Cardiovascular disease risk communication and prevention: a meta-analysis.

BACKGROUND AND AIMS: Knowledge of quantifiable cardiovascular disease (CVD) risk may improve health outcomes and trigger behavioural change in patients or clinicians. This review aimed to investigate the impact of CVD risk communication on patient-perceived CVD risk and changes in CVD risk factors. METHODS: PubMed, Embase, and PsycINFO databases were searched from inception to 6 June 2023, supplemented by citation analysis. Randomized trials that compared any CVD risk communication strategy versus usual care were included. Paired reviewers independently screened the identified records and extracted the data; disagreements were resolved by a third author. The primary outcome was the accuracy of risk perception. Secondary outcomes were clinician-reported changes in CVD risk, psychological responses, intention to modify lifestyle, and self-reported changes in risk factors and clinician prescribing of preventive medicines. RESULTS: Sixty-two trials were included. Accuracy of risk perception was higher among intervention participants (odds ratio = 2.31, 95% confidence interval = 1.63 to 3.27). A statistically significant improvement in overall CVD risk scores was found at 6-12 months (mean difference = -0.27, 95% confidence interval = -0.45 to -0.09). For primary prevention, risk communication significantly increased self-reported dietary modification (odds ratio = 1.50, 95% confidence interval = 1.21 to 1.86) with no increase in intention or actual changes in smoking cessation or physical activity. A significant impact on patients' intention to start preventive medication was found for primary and secondary prevention, with changes at follow-up for the primary prevention group. CONCLUSIONS: In this systematic review and meta-analysis, communicating CVD risk information, regardless of the method, reduced the overall risk factors and enhanced patients' self-perceived risk. Communication of CVD risk to patients should be considered in routine consultations.

Misdiagnosis of Uncomplicated Cellulitis: a Systematic Review and Meta-analysis.

BACKGROUND: Cellulitis is a clinical diagnosis with several mimics and no gold standard diagnostic criteria. Misdiagnosis is common. This review aims to quantify the proportion of cellulitis misdiagnosis in primary or unscheduled care settings based on a second clinical assessment and describe the proportion and types of alternative diagnoses. METHODS: Electronic searches of Medline, Embase and Cochrane library (including CENTRAL) using MeSH and other subject terms identified 887 randomised and non-randomised clinical trials, and cohort studies. Included articles assessed the proportion of cellulitis misdiagnosis in primary or unscheduled care settings through a second clinical assessment up to 14 days post initial diagnosis of uncomplicated cellulitis. Studies on infants and patients with (peri-)orbital, purulent and severe or complex cellulitis were excluded. Screening and data extraction was conducted independently in pairs. Risk of bias was assessed using a modified risk of bias tool from Hoy et al. Meta-analyses were undertaken where ≥ 3 studies reported the same outcome. RESULTS: Nine studies conducted in the USA, UK and Canada, including a total of 1600 participants, were eligible for inclusion. Six studies were conducted in the inpatient setting; three were in outpatient clinics. All nine included studies provided estimates of the proportion cellulitis misdiagnosis, with a range from 19 to 83%. The mean proportion misdiagnosed was 41% (95% CI 28 to 56% for random effects model). Heterogeneity between studies was very high both statistically (I2 96%, p-value for heterogeneity < 0.001) and clinically. Of the misdiagnoses, 54% were attributed to three conditions (stasis dermatitis, eczematous dermatitis and edema/lymphedema). DISCUSSION: The proportion of cellulitis misdiagnosis when reviewed within 14 days was substantial though highly variable, with the majority attributable to three diagnoses. This highlights the need for timely clinical reassessment and system initiatives to improve diagnostic accuracy of cellulitis and its most common mimics. TRIAL REGISTRATION: Open Science Framework ( https://osf.io/9zt72 ).

Co-designing nutrition interventions with consumers: A scoping review.

BACKGROUND: There is little known about nutrition intervention research involving consumer co-design. The aim of this scoping review was to identify and synthesise the existing evidence on the current use and extent of consumer co-design in nutrition interventions. METHODS: This scoping review is in line with the methodological framework developed by Arksey and O'Malley and refined by the Joanna Briggs Institute using an adapted 2weekSR approach. We searched Medline, EMBASE, PsycInfo, CINAHL and Cochrane. Only studies that included consumers in the co-design and met the 'Collaborate' or 'Empower' levels of the International Association of Public Participation's Public Participation Spectrum were included. Studies were synthesised according to two main concepts: (1) co-design for (2) nutrition interventions. RESULTS: The initial search yielded 8157 articles, of which 19 studies were included (comprising 29 articles). The studies represented a range of intervention types and participants from seven countries. Sixteen studies were published in the past 5 years. Co-design was most often used for intervention development, and only two studies reported a partnership with consumers across all stages of research. Overall, consumer involvement was not well documented. No preferred co-design framework or approach was reported across the various studies. CONCLUSIONS: Consumer co-design for nutrition interventions has become more frequent in recent years, but genuine partnerships with consumers across all stages of nutrition intervention research remain uncommon. There is an opportunity to improve the reporting of consumer involvement in co-design and enable equal partnerships with consumers in nutrition research.

