Evidence Base For Clinical Practice Research Articles

Endorsement of open science practices by dental journals: A meta-research study

ObjectivesThis study evaluates the endorsement of open science practices by dental journals. Materials and methodsThis was a meta-research study that included journals listed in the 2021 Journal Citation Reports under Dentistry. A comprehensive evaluation was performed by accessing journal websites to ascertain the availability of publicly accessible instructions to authors in Portuguese, English, or Spanish. A researcher extracted information from the "Instructions for Authors" section, encompassing the journal's impact factor, mention of any reporting guidelines, details on data sharing, acceptance of articles in preprint format, and information regarding study protocol registration. Descriptive data analysis was conducted using the Stata 14.0 program, and an Open Science Score (OSS) (ranging from 0 to 100 %) was calculated for each journal by considering five open science practices. Pearson's correlation test was conducted to determine the relationship between the OSS score and journal impact factor. ResultsNinety journals were included in the study. Most journals (70 %) indicated the mandatory use of reporting guidelines, while 60 % recommended data sharing. Conversely, 46.7 % did not provide information on study protocol registration, and 44.4 % stipulated them as mandatory for authors. Regarding preprints, 50 % of the journals did not provide any information, but 46.7 % confirmed their acceptance. The mean OSS was 52.9 % (standard deviation 26.2). There was a weak correlation (Pearson's correlation coefficient of 0.221) between the journal impact factor and OSS (P-value=0.036). ConclusionThis study found varying degrees of endorsement of open science practices among dental journals. Clinical significanceDental practitioners rely on high-quality, evidence-based research for informed decision-making. By assessing the endorsement of open science practices, our study contributes to improving the quality and reliability of dental research, ultimately enhancing the evidence base for clinical practice.

Percutaneous vertebroplasty versus percutaneous kyphoplasty for osteoporotic vertebral compression fractures: an umbrella review protocol of systematic reviews and meta-analyses

IntroductionSeveral systematic reviews and meta-analyses have confirmed that percutaneous vertebroplasty and percutaneous kyphoplasty showed safety and beneficial efficacy in patients with osteoporotic vertebral compression fractures. Whereas, there is wide variation...

Abstract A064: My Choices: A multilevel, multicomponent intervention to improve informed decision-making about clinical trial participation among cancer patients

Abstract Background: Knowledge gained through cancer clinical trials (CTs) has been proven critical to preventing, diagnosing and treating the disease, and providing the evidence base for clinical practice. Major advances in cancer treatment, which are essential for improving patients’ outcomes, come from investigations of new therapeutic agents in CTs. Despite the large number of available studies and improvements in public awareness about CTs, participation of underrepresented minorities in clinical research has been persistently low, with only 2-5% of Latinos and African Americans participating in cancer treatment trials. Barriers to participation are multilevel, complex, and multifactorial, including study design, healthcare system barriers, and patient- and medical team-related factors. Structural inequities, social determinants of health (SDoH), distrust of government, patient-doctor communications, cultural and language barriers, and lower levels of health literacy are barriers for Latino and African American populations. Purpose: To improve informed decision-making about cancer CT participation among cancer patients and community members through a bilingual multilevel, multi-communication approach, including: 1) a 2-group parallel randomized controlled educational trial, and 2) a community awareness campaign. Methods: The randomized study involves 400 patients from the Mays Cancer Center. The intervention group receives 1) a bilingual educational video on CTs with patients’ testimonials, 2) a low literacy booklet, 3) support from a patient navigator (PN), and 4) Salud America! weekly emails with links to online/social media posts on CT. The control group receives a general fact sheet on CTs. Healthcare providers involved in clinical research are invited to participate in Webinars to raise awareness of implicit bias and the importance of inclusive research. The community intervention features a prospective single-group pre/post design, where participants (400) act as their own controls. They receive an educational session on CTs provided by a community health educator + a low literacy booklet. Results: Focus groups guided the development of the video script, booklet, and educational materials. The short video features real cancer patients sharing their experiences with CTs and how they overcame common barriers. Study recruitment began in February 2023. So far, we have recruited 36 cancer patients with a mean age of 51 years, 80% White and 61% Hispanic/Latino, 64% married, 44% had Medicare/Medicaid; 36% < high school education; and 33% earned <$40K. Preliminary results will be presented. Conclusions: Multilevel interventions involving culturally tailored decision aids (i.e., video, booklet) in combination with PN support can effectively address common barriers influencing patient decision-making, raise awareness of CTs, and increase positive attitudes, intentions, and participation in CTs among groups experiencing SDoH. Citation Format: Patricia Chalela, Vivian Cortez, Armida Flores, Sandra Sivak, Edgar Munoz, Cliff Despres, Callie Rainosek, Alyssa Gonzalez, Mio Kitano, Virginia Kaklamani, Kate Lathrop, Sukeshi Arora, Andrew Brenner, Deepak K. Pruthi, Amelie G. Ramirez. My Choices: A multilevel, multicomponent intervention to improve informed decision-making about clinical trial participation among cancer patients [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr A064.

