Use of Patient and Investigator Global Impression Scales: A Review of Food and Drug Administration–Approved Labeling, 2009 to 2019

Gnanasakthy, Ari; Barrett, Amy; Norcross, Lindsey; D’Alessio, Denise; Romano, Carla

doi:10.1016/j.jval.2021.01.005

Cited by 14 publications

(12 citation statements)

References 29 publications

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“…The PGI-I was a questionnaire scale (ranging from [1] = Very Much Better to [7] = Very Much Worse) that was widely used in clinical practice and research to assess patient impression of an intervention. [61,62] PGI-I scores were tabulated, and patient comments were abstracted and tabulated (Table S1, Supporting Information).…”

Section: Methodsmentioning

confidence: 99%

A Readily Scalable, Clinically Demonstrated, Antibiofouling Zwitterionic Surface Treatment for Implantable Medical Devices

et al. 2022

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conditions to maintain the scale of medical device manufacturing; and 4) the treatment must not incorporate antibiotics to maintain global antimicrobial stewardship efforts. The zwitterionic polymer polysulfobetaine (PSB) was selected as the antifouling component of the surface modification to benefit from its biocompatibility, ultralow-fouling properties, and oxidative stability. By adsorbing water electrostatically, PSB coatings form a thin hydration barrier that prevents organic materials from adhering to surfaces. [22] Commonly used approaches to attach PSB coatings to surfaces, such as radical-initiated graft polymerizations of PSB-methacrylate necessitate the use of oxygen-free conditions, [23] preconditioning steps, [24] or long reaction times [25] that do not meet scalability requirements. To circumvent the use of air-free graft polymerizations, we employ perfluorophenylazide (PFPA) chemistry as a molecular anchor to link the PSB coatings onto the surfaces of polymeric materials under ambient conditions. When triggered with UV-light, PFPA moieties generate a highly reactive nitrene that forms covalent bonds with materials containing amines, CC double bonds, and CH bonds. [26,27] With this method, PSB is rapidly coated onto a broad range of substrates using UV light under ambient conditions with no preconditioning steps. Thus, many different medical devices may be quickly and conveniently treated on the manufacturing level.We first demonstrate the effect of the treatment on polydimethylsiloxane (PDMS) as an exemplary, extremely difficultto-modify model for a common elastomer used in implantable medical devices. [28] Commonly known as silicone, PDMS is widely used for its biocompatibility, good chemical stability, ease of fabrication using injection molding or extrusion, and low cost. [29][30][31] Many implantable device makers have moved away from classical medical elastomers and plastics such as latex and polyvinyl chloride due to allergens [32] or plasticizers [33] in these materials that leach out and often lead to irritation or complications. PDMS-based devices do not require plasticizers and have been shown to lead to fewer complications than latex and polyurethane-based devices. [34] Despite its ideal properties, the nonpolar nature of PDMS facilitates the adhesion of organic materials. Bacteria, platelets, proteins, and other biomolecules bind strongly to the hydrophobic surfaces of PDMS elastomers, leading to the colonization and proliferation of biofilms. [22] When common hydrophilic surface treatments are performed on PDMS, such as plasma oxidation, [35] UV-ozone, [36] or corona discharge, [37] the effects are short-term due to rapid hydrophobic recovery. The highly mobile chains of PDMS (glass transition temperature ≈ −120 °C) can reorient themselves to "hide" the surface modified elastomers, when exposed to air, within hours. [38] Other methods seeking long-lasting hydrophilic PDMS surfaces typically require preconditioning steps with silane [39][40][41] chemistry or radical polymerization. [...

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Section: Methodsmentioning

confidence: 99%

A Readily Scalable, Clinically Demonstrated, Antibiofouling Zwitterionic Surface Treatment for Implantable Medical Devices

et al. 2022

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“…PET provides an invaluable tool to determine precisely the occupancy of each receptor affected by lumateperone. 21,46 The utilization of PET along with behavioral, cognitive, physiological, 90 and environmental measurements 14,89,91 provide a foundation for optimal clinical trials of schizophrenia, 10,15 and other neuropsychiatric disorders 92–100 and medical disorders. 101–103 PET will provide a tool to identify the effects of lumateperone on neurotransmitter systems already studied 21,46 and other possible pathways.…”

Section: Discussionmentioning

confidence: 99%

“…Future reviews will be enhanced by the inclusion of postmarketing surveillance for adverse effects. 5 Future investigations may be enhanced by the identification of subtypes of schizophrenia incorporating genetic and environmental influences, 19,41 as well as specific indications and optimal doses, 32 utilizing valid, reliable, and responsive single-item global impression 89 and other rating scales in order to apply the principles of precision medicine to tailor an optimal treatment plan to the specific needs of individual patients. Head-to-head comparisons of newer and older agents for efficacy and adverse effects will enhance objective assessments of pharmaceuticals for schizophrenia.…”

