through pregnancy and the first 2 years of the child's life. METHODS: At a large inner-city Australian hospital from 2010 to 2012, anti-HCV positive pregnant women were recruited into a cohort study from pregnancy to 2 years post-delivery. Maternal and child data were collected by questionnaire and medical record extraction. RESULTS: During the study 29 women participants delivered 31 children. HCV RNA was detected in 64% (18/28) of pregnancies, with injecting drug use, the most likely route of maternal infection. Relatively high maternal health-care engagement during pregnancy reduced after delivery. There was evidence of ongoing illicit drug use in the majority of women. Of the children, 58% (18/31) had some HCV testing confirmed but complete testing was confirmed for only 10% (3/31). Largely, testing was incomplete or unknown. No vertical transmission was identified. Forty-two percent (13/31) of children were placed in out-of-home-care. CONCLUSIONS: Potentially, there is a high risk of inadequate or incomplete HCV testing of vulnerable children. Ongoing maternal drug use, poor maternal health-care engagement and placement in out-of-home-care may increase the risk. Complete testing of all children at risk of vertically acquired HCV needs to be ensured.
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Hepatite C/transmissão , Transmissão Vertical de Doenças Infecciosas , Adulto , Austrália , Pré-Escolar , Estudos de Coortes , Feminino , Hepacivirus , Humanos , Auditoria Médica , Gravidez , Fatores de Risco , Inquéritos e Questionários , Adulto JovemRESUMO
Administration of probiotic bacteria such as Bifidobacterium spp. can prevent antibiotic associated diarrhoea since they can survive the often harsh conditions of the gut. In Bifidobacterium longum subsp. longum(T) NCIMB 702259, two gene clusters, with homology to the ATP-binding cassette (ABC) family of efflux transporters, were identified and studied to assess their functional contribution to antibiotic resistance. Both gene clusters contained two genes encoding putative efflux transporters and a regulator gene, upstream of the structural genes. Reverse transcriptase analysis indicated that the genes in each cluster were transcribed as operons, one where all three genes, including a putative MarR-type regulator were transcribed together (BLLJ_1496/1495/1494), and the other where the two ABC-type transporter genes (BLLJ_1837/1836) were co-transcribed, but excluded the putative regulator (BLLJ_1838). Heterologous expression of the cloned BLLJ_1837/1836 transporter genes in Lactococcus lactis conferred resistance to erythromycin and tetracycline by increasing the minimum inhibitory concentration between 1.5 and 3 fold. The presence of these genes also allowed a 16% increase in the efflux of Hoechst 33342 from L. lactis cells containing the two transporter genes, BLLJ_1837-6. In B. longum, an increase in the levels of transcription of 3.3 fold was observed for BLLJ_1837 in the presence of erythromycin, as measured by multiplex quantitative PCR. In contrast to this, the expression of the genes of the BLLJ_1495/1494 operon in L. lactis did not show significant drug resistance functionality. Gel shift experiments showed that in the BLLJ_1495/1494 operon, the putative MarR-type regulator protein (BLLJ_1496) bound with high affinity to the DNA sequence upstream of the operon in which it was located but this was not erythromycin dependent. This study demonstrated the occurrence of a drug inducible, ABC-type transporter system (BLLJ_1837/1836) in B. longum as well as a putative MarR-type DNA binding protein (BLLJ_1496).