"A wolf in sheep's clothing": when so-called placebo interventions are not what they seem.

"A wolf in sheep's clothing": when so-called placebo interventions are not what they seem.

Abstract P6-05-22: Multilevel, Multicomponent Intervention to Improve Informed Decision-Making about Clinical Trial Participation among Cancer Patients

Abstract Background: Knowledge gained through cancer clinical trials (CTs) has been proven critical to preventing, diagnosing and treating the disease, and providing the evidence base for clinical practice. Major advances in cancer treatment, which are essential for improving patients’ outcomes, come from investigations of new therapeutic agents in CTs. Despite the large number of available studies and improvements in public awareness about CTs, participation of underrepresented minorities in clinical research has been persistently low, with only 2 to 5% of Latinos and African Americans participating in cancer treatment trials. Barriers to participation are multilevel, complex, and multifactorial, including study design, healthcare system barriers, and patient- and medical team-related factors. Structural inequities, social determinants of health, distrust of government, patient-doctor communication, cultural and language barriers, and lower levels of health literacy have all been cited as common barriers for Latino and African American populations. Purpose: To improve informed decision-making about cancer CT participation among cancer patients and community members through a bilingual multilevel, multi-communication approach, including 1) a randomized controlled educational trial (clinic-based settings), and 2) a community education module (community-based settings). We will assess the impact of the intervention on awareness, attitudes, self-efficacy, and intentions to consider CTs as an appropriate treatment option for cancer and improve CT participation rates. Methods: The clinical setting includes a 2-group, parallel, randomized study with 400 patients from the Mays Cancer Center. The intervention group receives 1) a bilingual educational video on CTs, 2) a low literacy booklet, 3) support from a patient navigator (PN), and 4) an invitation to join our Salud America! network providing online/social media CT information. The control group receives a general fact sheet on CTs. All healthcare providers involved in clinical research will participate in Webinars to raise awareness of implicit bias and the importance of inclusive research. The community-setting intervention features a prospective single-group pre/post design, where participants (400) act as their own controls. They will receive an educational session on CTs provided by a community health educator + a low literacy booklet. Results: Focus groups guided the development of the video script, booklet, and educational materials. The short video features real cancer patients sharing their experience with CTs and how they overcame common barriers. Patient recruitment starts in August 2022. Preliminary results will be presented. Conclusions: Multilevel interventions involving culturally tailored decision aids (i.e., online video, low literacy booklet) in combination with care coordination by a PN can effectively address common barriers influencing patient decision-making regarding CTs, raise awareness, and increase positive attitudes and CT participation among specific groups with low participation in clinical research. Keywords: health equity, clinical trials, Latinos, underrepresented groups Citation Format: Patricia Chalela, Vivian Cortez, Armida Flores, Sandra Sivak, Ysabel Lew, Edgar Munoz, Cliff Despres, Callie Rainosek, Alyssa Gonzalez, Amara Ali, Ruben Mesa, Amelie Ramirez. Multilevel, Multicomponent Intervention to Improve Informed Decision-Making about Clinical Trial Participation among Cancer Patients [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-22.

The Past, Present, and Future of Podiatry.

The Past, Present, and Future of Podiatry.

Recruiting and retaining participants in three randomised controlled trials of psychological interventions conducted on acute psychiatric wards: top ten tips for success.

