scholarly journals Open Pharma recommendations for plain language summaries of peer-reviewed medical journal publications

2021 ◽  
Author(s):  
Adeline Rosenberg ◽  
Slávka Baróniková ◽  
Linda Feighery ◽  
William Gattrell ◽  
Rikke Egelund Olsen ◽  
...  

Plain language summaries of peer-reviewed publications are intended for everyone engaging with medical research, such as patients, patient advocates, caregivers, healthcare professionals, and policymakers. These summaries encourage discussions around medical research and aid fully informed and shared decision-making. The broad range of stakeholders involved in pharmaceutical research now puts the pharmaceutical industry in a unique position to make the medical publishing model more open. We believe that the next step of openness is to create a more accessible and inclusive environment through the routine development of plain language summaries of peer-reviewed medical journal publications.There are many formats of plain language summaries, but plain text is the most discoverable through indexing in directories such as PubMed. Standardizing the minimum steps for the development and sharing of index-friendly plain language summaries can help promote the quality and credibility of these lay communications. The aim of a minimum standard is to build a universal foundation that encourages the accessibility, discoverability, and inclusivity of plain language summaries. This standard can then serve as a basis for summaries written for a more specific target audience or that include graphically and digitally enhanced formats that increase understanding and engagement, which we strongly encourage.

This video summarizes the underlying cause of hypertrophic cardiomyopathy (HCM), common symptoms of HCM, mechanism of action of mavacamten, and key results of the EXPLORER-HCM trial, which compared mavacamten to placebo in patients with obstructive HCM. The results of the EXPLORER-HCM study were recently published in the The Lancet. A plain language summary of the study has subsequently been published in Future Cardiology and helps patients, their caregivers, patient advocates and healthcare professionals understand the results of the trial.


Author(s):  
María José Hernández-Leal ◽  
María José Pérez-Lacasta ◽  
María Feijoo-Cid ◽  
Vanesa Ramos-García ◽  
Misericòrdia Carles-Lavila

2021 ◽  
Vol 164 (4) ◽  
pp. 704-711
Author(s):  
Samantha Anne ◽  
Sandra A. Finestone ◽  
Allison Paisley ◽  
Taskin M. Monjur

This plain language summary explains pain management and careful use of opioids after common otolaryngology operations. The summary applies to patients of any age who need treatment for pain within 30 days after having a common otolaryngologic operation (having to do with the ear, nose, or throat). It is based on the 2021 “Clinical Practice Guideline: Opioid Prescribing for Analgesia After Common Otolaryngology Operations.” This guideline uses available research to best advise health care providers, and it includes recommendations that are explained in this summary. Recommendations may not apply to every patient but can be used to facilitate shared decision making between patients and their health care providers.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
I. E. H. Kremer ◽  
P. J. Jongen ◽  
S. M. A. A. Evers ◽  
E. L. J. Hoogervorst ◽  
W. I. M. Verhagen ◽  
...  

Abstract Background Since decision making about treatment with disease-modifying drugs (DMDs) for multiple sclerosis (MS) is preference sensitive, shared decision making between patient and healthcare professional should take place. Patient decision aids could support this shared decision making process by providing information about the disease and the treatment options, to elicit the patient’s preference and to support patients and healthcare professionals in discussing these preferences and matching them with a treatment. Therefore, a prototype of a patient decision aid for MS patients in the Netherlands—based on the principles of multi-criteria decision analysis (MCDA) —was developed, following the recommendations of the International Patient Decision Aid Standards. MCDA was chosen as it might reduce cognitive burden of considering treatment options and matching patient preferences with the treatment options. Results After determining the scope to include DMDs labelled for relapsing-remitting MS and clinically isolated syndrome, users’ informational needs were assessed using focus groups (N = 19 patients) and best-worst scaling surveys with patients (N = 185), neurologists and nurses (N = 60) to determine which information about DMDs should be included in the patient decision aid. Next, an online format and computer-based delivery of the patient decision aid was chosen to enable embedding of MCDA. A literature review was conducting to collect evidence on the effectiveness and burden of use of the DMDs. A prototype was developed next, and alpha testing to evaluate its comprehensibility and usability with in total thirteen patients and four healthcare professionals identified several issues regarding content and framing, methods for weighting importance of criteria in the MCDA structure, and the presentation of the conclusions of the patient decision aid ranking the treatment options according to the patient’s preferences. Adaptations were made accordingly, but verification of the rankings provided, validation of the patient decision aid, evaluation of the feasibility of implementation and assessing its value for supporting shared decision making should be addressed in further development of the patient decision aid. Conclusion This paper aimed to provide more transparency regarding the developmental process of an MCDA-based patient decision aid for treatment decisions for MS and the challenges faced during this process. Issues identified in the prototype were resolved as much as possible, though some issues remain. Further development is needed to overcome these issues before beta pilot testing with patients and healthcare professionals at the point of clinical decision-making can take place to ultimately enable making conclusions about the value of the MCDA-based patient decision aid for MS patients, healthcare professionals and the quality of care.


2021 ◽  
Author(s):  
Peter Klimek ◽  
Dejan Baltic ◽  
Martin Brunner ◽  
Alexander Degelsegger-Marquez ◽  
Gerhard Garhöfer ◽  
...  