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Transportadores de Cassetes de Ligação de ATP/genética , Proteínas de Bactérias/genética , Bifidobacterium/classificação , Bifidobacterium/genética , Tipagem Molecular , Animais , Antibacterianos/farmacologia , Bifidobacterium/efeitos dos fármacos , Clonagem Molecular , DNA Intergênico , Farmacorresistência Bacteriana Múltipla , Regulação Bacteriana da Expressão Gênica , Rearranjo Gênico , Humanos , Testes de Sensibilidade Microbiana , Família Multigênica , Reação em Cadeia da Polimerase , Transcrição GênicaRESUMO
AIMS AND OBJECTIVES: To understand the experiences of women with a history of substance dependence when they attempted to gain parenting support. BACKGROUND: Becoming a mother provides a window of opportunity to support women with a substance dependence make changes to their lives and the way they will parent their infants and young children. Yet there are many barriers and a constant fear of the removal of their children from their care. DESIGN: Focus groups were conducted using a qualitative interpretive descriptive approach to enable exploration of the women's experiences as mothers with infants and young children. METHOD: A series of three focus groups were facilitated with three to six women per group. Thirteen women who were substance dependent participated in this study. Semi-structured interviews guided the collection of data. Thematic content analysis was used to work with the data. RESULTS: Four themes were identified: (1) feelings of guilt, (2) judged by others, (3) normalising and (4) support and learning to be a mother. CONCLUSION: The mothers expressed alienation from mainstream health services. Providing parenting and child health services, which avoid mothers feeling judged by the staff and other mothers, is an important step to enabling these women to appropriately and sensitively care for their infants and young children. RELEVANCE TO CLINICAL PRACTICE: Midwives and nurses working with mothers and their infants and young children are well positioned to support women who are or have experienced substance dependence. Working with this group of mothers requires the development of a therapeutic relationship to provide optimum support, education and, if necessary, intervention.
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Adaptação Psicológica , Mães/psicologia , Poder Familiar/psicologia , Apoio Social , Transtornos Relacionados ao Uso de Substâncias/psicologia , Adulto , Criança , Serviços de Saúde da Criança , Feminino , Grupos Focais , Humanos , Lactente , Entrevistas como Assunto , Serviços de Saúde Materna , Processo de Enfermagem , Cuidado Pós-Natal , Transtornos Relacionados ao Uso de Substâncias/enfermagem , Adulto JovemRESUMO
OBJECTIVES: To describe the development and use of an Evidence to Decision (EtD) framework when formulating recommendations for the Evidence-Based Clinical Practice Guideline for Deprescribing Opioid Analgesics. STUDY DESIGN AND SETTING: Evidence was derived from an overview of systematic reviews and qualitative studies conducted with healthcare professionals and people who take opioids for pain. A multidisciplinary guideline development group conducted extensive EtD framework review and iterative refinement to ensure that guideline recommendations captured contextual factors relevant to the guideline target setting and audience. RESULTS: The guideline development group considered and accounted for the complexities of opioid deprescribing at the individual and health system level, shaping recommendations and practice points to facilitate point-of-care use. Stakeholders exhibited diverse preferences, beliefs, and values. This variability, low certainty of evidence, and system-level policies and funding models impacted the strength of the generated recommendations, resulting in the formulation of four 'conditional' recommendations. CONCLUSION: The context within which evidence-based recommendations are considered, as well as the political and health system environment, can contribute to the success of recommendation implementation. Use of an EtD framework allowed for the development of implementable recommendations relevant at the point-of-care through consideration of limitations of the evidence and relevant contextual factors.
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Desprescrições , Medicina Baseada em Evidências , Humanos , Analgésicos Opioides/uso terapêutico , Sistemas Automatizados de Assistência Junto ao Leito , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Women experiencing substance use disorders face barriers to treatment, including childcare, stigma and lack of gender/trauma-informed programming. Several non-government organizations in New South Wales run women-only treatment services to address these needs. OBJECTIVES: We aim to assess characteristics of women entering treatment in these services. DESIGN: Data on client characteristics from six women-only non-government organization substance use disorder treatment services in New South Wales between 2014 and 2018 were extracted from a database containing demographics, drug use and treatment characteristics and psychological distress (Kessler-10 scale) of women entering the services. Logistic regression models were used to estimate unadjusted odds ratio and adjusted odds ratio for treatment completion and different drugs on entry. RESULTS: Data were available for 1357 women. Most (91%) episodes were for residential treatment. Women's mean age was 35.4 years (standard deviation = 9.8; range = 17-67). Residential clients tended to be younger than non-residential clients (35.1 vs 38.5 years, p < 0.001). Methamphetamine (43%) and alcohol (32%) were the most reported principal drug of concern. Women (89%) reported high levels of psychological distress (median Kessler-10 scale score = 27.5, range = 10-50), highest for women reporting alcohol as their principal drug. Overall, 43% of episodes resulted in treatment completion, most commonly for women entering residential treatment (45% vs 22%, p < 0.001) and for alcohol treatment (adjusted odds ratio = 1.42; confidence interval = 1.07-1.90; p < 0.001). Women with Kessler-10 scale scores indicating anxiety or depression at treatment entry were less likely to complete treatment than those with lower scores (adjusted odds ratio = 0.56; confidence interval = 0.38-0.80; p < 0.001). CONCLUSION: Women entering women-only residential treatment tend to be younger and report methamphetamine as principal drug of concern. Women enter treatment with high degrees of psychological distress. Women's services need to ensure their programmes can respond to diverse needs of younger women presenting with methamphetamine use disorder and older women with alcohol use disorder experiencing high levels of psychological distress.