It is essential to conduct randomised controlled trials of psychological interventions on acute psychiatric wards to build a robust evidence base for clinical practice. This paper aims to share strategies from three different in-patient trials that successfully recruited and retained participants, to disseminate good practice for the conduct of future trials in this challenging and complex clinical setting. We present strategies from three in-patient trials of psychological interventions: TULIPS (Talk, Understand, Listen for Inpatient Settings), amBITION (Brief Talking Therapies on Wards) and INSITE (Inpatient Suicide Intervention and Therapy Evaluation). All studies recruited participants from acute in-patient wards, initiated therapy within the in-patient setting and followed up on participants post-discharge. We summarise our recommendations for good practice in the form of ten top tips for success, based on our collective experience of conducting trials on psychiatric wards. Key themes relate to the importance of relationships between the research team and clinical staff; good stakeholder involvement and getting early buy-in from the team; and adapting to the particular demands of the clinical setting. Sharing good practice recommendations can help reduce research waste arising from poor recruitment and/or retention in future in-patient clinical trials.

Evaluation of the design, conduct and reporting of randomised controlled trials in the haemodialysis population: a scoping review and interview study.

BackgroundFewer trials are conducted in nephrology than any other specialty, often failing to recruit to target, resulting in unclear evidence affecting translation to clinical practice. This mixed-methods study aims to provide guidance for designing and reporting future randomised controlled trials (RCTs) in the haemodialysis population.MethodA scoping review was conducted. Five databases (MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Embase, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov) were searched for RCTs published between 2013 and 2019 involving prevalent adult haemodialysis patients. Reporting of sample size, recruitment, retention and statistical significance of primary outcome were assessed. Face-to-face semistructured interviews were conducted with individuals from a single centre during dialysis sessions. Interviews were analysed thematically.ResultsOf 786 RCTs identified, 636 (80.9%) were parallel-group, 139 (17.7%) were crossover and 11 (1.4%) were cluster (including one stepped-wedge) design. Sample size justification was reported in 73.1%, 53.8% and 45.5% of parallel-group, crossover and cluster trials, respectively.Target recruitment was achieved by 45.5% of cluster, 53.8% of crossover and 57.7% of parallel-group trials with patient retention at 75.6%, 83.1% and 87.8%, respectively. Primary outcome reached statistical significance in 81.8% of cluster trials, 69.2% of parallel-group and 38.5% of crossover trials.Themes identified from individual interviews: perceptions of the convenience of trial participation; group allocation; perceptions of the benefits and adverse effects of taking part in clinical trials.ConclusionThe recruitment and reporting of RCTs involving people on haemodialysis could be improved. Involvement of all stakeholders and especially participants in the trial design process may address issues around participant burden and ultimately improve the evidence base for clinical practice.

Associations between metabolic syndrome and female stress urinary incontinence: a meta-analysis.

The objective was to identify the associations between metabolic syndrome (MS) and stress urinary incontinence (SUI) in women and to provide an evidence base for clinical practice. A meta-analysis of cohort, case-control, and cross-sectional studies about the association between MS and SUI was performed using databases including PubMed, Cochrane Library, Web of Science, Embase, China National Knowledge Infrastructure (CNKI), China Biology Medicine disc (CBMdisc), Wanfang Database (WanFang Data), and VIP database (VIP). The time limit was from the commencement of each database to 1 November 2020. Two researchers independently screened literature, extracted data, and assessed the risk of bias. RevMan 5.3 software was used for statistical analysis. The dichotomous variables were presented as the risk ratio (odds ratio, OR) and 95% CI as the effect indicators. Six studies were included in the meta-analysis, with a total sample size of 3,678 cases. The results showed that the risk for SUI in women with MS was three times those without MS (OR = 3.41, 95% CI 2.01, 5.77, p <0.00001), and the difference was statistically significant. The results of subgroup analysis showed that MS was significantly associated with SUI in the subgroups of pre- and postmenopausal women (OR = 2.46, 95% CI 1.63, 3.73, p < 0.00001), and in the subgroups of other types of women (OR = 3.41, 95% CI 2.01, 5.77, p = 0.0003), and the differences were statistically significant. Metabolic syndrome is associated with SUI in women and increases its risk.

Animal-Assisted Intervention in Speech-Language Pathology: Practical, Clinical, and Theoretical Considerations.

Interest in animal-assisted interventions within the field of communication sciences and disorders is growing. As more clinicians become interested in engaging in animal-assisted therapy (AAT) and more researchers begin to study its potential benefits, it will be critical for all stakeholders to demonstrate knowledge of the standards and qualifications for service delivery as well as the challenges that must be met in developing an evidence base for clinical practice. This review highlights some of the foundational information relevant to AAT in the context of speech-language pathology.

