Template For Replication Research Articles

Changes in a Digital Type 2 Diabetes Self-management Intervention During National Rollout: Mixed Methods Study of Fidelity

"Healthy Living for People with type 2 Diabetes (HeLP-Diabetes)" was a theory-based digital self-management intervention for people with type 2 diabetes mellitus that encouraged behavior change using behavior change techniques (BCTs) and promoted self-management. HeLP-Diabetes was effective in reducing HbA1c levels in a randomized controlled trial (RCT). National Health Service (NHS) England commissioned a national rollout of HeLP-Diabetes in routine care (now called "Healthy Living"). Healthy Living presents a unique opportunity to examine the fidelity of the national rollout of an intervention originally tested in an RCT. This research aimed to describe the Healthy Living BCT and self-management content and features of intervention delivery, compare the fidelity of Healthy Living with the original HeLP-Diabetes intervention, and explain the reasons for any fidelity drift during national rollout through qualitative interviews. Content analysis of Healthy Living was conducted using 3 coding frameworks (objective 1): the BCT Taxonomy v1, a new coding framework for assessing self-management tasks, and the Template for Intervention Description and Replication. The extent to which BCTs and self-management tasks were included in Healthy Living was compared with published descriptions of HeLP-Diabetes (objective 2). Semistructured interviews were conducted with 9 stakeholders involved in the development of HeLP-Diabetes or Healthy Living to understand the reasons for any changes during national rollout (objective 3). Qualitative data were thematically analyzed using a modified framework approach. The content analysis identified 43 BCTs in Healthy Living. Healthy Living included all but one of the self-regulatory BCTs ("commitment") in the original HeLP-Diabetes intervention. Healthy Living was found to address all areas of self-management (medical, emotional, and role) in line with the original HeLP-Diabetes intervention. However, 2 important changes were identified. First, facilitated access by a health care professional was not implemented; interviews revealed this was because general practices had fewer resources in comparison with the RCT. Second, Healthy Living included an additional structured web-based learning curriculum that was developed by the HeLP-Diabetes team but was not included in the original RCT; interviews revealed that this was because of changes in NHS policy that encouraged referral to structured education. Interviewees described how the service provider had to reformat the content of the original HeLP-Diabetes website to make it more usable and accessible to meet the multiple digital standards required for implementation in the NHS. The national rollout of Healthy Living had good fidelity to the BCT and self-management content of HeLP-Diabetes. Important changes were attributable to the challenges of scaling up a digital intervention from an RCT to a nationally implemented intervention, mainly because of fewer resources available in practice and the length of time since the RCT. This study highlights the importance of considering implementation throughout all phases of intervention development.

Protocol for a meta-research study of protocols for diet or nutrition-related trials published in indexed journals: general aspects of study design, rationale and reporting limitations

IntroductionThe Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) reporting guideline establishes a minimum set of items to be reported in any randomised controlled trial (RCT) protocol. The Template for...

A collaborative care package for depression comorbid with chronic physical conditions in South Africa

IntroductionA task-sharing collaborative care model for integrated depression care for South Africa’s burgeoning primary health care population with chronic conditions was developed and tested through two pragmatic cluster randomized controlled trials. One trial focused on patients with hypertension and was located in one district where a collaborative care model was co-designed with district stakeholders. The other trial, focused on patients on antiretroviral treatment, was located in the same district site, with the addition of a second neighbouring district, without adaptation of the original model. This paper describes the package used to implement this model, and implementation outcomes across the two sites, and summarises lessons and challenges.MethodsThe Template for Intervention Description and Replication (TIDieR) framework, adapted for complex health systems interventions, was used to describe components of the package. Additional elements of ‘modifications made’ and ‘actual implementation’ introduced in the ‘Getting messier with TIDieR’ framework, were used to describe implementation outcomes in terms of reach, adoption and implementation across the two trial districts.ResultsIn the absence of a co-design process to adapt the model to the context of the second site, there was less system level support for the model. Consequently, more project employed human resources were deployed to support training of primary care nurses in identification and referral of patients with depression; and supervise co-located lay counsellors. Referrals to co-located lay counselling services were more than double in the second site. However, uptake of counselling sessions was greater in the first site. This was attributed to greater in-vivo supervision and support from existing mental health specialists in the system. There was greater reliance on online supervision and support in the second site where geographical distances between clinics were larger.ConclusionThe need for in-country co-designed collaborative care models, and ‘implementation heavy’ implementation research to understand adaptations required to accommodate varying in-country health system contexts is highlighted.