UNSTRUCTURED Real-world data (RWD) collected in routine healthcare processes and transformed to real-world evidence (RWE) has become increasingly interesting within research and medical communities to enhance medical research and support regulatory decision making. Despite numerous European initiatives, there is still no cross-border consensus or guideline determining which quality RWD must meet in order to be acceptable for decision making within regulatory or routine clinical decision support. An Austrian expert group led by GPMed (Gesellschaft für Pharmazeutische Medizin, Austrian Society for Pharmaceutical Medicine) reviewed drafted guidelines, published recommendations or viewpoints to derive a consensus statement on quality criteria for RWD to be used more effectively for medical research purposes beyond registry-based studies discussed in the European Medicines Agency (EMA) guideline for registry-based studies


Author(s):  
Dawn M. Magnusson ◽  
Irena Shwayder ◽  
Natalie J. Murphy ◽  
Lindsay Ollerenshaw ◽  
Michele Ebendick ◽  
...  

Purpose Despite increasing standardization of developmental screening and referral processes, significant early intervention service disparities exist. The aims of this article are to: (a) describe methods used to develop a decision support tool for caregivers of children with developmental concerns, (b) summarize key aspects of the tool, and (c) share preliminary results regarding the tool's acceptability and usability among key stakeholders. Method Content and design of the decision support tool was guided by a systematic process outlined by the International Patient Decision Aid Standards (IPDAS) Collaborative. Three focus group interviews were conducted with caregivers ( n = 7), early childhood professionals ( n = 28), and a mix of caregivers and professionals ( N = 20) to assess caregiver decisional needs. In accordance with the IPDAS, a prototype of the decision support tool was iteratively cocreated by a subset of caregivers ( n = 7) and early child health professionals ( n = 5). Results The decision support tool leverages images and plain language text to guide caregivers and professionals along key steps of the early identification to service use pathway. Participants identified four themes central to shared decision making: trust, cultural humility and respect, strength-based conversations, and information-sharing. End-users found the tool to be acceptable and useful. Conclusions The decision support tool described offers an individualized approach for exploring beliefs about child development and developmental delay, considering service options within the context of the family's values, priorities, and preferences, and outlining next steps. Additional research regarding the tool's effectiveness in optimizing shared decision-making and reducing service use disparities is warranted.


Author(s):  
France Légaré ◽  
Rhéda Adekpedjou ◽  
Dawn Stacey ◽  
Stéphane Turcotte ◽  
Jennifer Kryworuchko ◽  
...  

2015 ◽  
Vol 88 (4) ◽  
pp. 483-488
Author(s):  
Daniel-Corneliu Leucuța ◽  
Tudor Drugan ◽  
Andrei Achimaș

Background and aim. Medical research needs statistical analyses to understand the reality of variable phenomena. There are numerous studies showing poor statistical reporting in many journals with different rankings, in different countries. Our aim was to assess the reporting of statistical analyses in original papers published in Clujul Medical journal in the year 2014.Methods. All original articles published in Clujul Medical in the year 2014 were assessed using mainly Statistical Analyses and Methods in the Published Literature guidelines.Results. The most important issues found in reporting statistical analyses were reduced reporting of:  assumptions checking, difference between groups or measures of associations, confidence intervals for the primary outcomes, and errors in the statistical test choice or the descriptive statistic choice for several analyses. These results are similar with other studies assessing different journals worldwide.Conclusion. Statistical reporting in Clujul Medical, like in other journals, have to be improved. 


2021 ◽  
pp. 0272989X2110285
Author(s):  
Karen Scherr ◽  
Rebecca K. Delaney ◽  
Peter Ubel ◽  
Valerie C. Kahn ◽  
Daniel Hamstra ◽  
...  

Background Rates of shared decision making (SDM) are relatively low in early stage prostate cancer decisions, as patients’ values are not well integrated into a preference-sensitive treatment decision. The study objectives were to develop a SDM training video, measure usability and satisfaction, and determine the effect of the intervention on preparing patients to participate in clinical appointments. Methods A randomized controlled trial was conducted to compare a plain-language decision aid (DA) to the DA plus a patient SDM training video. Patients with early stage prostate cancer completed survey measures at baseline and after reviewing the intervention materials. Survey items assessed patients’ knowledge, beliefs related to SDM, and perceived readiness/intention to participate in their upcoming clinical appointment. Results Of those randomized to the DA + SDM video group, most participants (91%) watched the video and 93% would recommend the video to others. Participants in the DA + SDM video group, compared to the DA-only group, reported an increased desire to participate in the decision (mean = 3.65 v. 3.39, P < 0.001), less decision urgency (mean = 2.82 v. 3.39, P < 0.001), and improved self-efficacy for communicating with physicians (mean = 4.69 v. 4.50, P = 0.05). These participants also reported increased intentions to seek a referral from a radiation oncologist (73% v. 51%, P = 0.004), to take notes (mean = 3.23 v. 2.86, P = 0.004), and to record their upcoming appointments (mean = 1.79 v. 1.43, P = 0.008). Conclusions A novel SDM training video was accepted by patients and changed several measures associated with SDM. This may be a scalable, cost-effective way to prepare patients with early stage prostate cancer to participate in their clinical appointments. [Box: see text]


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