Development of Biostatistics: From Past to Future

Biostatistics which is the application of statistics in the field of health and biology; provides powerful tools for creating questions, designing studies, developing measurements, and analyzing data and has an important place in determining the efficacy and safety of products such as drugs and vaccines. The impact of statistical sciences on medical and biological sciences has increased rapidly during the last few decades. Clinicians need to understand statistics well enough to follow up and evaluate empirical studies that provide an evidence base for clinical practice. Recent advances in biomedical research have created both new challenges and opportunities for statisticians and data scientists. Big data analytics, precision medicine, artificial intelligence, causal inference, and other new research resources inspire data scientists to develop modern statistical methods and innovative inference procedures. Therefore new philosophies such as causal models and prediction, new models such as graphical chain models and random effects models, faster computers and new clever algorithms for integration and maximization are needed. Without adequate investment in biostatistics, all medical research is at a significant risk of “drowning in data, but starving for knowledge”.

Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study

Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. In this cohort study, we set out to assess compliance. We downloaded data for all registered trials on ClinicalTrials.gov each month from March, 2018, to September, 2019. All cross-sectional analyses in this manuscript were performed on data extracted from ClinicalTrials.gov on Sept 16, 2019; monthly trends analysis used archived data closest to the 15th day of each month from March, 2018, to September, 2019. Our study cohort included all applicable trials due to report results under FDAAA. We excluded all non-applicable trials, those not yet due to report, and those given a certificate allowing for delayed reporting. A trial was considered reported if results had been submitted and were either publicly available, or undergoing quality control review at ClinicalTrials.gov. A trial was considered compliant if these results were submitted within 1 year of the primary completion date, as required by the legislation. We described compliance with the FDAAA 2007 Final Rule, assessed trial characteristics associated with results reporting using logistic regression models, described sponsor-level reporting, examined trends in reporting, and described time-to-report using the Kaplan-Meier method. 4209 trials were due to report results; 1722 (40·9%; 95% CI 39·4-42·2) did so within the 1-year deadline. 2686 (63·8%; 62·4-65·3) trials had results submitted at any time. Compliance has not improved since July, 2018. Industry sponsors were significantly more likely to be compliant than non-industry, non-US Government sponsors (odds ratio [OR] 3·08 [95% CI 2·52-3·77]), and sponsors running large numbers of trials were significantly more likely to be compliant than smaller sponsors (OR 11·84 [9·36-14·99]). The median delay from primary completion date to submission date was 424 days (95% CI 412-435), 59 days higher than the legal reporting requirement of 1 year. Compliance with the FDAAA 2007 is poor, and not improving. To our knowledge, this is the first study to fully assess compliance with the Final Rule of the FDAAA 2007. Poor compliance is likely to reflect lack of enforcement by regulators. Effective enforcement and action from sponsors is needed; until then, open public audit of compliance for each individual sponsor may help. We will maintain updated compliance data for each individual sponsor and trial at fdaaa.trialstracker.net. Laura and John Arnold Foundation.

Using a Delphi Survey to Develop Clinical Nursing Research Priorities Among Nursing Management.

The aim of this study was to identify clinical nursing research priorities among nurse managers (NMs). Determining research priorities is the 1st step toward building a solid evidence base for clinical practice. NMs are well poised to identify research priorities, and yet, a literature review revealed a dearth of research priorities as determined by clinical NMs. Using a Delphi survey, 38 NMs were queried at a large, urban hospital regarding critical priorities for nursing research. Critical priorities for clinical nursing research included nursing workforce/nursing workflow and communication (categorized as critical by 68% and 53% of NMs, respectively). Other important priorities focused on falls/patient safety/hospital-acquired infections, patient/family satisfaction, emergency preparedness, patient outcomes, and collaboration/interdisciplinary research. Because NMs are positioned to direct clinical research agendas, the results provide a critical guide for policy development surrounding nursing research. Directing research toward these identified topics will help build a solid evidence base for nurses and ultimately improve patient outcomes.

Considerations from the 2017 IMFAR Preconference on Measuring Meaningful Outcomes from School-Age to Adulthood.

