Highlights
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• The routine measurement of somatic symptoms and signs in patients with psychiatric disorders is highly important, as this population often suffers from comorbidities and adverse reactions to medications that can significantly contribute to increased non-adherence, morbidity and mortality.
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• The Transdiagnostic Global Impression–Somatic Symptoms and Signs (TGI-3S) scale assesses the severity of 10 most relevant somatic symptom domains – including key adverse events – on a 7-point Likert scale, providing a structured and clinically meaningful overview of physical health burden.
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• The TGI-3S was developed through a rigorous, multistage process and demonstrated clarity, usability, and acceptability in expert and patient–caregiver testing, with most respondents completing it in under 5 minutes and reporting high usability and satisfaction with the visual output.
Introduction
Mental and physical health are fundamentally interlinked, inviting the need to simultaneously assess both [Reference Kolappa, Henderson and Kishore1, Reference McIntyre, Berk, Brietzke, Goldstein, López-Jaramillo and Kessing2]. The overlap of mental and physical health is especially relevant in the field of psychiatry, where both the genetic background and pathophysiological mechanisms of disorders as well as lifestyle behaviours and psychotropic medications have direct implications for the physical health of affected individuals [Reference De Hert, Cohen, Bobes, Cetkovich-Bakmas, Leucht and Ndetei3–Reference Correll, Detraux, De Lepeleire and De Hert5]. Indeed, research indicates that patients with psychiatric disorders experience substantially worse physical health outcomes compared to the general population, experiencing higher rates of obesity [Reference Lopresti and Drummond6], cardiovascular disease [Reference Pérez-Piñar, Mathur, Foguet, Ayis, Robson and Ayerbe7], and type 2 diabetes [Reference Bent-Ennakhil, Cécile Périer, Sobocki, Gothefors, Johansson and Milea8–Reference McIntyre and Le10], just to name a few. Importantly, this predisposition leads to a reduced life expectancy of 15–20 years [Reference Chan, Correll, Wong, Chu, Fung and Wong11], with physical health conditions accounting for 77.7% of excess deaths in psychiatric patients [Reference Lawrence, Hancock and Kisely12, Reference Nordentoft, Wahlbeck, Hällgren, Westman, Ösby and Alinaghizadeh13]. Similarly, patients with somatic conditions experience poorer outcomes if mental disorders are present [Reference Dragioti, Radua, Solmi, Gosling, Oliver and Lascialfari14], particularly alcohol use disorders, depressive disorders, and schizophrenia.
Notably, psychotropic medications, including antipsychotics, antidepressants, and mood stabilisers, contribute to this increased risk [Reference Correll, Detraux, De Lepeleire and De Hert5, Reference McIntyre, Kwan, Rosenblat, Teopiz and Mansur15], with lifestyle factors [Reference Cormac, Ferriter, Benning and Saul16], stigma [Reference Lykouras and Douzenis17], and disparities in healthcare access and utilisation exacerbating the issue [Reference De Hert, Cohen, Bobes, Cetkovich-Bakmas, Leucht and Ndetei3, Reference Cradock-O’Leary, Young, Yano, Wang and Lee18]. Numerous studies have shown that individuals with psychiatric diagnoses are less likely to receive standard physical healthcare and are more likely to have undiagnosed or untreated medical conditions [Reference De Hert, Cohen, Bobes, Cetkovich-Bakmas, Leucht and Ndetei3, Reference Dickerson, McNary, Brown, Kreyenbuhl, Goldberg and Dixon19]. This disparity represents a major ethical and clinical gap in care. Thus, a holistic, person-centred approach in psychiatric care requires the recognition of the body–mind continuum [Reference Slagstad20]; mental recovery should be contingent not only on symptom remission but also on the physical wellbeing and functionality of the individual [Reference Killackey and Alvarez-Jimenez21], especially given that research has shown that adverse reactions to medications can impair functioning and quality of life and are also related to nonadherence [Reference Di Bonaventura, Gabriel, Dupclay, Gupta and Kim22, Reference Tandon, Lenderking, Weiss, Shalhoub, Barbosa and Chen23].
