A scoping review establishes need for consensus guidance on reporting health equity in observational studies.

OBJECTIVES: To evaluate the support from the available guidance on reporting of health equity in research for our candidate items and to identify additional items for the Strengthening Reporting of Observational studies in Epidemiology-Equity extension. STUDY DESIGN AND SETTING: We conducted a scoping review by searching Embase, MEDLINE, CINAHL, Cochrane Methodology Register, LILACS, and Caribbean Center on Health Sciences Information up to January 2022. We also searched reference lists and gray literature for additional resources. We included guidance and assessments (hereafter termed "resources") related to conduct and/or reporting for any type of health research with or about people experiencing health inequity. RESULTS: We included 34 resources, which supported one or more candidate items or contributed to new items about health equity reporting in observational research. Each candidate item was supported by a median of six (range: 1-15) resources. In addition, 12 resources suggested 13 new items, such as "report the background of investigators". CONCLUSION: Existing resources for reporting health equity in observational studies aligned with our interim checklist of candidate items. We also identified additional items that will be considered in the development of a consensus-based and evidence-based guideline for reporting health equity in observational studies.

How We Might Further Integrate Considerations of Environmental Impact When Assessing the Value of Health Technologies.

There is growing awareness of the impact health technologies can have on the environment and the negative consequences of these environmental impacts on human health. However, health system decision-makers may lack the expertise, data, or resources to incorporate environmental considerations when making decisions about the adoption and use of health technologies. In this article, we describe how health technology assessment (HTA) is evolving to address climate change by providing health system decision-makers with the information they can use to reduce the impact of health care systems on the environment. Our objective is to consider approaches for including the environment domain when conducting an HTA-in particular, the use of the deliberative process-and for determining when the domain should be included. We explore the challenges of gathering the relevant data necessary to assess the environmental impact of a health technology, and we describe a "triage" approach for determining when an in-depth environmental impact assessment is warranted. We also summarize related initiatives from HTA agencies around the world.

Guidance on review type selection for health technology assessments: key factors and considerations for deciding when to conduct a de novo systematic review, an update of a systematic review, or an overview of systematic reviews.

BACKGROUND: A systematic review (SR) helps us make sense of a body of research while minimizing bias and is routinely conducted to evaluate intervention effects in a health technology assessment (HTA). In addition to the traditional de novo SR, which combines the results of multiple primary studies, there are alternative review types that use systematic methods and leverage existing SRs, namely updates of SRs and overviews of SRs. This paper shares guidance that can be used to select the most appropriate review type to conduct when evaluating intervention effects in an HTA, with a goal to leverage existing SRs and reduce research waste where possible. PROCESS: We identified key factors and considerations that can inform the process of deciding to conduct one review type over the others to answer a research question and organized them into guidance comprising a summary and a corresponding flowchart. This work consisted of three steps. First, a guidance document was drafted by methodologists from two Canadian HTA agencies based on their experience. Next, the draft guidance was supplemented with a literature review. Lastly, broader feedback from HTA researchers across Canada was sought and incorporated into the final guidance. INSIGHTS: Nine key factors and six considerations were identified to help reviewers select the most appropriate review type to conduct. These fell into one of two categories: the evidentiary needs of the planned review (i.e., to understand the scope, objective, and analytic approach required for the review) and the state of the existing literature (i.e., to know the available literature in terms of its relevance, quality, comprehensiveness, currency, and findings). The accompanying flowchart, which can be used as a decision tool, demonstrates the interdependency between many of the key factors and considerations and aims to balance the potential benefits and challenges of leveraging existing SRs instead of primary study reports. CONCLUSIONS: Selecting the most appropriate review type to conduct when evaluating intervention effects in an HTA requires a myriad of factors to be considered. We hope this guidance adds clarity to the many competing considerations when deciding which review type to conduct and facilitates that decision-making process.

Rapid qualitative evidence syntheses (rQES) in health technology assessment: experiences, challenges, and lessons.