Pregenomic RNA Launch Hepatitis B Virus Replication System Facilitates the Mechanistic Study of Antiviral Agents and Drug-Resistant Variants on Covalently Closed Circular DNA Synthesis.

Hepatitis B virus (HBV) replicates its genomic DNA by reverse transcription of an RNA intermediate, termed pregenomic RNA (pgRNA), within nucleocapsid. It had been shown that transfection of in vitro-transcribed pgRNA initiated viral replication in human hepatoma cells. We demonstrated here that viral capsids, single-stranded DNA, relaxed circular DNA (rcDNA) and covalently closed circular DNA (cccDNA) became detectable sequentially at 3, 6, 12, and 24 h post-pgRNA transfection into Huh7.5 cells. The levels of viral DNA replication intermediates and cccDNA peaked at 24 and 48 h post-pgRNA transfection, respectively. HBV surface antigen (HBsAg) became detectable in culture medium at day 4 posttransfection. Interestingly, the early robust viral DNA replication and cccDNA synthesis did not depend on the expression of HBV X protein (HBx), whereas HBsAg production was strictly dependent on viral DNA replication and expression of HBx, consistent with the essential role of HBx in the transcriptional activation of cccDNA minichromosomes. While the robust and synchronized HBV replication within 48 h post-pgRNA transfection is particularly suitable for the precise mapping of the HBV replication steps, from capsid assembly to cccDNA formation, targeted by distinct antiviral agents, the treatment of cells starting at 48 h post-pgRNA transfection allows the assessment of antiviral agents on mature nucleocapsid uncoating, cccDNA synthesis, and transcription, as well as viral RNA stability. Moreover, the pgRNA launch system could be used to readily assess the impacts of drug-resistant variants on cccDNA formation and other replication steps in the viral life cycle. IMPORTANCE Hepadnaviral pgRNA not only serves as a template for reverse transcriptional replication of viral DNA but also expresses core protein and DNA polymerase to support viral genome replication and cccDNA synthesis. Not surprisingly, cytoplasmic expression of duck hepatitis B virus pgRNA initiated viral replication leading to infectious virion secretion. However, HBV replication and antiviral mechanism were studied primarily in human hepatoma cells transiently or stably transfected with plasmid-based HBV replicons. The presence of large amounts of transfected HBV DNA or transgenes in cellular chromosomes hampered the robust analyses of HBV replication and cccDNA function. As demonstrated here, the pgRNA launch HBV replication system permits the accurate mapping of antiviral target and investigation of cccDNA biosynthesis and transcription using secreted HBsAg as a convenient quantitative marker. The effect of drug-resistant variants on viral capsid assembly, genome replication, and cccDNA biosynthesis and function can also be assessed using this system.

Early rehabilitation to improve functional outcomes in childhood cancer in Singapore

Dear Editor, We conducted a prospective, single-centre cohort study to review the impact of a multidisciplinary rehabilitation programme in children with cancer in Singapore. The Template for Intervention Description and Replication (TIDieR) checklist was used to allow sufficient details for replication of the study (see Appendix in online Supplementary Material).1 The study was funded by

Globefish-Inspired Balloon Catheter with Intelligent Microneedle Coating for Endovascular Drug Delivery.

