Enhancing Partnerships of Institutions and Journals to Address Concerns About Research Misconduct: Recommendations From a Working Group of Institutional Research Integrity Officers and Journal Editors and Publishers.

Importance: Institutions and journals strive to promote and protect the integrity of the research record, and both groups are equally committed to ensuring the reliability of all published data. Observations: Three US universities coordinated a series of virtual meetings from June 2021 to March 2022 for a working group composed of senior, experienced US research integrity officers (RIOs), journal editors, and publishing staff who are familiar with managing issues of research integrity and publication ethics. The goal of the working group was to improve the collaboration and transparency between institutions and journals to ensure that research misconduct and publication ethics are managed properly and efficiently. Recommendations address the following: identifying proper contacts at institutions and journals, specifying information to share between institutions and journals, correcting the research record, reconsideration of some fundamental research misconduct concepts, and journal policy changes. The working group identified 3 key recommendations to be adopted and implemented to change the status quo for better collaboration between institutions and journals: (1) reconsideration and broadening of the interpretation by institutions of the need-to-know criteria in federal regulations (ie, confidential or sensitive information and data are not disclosed unless there is a need for an individual to know the facts to perform specific jobs or functions), (2) uncoupling the evaluation of the accuracy and validity of research data from the determination of culpability and intent of the individuals involved, and (3) initiating a widespread change for the policies of journals and publishers regarding the timing and appropriateness for contacting institutions, either before or concurrently under certain conditions, when contacting the authors. Conclusions and Relevance: The working group recommends specific changes to the status quo to enable effective communication between institutions and journals. Using confidentiality clauses and agreements to impede sharing does not benefit the scientific community nor the integrity of the research record. However, a careful and informed framework for improving communications and sharing information between institutions and journals can foster better working relationships, trust, transparency, and most importantly, faster resolution to data integrity issues, especially in published literature.

First meeting in Asia of the Asia Pacific Research Integrity network.

In 2017, the University of Hong Kong and the University of California San Diego co-hosted the first Asian meeting of the recently formed Asia Pacific Research Integrity (APRI) network in Hong Kong. Aligned with planning meetings in 2015 and 2016 funded in part by the US Office of Research Integrity (ORI), the Hong Kong meeting was designed by a multi-national planning committee to address pressing challenges in research integrity: improving multi-national communication; exchanging information on managing misconduct investigations; and sharing best practices to promote research integrity. To create a sustainable, robust international partnership to promote research integrity in the region, the purpose of this 2017 meeting was to foster multi-national awareness, understanding, and opportunities for collaboration. The meeting was defined by four objectives that emerged from the previous meetings: (1) Articulate differences as well as areas of common ground; (2) Identify best or recommended practices; (3) Identify opportunities for research or collaboration; and (4) Set an APRI network agenda for coming years. The key anticipated outcome was to advance the conversation surrounding research integrity among academic institutions and regulators in Asian and Pacific Rim nations. This outcome was evidenced by meeting participation, participant satisfaction, and articulation of next steps for the APRI network.

Atypical antipsychotics and parkinsonism.

BACKGROUND: Atypical antipsychotic agents are thought to be less likely than older typical agents to produce parkinsonism. This has not been well documented. We compared the risk of development of incident parkinsonism among older adults dispensed atypical relative to typical antipsychotics. METHODS: Retrospective cohort study of all adults 66 years and older in Ontario. We used Cox proportional hazards models to study the association between the type, potency, and dose of antipsychotic dispensed and the development of parkinsonism during 1 year of follow-up. RESULTS: All 25,769 older adults prescribed antipsychotics were observed for 11,573 person-years, and 449 events of parkinsonism were identified. Relative to individuals dispensed an atypical antipsychotic, those dispensed a typical agent were 30% more likely (adjusted hazard ratio [HR], 1.30; 95% confidence interval [CI], 1.04-1.58) and those exposed to neither agent were 60% less likely (HR, 0.40; 95% CI, 0.29-0.43) to experience development of parkinsonism. Furthermore, those dispensed lower-potency typical agents were no different (HR, 0.75; 95% CI, 0.48-1.15), and those dispensed higher-potency typical antipsychotics were at close to a 50% greater risk (HR, 1.44; 95% CI, 1.13-1.84) of development of parkinsonism relative to atypical antipsychotics. Relative to those dispensed a high-dose atypical antipsychotic, those dispensed a typical antipsychotic were at similar risk for parkinsonism (Wald chi(2) = 0.14, P = .7). CONCLUSIONS: The risk of development of parkinsonism associated with the use of high-dose atypical antipsychotics was similar to that associated with the use of typical antipsychotics. Caution should be used when prescribing atypical antipsychotic therapy at high doses.