Healthcare decision makers are increasingly demanding that health technology assessment (HTA) is patient focused, and considers data about patients' perspectives on and experiences with health technologies in their everyday lives. Related data are typically generated through qualitative research, and in HTA the typical approach is to synthesize primary qualitative research through the conduct of qualitative evidence synthesis (QES). Abbreviated HTA timelines often do not allow for the full 6-12 months it may take to complete a QES, which has prompted the Canadian Agency for Drugs and Technologies in Health (CADTH) to explore the concept of "rapid qualitative evidence synthesis" (rQES). In this paper, we describe our experiences conducting three rQES at CADTH, and reflect on challenges faced, successes, and lessons learned. Given limited methodological guidance to guide this work, our aim is to provide insight for researchers who may contemplate rQES. We suggest several lessons, including strategies to iteratively develop research questions and search for eligible studies, use search of filters and limits, and use of a single reviewer experienced in qualitative research throughout the review process. We acknowledge that there is room for debate, though believe rQES is a laudable goal and that it is possible to produce a quality, relevant, and useful product, even under restricted timelines. That said, it is vital to recognize what is lost in the name of rapidity. We intend our paper to advance the necessary debate about when rQES may be appropriate, and not, and enable productive discussions around methodological development.

A scoping review found increasing examples of rapid qualitative evidence syntheses and no methodological guidance.

OBJECTIVES: The objective of the study was to identify existing methodological guidance for the conduct of rapid qualitative evidence syntheses and examples of rapid qualitative evidence syntheses to describe the methods used. STUDY DESIGN AND SETTING: We conducted a systematic scoping review. We searched MEDLINE, CINAHL, gray literature, including PROSPERO, with no date limits and solicited examples through experts and researchers in the field. RESULTS: We found no methodological guidance to direct the conduct of rapid qualitative evidence synthesis and 15 examples including 13 completed reviews and two protocols. Diverse methods to abbreviate the review process were followed, which largely mirror methods developed for rapid reviews of clinical effects. Abbreviated search strategies, including date and language restrictions, were common, as was the use of a single reviewer for screening, data extraction, and quality appraisal. Descriptive approaches to synthesis, such as thematic synthesis, were more common than interpretive approaches, such as metaethnography. CONCLUSION: There is a need to develop and explore methods for the synthesis of qualitative research that balance the need for rapidity with rigor. In the meantime, providing details on the methods used, shortcuts made, and the implications of such methodological choices, together with collective sharing of innovations, becomes more important under increased time constraints.

PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation.

Scoping reviews, a type of knowledge synthesis, follow a systematic approach to map evidence on a topic and identify main concepts, theories, sources, and knowledge gaps. Although more scoping reviews are being done, their methodological and reporting quality need improvement. This document presents the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist and explanation. The checklist was developed by a 24-member expert panel and 2 research leads following published guidance from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network. The final checklist contains 20 essential reporting items and 2 optional items. The authors provide a rationale and an example of good reporting for each item. The intent of the PRISMA-ScR is to help readers (including researchers, publishers, commissioners, policymakers, health care providers, guideline developers, and patients or consumers) develop a greater understanding of relevant terminology, core concepts, and key items to report for scoping reviews.

Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies: The PRISMA-DTA Statement.