Comparison of Telephone and Video Telehealth Consultations: Systematic Review.

BACKGROUND: Telehealth has been used for health care delivery for decades, but the COVID-19 pandemic greatly accelerated the uptake of telehealth in many care settings globally. However, few studies have carried out a direct comparison among different telehealth modalities, with very few studies having compared the effectiveness of telephone and video telehealth modalities. OBJECTIVE: This study aimed to identify and synthesize randomized controlled trials (RCTs) comparing synchronous telehealth consultations delivered by telephone and those conducted by video with outcomes such as clinical effectiveness, patient safety, cost-effectiveness, and patient and clinician satisfaction with care. METHODS: PubMed (MEDLINE), Embase, and CENTRAL were searched via the Cochrane Library from inception until February 10, 2023, for RCTs without any language restriction. Forward and backward citation searches were conducted on included RCTs. The Cochrane Risk of Bias 2 tool was used to assess the quality of the studies. We included studies carried out in any health setting-involving all types of outpatient cohorts and all types of health care providers-that compared synchronous video consultations directly with telephone consultations and reported outcomes specified in the objective. We excluded studies of clinician-to-clinician telehealth consults, hospitalized patients, and asynchronous consultations. RESULTS: Sixteen RCTs-10 in the United States, 3 in the United Kingdom, 2 in Canada, and 1 in Australia involving 1719 participants-were included in the qualitative and quantitative analyses. Most of the telehealth interventions were for hospital-based outpatient follow-ups, monitoring, and rehabilitation (n=13). The 3 studies that were conducted in the community all focused on smoking cessation. In half of the studies, nurses delivered the care (n=8). Almost all included studies had high or unclear risk of bias, mainly due to bias in the randomization process and selection of reported results. The trials found no substantial differences between telephone and video telehealth consultations with regard to clinical effectiveness, patient satisfaction, and health care use (cost-effectiveness) outcomes. None of the studies reported on patient safety or adverse events. We did not find any study on telehealth interventions for diagnosis, initiating new treatment, or those conducted in a primary care setting. CONCLUSIONS: Based on a small set of diverse trials, we found no notable differences between telephone and video consultations for the management of patients with an established diagnosis. There is also a significant lack of telehealth research in primary care settings despite its high uptake.

Telehealth v. face-to-face provision of care to patients with depression: a systematic review and meta-analysis.

Ensuring continuity of care for patients with major depressive disorders poses multiple challenges. We conducted a systematic review and meta-analysis of randomised controlled trials comparing real-time telehealth to face-to-face therapy for individuals with depression. We searched Medline, Embase, and Cochrane Central (to November 2020), conducted a citation analysis (January 2021), and searched clinical trial registries (March 2021). We included randomised controlled trials comparing similar or identical care, delivered via real-time telehealth (phone, video) to face-to-face. Outcomes included: depression severity, quality of life, therapeutic alliance, and care satisfaction. Where data were sufficient, mean differences were calculated. Nine trials (1268 patients) were included. There were no differences between telehealth and face-to-face care for depression severity at post-treatment (SMD -0.04, 95% CI -0.21 to 0.13, p = 0.67) or at other time points, except at 9 months post-treatment (SMD -0.39, 95% CI -0.75 to -0.02, p = 0.04). One trial reported no differences in quality-of-life scores at 3- or 12-months post-treatment. One trial found no differences in therapeutic alliance at weeks 4 and 14 of treatment. There were no differences in treatment satisfaction between telehealth and face-to-face immediately post-treatment (SMD -0.14, 95% CI -0.56 to 0.28, p = 0.51) or at 3 or 12-months. Evidence suggests that for patients with depression or depression symptoms, the provision of care via telehealth may be a viable alternative to the provision of care face-to-face. However, additional trials are needed with longer follow-up, conducted in a wider range of settings, and with younger patients.

The impact of antibiotics on clinical response over time in uncomplicated cellulitis: a systematic review and meta-analysis.