Designing theoretically-informed implementation interventions: fine in theory, but evidence of effectiveness in practice is needed.

The Improved Clinical Effectiveness through Behavioural Research Group (ICEBeRG) authors assert that a key weakness in implementation research is the unknown applicability of a given intervention outside its original site and problem, and suggest that use of explicit theory offers an effective solution. This assertion is problematic for three primary reasons. First, the presence of an underlying theory does not necessarily ease the task of judging the applicability of a piece of empirical evidence. Second, it is not clear how to translate theory reliably into intervention design, which undoubtedly involves the diluting effect of "common sense." Thirdly, there are many theories, formal and informal, and it is not clear why any one should be given primacy. To determine whether explicitly theory-based interventions are, on average, more effective than those based on implicit theories, pragmatic trials are needed. Until empirical evidence is available showing the superiority of theory-based interventions, the use of theory should not be used as a basis for assessing the value of implementation studies by research funders, ethics committees, editors or policy decision makers.

Interruptions to amputee rehabilitation.

OBJECTIVES: To determine the frequency of interruptions to inpatient amputee rehabilitation, and to identify the causes, risk factors, and consequences of these interruptions. DESIGN: Retrospective cohort study. SETTING: Inpatient amputee rehabilitation service. PATIENTS: A total of 254 consecutive patients admitted within 90 days of amputation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Patient age, gender, comorbid medical conditions, amputation type(s), days from amputation to admission, admission Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) score, rehabilitation length of stay (LOS), whether a prosthesis was fabricated, discharge destination, discharge Houghton Scale score, discharge 2-minute walk test, and discharge SF-36 score. RESULTS: Interruptions occurred in 76 patients (30%). Impaired stump healing caused 46 (18%) interruptions and acute medical illness caused 26 (10%); 4 (2%) interruptions were because of other causes. Higher incidence of interruption was associated with female gender, peripheral vascular disease, and decreased days from amputation to rehabilitation. The majority of patients with interruptions (60/76, 79%) returned to complete rehabilitation. Patients with interruptions had significantly longer rehabilitation LOS (48.5 vs 37.0d, P<.001), but functional outcome measures at rehabilitation discharge were similar between those patients who returned to complete rehabilitation after interruption and those patients without interruption. CONCLUSIONS: Interruptions to amputee rehabilitation are common and result in longer rehabilitation LOS but do not adversely affect rehabilitation outcomes in those who are able to return to complete rehabilitation. No subgroup of patients with exceptionally high incidence of interruption could be identified.

Houghton Scale of prosthetic use in people with lower-extremity amputations: Reliability, validity, and responsiveness to change.

OBJECTIVE: To evaluate the responsiveness to change and the floor and ceiling effects of the Houghton Scale. DESIGN: One-week and 3-month test-retest to evaluate reliability, validity, and responsiveness to change. SETTING: Amputee rehabilitation program. PARTICIPANTS: Persons (N=125) with unilateral or bilateral lower-extremity amputation who were wearing a prostheses: 1 group (n=49) for the reliability component and another group (n=76) for the responsiveness and validity component. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Responsiveness to change, ceiling and floor effects, and reliability and convergent validity. RESULTS: Evaluation of responsiveness to change (n=76) showed that the total score increased from a mean +/- standard deviation of 6.14+/-2.40 at discharge to 7.70+/-2.62 (P<.001) at follow-up 3 months later. Floor and ceiling effects were not detected for the overall score but were noted for the individual subscales. The internal consistency was moderate at discharge (Cronbach alpha=.71) and follow-up (Cronbach alpha=.70). The Houghton Scale correlated significantly, although moderately, with the physical composite score of the Medical Outcomes Study 36-Item Short-Form Health Survey (r=.393, P<.01) and the 2-minute walk test at admission (r=.620, P<.01) and discharge (r=.653, P<.01). The reliability (intraclass correlation coefficient=.96) of the Houghton Scale was high (n=49). CONCLUSIONS: The Houghton Scale is appropriately responsive to change in prosthetic use in individuals with lower-limb amputation after rehabilitation.