Importance: Systematic reviews of diagnostic test accuracy synthesize data from primary diagnostic studies that have evaluated the accuracy of 1 or more index tests against a reference standard, provide estimates of test performance, allow comparisons of the accuracy of different tests, and facilitate the identification of sources of variability in test accuracy. Objective: To develop the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagnostic test accuracy guideline as a stand-alone extension of the PRISMA statement. Modifications to the PRISMA statement reflect the specific requirements for reporting of systematic reviews and meta-analyses of diagnostic test accuracy studies and the abstracts for these reviews. Design: Established standards from the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network were followed for the development of the guideline. The original PRISMA statement was used as a framework on which to modify and add items. A group of 24 multidisciplinary experts used a systematic review of articles on existing reporting guidelines and methods, a 3-round Delphi process, a consensus meeting, pilot testing, and iterative refinement to develop the PRISMA diagnostic test accuracy guideline. The final version of the PRISMA diagnostic test accuracy guideline checklist was approved by the group. Findings: The systematic review (produced 64 items) and the Delphi process (provided feedback on 7 proposed items; 1 item was later split into 2 items) identified 71 potentially relevant items for consideration. The Delphi process reduced these to 60 items that were discussed at the consensus meeting. Following the meeting, pilot testing and iterative feedback were used to generate the 27-item PRISMA diagnostic test accuracy checklist. To reflect specific or optimal contemporary systematic review methods for diagnostic test accuracy, 8 of the 27 original PRISMA items were left unchanged, 17 were modified, 2 were added, and 2 were omitted. Conclusions and Relevance: The 27-item PRISMA diagnostic test accuracy checklist provides specific guidance for reporting of systematic reviews. The PRISMA diagnostic test accuracy guideline can facilitate the transparent reporting of reviews, and may assist in the evaluation of validity and applicability, enhance replicability of reviews, and make the results from systematic reviews of diagnostic test accuracy studies more useful.

USING THE INTEGRATE-HTA GUIDANCE: EXPERIENCE FROM CADTH.

OBJECTIVES: The aim of this study was to describe an initial exploration by CADTH, Canada's pan-Canadian health technology assessment (HTA) agency, in using the INTEGRATE-HTA guidance in the production of an HTA that examined the use of both in-center and in-home dialysis modalities for the treatment of end-stage kidney disease in adults in Canada. METHODS AND RESULTS: We outline CADTH's standard HTA production process and context and then describe the experience of the assessment team in using the INTEGRATE-HTA guidance, specifically to help structure and guide the use of a logic model, the identification of implementation issues, and the identification and examination of ethical issues. For each of the aspects, we describe and reflect on how the assessment team used the guidance, challenges that were encountered in its use, and whether and how we might address these challenges when using the INTEGRATE-HTA guidance in the future. CONCLUSIONS: INTEGRATE-HTA provided detailed and helpful guidance for truly integrating wide-ranging aspects of HTA. Our agency was challenged by a steep learning curve for assessment team members, tight project timelines, and a misalignment of current HTA processes with those required to implement the guidance. Nevertheless, using the guidance initiated a dialogue about what might be needed to assess complex interventions and the potential process changes that could facilitate conducting more integrated assessments.

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

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

Evaluating the feasibility of using online software to collect patient information in a chiropractic practice-based research network.

BACKGROUND: Practice based research networks (PBRNs) are increasingly used as a tool for evidence based practice. We developed and tested the feasibility of using software to enable online collection of patient data within a chiropractic PBRN to support clinical decision making and research in participating clinics. PURPOSE: To assess the feasibility of using online software to collect quality patient information. METHODS: The study consisted of two phases: 1) Assessment of the quality of information provided, using a standardized form; and 2) Exploration of patients' perspectives and experiences regarding online information provision through semi-structured interviews. Data analysis was descriptive. RESULTS: Forty-five new patients were recruited. Thirty-six completed online forms, which were submitted by an appropriate person 100% of the time, with an error rate of less than 1%, and submitted in a timely manner 83% of the time. Twenty-one participants were interviewed. Overall, online forms were preferred given perceived security, ease of use, and enabling provision of more accurate information. CONCLUSIONS: Use of online software is feasible, provides high quality information, and is preferred by most participants. A pen-and-paper format should be available for patients with this preference and in case of technical difficulties.