Balloon catheters exhibit important values in treating cardiovascular diseases, while their functions are still under improvements. Here, inspired by the thorn-hiding and deflating-inflating characteristics of globefish, intelligent balloon catheters decorated with invisible microneedles are presented for endovascular drug delivery to inhibit postintervention restenosis (PIRS). These microneedle balloon catheters (MNBCs) fabricated by dipping and rolling-assisted template replication contain three coating layers of sandwiched drug-carrying microneedles and black phosphorus (BP)-carrying gelatin. During the emplacement, the microneedles of MNBCs are hidden under the outermost gelatin protective layer, allowing smooth movements inside the blood vessel. After reaching the destination, the embedded BP converts near infrared (NIR) into heat, increases local temperature, and melts the gelatin layer, enabling the exposure and vascular penetration of the microneedles. Besides, as the innermost gelatin also melts, the microneedles can detach from the balloon catheter and be left inside the blood vessel for continuous drug release. Based on advantages of responsiveness, penetration capacity, and biosafety, it is demonstrated that the MNBCs behave satisfactorily in delivering rapamycin to inhibit abdominal aorta restenosis in rats. All these features indicate that these MNBCs are promising medical devices for clinical applications.

Supporting Carers as Patients Move between Hospital and Home: A Systematic Review of Interventions to Support These Transitions in Care.

Background: Hospital-to-home transitions become more frequent and complex as people approach end of life. Although carers are critical to enabling these transitions, they report high levels of unmet need. A review of the interventions to assist these care transitions, along with understanding those intervention components and mechanisms that support carers of people with advanced illness, is required to inform an optimal care model for palliative care practice. Aim: To describe the characteristics and reporting quality of intervention studies aimed at improving hospital-to-home transitions for carers of people with advanced illness. Design: This is a systematic review with a narrative synthesis. (international prospective register of systematic reviews [PROSPERO] ID: CRD42020192088). Data Sources: MEDLINE, EMCare, and PsychINFO databases were searched (2000-2021) for prospective studies reporting on interventions that (1) aimed to improve hospital-to-home transitions and (2) targeted carers of people with advanced illness. The Template for Intervention Description and Replication (TIDieR) checklist and constructs of the Care Transition Framework were used to assess the reporting quality of intervention design, delivery, and outcomes. Results: In total, 37 articles were analyzed that included a range of study designs, interventions, and outcomes. Health care utilization (n = 29) and clinical patient-related (n = 21) measures were the most reported outcome. Theoretical discussion was minimal (n = 5) with most studies using efficacy data from past research to justify intervention choice. Conclusion: Carers are critical partners in hospital-to-home transitions at end of life; yet they are largely under-represented in intervention design, delivery, and outcomes. Improving the reporting quality of carer-focused care transition interventions will inform future study design and support translation into practice and policy.

Postpartum Women's Preferences for Lifestyle Intervention after Childbirth: A Multi-Methods Study Using the TIDieR Checklist.

Postpartum lifestyle interventions are known to be efficacious in reducing postpartum weight retention, but uptake and engagement are poor. This multi-method study explored the preferences of postpartum women for the delivery of lifestyle interventions based on the Template for Intervention Description and Replication (TIDieR) checklist. Semi-structured interviews were conducted with 21 women within 2 years of childbirth, recruited through convenience and snowball sampling throughout Australia (15 May 2020 to 20 July 2020). Transcripts were analysed thematically using an open coding approach. A cross-sectional online survey was conducted in November 2021 among postpartum women within 5 years of childbirth in Australia. Data were summarised using descriptive statistics. The survey was completed by 520 women. Both the survey and interviews revealed that women were interested in receiving lifestyle support postpartum and wanted a program delivered by health professionals. They preferred a flexible low-intensity program embedded within existing maternal and child health services that is delivered through both online and face-to-face sessions. Having a pragmatic approach that taught practical strategies and enlists the support of partners, family and peers was important to mothers. Consumer-informed postpartum lifestyle interventions promote optimal engagement and improve program reach and therefore, impact.

Preparation and Properties of Partial-Degradable ZrO2-Chitosan Particles-GelMA Composite Scaffolds.