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Alcoolismo , Metanfetamina , Transtornos Relacionados ao Uso de Substâncias , Humanos , Feminino , Idoso , Adulto , New South Wales , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Transtornos Relacionados ao Uso de Substâncias/terapia , Transtornos Relacionados ao Uso de Substâncias/psicologia , Alcoolismo/terapia , AnsiedadeRESUMO
BACKGROUND: Assessing the fidelity of intervention components enables researchers to make informed judgements about the influence of those components on the observed outcome. The 'Implementing work-related Mental health guidelines in general PRacticE' (IMPRovE) trial is a hybrid III trial aiming to increase adherence to the 'Clinical Guidelines for the diagnosis and management of work-related mental health conditions in general practice'. IMPRovE is a multifaceted intervention, with one of the central components being academic detailing (AD). This study describes the fidelity to the protocol for the AD component of the IMPRovE intervention. METHOD: All AD sessions for the trial were audio-recorded and a sample of 22% were randomly selected for fidelity assessment. Fidelity was assessed using a tailored proforma based on the Modified Conceptual Framework for fidelity assessment, measuring duration, coverage, frequency and content. A descriptive analysis was used to quantify fidelity to the protocol and a content analysis was used to elucidate qualitative aspects of fidelity. RESULTS: A total of eight AD sessions were included in the fidelity assessment. The average fidelity score was 89.2%, ranging from 80 to 100% across the eight sessions. The sessions were on average 47 min long and addressed all of the ten chapters in the guideline. Of the guideline chapters, 9 were frequently discussed. The least frequently discussed chapter related to management of comorbid conditions. Most general practitioner (GP) participants used the AD sessions to discuss challenges with managing secondary mental conditions. In line with the protocol, opinion leaders who delivered the AD sessions largely offered evidence-based strategies aligning with the clinical guideline recommendations. CONCLUSIONS/IMPLICATIONS: The IMPRovE AD intervention component was delivered to high fidelity. The sessions adhered to the intended duration, coverage, frequency, and content allowing participating GPs to comprehend the implementation of the guideline in their own practice. This study also demonstrates that the Modified Conceptual Fidelity Framework with a mixed methods approach can support the assessment of implementation fidelity of a behavioural intervention in general practice. The findings enhance the trustworthiness of reported outcomes from IMPRovE and show that assessing fidelity is amenable for AD and should be incorporated in other studies using AD. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN 12620001163998, November 2020.
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INTRODUCTION: Low back pain (LBP) is commonly treated with opioid analgesics despite evidence that these medicines provide minimal or no benefit for LBP and have an established profile of harms. International guidelines discourage or urge caution with the use of opioids for back pain; however, doctors and patients lack practical strategies to help them implement the guidelines. This trial will evaluate a multifaceted intervention to support general practitioners (GPs) and their patients with LBP implement the recommendations in the latest opioid prescribing guidelines. METHODS AND ANALYSIS: This is a cluster randomised controlled trial that will evaluate the effect of educational outreach visits to GPs promoting opioid stewardship alongside non-pharmacological interventions including heat wrap and patient education about the possible harms and benefits of opioids, on GP prescribing of opioids medicines dispensed. At least 40 general practices will be randomised in a 1:1 ratio to either the intervention or control (no outreach visits; GP provides usual care). A total of 410 patient-participants (205 in each arm) who have been prescribed an opioid for LBP will be enrolled via participating general practices. Follow-up of patient-participants will occur over a 1-year period. The primary outcome will be the cumulative dose of opioid dispensed that was prescribed by study GPs over 1 year from the enrolment visit (in morphine milligram equivalent dose). Secondary outcomes include prescription of opioid medicines, benzodiazepines, gabapentinoids, non-steroidal anti-inflammatory drugs by study GPs or any GP, health services utilisation and patient-reported outcomes such as pain, quality of life and adverse events. Analysis will be by intention to treat, with a health economics analysis also planned. ETHICS AND DISSEMINATION: The trial received ethics approval from The University of Sydney Human Research Ethics Committee (2022/511). The results will be disseminated via publications in journals, media and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12622001505796.