PURPOSE: Antibiotic treatment of uncomplicated cellulitis is highly variable with respect to agent, dose, and route of administration. As there is uncertainty about optimal/appropriate time to reassess, we aimed to assess time to clinical response. METHODS: We conducted a systematic review of randomized controlled trials reporting clinical response of uncomplicated cellulitis to antibiotic treatment over multiple timepoints. PubMed, Embase, CENTRAL, WHO ICTRP, and clinicaltrials.gov were searched from inception to June 2021 without language restrictions. The primary outcome was time to clinical response. Other outcomes were components of clinical response (pain, severity score, redness, edema measured at ≥ 2 timepoints) and the proportion of patients with treatment failure. We performed a pooled estimate of the average time to clinical response together with 95% confidence intervals using a random effects model. RESULTS: We included 32 randomized controlled trials (n = 13,576 participants). The mean time to clinical response was 1.68 days (95%CI 1.48-1.88; I2 = 76%). The response to treatment for specific components was as follows: ~ 50% reduction of pain and severity score by day 5, a ~ 33% reduction in area of redness by day 2-3, and a 30-50% reduction of proportion of patients with edema by day 2-4. Treatment failure was variably defined with an overall failure rate of 12% (95%CI 9-16%). CONCLUSION: The best available data suggest the optimal time to clinical reassessment is between 2 and 4 days, but this must be interpreted with caution due to considerable heterogeneity and small number of included studies.

Occupational therapy for cognitive impairment in stroke patients.

BACKGROUND: Cognitive impairment is a frequent consequence of stroke and can impact on a person's ability to perform everyday activities. Occupational therapists use a range of interventions when working with people who have cognitive impairment poststroke. This is an update of a Cochrane Review published in 2010. OBJECTIVES: To assess the impact of occupational therapy on activities of daily living (ADL), both basic and instrumental, global cognitive function, and specific cognitive abilities in people who have cognitive impairment following a stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, four other databases (all last searched September 2020), trial registries, and reference lists. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials that evaluated an intervention for adults with clinically defined stroke and confirmed cognitive impairment. The intervention needed either to be provided by an occupational therapist or considered within the scope of occupational therapy practice as defined in the review. We excluded studies focusing on apraxia or perceptual impairments or virtual reality interventions as these are covered by other Cochrane Reviews. The primary outcome was basic activities of daily living (BADL) such as dressing, feeding, and bathing. Secondary outcomes were instrumental ADL (IADL) (e.g. shopping and meal preparation), community integration and participation, global cognitive function and specific cognitive abilities (including attention, memory, executive function, or a combination of these), and subdomains of these abilities. We included both observed and self-reported outcome measures. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies that met the inclusion criteria, extracted data, and assessed the certainty of the evidence. A third review author moderated disagreements if consensus was not reached. We contacted trial authors for additional information and data, where available. We assessed the certainty of key outcomes using GRADE.  MAIN RESULTS: We included 24 trials from 11 countries involving 1142 (analysed) participants (two weeks to eight years since stroke onset). This update includes 23 new trials in addition to the one study included in the previous version. Most were parallel randomised controlled trials except for one cross-over trial and one with a two-by-two factorial design. Most studies had sample sizes under 50 participants. Twenty studies involved a remediation approach to cognitive rehabilitation, particularly using computer-based interventions. The other four involved a compensatory and adaptive approach. The length of interventions ranged from 10 days to 18 weeks, with a mean total length of 19 hours. Control groups mostly received usual rehabilitation or occupational therapy care, with a few receiving an attention control that was comparable to usual care; two had no intervention (i.e. a waiting list). Apart from high risk of performance bias for all but one of the studies, the risk of bias for other aspects was mostly low or unclear.  For the primary outcome of BADL, meta-analysis found a small effect on completion of the intervention with a mean difference (MD) of 2.26 on the Functional Independence Measure (FIM) (95% confidence interval (CI) 0.17 to 4.22; P = 0.03, I2 = 0%; 6 studies, 336 participants; low-certainty evidence). Therefore, on average, BADL improved by 2.26 points on the FIM that ranges from 18 (total assist) to 126 (complete independence). On follow-up, there was insufficient evidence of an effect at three months (MD 10.00, 95% CI -0.54 to 20.55; P = 0.06, I2 = 53%; 2 studies, 73 participants; low-certainty evidence), but evidence of an effect at six months (MD 11.38, 95% CI 1.62 to 21.14, I2 = 12%; 2 studies, 73 participants; low-certainty evidence). These differences are below 22 points which is the established minimal clinically important difference (MCID) for the FIM for people with stroke. For IADL, the evidence is very uncertain about an effect (standardised mean difference (SMD) 0.94, 95% CI 0.41 to 1.47; P = 0.0005, I2 = 98%; 2 studies, 88 participants). For community integration, we found insufficient evidence of an effect (SMD 0.09, 95% CI -0.35 to 0.54; P = 0.68, I2 = 0%; 2 studies, 78 participants). There was an improvement of clinical importance in global cognitive functional performance after the intervention (SMD 0.35, 95% CI 0.16 to 0.54; P = 0.0004, I2 = 0%; 9 studies, 432 participants; low-certainty evidence), equating to 1.63 points on the Montreal Cognitive Assessment (MoCA) (95% CI 0.75 to 2.52), which exceeds the anchor-based MCID of the MoCA for stroke rehabilitation patients of 1.22. We found some effect for attention overall (SMD -0.31, 95% CI -0.47 to -0.15; P = 0.0002, I2 = 20%; 13 studies, 620 participants; low-certainty evidence), equating to a difference of 17.31 seconds (95% CI 8.38 to 26.24), and for executive functional performance overall (SMD 0.49, 95% CI 0.31 to 0.66; P < 0.00001, I2 = 74%; 11 studies, 550 participants; very low-certainty evidence), equating to 1.41 points on the Frontal Assessment Battery (range: 0-18). Of the cognitive subdomains, we found evidence of effect of possible clinical importance, immediately after intervention, for sustained visual attention (moderate certainty) equating to 15.63 seconds, for working memory (low certainty) equating to 59.9 seconds, and thinking flexibly (low certainty), compared to control. AUTHORS' CONCLUSIONS: The effectiveness of occupational therapy for cognitive impairment poststroke remains unclear. Occupational therapy may result in little to no clinical difference in BADL immediately after intervention and at three and six months' follow-up. Occupational therapy may slightly improve global cognitive performance of a clinically important difference immediately after intervention, likely improves sustained visual attention slightly, and may slightly increase working memory and flexible thinking after intervention. There is evidence of low or very low certainty or insufficient evidence for effect on other cognitive domains, IADL, and community integration and participation.  Given the low certainty of much of the evidence in our review, more research is needed to support or refute the effectiveness of occupational therapy for cognitive impairment after stroke. Future trials need improved methodology to address issues including risk of bias and to better report the outcome measures and interventions used.