In the field of bone repair, the inorganic–organic composite scaffold is a promising strategy for mimicking the compositions of the natural bone. In addition, as implants for repairing load-bearing sites, an inert permanent bone substitute composites with bioactive degradable ingredients may make full use of the composite scaffold. Herein, the porous zirconia (ZrO2) matrix was prepared via the template replication method, and the partial degradable ZrO2–chitosan particles–GelMA composite scaffolds with different chitosan/GelMA volume ratios were prepared through the vacuum infiltration method. Dynamic light scattering (DLS) and the scanning electron microscope (SEM) were adopted to observe the size of the chitosan particles and the morphologies of the composites scaffold. The mechanical properties, swelling properties, and degradation properties of the composite scaffolds were also characterized by the mechanical properties testing machine and immersion tests. The CCK-8 assay was adopted to test the biocompatibility of the composite scaffold preliminarily. The results show that chitosan particles as small as 60 nm were obtained. In addition, the ratio of chitosan/GelMA can influence the mechanical properties and the swelling and degradation behaviors of the composites scaffold. Furthermore, improved cell proliferation performance was obtained for the composite scaffolds.

The effect of mother-infant group music classes on postnatal depression-A systematic review protocol.

Postnatal mental health problems affect 10-15% of women and can adversely impact on mother-infant interactions and bonding, the mother's mood, and feelings of competence. There is evidence that attending performing arts activities, such as singing, dancing, and listening to music, may improve maternal mental health with potential for an effect on postnatal depression. A systematic review will be conducted to assess the effect of mother-infant group music classes on postnatal depression compared to standard care, no control or wait list control. Studies will be included that report on postnatal depression. Further outcomes of interest include anxiety, stress, parenting competence, confidence and self-efficacy, perceived social support and mother-infant bonding. Infant and child outcomes measuring cognitive development, behaviour and social and emotional development will be included. Search databases to be used will be Medline, EMBASE, CINAHL, PsycINFO, Scopus, CENTRAL, Web of Science, Maternity and Infant Care and discipline-specific journals for music. The Cochrane's Template for Intervention description and replication (TIDieR) checklist and guide will be utilised to aid a detailed description, standardised assessment and quality assurance. Risk of bias will be assessed by the authors using the Cochrane Handbook for Systematic Reviews of Interventions risk of bias tool. If sufficient studies are available, meta-analyses will be conducted to combine, compare and summarise the results of the studies for more precise estimates of effects. Where meta-analysis is not possible, results for each individual study will be reported through qualitative narrative data synthesis. This systematic review will identify and synthesise evidence of the measured effect of postnatal mother-infant interventions involving music on maternal psychological and psychosocial outcomes and infant/child outcomes. This protocol was registered with Prospero on 18 October 2021 (registration number CRD42021283691). https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021283691.

Intervention components of link worker social prescribing programmes: A scoping review.

In the United Kingdom (UK), link worker social prescribing has emerged as an option to improve long-term condition management and address primary care patients' non-medical needs by linking patients with community-based activities and support. Social prescribing is a complex, heterogenous intervention, and there is currently no taxonomy of components to guide its implementation and evaluation. This study aimed to identify and categorise the components of link worker social prescribing schemes in the United Kingdom. A scoping review of peer-reviewed literature was conducted. Six databases were used to identify papers that met inclusion criteria. Eligible articles were original research studies in the United Kingdom describing interventions that included (1) initial referral of adults with chronic physical health conditions and/or unmet social needs from primary care to a link worker or equivalent role, (2) consultation with a link worker or equivalent role and (3) referral to a community-based or government service. Of the 1078 articles identified, 32 met study eligibility criteria, representing 22 social prescribing schemes. We drew from the template for intervention description and replication (TIDieR) to identify, organise and report intervention components. We found wide variations in geography, target populations and intervention components such as activities and procedures conducted by primary care staff and link workers, organisational and staffing configurations and use of tools and financing approaches to facilitate adoption. Intervention components are summarised into a taxonomy to guide future research, policy and practice efforts in addition to supporting standardised intervention reporting.

Tracking of progressing human DNA polymerase δ holoenzymes reveals distributions of DNA lesion bypass activities.