CONTEXTE: Les réseaux de recherche basés sur la pratique (RRBP) sont de plus en plus utilisés comme un outil pour la pratique fondée sur des preuves. Nous avons mis en place et évalué la faisabilité de l'utilisation de logiciels pour permettre la collecte en ligne de données de patients dans un RRBP chiropratique à l'appui de la prise de décision clinique et de la recherche dans les cliniques participantes. OBJECTIF: Évaluer la faisabilité d'utiliser des logiciels en ligne pour recueillir des renseignements de qualité sur les patients. MÉTHODOLOGIE: L'étude a consisté en deux phases : 1) l'évaluation de la qualité des renseignements fournis en utilisant un formulaire standardisé; et 2) l'exploration des points de vue et des expériences des patients en ce qui concerne les renseignements fournis en ligne, à l'aide d'entretiens semi-structurés. L'analyse des données était descriptive. RÉSULTATS: Quarante-cinq nouveaux patients ont été recrutés. Trente-six formulaires ont été remplis en ligne et soumis par une personne compétente (100 % du temps), avec un taux d'erreur de moins de 1 %, et soumis dans les délais (83 % du temps). Vingt et un participants ont été interrogés. Dans l'ensemble, les formulaires en ligne étaient privilégiés, compte tenu de la sécurité perçue, la facilité d'utilisation et la disposition des gens permettant de donner des renseignements plus précis. CONCLUSIONS: L'utilisation d'un logiciel en ligne est possible. Cela permet de fournir des renseignements de grande qualité et est privilégié par la plupart des participants. Un stylo et une feuille de papier doivent être mis à la disposition des patients qui préfèrent cette forme d'interaction ou en cas de difficultés techniques.

Patients' perspectives can be integrated in health technology assessments: an exploratory analysis of CADTH Common Drug Review.

PLAIN LANGUAGE SUMMARY: In Canada, the CADTH Common Drug Review helps ensure that scarce health care resources are used to fund the most effective drugs. Clinicians, researchers, payers, and patients all have important, but potentially different, ideas on what should be considered, to determine a drug's value. Since 2010, CADTH has invited patient groups to contribute their perspectives to the Common Drug Review. We explored whether, and how, insights offered by patient groups are integrated into assessment reports and Recommendations by the CADTH Canadian Drug Expert Committee. After examining 30 completed drug assessments, we found that:Patient insights are used by CADTH reviewers to frame an assessment and are used by the expert committee to interpret the evidence.Drug trials do not always measure outcomes that patients consider important.Survival, symptom relief, the process of recovery, and maintaining health are all important aspects to consider when determining value during health technology assessments. ABSTRACT: Background Since 2010, Canadian patient groups have contributed to the CADTH Common Drug Review (CDR). CADTH conducts health technology assessments of new drugs to support publicly funded drug plans' reimbursement decisions. We explored whether, and how, patient insights were integrated into assessment reports and Recommendations by the CADTH Canadian Drug Expert Committee (CDEC). Methods We descriptively analyzed 30 consecutive assessments. One researcher identified a set of issues, insights, and desired treatment outcomes provided by patient groups for each included drug assessment. We tracked the presence of each identified patient insight in the relevant assessment protocol, in clinical trials as reported in the assessment, and in the CDEC Recommendations. Additionally, patient insights were categorized by topic and grouped into a three-tier framework to explore the observed juxtaposition between immediate treatment outcomes as seen in clinical trials and the insights from patients living with a chronic condition. Results In 30 drug assessments, 119 patient insights were identified. Of these insights, 89 were included in assessment protocols; 61 in reported clinical trial data; and 67 insights were reflected upon within the CDEC Recommendations. Patient insights within the first framework tier (health status achieved) were frequently included in all aspects of CDR assessments. Within the second tier (progress of recovery), although two-thirds of patient insights were included in protocols, only one-third was reflected in reported trial data or in CDEC Recommendations. Insights within the third tier, which address the long-term consequences of illness and treatment, were even less frequently addressed in all aspects of CDR assessments. Conclusions Patients' perspectives need not be "considered" in isolation. Patient insights are used by CADTH reviewers to frame an assessment and used by CDEC to interpret the evidence. As health technology assessments should address the indirect and unintended consequences of a technology, as well as its direct and intended effects, drug assessments should consider the progress of recovery and sustainability of health, in addition to survival and immediate health achieved.