Measurement-based care (MBC), the systematic and routine use of validated rating scales in clinical practice [Reference Aboraya, Nasrallah, Elswick, Elshazly, Estephan and Aboraya24], has been shown to improve outcomes in psychiatry by enhancing clinical decision-making, facilitating communication, and supporting shared treatment planning [Reference Guo, Xiang, Xiao, Hu, Chiu and Ungvari25, Reference DeSimone and Hansen26]. However, MBC has historically focused on psychiatric illness-related symptom reduction, often overlooking the physical health status of people with severe mental illness [Reference Lustbader27]. Indeed, side effects and physical health problems are often underreported and inconsistently tracked in psychiatric settings [Reference Fagiolini and Goracci28] despite experts recommending regular monitoring of body mass index, glucose levels, lipid profiles, and other physical health parameters [Reference Marder, Essock, Miller, Buchanan, Casey and Davis29].
For example, sexual side effects are rarely discussed, unless directly inquired about by the clinician, and patients may be reluctant to share such information voluntarily if unprompted [Reference Segraves and Balon30, Reference Rosenberg, Bleiberg, Koscis and Gross31]. Despite the existence of validated adverse effects rating scales, such as the UKU Side Effect Rating Scale [Reference Lingjærde, Ahlfors, Bech, Dencker and Elgen32] or the Antidepressant Side-Effect Checklist (ASEC) [Reference Uher, Farmer, Henigsberg, Rietschel, Mors and Maier33], these tools are often lengthy, complex, and designed primarily for use associated with certain medications and in research settings [Reference Yahya34]; in routine psychiatric practice, they are rarely implemented.
This lack of systematic assessment of physical health status and adverse treatment effects in everyday clinical practice is problematic. In order to improve the issue, psychiatrists should expand their role to include some monitoring and treating physical health parameters, while healthcare systems need to improve the integration of mental and physical health care services [Reference De Hert, Cohen, Bobes, Cetkovich-Bakmas, Leucht and Ndetei3, Reference Reddy and Rado35].
To address this gap, the Transdiagnostic Global Impression–Somatic Symptoms and Signs (TGI-3S) scale was developed as a counterpart to the recently published TGI–Psychopathology (TGI-P) scale [Reference Correll, Dombi, Barabássy, Németh, Brevig and McIntyre36, Reference McIntyre, Dombi, Barabassy, Brevig, Németh and Correll37]. The TGI-3S is designed to function as a front-end, anamnesis-embedded, screening and monitoring tool that provides a brief, intuitive, and transdiagnostic assessment of physical health problems and adverse effects associated with psychotropic medications, making it feasible for routine clinical use. The scale deliberately does not make any distinction between somatic symptoms, physical signs and medication adverse effects and supports the potential use of more specific scales and other diagnostic instruments once a symptom or sign is detected. Similar to the TGI-P, the TGI-3S is designed for being rated by all parties of the triangle of care: clinicians, patients, and caregivers/informants, thus facilitating more comprehensive and collaborative care. The present manuscript describes the development, preliminary validation, and clinical utility of the TGI-3S scale.
Methods
Multistage scale development framework
Throughout the development of the TGI-3S scale, the framework proposed by Boateng et al. was followed [Reference Boateng, Neilands, Frongillo, Melgar-Quiñonez and Young38]. This structured, three-phase process for developing psychiatric rating scales includes: (I) item development, (II) scale construction, and (III) scale evaluation. Phase I involves defining the construct, generating items through literature review and expert input and assessing content validity [Reference Boateng, Neilands, Frongillo, Melgar-Quiñonez and Young38]. In Phase II, items are pre-tested for clarity and then administered to a sample; statistical methods such as item analysis and factor analysis are used to refine the scale [Reference Boateng, Neilands, Frongillo, Melgar-Quiñonez and Young38]. Finally, Phase III evaluates the scale’s reliability (e.g., internal consistency, test–retest) and validity (e.g., construct, criterion) [Reference Boateng, Neilands, Frongillo, Melgar-Quiñonez and Young38].