During DNA replication, DNA lesions in lagging strand templates are initially encountered by DNA polymerase δ (pol δ) holoenzymes comprised of pol δ and the PCNA processivity sliding clamp. These encounters are thought to stall replication of an afflicted template before the lesion, activating DNA damage tolerance (DDT) pathways that replicate the lesion and adjacent DNA sequence, allowing pol δ to resume. However, qualitative studies observed that human pol δ can replicate various DNA lesions, albeit with unknown proficiencies, which raises issues regarding the role of DDT in replicating DNA lesions. To address these issues, we re-constituted human lagging strand replication to quantitatively characterize initial encounters of pol δ holoenzymes with DNA lesions. The results indicate pol δ holoenzymes support dNTP incorporation opposite and beyond multiple lesions and the extent of these activities depends on the lesion and pol δ proofreading. Furthermore, after encountering a given DNA lesion, subsequent dissociation of pol δ is distributed around the lesion and a portion does not dissociate. The distributions of these events are dependent on the lesion and pol δ proofreading. Collectively, these results reveal complexity and heterogeneity in the replication of lagging strand DNA lesions, significantly advancing our understanding of human DDT.

Integrated hepatitis B virus DNA maintains surface antigen production during antiviral treatment.

The focus of hepatitis B functional cure, defined as sustained loss of hepatitis B virus (HBV) surface antigen (HBsAg) and HBV DNA from blood, is on eliminating or silencing the intranuclear template for HBV replication, covalently closed circular DNA (cccDNA). However, HBsAg also derives from HBV DNA integrated into the host genome (iDNA). Little is known about the contribution of iDNA to circulating HBsAg with current therapeutics. We applied a multiplex droplet digital PCR assay to demonstrate that iDNA is responsible for maintaining HBsAg quantities in some individuals. Using paired bulk liver tissue from 16 HIV/HBV-coinfected persons on nucleos(t)ide analog (NUC) therapy, we demonstrate that people with larger HBsAg declines between biopsies derive HBsAg from cccDNA, whereas people with stable HBsAg levels derive predominantly from iDNA. We applied our assay to individual hepatocytes in paired tissues from 3 people and demonstrated that the individual with significant HBsAg decline had a commensurate loss of infected cells with transcriptionally active cccDNA, while individuals without HBsAg decline had stable or increasing numbers of cells producing HBsAg from iDNA. We demonstrate that while NUC therapy may be effective at controlling cccDNA replication and transcription, innovative treatments are required to address iDNA transcription that sustains HBsAg production.

The influence of exercise therapy dosing on pain and functional outcomes in patients with subacromial pain syndrome: A systematic review.

The objective was to identify exercise therapy dosing parameters for subacromial pain syndrome (SAPS) associated with improved pain and function outcomes (via effect sizes) and determine the extent of exercise intervention reproducibility. An electronic search of PubMed/MEDLINE, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Cochrane Database of Systematic Reviews, and SportDiscus identified studies that used exercise therapy exclusively to treat SAPS. Exercise therapy dosing parameters were extracted and within-group effect sizes were calculated for all pain and functional outcomes. Template for Intervention Description and Replication and Consensus on Exercise Reporting were used to record intervention reporting. The risk of bias and Grading of Recommendations, Assessment, Development, and Evaluation were assessed by two reviewers. Twenty-one trials with 674 subjects were included. Effect sizes for pain and function were large in 18 studies, medium in six studies, and small or no effect in four studies, despite the type of supervision. With moderate certainty, effect sizes of pain and function were not influenced by exercise therapy dosing parameters. Intervention reporting was generally poor. Exercise therapy for SAPS was associated with large effect sizes for improvement in pain and function but optimal exercise therapy dosing parameters could not be identified. Strong recommendations conditionally suggest treating SAPS with a variety of exercise therapy dosing parameters.

Development and Implementation of a Peer Curbside Consult Service for Pediatric Hospitalists.