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Clínicos Gerais , Dor Lombar , Humanos , Analgésicos Opioides/uso terapêutico , Dor Lombar/tratamento farmacológico , Qualidade de Vida , Padrões de Prática Médica , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Prescribed opioid doses > 100 mg oral morphine equivalent (OME) and/or co-prescribing of sedating psychoactive medications increase the risk of unintentional fatal overdose. We describe general practice encounters where opioids are prescribed and examine high-risk opioid prescribing. METHODS: The 2006-2016 BEACH study data, a rolling national cross-sectional survey of randomly selected GPs, was analysed. RESULTS: Opioid prescribing increased 2006-2007 to 2015-2016, however, this plateaued across the latter half-decade. From 2012-2016 3,897 GPs recorded 389,700 encounters and at least one opioid was prescribed at 5.2%. Opioid encounters more likely involved males, those 45-64 years, concession card holders and the socioeconomically disadvantaged. GPs more likely to prescribe opioids were 55 years or older, male, Australian graduates, and in regional and remote areas. The most common problems managed with opioids involved chronic non-cancer pain. One-in-ten opioid prescribing episodes involved high-risk doses and 11% involved co-prescription of sedating psychoactive medications. Over one-third of GPs provided other (non-pharmacological) interventions at encounters with opioid prescriptions. CONCLUSIONS: Only 5% of GP encounters involved an opioid prescription. Of concern, were: prescribing for chronic non-cancer pain, potentially high-risk opioid encounters where > 100 OME daily dose was prescribed, and/or there was co-prescription of sedating psychoactive medication. However, approximately one-in-three opioid prescribing encounters involved non-pharmacological interventions.
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Analgésicos Opioides , Medicina Geral , Padrões de Prática Médica , Analgésicos Opioides/efeitos adversos , Austrália , Dor Crônica/tratamento farmacológico , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
BACKGROUND: IgA nephropathy (IgAN) is the most common primary glomerular disease with approximately 30% to 40% of patients progressing to end-stage kidney disease (ESKD) within 20 years. The most common regimens include immunosuppressive agents, however the risks of long-term treatment often outweigh the potential benefits. Non-immunosuppressive options, including fish oils, anticoagulants, antihypertensive agents and tonsillectomy have also been examined but not reviewed systematically. OBJECTIVES: To assess the benefits and harms of non-immunosuppressive treatments for treating IgAN in adults and children. SEARCH STRATEGY: In July 2010 we searched the Cochrane Renal Group's specialised register, CENTRAL (in The Cochrane Library), MEDLINE (from 1966) and EMBASE (from 1980). We also searched reference lists of included studies, review articles and contacted local and international experts. SELECTION CRITERIA: Randomised controlled trials (RCTs) of non-immunosuppressive agents in adults and children with biopsy-proven IgAN were included. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed search results, extracted data and assessed study quality. Results were expressed as mean differences (MD) for continuous outcomes and risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CI) using a random-effects model. MAIN RESULTS: We included 56 studies (2838 participants). Antihypertensive agents were the most beneficial non-immunosuppressive intervention for IgAN. The antihypertensives examined were predominantly angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB) or combinations of both, versus other antihypertensives and other agents. The benefits of antihypertensive agents, particularly inhibitors of the renin angiotensin system, appear to potentially outweigh the harms in patients with IgAN. The benefits are largely manifest as a reduction in proteinuria, a surrogate outcome. There is no evidence that treatment with any of the antihypertensive agents evaluated affect major renal and/or cardiovascular endpoints or long-term mortality risk beyond the benefit that arises from controlling hypertension in patients with IgAN. The RCT evidence is insufficiently robust to demonstrate efficacy for any of the other non-immunosuppressive therapies evaluated here. AUTHORS' CONCLUSIONS: IgAN remains a disease in search of adequately powered RCTs to reliably inform clinical practice. More and better evidence is needed to understand the magnitude of benefit and the possible risks of anti-hypertensive or more specifically of ACEi/ARB therapy alone or in combination and which specific types of patients with the IgAN might have the greatest potential for benefit. For other non-immunosuppressive therapies, where neither benefit nor significant harm has yet to be demonstrated, there remains some justification for further exploration of the potential benefits.