The autism spectrum disorder (ASD) research community is increasingly considering the importance of measuring outcomes that are meaningful to individuals with ASD and their families. The 2017 IMFAR preconference aimed to gain the perspectives of how to define and measure "meaningful outcomes" from 280 participants, including people with ASD and their families, service providers, and researchers. Six themes were identified: (a) the definition of "outcome" varies by context and perspective; (b) the need to broaden the scope of what researchers measure; (c) the need for new assessment tools; (d) the need to expand data analytic methods; (e) where to focus (with emphasis on considering different developmental stages and aspects of diversity); and (f) a need for community partnerships to bridge research and daily practice. The challenge that the research community now faces is how to move the evidence base for clinical practice forward while keeping alive the divergence of views and considerations that are relevant for thinking about complex outcomes for the highly heterogeneous group of individuals with ASD. This commentary provides recommendations, with an emphasis on lifespan viewpoints that encompass individual strengths and preferences. Autism Research 2018, 11: 1446-1454. © 2018 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: The 2017 IMFAR preconference aimed to gain the perspectives of how to define and measure "meaningful outcomes" from a variety of stakeholders. This commentary outlines the six themes identified from keynote and panel presentations and audience-participated discussions. Recommendations are made to emphasize perspectives that look across the lifespan and encompass individual strengths and preferences.

What do speech–language pathologists describe as most important when trying to achieve client participation during aphasia rehabilitation? A qualitative focus group interview study

Purpose: The aim of this study was to investigate what speech–language pathologists describe as most important when trying to achieve client-oriented participation during aphasia rehabilitation.Method: A qualitative study including semi-structured focus group interviews with 11 speech–language pathologists. Interviews were analysed with the use of systematic text condensation.Result: Four main themes emerged from the analysis. (1) It is important to take the vulnerability of the client group into account. (2) It is important to address the client’s process of realisation by navigating around unrealistic wishes and goals. (3) It is challenging to involve clients when the evidence-base for clinical practice is limited. (4) It is crucial to make therapy meaningful to the client.Conclusion: This study showed that speech–language pathologists perceived prediction of a clinical course in aphasia rehabilitation as challenging due to the vulnerable client group and the perceived need to guide the clients through the rehabilitation process. They talked about how unrealistic client goals, and the lack of a solid evidence-base to guide their clinical practice, made collaborative goal setting and treatment planning challenging. Due to these barriers, the speech–language pathologists struggled to achieve client participation, and thereby aphasia rehabilitation could not be described as fully client-oriented.

Standardising the reporting of outcomes in gastric cancer surgery trials: protocol for the development of a core outcome set and accompanying outcome measurement instrument set (the GASTROS study)

BackgroundGastric cancer is one of the leading causes of cancer-related deaths worldwide. Whilst surgery is the mainstay of curative treatment, it is associated with significant risks. Surgical strategies for treating gastric cancer should be based on evidence from systematic reviews of well-designed randomised controlled trials. However, inconsistencies in the reporting of outcomes from these trials makes evidence synthesis unreliable. We present a protocol for an international consensus study to develop a standardised set of outcomes and measurement tools – a ‘core outcome set’ (COS) – to be used by all future trials examining therapeutic surgical interventions for gastric cancer. The GASTROS study aims to standardise the reporting of outcomes in gastric cancer surgery trials through an international consensus process of key stakeholders including health care professionals and patients.MethodsThe first of three stages in the study will identify a ‘long-list’ of potentially important outcomes to be prioritised. These will be extracted from a systematic review of relevant academic literature and patient interviews. Stage 2 will comprise an eDelphi survey which will consider the views of patients, nurse specialists and surgeons to prioritise the most important outcomes. A meeting of stakeholder representatives will ratify the COS.Stage 3 will focus on identifying appropriate instruments to measure the prioritised outcomes by means of quality assessment of available measurement instruments and stakeholder consultation.DiscussionThis study aims to standardise the reporting of outcomes in future trials examining therapeutic surgical interventions for gastric cancer. It is anticipated that standardisation of outcome reporting in these surgical effectiveness trials will enhance the evidence base for clinical practice. Highlighting outcomes of greatest importance to patients will ensure that their perspectives are central to research in this field.

A randomised controlled trial of PEGASUS, a psychoeducational programme for young people with high-functioning autism spectrum disorder.