To describe the development and implementation of a Peer Curbside Consult Service (PCCS) for a pediatric hospital medicine (PHM) division. We developed a pilot intervention with hospitalists at a freestanding children's hospital to provide peer consultation services for challenging clinical cases. Postconsultation surveys collected from both the requesting and consulting hospitalists provided feedback about the program. The 12-point Template for Intervention Description and Replication (TIDieR) checklist is used to describe the process for program creation and implementation. The PCCS has provided 60 consultations in the first 2 years since implementation in April 2020 and supports a large PHM division with >75 members who practice at a tertiary care, freestanding children's hospital and 7 affiliate sites. Hospitalists request peer consultation for challenging clinical cases. The consultations were typically conducted in person or via telephone. Currently, 11 PHM faculty members within the division volunteer as consultants, with 2 assigned per week. Electronic postconsultation experience surveys were received from 70% of requesting and 89% of consultant hospitalists. We also provide preliminary data from this pilot intervention in the Supplemental Information. We successfully established a peer consult service that provided just-in-time clinical decision support across the various practice sites. Through transparent reporting using the TIDieR checklist, other divisions may be able to replicate and adapt their own peer consult program.

Digital behaviour change interventions to promote physical activity in overweight and obese adolescents: a systematic review protocol

BackgroundWith the increasing prevalence of obesity in youth, behavioural interventions to alter its modifiable risk factors such as physical activity can support the management of this epidemic. Digital behaviour changes interventions (DBCI) such as mobile applications, websites and wearables have the potential to reach many adolescents to promote physical activity as its use may be more accessible, effective and engaging compared to traditional face-to-face approaches. However, there is insufficient evidence on their use at promoting physical activity amongst overweight and obese adolescents. This review aims to assess the effectiveness of DBCIs aiming to increase physical activity in overweight and obese adolescents (aged 10–19 years) and the behaviour change techniques used in these interventions.MethodsElectronic databases (MEDLINE, EMBASE, PsycINFO, CINAHL, Cochrane and Scopus) will be searched for English language studies from January 2000 to December 2022 using appropriate search terms relating to digital interventions, physical activity, adolescents and obesity. Experimental studies (either randomised or non-randomised controlled trials) assessing effects of DBCIs on physical activity behaviour, objectively or subjectively measured, in overweight and obese (body mass index [BMI] ≥ 85th percentile for age) adolescents will be eligible for inclusion. Intervention characteristics will be coded using the Template for Intervention Description and Replication (TIDieR) checklist and the BCT taxonomy v1. Risk of bias and the overall quality of the included studies will be assessed using Cochrane’s Collaboration’s tool and GRADE approach respectively. If the data allows, meta-analyses using random effect models will be conducted to assess the effects of DBCIs on physical activity.DiscussionThe proposed systematic review will summarise the effectiveness of digital behaviour change interventions aiming to increase physical activity in overweight and obese adolescents, as well as adding new information on the behaviour change techniques used in these interventions. The findings of this review will facilitate stakeholders with a current, rigorous and reliable research base to support the development and implementation of effective health promotion interventions for this population.Systematic review registrationPROSPERO CRD42021270008.

Inhibition of Cell-Free Translation and Replication of Tobacco Mosaic Virus RNA by Exogenously Added 5'-Proximal Fragments of the Genomic RNA.

Replication proteins of tobacco mosaic virus (TMV), a positive-sense RNA virus, co-translationally bind to a 5′-proximal ~70-nucleotide (nt) region of the genomic RNA, referred to as the nuclease-resistant (NR) region for replication template selection. Therefore, disruption of the interaction between the viral replication proteins and viral genomic RNA is expected to inhibit the replication of TMV. In this study, we demonstrate that the addition of small RNA fragments (18–33 nts in length) derived from different regions within the NR region inhibit the binding of TMV replication proteins to viral RNA and TMV RNA replication in a cell-free system. Intriguingly, some of the small RNA fragments also inhibited the translation of mRNA in a sequence-nonspecific manner. These results highlight the pleiotropic roles of the 5′-proximal region of the TMV genome.

Turnip Mosaic Virus Transcriptional Slippage Dynamics and Distribution in RNA Subpopulations.