The responsiveness, content validity, and convergent validity of the Measure Yourself Concerns and Wellbeing (MYCaW) patient-reported outcome measure.

OBJECTIVE: Measure Yourself Concerns and Wellbeing (MYCaW) is a patient-centered questionnaire that allows cancer patients to identify and quantify the severity of their "concerns" and "wellbeing," as opposed to using a predetermined list. MYCaW administration is brief and aids in prioritizing treatment approaches. Our goal was to assess the convergent validity and responsiveness of MYCaW scores over time, the generalizability of the existing qualitative coding framework in different complementary and integrative oncology settings and content validity. METHODS: Baseline and 6-week follow-up data (n = 82) from MYCaW and FACIT-SpEx questionnaires were collected for a service evaluation of the Living Well with the Impact of Cancer course at Penny Brohn Cance Care. MYCaW convergent validity was determined using Spearman's rank correlation test, and responsiveness indices assessed score changes over time. The existing qualitative coding framework was reviewed using a new data set (n = 158) and coverage of concern categories compared with items of existing outcome measures. RESULTS: Good correlation between MYCaW and FACIT-SpEx score changes were achieved (r = -0.57, P ≥ .01). MYCaW Profile and Concern scores were highly responsive to change: standardized response mean = 1.02 and 1.08; effect size = 1.26 and 1.22. MYCaW change scores showed the anticipated gradient of change according to clinically relevant degrees of change. Categories, including "spirituality," "weight change," and "practical concerns" were added to the coding framework to improve generalizability. CONCLUSIONS: MYCaW scores were highly responsive to change, allowing personalized patient outcomes to be quantified; the qualitative coding framework appears generalizable across different integrative oncology settings and has broader coverage of patient-identified concerns compared with existing cancer-related patient-reported outcome measures.

Decision-making about complementary and alternative medicine by cancer patients: integrative literature review.

BACKGROUND: Patients with cancer consistently report conflict and anxiety when making decisions about complementary and alternative medicine (CAM) treatment. To design evidence-informed decision-support strategies, a better understanding is needed of how the decision-making process unfolds for these patients during their experience with cancer. We undertook this study to review the research literature regarding CAM-related decision-making by patients with cancer within the context of treatment, survivorship, and palliation. We also aimed to summarize emergent concepts within a preliminary conceptual framework. METHODS: We conducted an integrative literature review, searching 12 electronic databases for articles published in English that described studies of the process, context, or outcomes of CAM-related decision-making. We summarized descriptive data using frequencies and used a descriptive constant comparative method to analyze statements about original qualitative results, with the goal of identifying distinct concepts pertaining to CAM-related decision-making by patients with cancer and the relationships among these concepts. RESULTS: Of 425 articles initially identified, 35 met our inclusion criteria. Seven unique concepts related to CAM and cancer decision-making emerged: decision-making phases, information-seeking and evaluation, decision-making roles, beliefs, contextual factors, decision-making outcomes, and the relationship between CAM and conventional medical decision-making. CAM decision-making begins with the diagnosis of cancer and encompasses 3 distinct phases (early, mid, and late), each marked by unique aims for CAM treatment and distinct patterns of information-seeking and evaluation. Phase transitions correspond to changes in health status or other milestones within the cancer trajectory. An emergent conceptual framework illustrating relationships among the 7 central concepts is presented. INTERPRETATION: CAM-related decision-making by patients with cancer occurs as a nonlinear, complex, dynamic process. The conceptual framework presented here identifies influential factors within that process, as well as patients' unique needs during different phases. The framework can guide the development and evaluation of theory-based decision-support programs that are responsive to patients' beliefs and preferences.