Section: Limitationsmentioning

confidence: 99%

The role of lumateperone in the treatment of schizophrenia

Syed

Brašić

2021

Therapeutic Advances in Psychopharmacology

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Schizophrenia is a devastating mental disorder resulting in marked morbidity and mortality despite the optimal use of all currently available interventions. For this reason, the release of lumateperone (CaptylaR), also known as ITI-007, an orally administered, atypical antipsychotic provided a welcome novel tool for clinicians to utilize precision medicine to tailor an optimal treatment plan to the specific needs of each person with schizophrenia. To generate a foundation for clinicians to assess the risks and benefits of lumateperone in relation to other interventions for schizophrenia, we conducted a search of items for ‘ITI-007’ and ‘lumateperone’ on PubMed, ScienceDirect, Web of Science, Google Scholar, and www.clinicaltrials.gov . We present a critical evaluation of the limited information about lumateperone for schizophrenia, its use approved by the US Food and Drug Administration. Lumateperone merits consideration for patients with treatment-resistant schizophrenia and for patients with schizophrenia who are vulnerable to developing metabolic dysfunction and movement disorders. On the other hand, lumateperone should not be used for (a) women who are pregnant or breastfeeding, children, adolescents, and elderly patients with dementia-related psychosis, (b) patients who are at risk for cerebrovascular diseases, (c) patients who use inducers and moderate or strong inhibitors of the cytochrome P450-3A4 (CYP3A4) isozyme, and (d) patients who use alcohol and other sedating agents. Clinical trials from multiple centers without financial conflicts of interest to market lumateperone are needed to directly compare and contrast lumateperone and other antipsychotic agents to generate trustworthy evidence to be assessed objectively by clinicians treating patients with schizophrenia. Future investigations will provide the foundations to identify the evidence for comprehensive evaluations of the role of lumateperone in the treatment of people with schizophrenia and other conditions.

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“…Also included to assess child participants’ reading ability Child Global Impression of Severity (CGI-S) Single-item global assessment asking “How bad is your cold today?” Answers recorded on a 0–4 verbal descriptor response scale (‘no cold’, ‘a tiny bit bad’, ‘a little bad’, ‘bad’ and ‘very bad’). The CGI-S item was drafted in line with common practice for static global impression items assessing disease severity [ 7 , 8 ]. Further, the descriptor words used for the CGI-S response scale (e.g., ‘a tiny bit’ and a ‘little bit’) were similar to those included in the chest-related ePRO itself, where cognitive debriefing (CD) evidence suggested good understanding of response scales [ 6 ] The CGI-S was completed by all participants at Visit 1 and each afternoon during the ten day at-home completion period Child Global Impression of Change (CGI-C) The CGI-C was a single global item which asks “How much has your cold changed since Visit 1 when you started the study?…”

Section: Methodsmentioning

confidence: 99%

“…Response options: ‘much better’, ‘a little better’, ‘the same’, ‘a little worse’, ‘much worse’. Similar to the CGI-S, the CGI-C item was drafted in line with common practice for impression of change items, and ensuring appropriate wording for pediatric completion [ 7 , 8 ] The CGI-S was completed by all participants at Visit 1 and each afternoon during the ten day at-home completion period …”

Section: Methodsmentioning

confidence: 99%

Psychometric validation and testing of the 10-item pediatric daily chest-related electronic patient reported outcome (ePRO) diary

Arbuckle

Shea

Burrows

et al. 2023

J Patient Rep Outcomes

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Background and objective The chest-related electronic patient reported outcome (ePRO) diary was recently developed to assess chest-related symptoms experienced by pediatric and adolescent populations during upper respiratory tract infections (URTI). The objective of this research was the psychometric evaluation of the chest-related ePRO diary in pediatric, adolescent and adult participants. Methods This non-interventional, psychometric validation study involved participants (N = 195; n = 42 6–8 years; n = 47 9–11 years; n = 55 12–17 years, n = 51 18+ years) completing the chest-related ePRO diary twice daily for 10 days while experiencing an acute URTI. Preliminary item-level performance and dimensionality results, along with consideration of previous qualitative findings, were used to inform item reduction decisions, the structure of the measure and scoring algorithm development. Subsequent analyses on the finalized measure included assessments of reliability (internal consistency and test-retest reliability), construct validity (convergent validity and known groups validity) and ability to detect change. Comparisons of findings were made between the different age groups as part of the analyses to assess the psychometric properties of the chest-related ePRO diary and to characterize potential differences in the symptom experience of children, adolescents, and adults. Results The measure demonstrated strong quality of completion and showed relatively similar trajectories of symptom scores over time within different age subgroups and good item response distribution properties. Exploratory factor analysis supported a one-factor solution in the total population and within age subgroups, and test-retest reliability of the measure was strong (Intra-class correlation: 0.843–0.894 between Visit 1 and Day 1). The measure also demonstrated strong construct validity through high correlations with relevant items on the Child Cold Symptom Questionnaire (CCSQ), strong known groups validity (with statistically significant differences between severity groups) and was responsive to change over time with change groups defined based on change on global items. Conclusion The findings demonstrate that the chest-related ePRO diary provides a valid, reliable, responsive measure of chest congestion symptoms experienced with the common cold in pediatric and adolescent populations, and that only minor differences are present in the disease trajectory when comparing adults to younger participants, supporting the use of the measure in interventional studies.

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Use of Patient and Investigator Global Impression Scales: A Review of Food and Drug Administration–Approved Labeling, 2009 to 2019

Cited by 14 publications

References 29 publications

A Readily Scalable, Clinically Demonstrated, Antibiofouling Zwitterionic Surface Treatment for Implantable Medical Devices

A Readily Scalable, Clinically Demonstrated, Antibiofouling Zwitterionic Surface Treatment for Implantable Medical Devices

The role of lumateperone in the treatment of schizophrenia

Psychometric validation and testing of the 10-item pediatric daily chest-related electronic patient reported outcome (ePRO) diary

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