Potyviruses comprise the largest and most important group of plant positive-strand RNA viruses. The potyviral cell-to-cell movement protein P3N-PIPO is expressed via transcriptional slippage at a conserved GAAAAAA sequence, leading to insertion of an extra 'A' in a proportion of viral transcripts. Transcriptional slippage is determined by the potyviral replicase, the conserved slippery site, and its flanking nucleotides. Here, we investigate the dynamics of transcriptional slippage at different slip-site sequences, infection stages, and environmental conditions. We detect a modest increase in the level of transcripts with insertion towards later timepoints. In addition, we investigate the fate of transcripts with insertion by separately looking at different RNA subpopulations: (+)RNA, (-)RNA, translated RNA, and virion RNA. We find differences in insertional slippage between (+)RNA and (-)RNA but not other subpopulations. Our results suggest that there can be selection against the use of (-)RNAs with insertions as templates for transcription or replication and demonstrate that insertional slippage can occur at high frequency also during (-)RNA synthesis. Since transcripts with insertions are potential targets for degradation, we investigate the connection to nonsense-mediated decay (NMD). We find that these transcripts are targeted to NMD, but we only observe an impact on the level of transcripts with insertion when the insertional slippage rate is high. Together, these results further our understanding of the mechanism and elucidate the dynamics of potyviral transcriptional slippage. [Formula: see text] Copyright © 2022 The Author(s). This is an open access article distributed under the CC BY 4.0 International license.

Who, what, when, where, why, and how: A systematic review of the quality of post-stroke cognitive rehabilitation protocols.

Rehabilitation research findings are not routinely incorporated into clinical practice. A key barrier is the quality of reporting in the original study, including who provided the intervention, what it entailed, when and where it occurred, how patient outcomes were monitored, and why the intervention was efficacious. To facilitate clinical implementation of post-stroke cognitive rehabilitation research, we undertook a review to examine the quality of intervention reporting in this literature. Four databases were systematically searched, identifying 27 randomised controlled trials of post-stroke cognitive rehabilitation. The quality of intervention protocol descriptions in each study was independently rated by 2 of the authors using the 12-item Template for Intervention Description and Replication (TIDieR) checklist. Why, when, and where items were reported in more than 70% of interventions, what materials and procedures used was described in 50% to 70%, how items were described in approximately half of the interventions, and who provided interventions was reported in 22% of studies. No study addressed all 12 TIDieR items. "Active ingredients" that may further characterise an intervention and the potential mechanisms of action included restorative training, massed practice, feedback, and tailoring demands (present in approximately 50% of studies). Descriptions of intervention protocols are variable and frequently insufficient, thereby restricting the ability to understand, replicate, and implement evidence-based cognitive rehabilitation. Use of reporting checklists to address this barrier to research translation is a readily achievable and effective means to advance post-stroke care.

Treatment-As-Usual Control Groups in Brief Alcohol Intervention Trials: A Systematic Review and Meta-Analysis.

Brief alcohol interventions (BAIs) are evidence-based practices that can help reduce hazardous drinking among patients in medical settings. However, descriptions of the treatment-as-usual (TAU) control groups that BAIs are compared to in clinical trials often lack clarity and detail. This systematic review and meta-analysis quantified and compared descriptions of intervention and TAU control arms within reports of randomized controlled trials and examined whether treatment effects were affected by level of detail in narrative descriptions. A systematic literature search to identify eligible articles was performed. Studies were rated on methodological quality, and the Template for Intervention Description and Replication (TIDieR) checklist was used to rate the level of clarity and detail included in descriptions of the intervention and TAU conditions in eligible articles. Data were extracted from articles for use in meta-analysis and meta-regression. Twenty-one studies met inclusion criteria. Across the studies, TIDieR ratings for intervention arms were higher than ratings for control arms. BAIs were linked to reductions in drinks per week, heavy drinking episodes, and alcohol consequences over time when compared with TAU. TIDieR ratings for control groups were significantly associated with larger treatment effects on drinks per week and alcohol consequences but were not significant for heavy drinking episodes. This meta-analysis reiterated the effectiveness of BAIs in medical settings. Yet the lack of clarity in TAU descriptions raises concerns regarding the validity of BAI trials, suggesting need for more detailed reporting and use of the TIDieR guidelines for support.