Improving the reporting of pragmatic trials: an extension of the CONSORT statement

Zwarenstein, Merrick; Treweek, Shaun; Gagnier, Joel; Altman, Douglas G.; Tunis, Sean; Haynes, Brian; Oxman, Andrew D; Moher, David

doi:10.1136/bmj.a2390

Cited by 1,460 publications

(1,259 citation statements)

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“…To address these issues, two Consolidated Standards of Reporting Trials (CONSORT) statements have been developed describing reporting criteria for EHIs [10] and pragmatic trials [11] that provide guidance for study designs and evaluation methods, and reporting to inform decisions pertaining to both effectiveness and practical implementation of EHIs [12]. The Pragmatic Explanatory Continuum Indicator Summary (PRECIS) developed by the CON-SORT Work Group on pragmatic trials is designed to assist researchers in study design and assess a study along the pragmatic-explanatory continuum, a multidimensional continuum displaying varying levels of pragmatism across study dimensions of a particular trial [11,12].…”

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confidence: 99%

“…The Pragmatic Explanatory Continuum Indicator Summary (PRECIS) developed by the CON-SORT Work Group on pragmatic trials is designed to assist researchers in study design and assess a study along the pragmatic-explanatory continuum, a multidimensional continuum displaying varying levels of pragmatism across study dimensions of a particular trial [11,12]. PRECIS has been used to develop intervention trial design [13,14], to assess Implications Practice: Practitioners should look for and expect research reports to provide transparent information to make it possible to determine whether an eHealth program is possible to implement in their setting.…”

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confidence: 99%

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A systematic review of eHealth cancer prevention and control interventions: new technology, same methods and designs?

Sánchez

Rabin

Gaglio

et al. 2013

Behav. Med. Pract. Policy Res.

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There has been a recent surge of eHealth programs in cancer and other content areas, but few reviews have focused on the methodologies and designs employed in these studies. We conducted a systematic review of studies on eHealth interventions on cancer prevention and control published between 2001 and 2010 applying the Pragmatic Explanatory Continuum Indicator Summary (PRECIS) criteria and external validity components from the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. We identified 113 studies that focused on cancer prevention and control of eHealth interventions. Most studies fell midway along the explanatory/ pragmatic trial continuum, but few reported on various practical feasibility criteria for translation. Despite vast interest in cancer eHealth and the applied nature of this field, few studies considered key external validity issues. There is a need for use of alternative pragmatic study designs and transparent reporting of external validity components to produce more rapid and generalizable results.Keywords eHealth, Pragmatic trials, Systematic review, Design, PRECIS, External validity, RE-AIM framework BACKGROUND Reductions in cancer morbidity and mortality are partly attributable to interventions addressing modifiable risk factors and screening behaviors [1]. However, such advancements in cancer outcomes are not observed among all populations, specifically those with limited access to cancer care and efficacious behavior interventions [2,3]. The recent surge of eHealth interventions (EHIs) presents unique opportunities to enhance cancer prevention and control by increasing intervention reach, adapting to various contextual conditions, being readily available where users live, work, and play, and tailoring information to patients' needs [4][5][6].eHealth research is a relatively young field that is rapidly growing. EHIs have been found to be effective in promoting change in behaviors, knowledge, self-

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confidence: 99%

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confidence: 99%

A systematic review of eHealth cancer prevention and control interventions: new technology, same methods and designs?

Sánchez

Rabin

Gaglio

et al. 2013

Behav. Med. Pract. Policy Res.

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“…Analyses were done in accordance with the CONSORT statement 27 and its extensions to cluster and pragmatic trials, 28,29 using SAS, version 9.3. 30 The unit of intervention was the PACT team, but the primary outcomes for the study were measured at the patient level, aggregated to the PCP.…”

Section: Resultsmentioning

confidence: 99%

Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial

et al. 2015

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BACKGROUND: Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. OBJECTIVE: We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. DESIGN: We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. PATRICIPANTS: Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. INTERVENTIONS: Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. MAIN MEASURES: Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. KEY RESULTS: Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR=1.4; 95 % CI 1.2-1.6) and enroll in the disease management services MOVE! (OR=1.2; 95 % CI 1.1-1.6) and Telehealth (OR=1.7, 95 % CI 1.4-2.1) than patients on control teams. CONCLUSIONS: Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.KEY WORDS: panel management; hypertension; smoking; PCMH. J Gen Intern Med 30(7):916-23

