Limited Evidence Of Effectiveness Research Articles

Understanding the factors that influence clinical decision-making - a sequential explanatory mixed methods study protocol

Background: Despite soaring healthcare costs, patient outcomes are suboptimal in the USA. Efforts to limit healthcare costs and improve quality of care have had limited success. An improved understanding of factors that influence clinical decision-making may provide insight into optimizing the quality and costs of care. The process of healthcare decision-making is contextual, complex and poorly understood. This study aims to explore the factors that influence clinical decision-making in the setting of limited evidence of effectiveness, limited or conflicting guidance, significant resource burden and variation in values and preferences.Rationale for study design: This sequential explanatory mixed methods study includes a case-based survey (quantitative phase). The results of the survey will guide the sampling and questions for the semi-structured interviews (qualitative phase). The interviews will provide an in-depth explanation of the survey results. Combining the two methods provides complementary information and deeper understanding of the phenomenon of clinical decision-making.Methods: The quantitative strand will consist of case-based surveys in the fields of neonatology and cardiology. Participants are asked to pick the best management choice for each question followed by a rating of the influence of different factors on a 7-point Likert scale. Follow-up questions explore knowledge and influence of evidence, guideline recommendations and costs on decision-making. Analysis of the survey results will inform sampling and the focus of qualitative interviews. The interviews will be analyzed using qualitative description.Discussion: To our knowledge, this is the first study using a mixed methods approach including a case-based survey of physicians practicing in diverse settings to explore the factors that influence clinical decision-making. The results of this study may assist with strategies to implement high value care resulting in improved patient outcomes and limiting costs.

Effect of interventions incorporating personalised cancer risk information on intentions and behaviour: a systematic review and meta-analysis of randomised controlled trials

ObjectiveTo provide a comprehensive review of the impact on intention to change health-related behaviours and health-related behaviours themselves, including screening uptake, of interventions incorporating information about cancer risk targeted at...

Mortality risk associated with psychotropic polypharmacy in patients with dementia

Background: Antipsychotics are frequently used for patients with dementia, despite limited evidence for effect on neuropsychiatric symptoms. In 2012, 75% of patients treated with an antipsychotic also used another psychotropic drug (psychotropic polypharmacy). Patients with dementia are more susceptible to side effects using psychotropic drugs.

Can traffic management strategies improve urban air quality? A review of the evidence

Abstract This paper reviews the effectiveness of traffic management strategies (TMS) for mitigating emissions, ambient concentrations, human exposure, and health effects of traffic-related air pollution in urban areas. The objective is to summarize the evidence base for a range of moderate-scale strategies broadly relevant to municipal and regional government decision-making. A systematic literature search was carried out to identify empirical studies of TMS effects on emissions, air quality, exposure, or health. Identified studies were reviewed to assess the state of evidence that TMS can improve urban air quality and pollution-related health outcomes for exposed populations. Overall, the evidence base is weak for these effects. There is limited evidence of effects on emissions for 7 of the 22 studied strategies, and limited evidence of effects on air quality for 2 of the strategies: area road pricing and low emission zones. Insufficient evidence exists for all other TMS and effects. Existing evidence suggests that aggressive area-based TMS such as low emission zones are needed to generate substantial air quality benefits, and that TMS must be implemented with care to avoid unintended detrimental and rebound effects. The evidence base is limited by a lack of ex post evaluations of implemented strategies, lack of evaluation of exposure and health impacts, small intervention effects relative to the influences of other factors, and insufficient evaluation of spillover and indirect effects. Evolving vehicle fleets add further uncertainty to the long-range effects of TMS on air quality. Effects of TMS on measured population exposure and public health outcomes have not been well-studied. An evidence-based approach to transportation systems planning necessitates additional resource allocation to ex post evaluations and performance monitoring for air quality impacts of traffic management strategies.

Systematic review of self-management interventions for people with eczema.

SummaryEczema is a common long‐term condition, but inadequate support and information can lead to poor adherence and treatment failure. We have reviewed the international literature of interventions designed to promote self‐management in adults and children with eczema. MEDLINE, MEDLINE in process, Embase, CINAHL and the Global Resource for EczemA Trials database were searched from their inception to August 2016, for randomized controlled trials. Two authors independently applied eligibility criteria, assessed risk of bias for all included studies and extracted data. Twenty studies (3028 participants) conducted in 11 different countries were included. The majority (n = 18) were based in secondary care and most (n = 16) targeted children with eczema. Reporting of studies, including descriptions of the interventions and the outcomes themselves, was generally poor. Thirteen studies were face‐to‐face educational interventions, five were delivered online and two were studies of written action plans. Follow‐up in most studies (n = 12) was short term (up to 12 weeks). Only six trials specified a single primary outcome. There was limited evidence of effectiveness. Only three studies collected and reported outcomes related to cost and just one study undertook any formal cost‐effectiveness analysis. In summary, we have identified a general absence of well‐conducted and well‐reported randomized controlled trials with a strong theoretical basis. Therefore, there is still uncertainty about how best to support self‐management of eczema in a clinically effective and cost‐effective way. Recommendations on design and conduct of future trials are presented.