'The ethics approval took 20 months on a trial which was meant to help terminally ill cancer patients. In the end we had to send the funding back': a survey of views on human research ethics reviews.

BACKGROUND: We conducted a survey to identify what types of health/medical research could be exempt from research ethics reviews in Australia. METHODS: We surveyed Australian health/medical researchers and Human Research Ethics Committee (HREC) members. The survey asked whether respondents had previously changed or abandoned a project anticipating difficulties obtaining ethics approval, and presented eight research scenarios, asking whether these scenarios should or should not be exempt from ethics review, and to provide (optional) comments. Qualitative data were analysed thematically; quantitative data in R. RESULTS: We received 514 responses. Forty-three per cent of respondents to whom the question applied, reported changing projects in anticipation of obstacles from the ethics review process; 25% reported abandoning projects for this reason. Research scenarios asking professional staff to provide views in their area of expertise were most commonly exempted from ethics review (to prioritise systematic review topics 84%, on software strengths/weaknesses 85%); scenarios involving surplus samples (82%) and N-of-1 (single case) studies (76%) were most commonly required to undergo ethics review. HREC members were 26% more likely than researchers to require ethics review. Need for independent oversight, and low risk, were most frequently cited in support of decisions to require or exempt from ethics review, respectively. CONCLUSIONS: Considerable differences exist between researchers and HREC members, about when to exempt from review the research that ultimately serves the interests of patients and the public. It is widely accepted that evaluative research should be used to reduce clinical uncertainties-the same principle should apply to ethics reviews.

Head of bed elevation to relieve gastroesophageal reflux symptoms: a systematic review.