Intravenous Vitamin C and Cancer: A Systematic Review.

BACKGROUND: Intravenous vitamin C (IVC) is a contentious adjunctive cancer therapy, widely used in naturopathic and integrative oncology settings. We conducted a systematic review of human interventional and observational studies assessing IVC for use in cancer patients. METHODS: We searched MEDLINE, EMBASE, The Cochrane Library, CINAHL, and AMED from inception to April 2013 for human studies examining the safety, effectiveness, or pharmacokinetics of IVC use in cancer patients. RESULTS: Of 897 records, a total of 39 reports of 37 studies were included: 2 randomized controlled trials (RCTs), 15 uncontrolled trials, 6 observational studies, and 14 case reports. IVC dosing ranged from 1 g to more than 200 g ascorbic acid per infusion, typically administered 2 to 3 times weekly. IVC does not appear to increase toxicity or interfere with antitumor effects of gemcitabine/erlotinib therapy or paclitaxel and carboplatin. Based on 1 RCT and data from uncontrolled human trials, IVC may improve time to relapse and possibly enhance reductions in tumor mass and improve survival in combination with chemotherapy. IVC may improve quality of life, physical function, and toxicities associated with chemotherapy, including fatigue, nausea, insomnia, constipation, and depression. Case reports document several instances of tumor regression and long-term disease-free survival associated with use of IVC. CONCLUSION: There is limited high-quality clinical evidence on the safety and effectiveness of IVC. The existing evidence is preliminary and cannot be considered conclusive but is suggestive of a good safety profile and potentially important antitumor activity; however, more rigorous evidence is needed to conclusively demonstrate these effects. IVC may improve the quality of life and symptom severity of patients with cancer, and several cases of cancer remission have been reported. Well-designed, controlled studies of IVC therapy are needed.

Evaluation of the Cochrane Collaboration's tool for assessing the risk of bias in randomized trials: focus groups, online survey, proposed recommendations and their implementation.

BACKGROUND: In 2008, the Cochrane Collaboration introduced a tool for assessing the risk of bias in clinical trials included in Cochrane reviews. The risk of bias (RoB) tool is based on narrative descriptions of evidence-based methodological features known to increase the risk of bias in trials. METHODS: To assess the usability of this tool, we conducted an evaluation by means of focus groups, online surveys and a face-to-face meeting. We obtained feedback from a range of stakeholders within The Cochrane Collaboration regarding their experiences with, and perceptions of, the RoB tool and associated guidance materials. We then assessed this feedback in a face-to-face meeting of experts and stakeholders and made recommendations for improvements and further developments of the RoB tool. RESULTS: The survey attracted 380 responses. Respondents reported taking an average of between 10 and 60 minutes per study to complete their RoB assessments, which 83% deemed acceptable. Most respondents (87% of authors and 95% of editorial staff) thought RoB assessments were an improvement over past approaches to trial quality assessment. Most authors liked the standardized approach (81%) and the ability to provide quotes to support judgements (74%). A third of participants disliked the increased workload and found the wording describing RoB judgements confusing. The RoB domains reported to be the most difficult to assess were incomplete outcome data and selective reporting of outcomes. Authors expressed the need for more guidance on how to incorporate RoB assessments into meta-analyses and review conclusions. Based on this evaluation, recommendations were made for improvements to the RoB tool and the associated guidance. The implementation of these recommendations is currently underway. CONCLUSIONS: Overall, respondents identified positive experiences and perceptions of the RoB tool. Revisions of the tool and associated guidance made in response to this evaluation, and improved provision of training, may improve implementation.

Developing an operational model for an integrative oncology program: a qualitative descriptive feasibility study.