The efficacy of fall-risk-increasing drug (FRID) withdrawal for the prevention of falls and fall-related complications: protocol for a systematic review and meta-analysis

BackgroundDespite limited evidence of effectiveness, withdrawal (discontinuation or dose reduction) of high risk medications known as “fall-risk increasing drugs” (FRIDs) is typically conducted as a fall prevention strategy based on presumptive benefit. Our objective is to determine the efficacy of fall-risk increasing drugs (FRIDs) withdrawal on the prevention of falls and fall-related complications.Methods/designWe will search for all published and unpublished randomized controlled trials evaluating the effect of FRID withdrawal compared to usual care on the rate of falls, incidence of falls, fall-related injuries, fall-related fractures, fall-related hospitalizations, or adverse effects related to the intervention in adults aged 65 years or older. Electronic database searches will be conducted in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and CINAHL. A grey literature search will be conducted including clinical trial registries and conference proceedings and abstracts. Two reviewers will independently perform in duplicate citation screening, full-text review, data abstraction, and risk of bias assessment. Conflicts will be resolved through team discussion or by a third reviewer if no consensus can be reached. The Grades of Recommendation, Assessment, Development and Evaluation (GRADE) criteria will be used to independently rate overall confidence in effect estimates for each outcome. Results will be synthesized descriptively, and a random effects meta-analysis will be conducted for each outcome if studies are deemed similar methodologically, clinically, and statistically.DiscussionWe will attempt to determine whether a FRID withdrawal strategy alone is effective at preventing falls in older adults. Our results will be used to optimize and focus fall prevention strategies and initiatives internationally with a goal of improving the health of older adults.Systematic review registrationPROSPERO CRD42016040203

Acceptability of Parental Financial Incentives and Quasi-Mandatory Interventions for Preschool Vaccinations: Triangulation of Findings from Three Linked Studies.

BackgroundChildhood vaccinations are a core component of public health programmes globally. Recent measles outbreaks in the UK and USA have prompted debates about new ways to increase uptake of childhood vaccinations. Parental financial incentives and quasi-mandatory interventions (e.g. restricting entry to educational settings to fully vaccinated children) have been successfully used to increase uptake of childhood vaccinations in developing countries, but there is limited evidence of effectiveness in developed countries. Even if confirmed to be effective, widespread implementation of these interventions is dependent on acceptability to parents, professionals and other stakeholders.MethodsWe conducted a systematic review (n = 11 studies included), a qualitative study with parents (n = 91) and relevant professionals (n = 24), and an on-line survey with embedded discrete choice experiment with parents (n = 521) exploring acceptability of parental financial incentives and quasi-mandatory interventions for preschool vaccinations. Here we use Triangulation Protocol to synthesise findings from the three studies.ResultsThere was a consistent recognition that incentives and quasi-mandatory interventions could be effective, particularly in more disadvantaged groups. Universal incentives were consistently preferred to targeted ones, but relative preferences for quasi-mandatory interventions and universal incentives varied between studies. The qualitative work revealed a consistent belief that financial incentives were not considered an appropriate motivation for vaccinating children. The costs of financial incentive interventions appeared particularly salient and there were consistent concerns in the qualitative work that incentives did not represent the best use of resources for promoting preschool vaccinations. Various suggestions for improving delivery of the current UK vaccination programme as an alternative to incentives and quasi-mandates were made.ConclusionsParental financial incentives and quasi-mandatory interventions for increasing uptake of preschool vaccinations do not currently attract widespread enthusiastic support in the UK; but some potential benefits of these approaches are recognised.

Chromium supplements for glycemic control in type 2 diabetes: limited evidence of effectiveness.