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Óleos de Peixe/uso terapêutico , Glomerulonefrite por IGA/terapia , Adulto , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Anticoagulantes/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Criança , Terapia Combinada/métodos , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Fenitoína/uso terapêutico , Fitoterapia , Preparações de Plantas/uso terapêutico , Inibidores da Agregação Plaquetária/uso terapêutico , Proteinúria/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , TonsilectomiaRESUMO
Injecting drug users (IDUs) experience numerous health problems, but report barriers to utilising general practitioners (GPs). A nurse-led Harm Minimisation-based Primary Healthcare (HMPH) service for IDUs was established within a needle and syringe program in inner-city Sydney with Area Health Service medical support and clinical governance. This paper aimed to describe the HMPH service, review service utilisation and assess nurses' perceptions of their work with IDUs. A review of the most recent 200 clinic files was undertaken. Service utilisation, GP and other health service use and access were extracted and analysed using SPSS. A semi-structured qualitative interview with clinic nurses regarding their experience working with IDUs and local GPs was conducted and analysed. Since its inception in mid-2006, the service has been utilised by 417 clients. Of the most recent 200 files, blood-borne virus and sexually transmitted infection screening were the primary reason for presentation (64.5%). At least one follow-up visit was attended by 90% of clients. A total of 62% of clients reported consulting a GP in the last 12 months. The service provided 102 referrals. Nurses believed that IDUs tend to utilise GPs ineffectively and that self-care is a low priority, but that they can support IDUs to overcome some barriers to GPs and facilitate access. Targeted primary health care services led by nurses with focussed medical support and co-located with needle and syringe programs can fill an important gap in delivering and facilitating health care to IDUs.
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Padrões de Prática em Enfermagem , Atenção Primária à Saúde/organização & administração , Abuso de Substâncias por Via Intravenosa/enfermagem , Adulto , Idoso , Controle de Doenças Transmissíveis , Prestação Integrada de Cuidados de Saúde , Feminino , Medicina Geral , Humanos , Masculino , Pessoa de Meia-Idade , New South Wales , Padrões de Prática em Enfermagem/estatística & dados numéricos , Desenvolvimento de Programas , Encaminhamento e ConsultaRESUMO
BACKGROUND: Drug consumption rooms (DCRs) and supervised injecting facilities (SIFs) provide a safe environment in which people who inject drugs (PWIDs) can inject under hygienic and supervised conditions. Numerous reviews have documented the benefits of these facilities; however, there is a lack of clarity surrounding their long-term effects. PURPOSE: To conduct, with a systematic approach, a literature review, of published peer-reviewed literature assessing the long-term impacts of DCRs/SIFs. METHODS: A systematic search of the PubMed and Embase database was performed using the keywords: ("SUPERVISED" OR "SAFE*") AND ("CONSUMPTION" OR "INJECT*" OR "SHOOTING") AND ("FACILITY*" OR "ROOM*" OR "GALLERY*" OR "CENTRE*" OR "CENTER*" OR "SITE*"). Included studies were original articles reporting outcomes for five or more years and addressed at least one of the following client or community outcomes; (i) drug-related harms; (ii) access to substance use treatment and other health services; (iii) impact on local PWID population; (iv) impact on public drug use, drug-related crime and violence; and (v) local community attitudes to DCRs. RESULTS: Four publications met our inclusion criteria, addressing four of the five outcomes. Long-term data suggested that while the health of PWID naturally declined over time, DCRs/SIFs helped reduce injecting-related harms. The studies showed that DCRs/SIFs facilitate drug treatment, access to health services and cessation of drug injecting. Local residents and business owners reported less public drug use and public syringe disposal following the opening of a DCR/SIF. CONCLUSION: Long-term evidence on DCRs/SIFs is consistent with established short-term research demonstrating the benefits of these facilities. A relative paucity of studies was identified, with most evidence originating from Sydney and Vancouver. The overall body of evidence would be improved by future studies following outcomes over longer periods and being undertaken in a variety of jurisdictions and models of DCRs/SIFs.