BACKGROUND: Overuse of proton pump inhibitors (PPIs) - frequently used for relieving symptoms of gastroesophageal reflux disease (GORD) - raises long-term safety concerns, warranting evidence-based non-drug interventions. We conducted a systematic review to evaluate the effect of head-of-bed elevation on relieving symptoms of GORD in adults. METHODS: We included controlled trials comparing the effect of head-of-bed elevation interventions to control in adults with GORD. Two independent reviewers screened articles, extracted data, and assessed quality of included studies. Primary outcomes were changes in GORD symptoms and use of PPIs. RESULTS: We screened 1206 records; and included five trials (four cross-over and one factorial) comprising 228 patients. All five included trials were judged to be at high-risk of performance bias and four of selection bias. Of five included trials, two used 'bed blocks' under the bed legs; one used 'sleeping on a wedge' pillow, and two used both. High heterogeneity in outcome measures and reported outcomes data precluded meta-analyses. The four studies that reported on GORD symptoms found an improvement among participants in the head-of-bed elevation; a high-quality crossover trial showed a clinical important reduction in symptom scores at 6 weeks (risk ratio of 2.1; 95% CI 1.2 to 3.6). These results are supported by the observed improvement in physiological intra-oesophageal pH measurements. CONCLUSIONS: Methodological and reporting limitations in available literature preclude definitive recommendations. However, head-of-bed elevation could be still considered as a cheap and safe alternative to drug interventions with unfavourable safety profiles. PROTOCOL REGISTRATION: Open Science Framework: http://osf.io/2hz3j.

Exploring women's priorities for the potential consequences of a gestational diabetes diagnosis: A pilot community jury.

BACKGROUND: There is no international diagnostic agreement for gestational diabetes mellitus (GDM). In 2014, Australia adopted a new definition and testing procedure. Since then, significantly more women have been diagnosed with GDM but with little difference in health outcomes. We explored the priorities and preferences of women potentially impacted by a GDM diagnosis. METHOD: We recruited 15 women from the Gold Coast, Australia, to participate in a pilot community jury (CJ). Over two days, the women deliberated on the following: (a) which important consequences of a diagnosis of GDM should be considered when defining GDM?; (b) what should Australian health practitioners call the condition known as GDM? RESULTS: Eight women attended the pilot CJ, and their recommendations were a consensus. Women were surprised that the level of risk for physical harms was low but emotional harms were high. The final ranking of important consequences (high to low) was as follows: women's negative emotions; management burden of GDM; overmedicalized pregnancy; minimizing infant risks; improving lifestyle; and macrosomia. To describe the four different clinical states of GDM, the women chose three different labels. One was GDM. CONCLUSIONS: The women from this pilot CJ prioritized the consequences of a diagnosis of GDM differently from clinicians. The current glucose threshold for GDM in Australia is set at a cut-point for adverse risks including macrosomia and neonatal hyperinsulinaemia. Definitions and guideline panels often fail to ask the affected public about their values and preferences. Community voices impacted by health policies should be embedded in the decision-making process.

Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands.

BACKGROUND: Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands. METHODS: We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together. RESULTS: Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories - evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation - were exempted by one country each. The remaining categories were exempted by two or three countries. CONCLUSIONS: Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.

Blue-Light Therapy for Acne Vulgaris: A Systematic Review and Meta-Analysis.

PURPOSE: Antibiotic use in acne treatment raises concerns about increased resistance, necessitating alternatives. We assessed the effectiveness of blue-light therapy for acne. METHODS: We analyzed randomized controlled trials comparing blue light with nonlight interventions. Studies included people of any age, sex, and acne severity, in any setting, and reported on investigator-assessed change in acne severity, patients' assessment of improvement, change in inflammatory or noninflammatory lesions, and adverse events. Where data were sufficient, mean differences were calculated. RESULTS: Eighteen references (14 trials) including 698 participants were included. Most of the trials were small and short (<12 weeks) and had high risk of bias. Investigator-assessed improvement was quantitatively reported in 5 trials, of which 3 reported significantly greater improvement in blue light than comparator, and 2 reported improvement. Patients' assessments of improvement were quantitatively reported by 2 trials, favoring blue light. Mean difference in the mean number of noninflammatory lesions was nonsignificant between groups at weeks 4, 8, and 10-12 and overall (mean difference [MD] = 3.47; 95% CI, -0.76 to 7.71; P = 0.11). Mean difference in the mean number of inflammatory lesions was likewise nonsignificant between groups at any of the time points and overall (MD = 0.16; 95% CI, -0.99 to 1.31; P = 0.78). Adverse events were generally mild and favored blue light or did not significantly differ between groups. CONCLUSION: Methodological and reporting limitations of existing evidence limit conclusions about the effectiveness of blue light for acne. Clinicians and patients should therefore consider the balance between its benefits and adverse events, as well as costs.

Developing and applying a deductive coding framework to assess the goals of Citizen/Community Jury deliberations.