PURPOSE: We describe a descriptive qualitative study with the purpose of assessing the feasibility of developing an integrative oncology program in our region. METHODS: We conducted 39 interviews and two focus groups (n = 20) with cancer patients, their caregivers and complementary and conventional (n = 15) healthcare professionals. RESULTS: One primary theme emerged, acceptance or tolerance of an integrative oncology program, which represents concepts within four emergent categories: (1) operational model; (2) values to guide an integrative oncology program; (3) physical location and design; and (4) facilitators and barriers to establishing an integrative oncology program. CONCLUSIONS: The study was instrumental in establishing support for an integrative oncology program in our region, including a feasible model. Based in part on the results of this study, the Ottawa Integrative Cancer Centre ( www.oicc.ca ) opened in November 2011. We recommend a similar process of stakeholder engagement for others who wish to develop an integrative program in their location.

Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals.

BACKGROUND: An overwhelming body of evidence stating that the completeness of reporting of randomised controlled trials (RCTs) is not optimal has accrued over time. In the mid-1990s, in response to these concerns, an international group of clinical trialists, statisticians, epidemiologists, and biomedical journal editors developed the CONsolidated Standards Of Reporting Trials (CONSORT) Statement. The CONSORT Statement, most recently updated in March 2010, is an evidence-based minimum set of recommendations including a checklist and flow diagram for reporting RCTs and is intended to facilitate the complete and transparent reporting of trials and aid their critical appraisal and interpretation. In 2006, a systematic review of eight studies evaluating the "effectiveness of CONSORT in improving reporting quality in journals" was published. OBJECTIVES: To update the earlier systematic review assessing whether journal endorsement of the 1996 and 2001 CONSORT checklists influences the completeness of reporting of RCTs published in medical journals. SEARCH METHODS: We conducted electronic searches, known item searching, and reference list scans to identify reports of evaluations assessing the completeness of reporting of RCTs. The electronic search strategy was developed in MEDLINE and tailored to EMBASE. We searched the Cochrane Methodology Register and the Cochrane Database of Systematic Reviews using the Wiley interface. We searched the Science Citation Index, Social Science Citation Index, and Arts and Humanities Citation Index through the ISI Web of Knowledge interface. We conducted all searches to identify reports published between January 2005 and March 2010, inclusive. SELECTION CRITERIA: In addition to studies identified in the original systematic review on this topic, comparative studies evaluating the completeness of reporting of RCTs in any of the following comparison groups were eligible for inclusion in this review: 1) Completeness of reporting of RCTs published in journals that have and have not endorsed the CONSORT Statement; 2) Completeness of reporting of RCTs published in CONSORT-endorsing journals before and after endorsement; or 3) Completeness of reporting of RCTs before and after the publication of the CONSORT Statement (1996 or 2001). We used a broad definition of CONSORT endorsement that includes any of the following: (a) requirement or recommendation in journal's 'Instructions to Authors' to follow CONSORT guidelines; (b) journal editorial statement endorsing the CONSORT Statement; or (c) editorial requirement for authors to submit a CONSORT checklist and/or flow diagram with their manuscript. We contacted authors of evaluations reporting data that could be included in any comparison group(s), but not presented as such in the published report and asked them to provide additional data in order to determine eligibility of their evaluation. Evaluations were not excluded due to language of publication or validity assessment. DATA COLLECTION AND ANALYSIS: We completed screening and data extraction using standardised electronic forms, where conflicts, reasons for exclusion, and level of agreement were all automatically and centrally managed in web-based management software, DistillerSR(®). One of two authors extracted general characteristics of included evaluations and all data were verified by a second author. Data describing completeness of reporting were extracted by one author using a pre-specified form; a 10% random sample of evaluations was verified by a second author. Any discrepancies were discussed by both authors; we made no modifications to the extracted data. Validity assessments of included evaluations were conducted by one author and independently verified by one of three authors. We resolved all conflicts by consensus.For each comparison we collected data on 27 outcomes: 22 items of the CONSORT 2001 checklist, plus four items relating to the reporting of blinding, and one item of aggregate CONSORT scores. Where reported, we extracted and qualitatively synthesised data on the methodological quality of RCTs, by scale or score. MAIN RESULTS: Fifty-three publications reporting 50 evaluations were included. The total number of RCTs assessed within evaluations was 16,604 (median per evaluation 123 (interquartile range (IQR) 77 to 226) published in a median of six (IQR 3 to 26) journals. Characteristics of the included RCT populations were variable, resulting in heterogeneity between included evaluations. Validity assessments of included studies resulted in largely unclear judgements. The included evaluations are not RCTs and less than 8% (4/53) of the evaluations reported adjusting for potential confounding factors.   Twenty-five of 27 outcomes assessing completeness of reporting in RCTs appeared to favour CONSORT-endorsing journals over non-endorsers, of which five were statistically significant. 'Allocation concealment' resulted in the largest effect, with risk ratio (RR) 1.81 (99% confidence interval (CI) 1.25 to 2.61), suggesting that 81% more RCTs published in CONSORT-endorsing journals adequately describe allocation concealment compared to those published in non-endorsing journals. Allocation concealment was reported adequately in 45% (393/876) of RCTs in CONSORT-endorsing journals and in 22% (329/1520) of RCTs in non-endorsing journals. Other outcomes with results that were significant include: scientific rationale and background in the 'Introduction' (RR 1.07, 99% CI 1.01 to 1.14); 'sample size' (RR 1.61, 99% CI 1.13 to 2.29); method used for 'sequence generation' (RR 1.59, 99% CI 1.38 to 1.84); and an aggregate score over reported CONSORT items, 'total sum score' (standardised mean difference (SMD) 0.68 (99% CI 0.38 to 0.98)). AUTHORS' CONCLUSIONS: Evidence has accumulated to suggest that the reporting of RCTs remains sub-optimal. This review updates a previous systematic review of eight evaluations. The findings of this review are similar to those from the original review and demonstrate that, despite the general inadequacies of reporting of RCTs, journal endorsement of the CONSORT Statement may beneficially influence the completeness of reporting of trials published in medical journals. Future prospective studies are needed to explore the influence of the CONSORT Statement dependent on the extent of editorial policies to ensure adherence to CONSORT guidance.