BackgroundPsychoeducation is an essential component of postdiagnostic care for people with ASD (autism spectrum disorder), but there is currently no evidence base for clinical practice. We designed, manualised and evaluated PEGASUS (psychoeducation group for autism spectrum understanding and support), a group psychoeducational programme aiming to enhance the self-awareness of young people with ASD by teaching them about their diagnosis.MethodsThis single-blind RCT (randomised control trial) involved 48 young people (9–14 years) with high-functioning ASD. Half were randomly assigned to PEGASUS, administered in six weekly group sessions, with the others receiving no additional intervention. ASD-related self-awareness, the primary outcome, was evaluated using the bespoke Autism Knowledge Quiz (AKQ). Secondary outcome measures included the Rosenberg Self-Esteem Scale. All measures were collected during home visits and scored by researchers blind to group assignment. The trial is registered on ClinicalTrials (NCT01187940, http://www.clinicaltrials.gov) and was funded by the Baily Thomas Charitable Trust.ResultsBootstrap multiple regression showed ASD knowledge (β = .29, p <. 001, 95% CIs [0.13, 0.44]) and ASD self-awareness (β = .42, p =. 001, 95% CIs [0.17, 0.67]), measured by number of ASD-related personal strengths and difficulties listed by participants, increased for those who attended PEGASUS (n = 24) compared with controls (n = 24). There was no effect of PEGASUS on self-esteem by self-report (β =. 10, p =. 404, 95% CIs [−0.14, 0.35]) or parent report (β =. 12, p =. 324, 95% CIs [−0.12, 0.36]).ConclusionsAfter PEGASUS, participants had more general knowledge about ASD, and showed a greater awareness of their collection of unique strengths and difficulties associated with ASD. Psychoeducation did not lower self-esteem. This RCT provides initial evidence for PEGASUS's efficacy as a psychoeducation programme for people with ASD.

Implications of using different methods to characterise anticoagulant control in patients with second generation mechanical heart valve prostheses.

ObjectiveCharacterisation of anticoagulant control is fundamental to investigations of its association with clinical outcome. Anticoagulant control depends on several factors. This paper aims to illustrate the implications of different methods for measuring and analysing anticoagulant control in patients with second generation mechanical heart valve prostheses.MethodsInternational normalised ratio (INR) data collected during the 10-year follow-up of a randomised controlled trial were analysed. We considered the influence of: 3 different target INR ranges; anticoagulant control expressed as the proportion of INR readings (PoR) vs. anticoagulant control follow-up time (PoT); 3 ways of describing the profile of anticoagulant control over time.ResultsDifferent target INR ranges dramatically influenced derived measures of anticoagulant control; the PoT within the target range varied from 88% for the widest to 28% for narrowest range. Overall distributions of PoR and PoT observations were similar but differed by up to ±20% for individuals; PoT exceeded PoR when control was good but was less than PoR when control was poor. Classifying PoT outside the target range showed that widely varying combinations of PoT too high and too low are possible across individuals.ConclusionsResearchers' choices about methods for measuring and quantifying anticoagulant control markedly influence the values derived from INR readings. The use of different methods across studies makes it difficult or impossible to compare findings and to establish an evidence base for clinical practice. Methods for quantifying anticoagulant control should be standardised.

Single-case experimental designs: Reflections on conduct and analysis

In this editorial discussion we reflect on the issues addressed by, and arising from, the papers in this special issue on Single-Case Experimental Design (SCED) study methodology. We identify areas of consensus and disagreement regarding the conduct and analysis of SCED studies. Despite the long history of application of SCEDs in studies of interventions in clinical and educational settings, the field is still developing. There is an emerging consensus on methodological quality criteria for many aspects of SCEDs, but disagreement on what are the most appropriate methods of SCED data analysis. Our aim is to stimulate this ongoing debate and highlight issues requiring further attention from applied researchers and methodologists. In addition we offer tentative criteria to support decision-making in relation to the selection of analytical techniques in SCED studies. Finally, we stress that large-scale interdisciplinary collaborations, such as the current Special Issue, are necessary if SCEDs are going to play a significant role in the development of the evidence base for clinical practice.

Evidence‐based genetic counselling implications for Huntington disease intermediate allele predictive test results

Intermediate alleles (IAs) for Huntington disease (HD) contain 27-35 CAG repeats, a range that falls just below the disease threshold of 36 repeats. While there is no firm evidence that IAs confer the HD phenotype, they are prone to germline CAG repeat instability, particularly repeat expansion when paternally transmitted. Consequently, offspring may inherit a new mutation and develop the disease later in life. Over the last 5 years there has been a renewed interest in IAs. This article provides an overview of the latest research on IAs, including their clinical implications, frequency, haplotype, and likelihood of CAG repeat expansion, as well as patient understanding and current genetic counselling practices. The implications of this growing evidence base for clinical practice are also highlighted. These evidence-based genetic counselling implications may help ensure individuals with an IA predictive test result receive appropriate support, education, and counselling.