Some adults with type 2 diabetes mellitus (T2DM) believe that chromium-containing supplements will help control their disease, but the evidence is mixed. This narrative review examines the efficacy of chromium supplements for improving glycemic control as measured by decreases in fasting plasma glucose (FPG) or hemoglobin A1c (HbA1c). Using systematic search criteria, 20 randomized controlled trials of chromium supplementation in T2DM patients were identified. Clinically meaningful treatment goals were defined as an FPG of ≤7.2 mmol/dL, a decline in HbA1c to ≤7%, or a decrease of ≥0.5% in HbA1c. In only a few randomized controlled trials did FPG (5 of 20), HbA1c (3 of 14), or both (1 of 14) reach the treatment goals with chromium supplementation. HbA1c declined by ≥0.5% in 5 of 14 studies. On the basis of the low strength of existing evidence, chromium supplements have limited effectiveness, and there is little rationale to recommend their use for glycemic control in patients with existing T2DM. Future meta-analyses should include only high-quality studies with similar forms of chromium and comparable inclusion/exclusion criteria to provide scientifically sound recommendations for clinicians.

Adaptive quizzing in introductory psychology: Evidence of limited effectiveness.

Adaptive quizzing in introductory psychology: Evidence of limited effectiveness.

Injury prevention in the meat industry: Limited evidence of effectiveness for ergonomic programs in reducing the severity of musculoskeletal injuries.

Injury prevention in the meat industry: Limited evidence of effectiveness for ergonomic programs in reducing the severity of musculoskeletal injuries.

Adverse events and the relation with quality of life in adults with intellectual disability and challenging behaviour using psychotropic drugs

BackgroundPsychotropic drugs are prescribed to approximately 30–40% of adults with intellectual disability (ID) and challenging behaviour, despite the limited evidence of effectiveness and the potential of adverse events. AimsTo assess the prevalence of adverse events in association with psychotropic drug use in adults with ID and challenging behaviour and to examine the relation of these adverse events with the person's quality of life. MethodThe presence of adverse events was measured with a questionnaire that had to be filled in by the physicians of the participants. Movement disorders were measured separately with a standardised protocol. The strength of the association between adverse events and Intellectual Disability Quality of Life-16 (IDQOL-16), and daily functioning was investigated using linear regression analyses, taking into account the severity of disease (CGI-S) as potential confounder. ResultsVirtually all of 103 adults with ID and challenging behaviour had at least one adverse event (84.4%) and almost half had ≥3 adverse events (45.6%) across different subclasses. Using psychotropic drugs increased the prevalence of adverse events significantly. Respectively 13% of the patients without psychotropic drugs and 61% of the patients with ≥2 psychotropic drugs had ≥3 adverse events. Having adverse events had a significantly negative influence on the quality of life. ConclusionsA large majority of all patients had at least one adverse event associated with psychotropic drug use. More attention is needed for these adverse events and their negative influence on the quality of life of these patients, taking into account the lack of evidence of effectiveness of psychotropic drugs for challenging behaviour.

Conceptualising Decadent Technology: A Case Study of Path Dependence in Radiotherapy

Large-scale investments in health technologies often have limited evidence for effectiveness when first introduced. Nevertheless, professional and public discourses often present the advantages of such investments, with unknown risks, as necessary and entailing significant improvement. Such discourses are evident with the introduction of the Linac Adapted Conebeam Imager (LACI), introduced to improve the accuracy of radiotherapy treatments. From one perspective, the introduction of such technologies can be considered to be decadent since there is limited, if any, evidence of improvement of current standards and procedures, yet they are promoted as the latest and best technologies for solving societal problems. Connecting the concepts of decadence to those of path dependence, through the case of the LACI, enables the exploration of the ‘technical interrelatedness’ of technological changes. Building on the concept of path dependence, it is possible to demonstrate how introducing a closely related technology does not only become a low-risk course of action. Rather change is demanded (but not determined) as well as potential alternative systems being obscured. With decadent technologies, any future changes are not only dependent upon past introductions; but also they create a need for future changes. Such a view demonstrates how these technologies may not necessarily offer any improvements, but rather contribute to the creation of ongoing demand for unproven technologies. As a result they may encourage the introduction of increasingly complex technologies.

Contracting for integrated health and social care: a critical review of four models

Purpose– Service transformation of health and social care is currently requiring commissioners to assess the suitability of their contracting mechanisms to ensure goodness of fit with the integration agenda. The purpose of this paper is to provide a description and critical account of four models of contracting, namely Accountable Care Organisations, the Alliance Model, the Lead Provider/Prime Contractor Model, and Outcomes-based Commissioning and Contracting.Design/methodology/approach– The approach taken to the literature review was narrative and the results were organised under an analytical framework consisting of six themes: definition and purpose; characteristics; application; benefits/success factors; use of incentives; and critique.Findings– The review highlighted that while the models have relevance, there are a number of uncertainties regarding their direct applicability and utility for the health and social care agenda, and limited evidence of effectiveness.Research limitations/implications– Due to the relative newness of the models and their emerging application, much of the commentary was limited to a narrow range of contributors and a broader discussion is needed. It is clear that further research is required to determine the most effective approach for integrated care contracting. It is suggested that instead of looking at individual models and assessing their transferable worth, there may be a place for examining principles that underpin the models to reshape current contracting processes.Practical implications– What appears to be happening in practice is an organic development. With the growing number of examples emerging in health and social care, these may act as “trailblazers” and support further development.Originality/value– There is emerging debate surrounding the best way to contract for health and social care services, but no literature review to date that takes these current models and examines their value in such critical detail. Given the pursuit for “answers” by commissioners, this review will raise awareness and provide knowledge for decision making.