BACKGROUND: Public participation in health policy decision making is thought to improve the quality of the decisions and enhance their legitimacy. Citizen/Community Juries (CJs) are a form of public participation that aims to elicit an informed community perspective on controversial topics. Reporting standards for CJ processes have already been proposed. However, less clarity exists about the standards for what constitutes a good quality CJ deliberation-we aim to begin to address this gap here. METHODS: We identified the goals that underlie CJs and searched the literature to identify existing frameworks assessing the quality of CJ deliberations. We then mapped the items constituting these frameworks onto the CJ goals; where none of the frameworks addressed one of the CJ goals, we generated additional items that did map onto the goal. RESULTS: This yielded a single operationalized deductive coding framework, consisting of four deliberation elements and four recommendation elements. The deliberation elements focus on the following: jurors' preferences and values, engagement with each other, referencing expert information and enrichment of the deliberation. The recommendation elements focus on the following: reaching a clear and identifiable recommendation, whether the recommendation directly addresses the CJ question, justification for the recommendation and adoption of societal (rather than individual) perspective. To explore the alignment between this framework and the goals underlying CJs, we mapped the operationalized framework onto the transcripts of a CJ. CONCLUSION: Results suggest that framework items map well onto what transpires in an actual CJ deliberation. Further testing of the validity, generalizability and reliability of the framework is planned.

An Australian community jury to consider case-finding for dementia: Differences between informed community preferences and general practice guidelines.

BACKGROUND: Case-finding for dementia is practised by general practitioners (GPs) in Australia but without an awareness of community preferences. We explored the values and preferences of informed community members around case-finding for dementia in Australian general practice. DESIGN, SETTING AND PARTICIPANTS: A before and after, mixed-methods study in Gold Coast, Australia, with ten community members aged 50-70. INTERVENTION: A 2-day citizen/community jury. Participants were informed by experts about dementia, the potential harms and benefits of case-finding, and ethical considerations. PRIMARY AND SECONDARY OUTCOMES: We asked participants, "Should the health system encourage GPs to practice 'case-finding' of dementia in people older than 50?" Case-finding was defined as a GP initiating testing for dementia when the patient is unaware of symptoms. We also assessed changes in participant comprehension/knowledge, attitudes towards dementia and participants' own intentions to undergo case-finding for dementia if it were suggested. RESULTS: Participants voted unanimously against case-finding for dementia, citing a lack of effective treatments, potential for harm to patients and potential financial incentives. However, they recognized that case-finding was currently practised by Australian GPs and recommended specific changes to the guidelines. Participants increased their comprehension/knowledge of dementia, their attitude towards case-finding became less positive, and their intentions to be tested themselves decreased. CONCLUSION: Once informed, community jury participants did not agree case-finding for dementia should be conducted by GPs. Yet their personal intentions to accept case-finding varied. If case-finding for dementia is recommended in the guidelines, then shared decision making is essential.

Resistance decay in individuals after antibiotic exposure in primary care: a systematic review and meta-analysis.

BACKGROUND: Antibiotic resistance is an urgent global problem, but reversibility is poorly understood. We examined the development and decay of bacterial resistance in community patients after antibiotic use. METHODS: This was a systematic review and meta-analysis. PubMed, EMBASE and CENTRAL (from inception to May 2017) were searched, with forward and backward citation searches of the identified studies. We contacted authors whose data were unclear, and of abstract-only reports, for further information. We considered controlled or times-series studies of patients in the community who were given antibiotics and where the subsequent prevalence of resistant bacteria was measured. Two authors extracted risk of bias and data. The meta-analysis used a fixed-effects model. RESULTS: Of 24,492 articles screened, five controlled and 20 time-series studies (total 16,353 children and 1461 adults) were eligible. Resistance in Streptococcus pneumoniae initially increased fourfold after penicillin-class antibiotic exposure [odds ratio (OR) 4.2, 95% confidence interval (CI) 3.5-5.4], but this fell after 1 month (OR 1.7, 95% CI 1.3-2.1). After cephalosporin-class antibiotics, resistance increased (OR 2.2, 95%CI 1.7-2.9); and fell to (OR 1.6, 95% CI 1.2-2.3) at 1 month. After macrolide-class antibiotics, resistance increased (OR 3.8, 95% CI 1.9-7.6) and persisted for 1 month (OR 5.2, 95% CI 2.6-10.3) and 3 months (OR 8.1, 95% CI 4.6-14.2, from controlled studies and OR 2.3, 95% CI 0.6-9.4, from time-series studies). Resistance in Haemophilus influenzae after penicillins was not significantly increased (OR 1.3, 95% CI 0.9-1.9) initially but was at 1 month (OR 3.4, 95% CI 1.5-7.6), falling after 3 months (OR 1.0, 95% CI 0.5-2.2). Data were sparse for cephalosporins and macrolides. Resistance in Enterobacter increased post-exposure (OR 3.2, 95% CI 0.9-10.8, from controlled studies and OR 7.1, 95% CI 4.2-12, from time-series studies], but was lower after 1 month (OR 1.8, 95% CI 0.9-3.6). CONCLUSIONS: Resistance generally increased soon after antibiotic use. For some antibiotic classes and bacteria, it partially diminished after 1 and 3 months, but longer-term data are lacking and urgently needed. TRIAL REGISTRATION: PROSPERO CRD42015025499 .

