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A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies.

ABSTRACT: The "card study," in which clinicians record brief information about patient visits during usual clinical care, has long been a rapid method for conducting descriptive studies in practice-based research networks. Because an increasingly stringent regulatory environment has made conducting card studies difficult, we developed a streamlined method for obtaining card study institutional review board (IRB) approval.We developed a protocol for a study of the card study method, allowing new card study proposals of specific research questions to be submitted as addenda to the approved Card Study Protocol.Seven card studies were proposed and approved under the Card Study Protocol during the first year after implementation, contrasted with one-card study proposed in the previous year. New card study ideas submitted as addenda to an approved protocol appeared to increase IRB comfort with the card study as a minimal risk method while reducing the hurdles to developing new study ideas.A Card Study Protocol allowing new study questions to be submitted as addenda decreases time between idea generation and IRB approval. Shortened turn-around times may be useful for translating ideas into action while reducing regulatory burden.

SUBMITTER: Hamilton MD

PROVIDER: S-EPMC4331110 | biostudies-literature | 2011 Sep-Oct

REPOSITORIES: biostudies-literature

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A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies.

Hamilton Michelle D MD Cola Philip A PA Terchek Joshua J JJ Werner James J JJ Stange Kurt C KC

Journal of the American Board of Family Medicine : JABFM 20110901 5

<h4>Purpose</h4>The "card study," in which clinicians record brief information about patient visits during usual clinical care, has long been a rapid method for conducting descriptive studies in practice-based research networks. Because an increasingly stringent regulatory environment has made conducting card studies difficult, we developed a streamlined method for obtaining card study institutional review board (IRB) approval.<h4>Methods</h4>We developed a protocol for a study of the card study ...[more]

PMID: 21900445

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Project description:Integrative medicine (IM) provides patient-centered care and addresses the full range of physical, emotional, mental, social, spiritual, and environmental influences that affect a person's health. IM is a "whole systems" approach that employs multiple modalities as opposed to an isolated complementary therapy. Thus, studying outcomes of IM is more challenging than evaluating an isolated intervention. Practice-based research networks (PBRNs) allow for clinicians/investigators at multiple diverse sites using common methodology to pool their data, increase participant sample size and increase generalizability of results. To conduct real-world, practice-based research, the Bravewell Collaborative founded BraveNet in 2007 as the first national integrative medicine PBRN.Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) is a prospective, non-randomized, observational evaluation conducted at fourteen clinical sites. Participants receive a non-standardized, personalized, multimodal IM approach for various medical conditions. Using the REDCap electronic platform, an anticipated 10,000 study participants will complete patient-reported outcome measures including Patient Reported Outcomes Measurement Information System (PROMIS)-29, Perceived Stress Scale-4, and the Patient Activation Measure at baseline, 2, 4, 6, 12, 18 and 24 months. Extractions from participants' electronic health records include IM services received, as well as ICD diagnostic codes, and CPT billing codes associated with each IM visit. Repeated-measures analyses will be performed on data to assess change from baseline through 24 months with planned subgroup analyses to include specific clinical population and specific IM intervention or combinations.As the PRIMIER registry grows, we anticipate that our results would provide an indication of the promise of PBRN research efforts in IM. Analyses will incorporate a large sample of participants and an expected 10-year observation period and will provide the ability to evaluate the effect of IM on outcomes for specific clinical populations and specific IM interventions or combinations. As such, PRIMIER will serve as a national platform for future evaluations of IM best practices.Clinical Trials.gov NCT01754038.

Project description:BackgroundInstitutional Review Boards (IRBs) have been criticized for inconsistency, delay, and bias, suggesting an opportunity for quality improvement. To aid such quality improvement, this study aimed at determining IRB members' and investigators' priorities regarding IRB review at 10 Veterans Affairs (VA) IRBs.Methods680 anonymous internet surveys were sent to 252 IRB members and staff, and 428 principal investigators and project coordinators at 9 VA Medical Centers and the VA Central IRB. Surveys included 27 statements adapted from Koocher and Kieth-Spiegel's IRB-RAT describing IRB activities or functions (e.g., "An IRB that is open to reversing its earlier decisions"). Respondents indicated how each statement described both their "ideal" and "actual" IRBs. The difference between the ratings of the actual and ideal IRBs was calculated for each item along with estimated 95% confidence intervals. Ratings outside those intervals indicated activities or functions with relatively good or poor performance compared to the ideal IRB.Results390 (57.4%) responses from 165 IRB members and staff (65.5%) and 225 investigators and project coordinators (52.6%) demonstrated that these IRBs were closest to the ideal when protecting human subjects, treating investigators with respect, and taking appropriate action for alleged scientific misconduct. The IRBs were furthest from the ideal regarding duplicative forms, timeliness of review, and provision of complete rationales for decisions. Although IRB members reported near-ideal willingness to reverse earlier decisions, investigators rated this capacity far from ideal. Investigators rated IRB members' knowledge about procedures and policy as nearly ideal, but IRB members themselves rated this aspect far from ideal. Noteworthy site-level differences in the ratings of IRB functions and activities were also identified.ConclusionsAlthough these VA IRBs perform well in some areas, these data support the need for ongoing quality improvement. The described method of administering and analyzing the IRB-RAT may help identify and monitor site- and activity- specific initiatives for quality improvement.