Influenza vaccine effectiveness against laboratory confirmed influenza in Greece during the 2013–2014 season: A test-negative study

BackgroundIn 2013–2014 Greece experienced a resurgence of severe influenza cases, coincidental with a shift to H1N1pdm09 predominance. We sought to estimate Vaccine Effectiveness (VE) for this season using available surveillance data from hospitals (including both inpatients and outpatients). MethodsSwab samples were sent by hospital physicians to one of three laboratories, covering the entire country, to be tested for influenza using RT-PCR. The test-negative design was employed, with patients testing positive serving as cases and those testing negative serving as controls. VE was estimated using logistic regression, adjusted for age group, sex, region and calendar time, with further adjustment for unknown vaccination status using inverse response propensity weights. Additional age group stratified estimates and subgroup estimates of VE against H1N1pdm09 and H3N2 were calculated. ResultsOut of 1310 patients with known vaccination status, 124 (9.5%) were vaccinated, and 543 patients (41.5%) tested positive for influenza. Adjusted VE was 34.5% (95% CI: 4.1–55.3%) against any influenza, and 56.7% (95% CI: 22.8–75.7%) against H1N1pdm09. VE estimates appeared to be higher for people aged 60 and older, while in those under 60 there was limited evidence of effectiveness. Isolated circulating strains were genetically close to the vaccine strain, with limited evidence of antigenic drift. ConclusionsThese results suggest a moderate protective effect of the 2013–2014 influenza vaccine, mainly against H1N1pdm09 and in people aged 60 and over. Vaccine coverage was very low in Greece, even among groups targeted for vaccination, and substantial efforts should be made to improve it. VE can and should be routinely monitored, and the results taken into account when deciding on influenza vaccine composition for next season.

Insurer Views on Reimbursement of Preventive Services in the Dental Setting: Results From a Qualitative Study

We explored insurers' perceptions regarding barriers to reimbursement for oral rapid HIV testing and other preventive screenings during dental care. We conducted semistructured interviews between April and October 2010 with a targeted sample of 13 dental insurance company executives and consultants, whose firms' cumulative market share exceeded 50% of US employer-based dental insurance markets. Participants represented viewpoints from a significant share of the dental insurance industry. Some preventive screenings, such as for oral cancer, received widespread insurer support and reimbursement. Others, such as population-based HIV screening, appeared to face many barriers to insurance reimbursement. The principal barriers were minimal employer demand, limited evidence of effectiveness and return on investment specific to dental settings, implementation and organizational constraints, lack of provider training, and perceived lack of patient acceptance. The dental setting is a promising venue for preventive screenings, and addressing barriers to insurance reimbursement for such services is a key challenge for public health policy.

One Size Does Not Fit All in Treatment of Intimate Partner Violence

A critical examination is needed of the often mandated one-size-fits-all Duluth intervention for male perpetrators of intimate partner violence (IPV). The underlying philosophy of Duluth-based interventions is evaluated as well as the treatment outcome literature for this intervention. There is very little evidence to justify the current legal system practice of mandating all perpetrators to psychological interventions addressing power and control issues. A literature review of scientific findings with IPV perpetrators and the issues that need to be taken into consideration in developing alternative evidence-based interventions are presented. The evidence seems to favor heterogeneity and not homogeneity with respect to both type of perpetrator and type of violence. Assessment and treatment suggestions are made to address this evidence-based heterogeneity and a call is made to those responsible to stop perpetuating the practice of mandating all perpetrators to attend a single intervention for which there is very limited evidence of effectiveness. About two-thirds of male perpetrators of IPV cease being physically aggressive against their partners if they are assigned to a probation officer, but there is minimal evidence that the addition of a Duluth-based intervention makes perpetration less likely.

Mixed-method process evaluation of the Welsh National Exercise Referral Scheme

Purpose Primary-care referral to community-based exercise specialists (exercise referral) is common in the UK despite limited evidence of effectiveness. A recent pragmatic randomised trial of the Welsh National Exercise Referral Scheme (NERS), demonstrated promising impacts upon physical activity and mental health. This paper presents a mixed-method process evaluation exploring how outcomes were achieved.