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INTRODUCTION: The absence of a clear model of care for services supporting pregnant women and mothers with substance use disorders has impeded opportunities to build an evidence base for the effectiveness of these services. Previous research has typically focused on the needs of pregnant women or mothers, as two distinct groups. This paper explores service providers' perceptions of key components of a model of care, extending from perinatal care to community-based support for up to 17 years post-delivery. A model of care is outlined and feasibility factors affecting implementation are highlighted. METHODS: Qualitative methods were adopted as a first step to informing development of the model of care. Semi-structured in-depth interviews were conducted with thirty-eight staff providing a range of substance use in pregnancy and parenting services (SUPPS) in hospital and community-based agencies, in a metropolitan health district in Sydney, Australia. Interview data was entered into NVivo and analysed using constant comparative methods. RESULTS: Guiding principles for the model of care included integrated care, harm reduction and person-centredness. Practice approaches integral to the model of care were promoting engagement with women, flexible service provision, trauma-informed care, and continuity of care. Feasibility factors influencing implementation of the model of care included fragmentation or siloing of the service network and workforce sustainability. CONCLUSIONS: A harm reduction approach was crucial for promoting engagement of women with SUPPS, particularly child protection services. A greater focus on providing ongoing community-based support for mothers also has the potential to achieve sustainable positive outcomes for women and children. Implementation of the SUPPS model of care could be undermined by threats to integration of service delivery and continuity of care. Further research is needed to explore consumer perspectives and inform the model of care as a framework for evaluation.
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Poder Familiar , Transtornos Relacionados ao Uso de Substâncias , Austrália , Criança , Feminino , Humanos , Mães , Gravidez , Transtornos Relacionados ao Uso de Substâncias/terapiaRESUMO
BACKGROUND: The Clinical Guideline for the Diagnosis and Management of Work-related Mental Health Conditions in General Practice (the Guideline) was published in 2019. The objective of this trial is to implement the Guideline in general practice. TRIAL DESIGN: Implementing work-related Mental health conditions in general PRacticE is a hybrid III, parallel cluster randomised controlled trial undertaken in Australia. Its primary aim is to assess the effectiveness of a complex intervention on the implementation of the Guideline in general practice. Secondary aims are to assess patient health and work outcomes, to evaluate the cost-effectiveness of the trial, and to develop a plan for sustainability. METHODS: A total of 86 GP clusters will be randomly allocated either to the intervention arm, where they will receive a complex intervention comprising academic detailing, enrolment in a community of practice and resources, or to the control arm, where they will not receive the intervention. GP guideline concordance will be assessed at baseline and 9 months using virtual simulated patient scenarios. Patients who meet the eligibility criteria (>18years, employed, and receiving care from a participating GP for a suspected or confirmed work-related mental health condition) will be invited to complete surveys about their health and work participation and provide access to their health service use data. Data on health service use and work participation compensation claim data will be combined with measures of guideline concordance and patient outcomes to inform an economic evaluation. A realist evaluation will be conducted to inform the development of a plan for sustainability. RESULTS: We anticipate that GPs who receive the intervention will have higher guideline concordance than GPs in the control group. We also anticipate that higher concordance will translate to better health and return-to-work outcomes for patients, as well as cost-savings to society. CONCLUSIONS: The trial builds on a body of work defining the role of GPs in compensable injury, exploring their concerns, and developing evidence-based guidelines to address them. Implementation of these guidelines has the potential to deliver improvements in GP care, patient health, and return-to-work outcomes. TRIAL REGISTRATION: ACTRN12620001163998 , November 2020.