The TGI-3S was initially developed as an adverse events-focused instrument (TGI-AE). An extended literature review was conducted to identify the most relevant physical health domains related to treatment in psychiatric populations. This process included both a narrative review of common comorbid physical conditions and a structured review of existing validated rating scales assessing physical health and medication side effects. Based on this comprehensive mapping, domains and symptoms that recurred consistently across both the literature and established instruments – particularly those with high prevalence, clinical relevance, and impact on functioning or treatment adherence – were identified. These recurring domains formed the initial item pool of the TGI-AE.
The draft items were reviewed by an expert panel and subsequently evaluated by patients and caregivers. Across these consultations, stakeholders consistently noted that many physical complaints in psychiatric populations cannot be clearly distinguished as treatment-emergent adverse effects versus manifestations of underlying comorbid somatic conditions. Moreover, neither the literature nor existing psychiatric assessment tools provided a comprehensive method for capturing both adverse events and physical symptoms across body systems.
To address this gap, the development team broadened the scope of the scale from adverse events to a holistic assessment of physical health. As part of this process, the system organ class structure of the Medical Dictionary for Regulatory Activities (MedDRA) was used as a comprehensive framework to ensure systematic coverage of somatic domains. MedDRA, developed by the International Council for Harmonisation (ICH), comprises 27 system organ classes (SOCs) covering the full spectrum of medical conditions and adverse events [Reference Brown, Wood and Wood39]. For the scale, the 27 MedDRA System Organ Classes were iteratively reduced (27 → 20 → 12 → 10 → 10) by grouping related physiological systems (e.g., cardiac and vascular into cardiovascular), excluding non-somatic or non-clinically actionable categories (including procedures, product issues, social circumstances, and selected psychiatric constructs), integrating general symptom clusters and laboratory-derived signs into broader clinically interpretable domains, and merging conceptually overlapping constructs (e.g., sleep disturbance with alertness/arousal).
This revised draft underwent a second round of review with the same clinical and research experts, which was followed by a new patient and caregiver survey to ensure clarity, clinical relevance, and usability across all respondent groups.
Expert consultation
As part of Phase I, an online advisory board with seven international experts was conducted to obtain initial feedback on the TGI-AE and to evaluate its face validity, content validity, criterion validity, internal consistency, and practical applicability. Experts (Katharina Domschke, MD, PhD; Paolo Fusar-Poli, MD; Philip Gorwood, MD, PhD; Philip D Harvey, MD; Stefan Leucht, MD; Søren Dinesen Østergaard, MD, PhD; Allan Young, MD) were selected based on extensive clinical and research experience and scientific contributions in psychopathology, psychopharmacology, adverse events, and psychometric scale development. The online survey was completed in December 2024 and included 19 single-choice and open-ended questions on the TGI-AE (Supplementary Material 1). The original TGI-AE scale was refined based on this expert feedback that focused on items being too much restricted to adverse effects and also on items being overly complex and complicated in wording and presentation.
This feedback prompted a second round of item generation with a broadened view of somatic issues rather than adverse events only and with a simplification of item description and presentation, which was followed by a subsequent review conducted via email in November 2025 with the same experts. The experts were asked to comment on (1) the comprehensiveness of the revised scale, (2) recommendations for adding or removing items, (3) any further suggestions prior to finalisation, and (4) the suitability of the instrument for routine clinical practice and clinical trials. Predefined criteria for item retention and removal included clarity of wording, perceived clinical relevance, redundancy with other items, and feasibility of rating within a brief clinical interaction. Items were removed or modified if multiple experts identified them as difficult to understand, overly technical, or impractical for routine use. Their responses informed the final refinement of the TGI-3S scale prior to the patient and caregiver survey.
Patient and Caregiver survey
In Phase II, the scale was evaluated by members of the target population across two consecutive survey rounds. In both rounds, participants (patients diagnosed with schizophrenia, bipolar disorder, or major depressive disorder, and caregivers of individuals with these conditions) were recruited in the US and UK by an external research company (Inspira Research). Caregivers were not matched with specific patients but supported individuals with the same diagnoses. Participants first tested the scale for usability, without recording responses to the scale items, and then completed a structured questionnaire assessing understandability, clarity of instructions, ease of use, wording, visual layout, and emotional or cognitive burden, as well as comparisons with current practices and suggestions for improvement.