Subacute effects of inhaled Jet Fuel-A (Jet A) on airway and immune function in female rats

Two studies were conducted to assess the potential airway and immune effects following subacute (14 d) exposure of female rats to 500, 1000 or 2000 mg/m3 of Jet-A for 4 h/d. The first study used Sprague-Dawley rats; the second study included both Fischer 344 (F344) and Sprague-Dawley rats. In the first study, exposure to 2000 mg/m3 jet fuel may have caused significant upper airway inflammation on day 7 post-exposure, as indicated by elevated protein and lactate dehydrogenase in nasal lavage fluid, but any inflammation resolved by day 14 post-exposure. No significant impact on immune cell populations in the spleens was observed. The histological examination showed no evidence of infectious or toxic effect. In the second study, body weights of the F344 rats in the 2000 mg/m3 group were depressed, as compared to the controls, at the end of the exposure. Some lung lavage fluid markers were increased at 24 h after the final exposure, however, no test article-induced histological changes were observed in the lungs, nasal cavities, or any other tissue of any of the jet fuel exposed animals. Overall, these studies demonstrated limited evidence of effects of 14 d of exposure to Jet A on the airways, immune system, or any other organ or system of female Sprague-Dawley and F344 rats, with no remarkable differences between strains. The lack of identified significant airway or immune effects was in contrast to previous examinations of jet fuel for pulmonary toxicity in mice and rats and for immunotoxicity in mice.

Are Oxygen-Conserving Devices Effective for Correcting Exercise Hypoxemia?

Correction of exercise hypoxemia in advanced lung diseases is crucial and often challenging. However, oxygen-conserving devices have been introduced in the market with limited evidence of effectiveness. In the present study the efficacy of 2 oxygen-conserving devices, a pulse demand oxygen delivery (DOD) system and pendant reservoir cannula (PRC), were evaluated in subjects with COPD and interstitial lung disease (ILD). A cross-sectional, crossover study included 28 COPD and 31 ILD subjects with oxygen desaturation on the 6-min walk test (average S(pO2) < 88%). Each subject underwent 3 walk tests with DOD, PRC, and continuous oxygen flow by standard nasal cannula (CFNC), in random order, taking average S(pO2) ≥ 90% as the resaturation criterion. Exercise desaturation was corrected in 79%, 79%, and 86% of COPD subjects with CFNC, DOD, and PRC, respectively, and in 77%, 61%, and 81% of ILD subjects with CFNC, DOD, and PRC, respectively. When compared to CFNC, the oxygen-conserving devices showed similar efficacy, except a lower performance for the DOD in the ILD subjects (P = .01). Although these oxygen-conserving devices corrected exercise hypoxemia in most COPD and ILD subjects, correction was not achieved in about 20% of the severe COPD subjects, regardless of the device, and in nearly 40% of the ILD subjects with the DOD device. These findings underscore that individualized adjustment of oxygen flow is needed for optimal correction of exercise hypoxemia, especially with a DOD in an ILD patient. (ClinicalTrials.gov NCT01086891).

Effectiveness of physical activity and dietary interventions in South Asian populations: a systematic review

Physical activity and dietary change interventions can prevent or delay a range of chronic disease. Little is known in primary care about their effectiveness in South Asian populations, who are often at higher risk of developing such diseases. To assess evidence for effectiveness of primary care based physical activity and dietary interventions in South Asian populations, and identify methods to inform future intervention development. Systematic review. Intervention studies conducted in developed countries that reported data for South Asian adults were sought by searching electronic databases, trial registries, and conference proceedings. Following wider screening of titles and abstracts, 119 full articles were reviewed. Of the 119 articles, four studies met the inclusion criteria and evaluated community-based interventions with South Asian individuals. Methodological quality was poor overall. Interventions appeared generally effective in promoting a decrease in weight, with some positive changes in blood pressure and biochemical outcomes, such as cholesterol. There was limited evidence for effects on behaviour. Theoretical frameworks were not identified and evidence on attitudinal or knowledge-based outcomes was sparse. The inclusion of individual feedback and community workers in communities of deprivation appeared important to the acceptability of the interventions. Information distinguishable for South Asian individuals within intervention studies of general populations was lacking. Physical activity and dietary interventions with South Asian populations show modest promise but, given the paucity of controlled evaluations or use of objective measures, outcomes are difficult to interpret. Potential insights may be missed if experience concerning South Asian groups within studies is not reported. Further development of culturally appropriate interventions that are theoretically informed and assessed in experimental designs are required.