Reducing antibiotic prescribing in Australian general practice: time for a national strategy.

In Australia, the antibiotic resistance crisis may be partly alleviated by reducing antibiotic use in general practice, which has relatively high prescribing rates - antibiotics are mostly prescribed for acute respiratory infections, for which they provide only minor benefits. Current surveillance is inadequate for monitoring community antibiotic resistance rates, prescribing rates by indication, and serious complications of acute respiratory infections (which antibiotic use earlier in the infection may have averted), making target setting difficult. Categories of interventions that may support general practitioners to reduce prescribing antibiotics are: regulatory (eg, changing the default to "no repeats" in electronic prescribing, changing the packaging of antibiotics to facilitate tailored amounts of antibiotics for the right indication and restricting access to prescribing selected antibiotics to conserve them), externally administered (eg, academic detailing and audit and feedback on total antibiotic use for individual GPs), interventions that GPs can individually implement (eg, delayed prescribing, shared decision making, public declarations in the practice about conserving antibiotics, and self-administered audit), supporting GPs' access to near-patient diagnostic testing, and public awareness campaigns. Many unanswered clinical research questions remain, including research into optimal implementation methods. Reducing antibiotic use in Australian general practice will require a range of approaches (with various intervention categories), a sustained effort over many years and a commitment of appropriate resources and support.

Enhancing capillary blood collection: The influence of nicotinic acid and nonivamide.

BACKGROUND: Nicotinic acid and nonivamide are often applied topically during capillary blood collection to induce vasodilation. These molecules may have an influence on immune effector cell activity in nearby tissues. This study investigates whether the induction of flushing by nicotinic acid and nonivamide causes an inflammatory response that influences the composition of immune cells present in a capillary blood sample. METHODS: Females aged between 18 and 30 years old provided capillary blood samples. Experimental samples were taken from an earlobe treated with nicotinic acid and nonivamide with controls obtained from the untreated earlobe. Immunophenotypic analyses were conducted using polychromatic flow cytometry to determine whether any changes occurred in leucocyte subpopulations (CD3, CD4, CD8, CD19, CD56, and CD14) and granulocytic functional-related surface antigen markers (CD11b, CD18, CD16b, and CD66b). RESULTS: No significant differences were observed between experimental and control samples in the mean percent of parent for the lymphocyte, monocyte, or granulocyte subpopulations, or in the median fluorescence intensity of particular surface markers expressed on these leucocytes. CONCLUSION: The topical application of nicotinic acid and nonivamide is a possible method to improve capillary blood collection for immunological assessments. The use of these agents may increase the safety and compliance of patients who suffer from needle phobia or are unable to provide venous blood samples.

WHY PATIENTS SHOULD BE INVOLVED IN HEALTH TECHNOLOGY ASSESSMENT.

OBJECTIVES: Some countries make considerable effort to involve patients and patient groups in their health technology assessment (HTA) processes; others are only just considering or are yet to consider patient involvement in HTA. METHODS: This commentary offers four arguments why patient involvement should be prioritized by those HTA agencies that do not yet involve patients: (1) from a patients' rights perspective, (2) based on patient and community values, (3) centering on evidentiary contributions, and (4) from a methodological perspective. RESULTS: The first argument builds on the Alma-Ata Declaration, which holds that patients have a right and duty to have a say in the planning and delivery of their health care, individually and collectively. Where HTA is used to determine access to technologies and services, we argue that patients have a right to be heard. The second argues that decisions about treatments and services need to be aligned with the core values and morals of the patients whom the health system serves. The third argues that patients have unique knowledge and insights about living with a health condition and their needs for services and treatments regarding that condition, which can add to the knowledge base and value of the HTA process. The fourth argues that involvement of patients can facilitate methodological advancement of HTA, in areas such as early scientific advice and managed entry with evidence development. CONCLUSIONS: An HTA process that includes patient perspectives can, therefore, provide added value to patients, policy makers and healthcare professionals alike.