Effectiveness of terbutaline pump for the prevention of preterm birth. A systematic review and meta-analysis.

BACKGROUND: Subcutaneous terbutaline (SQ terbutaline) infusion by pump is used in pregnant women as a prolonged (beyond 48-72 h) maintenance tocolytic following acute treatment of preterm contractions. The effectiveness and safety of this maintenance tocolysis have not been clearly established. We aimed to systematically evaluate the effectiveness and safety of subcutaneous (SQ) terbutaline infusion by pump for maintenance tocolysis. METHODOLOGY/PRINCIPAL FINDINGS: MEDLINE, EMBASE, CINAHL, the Cochrane Library, the Centre for Reviews and Dissemination databases, post-marketing surveillance data and grey literature were searched up to April 2011 for relevant experimental and observational studies. Two randomized trials, one nonrandomized trial, and 11 observational studies met inclusion criteria. Non-comparative studies were considered only for pump-related harms. We excluded case-reports but sought FDA summaries of post-marketing surveillance data. Non-English records without an English abstract were excluded. Evidence of low strength from observational studies with risk of bias favored SQ terbutaline pump for the outcomes of delivery at <32 and <37 weeks, mean days of pregnancy prolongation, and neonatal death. Observational studies of medium to high risk of bias also demonstrated benefit for other surrogate outcomes, such as birthweight and neonatal intensive care unit (NICU) admission. Several cases of maternal deaths and maternal cardiovascular events have been reported in patients receiving terbutaline tocolysis. CONCLUSIONS/SIGNIFICANCE: Although evidence suggests that pump therapy may be beneficial as maintenance tocolysis, our confidence in its validity and reproducibility is low, suggesting that its use should be limited to the research setting. Concerns regarding safety of therapy persist.