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Medicina Geral , Transtornos Mentais , Saúde Ocupacional , Medicina de Família e Comunidade , Humanos , Transtornos Mentais/diagnóstico , Transtornos Mentais/terapia , Saúde Mental , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Humans lack the enzymes needed to metabolize endogenous and dietary oxalate, a toxic compound causing hyperoxaluria and calcium oxalate urolithiasis. Oxalate in humans can be eliminated through (1) excretion in urine, (2) forming insoluble calcium oxalate and elimination in feces, or (3) oxalate degradation by gastrointestinal (GIT) microorganisms. In this article, anaerobic oxalate catabolism in gut bacteria is reviewed, and the possible use of these bacteria as probiotics for treating kidney stone disease is evaluated. Oxalobacter formigenes and Lactobacillus and Bifidobacterium species are the best studied in this regard, with oxalate degradation in the lactic acid bacteria being both species- and strain-specific. The GIT oxalate-degrading bacteria express the catabolic enzymes formyl-CoA transferase (Frc) and oxalyl-CoA decarboxylase (Oxc). The genes encoding these proteins are clustered on the genomes and show strong phylogenetic relationships. Clinical trials investigating reduced hyperoxaluria through administering O. formigenes or its enzymes show a promising trend, but the data need confirmation through larger scale, well-controlled trials. Similar studies using Lactobacillus and Bifidobacterium species also show in vivo oxalate reduction, but these data are still controversial. In particular, further investigations need to determine whether there is a direct link between the lack of oxalate-degrading bacteria and hyperoxaluria and whether their absence is a risk factor. Key experiments linking microbial numbers, functional oxalate degradation, molecular analysis of the regulation of the genes involved, and the ability of the bacteria to survive in the gut are crucial elements in identifying suitable probiotics for treating kidney stone disease.
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Trato Gastrointestinal/microbiologia , Cálculos Renais/microbiologia , Cálculos Renais/terapia , Oxalatos/metabolismo , Probióticos/farmacologia , Bifidobacterium/metabolismo , Trato Gastrointestinal/metabolismo , Humanos , Cálculos Renais/metabolismo , Cálculos Renais/prevenção & controle , Lactobacillus/metabolismo , FilogeniaRESUMO
Perceived knowledge gaps in general practice are not well documented but must be understood to ensure relevant and timely evidence for busy general practitioners (GPs) which reflects their diverse and changing needs. The aim of this study was to classify the types of questions submitted by Australian GPs to an evidence-based practice information service using established and inductive coding systems. We analysed 126 clinical questions submitted by 53 Australian GPs over a 1.5-year period. Questions were coded using the International Classification of Primary Care (ICPC-2 PLUS) and Ely and colleagues' generic questions taxonomy by two independent coders. Inductive qualitative content analysis was also used to identify perceived knowledge gaps. Treatment (71%), diagnosis (15%) and epidemiology (9%) were the most common categories of questions. Using the ICPC-2 classification, questions were most commonly coded to the endocrine/metabolic and nutritional chapter heading, followed by general and unspecified, digestive and musculoskeletal. Seventy per cent of all questions related to the need to stay up-to-date with the evidence, or be informed about new tests or treatments (including complementary and alternative therapies). These findings suggest that current guideline formats for common clinical problems may not meet the knowledge demands of GPs and there is gap in access to evidence updates on new tests, treatments and complementary and alternative therapies. Better systems for 'pulling' real-time questions from GPs could better inform the 'push' of more relevant and timely evidence for use in the clinical encounter.
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Competência Clínica , Medicina Baseada em Evidências , Medicina Geral , Serviços de Informação , Inquéritos e Questionários/classificação , Austrália , Humanos , Serviços de Informação/normasRESUMO
OBJECTIVE: To assess the feasibility and acceptability of integrating a contraception clinic within an opioid agonist treatment (OAT) service to improve access to contraception, especially long-acting reversible methods of contraception (LARC), for women receiving OAT, who have increased risk of unplanned pregnancies and adverse pregnancy outcomes. METHODS: A contraception clinic was established at a Sydney OAT service. Forty-eight female OAT clients were surveyed regarding their contraception knowledge and needs. Interested and eligible women were referred to the contraception clinic. RESULTS: Women were aged a median of 39 years (range 24-54 years). Most women (83%) agreed it was acceptable for their OAT clinician to discuss contraception with them. Eight women reported current LARC use and 21 reported they would consider using LARC. Twenty-three women were eligible for contraception (sexually active, aged <50 years, not using contraception, wishing to avoid pregnancy). Six months post-survey two women had presented to the clinic and two reported an unintended pregnancy. CONCLUSION: Uptake of an on-site contraception service within OAT clinic was low, despite participants' expressed willingness to use the service. Access is therefore not the only driver of low contraception uptake for this group. Implications for public health: Other issues besides access to contraception warrant investigation to improve contraception uptake for women receiving OAT.