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“…30 This is a pragmatic two-arm parallel-group randomised controlled trial (RCT) with a feasibility phase. Formal stop-go criteria were established to assess the feasibility of the trial: (1) sufficient participants willing to enter the trial and (2) retention of sufficient participants to assess the primary outcome measure.…”

Section: Methods For the Main Trialmentioning

confidence: 99%

Putting Life in Years (PLINY): a randomised controlled trial and mixed-methods process evaluation of a telephone friendship intervention to improve mental well-being in independently living older people

Hind

Mountain

Gossage-Worrall

et al. 2014

Public Health Research

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BackgroundSocial isolation in older adults is associated with morbidity. Evaluating interventions to promote social engagement is a research priority.MethodsA parallel-group randomised controlled trial was planned to evaluate whether telephone friendship (TF) improves the well-being of independently living older people. An internal pilot aimed to recruit 68 participants by 30 September 2012, with 80% retained at 6 months. Randomisation was web based and only analysts were blind to allocation. A service provider was contracted to train 10 volunteer facilitators by 1 April 2012 and 10 more by 1 September 2012. Participants were aged > 74 years with good cognitive function and living independently in an urban community. The intervention arm of the trial consisted of manualised TF with standardised training: (1) one-to-one befriending (10- to 20-minute calls once per week for up to 6 weeks made by volunteer facilitators) followed by (2) TF groups of six participants (1-hour teleconferences once per week for 12 weeks facilitated by the same volunteer). Friendship groups aimed to enhance social support and increase opportunities for social interaction to maintain well-being. This was compared with usual health and social care provision. The primary clinical outcome was the Short Form questionnaire-36 items (SF-36) mental health dimension score at 6 months post randomisation. Qualitative research assessing intervention acceptability (participants) and implementation issues (facilitators) and an intervention fidelity assessment were also carried out. Intervention implementation was documented through e-mails, meeting minutes and field notes. Acceptability was assessed through framework analysis of semistructured interviews. Two researchers coded audio recordings of telephone discussions for fidelity using a specially designed checklist.ResultsIn total, 157 people were randomised to the TF group (n = 78) or the control group (n = 79). Pilot recruitment and retention targets were met. Ten volunteers were trained by 1 September 2012; after volunteer attrition, three out of the 10 volunteers delivered the group intervention. In total, 50 out of the 78 TF participants did not receive the intervention and the trial was closed early. A total of 56 people contributed primary outcome data from the TF (n = 26) and control (n = 30) arms. The mean difference in SF-36 mental health score was 9.5 (95% confidence interval 4.5 to 14.5) after adjusting for age, sex and baseline score. Participants who were interviewed (n = 19) generally declared that the intervention was acceptable. Participant dissatisfaction with closure of the groups was reported (n = 4). Dissatisfaction focused on lack of face-to-face contact and shared interests or attitudes. Larger groups experienced better cohesion. Interviewed volunteers (n = 3) expressed a lack of clarity about procedures, anxieties about managing group dynamics and a lack of confidence in the training and in their management and found scheduling calls challenging. Training was 91–95% adherent with the checklist (39 items; three groups). Intervention fidelity ranged from 30.2% to 52.1% (28–41 items; three groups, three time points), indicating that groups were not facilitated in line with training, namely with regard to the setting of ground rules, the maintenance of confidentiality and facilitating contact between participants.ConclusionsAlthough the trial was unsuccessful for a range of logistical reasons, the experience gained is of value for the design and conduct of future trials. Participant recruitment and retention were feasible. Small voluntary sector organisations may be unable to recruit, train and retain adequate numbers of volunteers to implement new services at scale over a short time scale. Such risks might be mitigated by multicentre trials using multiple providers and specialists to recruit and manage volunteers.Trial registrationCurrent Controlled Trials ISRCTN28645428.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 2, No. 7. See the NIHR Journals Library website for further project information.

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Improving the reporting of pragmatic trials: an extension of the CONSORT statement

Cited by 1,460 publications

References 69 publications

A systematic review of eHealth cancer prevention and control interventions: new technology, same methods and designs?

A systematic review of eHealth cancer prevention and control interventions: new technology, same methods and designs?

Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial

Putting Life in Years (PLINY): a randomised controlled trial and mixed-methods process evaluation of a telephone friendship intervention to improve mental well-being in independently living older people

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