EVALUATION OF PATIENT AND PUBLIC INVOLVEMENT INITIATIVES IN HEALTH TECHNOLOGY ASSESSMENT: A SURVEY OF INTERNATIONAL AGENCIES.

OBJECTIVES: Although there is increased awareness of patient and public involvement (PPI) among health technology assessment (HTA) organizations, evaluations of PPI initiatives are relatively scarce. Our objective as members of Health Technology Assessment International's (HTAi's) Patient and Citizen Involvement Group (PCIG) was to advance understanding of the range of evaluation strategies adopted by HTA organizations and their potential usefulness. METHODS: In March 2016, a survey was sent to fifty-four HTA organizations through the International Network of Agencies for Health Technology Assessment (INAHTA) and contacts of members of HTAi's PCIG. Respondents were asked about their organizational structure; how patients and members of the public are involved; whether and how PPI initiatives have been evaluated, and, if so, which facilitators and challenges to evaluation were found and how results were used and disseminated. RESULTS: Fifteen (n = 15) programs from twelve countries responded (response rate 27.8 percent) that involved patients (14/15) and members of the public (10/15) in HTA activities. Seven programs evaluated their PPI activities, including participant satisfaction (5/7), process (5/7) and impact evaluations (4/7). Evaluation results were used to improve PPI activities, identify education and training needs, and direct strategic priorities. Facilitators and challenges revolved around the need for stakeholder buy-in, sufficient resources, senior leadership, and including patients in evaluations. CONCLUSIONS: A small but diverse set of HTA organizations evaluate their PPI activities using a range of strategies that reflect the range of rationales and approaches to PPI in HTA. It will be important for HTA organizations to draw on evaluation theories and methods.

Health technology assessment in Australia: a role for clinical registries?

Objective Health technology assessment (HTA) is a process of assessing evidence to inform policy decisions about public subsidy of new drugs and medical procedures. Where evidence is uncertain but the technology itself is promising, funders may recommend funding on an interim basis. It is unknown whether evidence from clinical registries is used to resolve uncertainties identified in interim-funded decisions made by Australian HTA bodies. Therefore, the present study evaluated the role of evidence from clinical registries in resolving evidence uncertainties identified by the Medical Services Advisory Committee (MSAC). Methods All HTAs considered by MSAC between 1998 and 2015 were reviewed and assessments that recommended interim funding were identified. The MSAC website was searched to identify reassessments of these recommendations and sources of evidence used to resolve the uncertainties were identified. Results Of 173 HTA reports considered by MSAC, 17 (10%) contained an interim funding recommendation. Eight recommendations cited uncertainty around safety, 15 cited uncertainty around clinical effectiveness and 13 cited uncertainty around economics (cost-effectiveness and/or budget impact). Of the 17 interim funding recommendations, 11 (65%) have been reassessed. Only two reassessments relied on clinical registry evidence to resolve evidence gaps identified at the time of the interim funding recommendation. Conclusions Clinical registries are underused as a source of evidence for resolving uncertainties around promising new health technologies in Australia. An open dialogue between stakeholders on the role of registries in this context is needed. What is known about the topic? HTA is a process of assessing the evidence to inform policy decisions about public subsidy of new health technologies (e.g. pharmaceuticals, diagnostic tests, medical procedures). Where evidence is uncertain but the technology under evaluation is promising, funders may recommend the funding of the technology on a temporary basis while additional evidence is collected. Clinical registries have been suggested as a means of collecting additional evidence in these situations. What is does this paper add? It is currently unknown whether evidence from clinical registries is used to resolve uncertainties identified at the time that temporary (interim) funding decisions are made by Australia's HTA bodies, in particular MSAC. The present study found that MSAC rarely relies on the interim funding mechanism (17/173 assessments). Of the 11 subsequent reassessments of interim recommendations, two relied on registry evidence to provide Australian-specific data for addressing uncertainties around long-term safety, effectiveness and cost-effectiveness. These findings suggest that clinical registries, although a feasible source of evidence for HTAs, are rarely used for this purpose. What are the implications for practitioners? Given the registries' ability to resolve both a wider range of questions than those typically addressed by randomised control trials and applicability to a wider group of patients (and, hence, providing estimates of outcomes that are more generalisable), the potential of clinical registries to resolve HTA issues needs more attention from both researchers and decision makers. Stakeholder collaboration to define the evidence requirements for new technologies early in their development phase would be valuable to determine the potential role for clinical registries.