Project description:IntroductionMusculoskeletal (MSK) pain conditions, a leading cause of global disability, are usually first managed in primary care settings such as medical, physiotherapy, and chiropractic community-based practices. While chiropractors often treat MSK conditions, there is limited real-world evidence on the topic of health service outcomes among patients receiving this type of care. A nationwide Swiss chiropractic practice-based research network (PBRN) and MSK pain patient cohort study will have potential to monitor the epidemiological trends of MSK pain conditions and contribute to healthcare quality improvement. The primary aims of this protocol are to (1) describe the development of an MSK-focused PBRN within the Swiss chiropractic setting, and (2) describe the methodology of the first nested study to be conducted within the PBRN-an observational prospective patient cohort pilot study.Methods and analysisThis initiative is conceptualised with two distinct phases. Phase I focuses on the development of the Swiss chiropractic PBRN, and will use a cross-sectional design to collect information from chiropractic clinicians nationwide. Phase II will recruit consecutive patients aged 18 years or older with MSK pain from community-based chiropractic practices participating in the PBRN into a prospective chiropractic cohort pilot study. All data collection will occur through electronic surveys offered in the three Swiss official languages (German, French, Italian) and English. Surveys will be provided to patients prior to their initial consultation in clinics, 1 hour after initial consultation, and at 2, 6 and 12 weeks after initial consultation.Ethics and disseminationEthics approval has been obtained from the independent research ethics committee of Canton Zurich (BASEC-Nr: 2021-01479). Informed consent will be obtained electronically from all participants. Findings will be reported to stakeholders after each study phase, presented at local and international conferences, and disseminated through peer-reviewed publications.Study pre-registrationPhase I-Swiss chiropractic PBRN (ClinicalTrials.gov identifier: NCT05046249); Phase 2-Swiss chiropractic cohort (Swiss ChiCo) pilot study (ClinicalTrials.gov identifier: NCT05116020).

Project description:BackgroundDental caries are largely preventable, and epidemiological evidence for a relationship between diet and oral health is abundant. To date, however, dentists' perceptions about the role of diet and dentists' practice patterns regarding diet counseling have not been clarified.ObjectiveTHE PURPOSES OF THIS STUDY WERE TO: (1) examine discordance between dentists' perception of the importance of diet in caries treatment planning and their actual provision of diet counseling to patients, and (2) identify dentists' characteristics associated with their provision of diet counseling.DesignThe study used a cross-sectional study design consisting of a questionnaire survey in Japan.ParticipantsThe study queried dentists working in outpatient dental practices who were affiliated with the Dental Practice-Based Research Network Japan (JDPBRN), which aims to allow dentists to investigate research questions and share experiences and expertise (n?=?282).MeasurementDentists were asked about their perceptions on the importance of diet and their practice patterns regarding diet counseling, as well as patient, practice, and dentist background data.ResultsThe majority of participants (n?=?116, 63%) recognized that diet is "more important" to oral health. However, among participants who think diet is "more important" (n?=?116), only 48% (n?=?56) provide diet counseling to more than 20% of their patients. Multiple logistic regression analysis suggested that several variables were associated with providing diet counseling; dentist gender, practice busyness, percentage of patients interested in caries prevention, caries risk assessment, and percentage of patients who receive blood pressure screening.ConclusionsSome discordance exists between dentists' perception of the importance of diet in caries treatment planning and their actual practice pattern regarding diet counseling to patients. Reducing this discordance may require additional dentist education, including nutritional and systemic disease concepts; patient education to increase perception of the importance of caries prevention; or removing barriers to practices' implementation of counseling.Trial registrationClinicalTrials.gov NCT01680848.

Project description:ObjectiveThe purposes of this study were to (1) quantify dentists' practice patterns regarding caries prevention and (2) test the hypothesis that certain dentists' characteristics are associated with these practice patterns.DesignThe study used a cross-sectional study design consisting of a questionnaire survey.ParticipantsThe study queried dentists who worked in outpatient dental practices who were affiliated with the Dental Practice-Based Research Network Japan, which seeks to engage dentists in investigating research questions and sharing experiences and expertise (n=282).MeasurementDentists were asked about their practice patterns regarding caries preventive dentistry. Background data on patients, practice and dentist were also collected.Results38% of dentists (n=72) provided individualised caries prevention to more than 50% of their patients. Overall, 10% of the time in daily practice was spent on caries preventive dentistry. Dentists who provided individualised caries prevention to more than 50% of their patients spent significantly more time on preventive care and less time on removable prosthetics treatment, compared to dentists who did not provide individualised caries prevention. Additionally, they provided oral hygiene instruction, patient education, fluoride recommendations, intraoral photographs taken and diet counselling to their patients significantly more often than dentists who did not provide individualised caries prevention. Multiple logistic regression analysis suggested that the percentage of patients interested in caries prevention and the percentage of patients who received hygiene instruction, were both associated with the percentage of patients who receive individualised caries prevention.ConclusionsWe identified substantial variation in dentists' practice patterns regarding preventive dentistry. Individualised caries prevention was significantly related to provision of other preventive services and to having a higher percentage of patients interested in caries prevention, but not to the dentist's belief about the effectiveness of caries risk assessment. (Clinicaltrials.gov registration number NCT01 680 848).

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A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies.

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A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies.

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