The first survey round (March 2025) included 50 participants and evaluated the initial adverse-events–focused version of the instrument (TGI-AE). Feedback was collected through a 19-item questionnaire and results informed revisions to the scale (Supplementary Material 2). The second round (January 2026) included 100 participants and assessed the updated, expanded version (TGI-3S). The corresponding evaluation questionnaire comprised the same domains of usability and interpretability. Completion time of the survey was approximately 10 minutes. In addition to descriptive statistics, open-ended responses were analysed using a qualitative thematic approach, whereby responses were grouped into recurrent themes (e.g., clarity of wording, usability of visual output, perceived burden). Themes mentioned by multiple participants were prioritised and directly informed modifications of wording, structure, and content of the instrument. Feedback from this round guided the final refinements prior to psychometric testing.
Results
Item development
Literature review
The literature review shed light on the high prevalence of somatic comorbidities and treatment-related physical adverse events among individuals with psychiatric disorders. Common physical health issues that were broadly reported in the literature were cardiovascular symptoms, metabolic disturbances, gastrointestinal issues, musculoskeletal conditions, chronic pain, and neurological and cognitive impairments [Reference De Hert, Cohen, Bobes, Cetkovich-Bakmas, Leucht and Ndetei3, Reference Nilsson, Borgstedt-Risberg, Brunner, Nyberg, Nylén and Ålenius40, Reference De Hert, Detraux, Van Winkel, Yu and Correll41]. These conditions are often exacerbated by psychiatric medications, which can lead to adverse effects, such as neuromotor symptoms, sedation, metabolic syndrome, and autonomic dysfunction [Reference Huhn, Nikolakopoulou, Schneider-Thoma, Krause, Samara and Peter42].
Validated rating scales assessing adverse events and physical health
The review of existing validated scales revealed a wide range of tools designed to assess physical symptoms and adverse events associated with psychiatric conditions and treatments. Clinician-administered scales such as the Barnes Akathisia Rating Scale (BARS) [Reference Barnes43], Simpson-Angus Scale (SAS) [Reference Hawley, Fineberg, Roberts, Baldwin, Sahadevan and Sharman44], Abnormal Involuntary Movement Scale (AIMS) [Reference Kane, Correll, Nierenberg, Caroff and Sajatovic45], and Extrapyramidal Symptom Rating Scale (ESRS) [Reference Chouinard and Margolese46] are primarily used to assess movement disorders and neurological adverse effects. In contrast, the Psychotropic-Related Sexual Dysfunction Questionnaire (PRSexDQ-SALSEX) is designed to evaluate sexual dysfunction, particularly that induced by antipsychotic medications [Reference Montejo and Rico-Villademoros47].
Broader side effect profiles are captured by tools like the UKU Side Effect Rating Scale [Reference Lingjærde, Ahlfors, Bech, Dencker and Elgen32], Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) [Reference Day, Wood, Dewey and Bentall48], and GASS [Reference Waddell and Taylor49], which assess autonomic, gastrointestinal, cardiovascular, and neurological symptoms. Self-report instruments, such as the PROMIS Global Health [Reference Katzan and Lapin50] and SF-36 [Reference Ware, Snow, Kosinski and Gandek51], evaluate general physical health, fatigue, pain, and functional limitations. While these tools provide valuable insights, most are either disorder-specific, medication-focused, and/or lengthy, highlighting the need for a concise, transdiagnostic and trans-medication scale that can efficiently assess key physical comorbidities and adverse treatment effects in routine psychiatric or primary care.
Broad list of adverse events and physical health domains
Drawing on published evidence and established validated instruments, an extensive set of domains was initially assembled for the TGI-AE scale to capture the wide spectrum of adverse events frequently encountered in psychiatric populations. This early list covered cardiovascular, metabolic, respiratory, gastrointestinal, musculoskeletal, neurological, and sexual health domains, along with chronic pain, sleep-related problems, cognitive manifestations, and overall physical functioning. The intention behind this broad scope was to ensure that all potentially relevant adverse events were represented.
MedDRA-based item development
The following sections will predominantly focus on the second development round (TGI-3S). Details of the first round (TGI-AE) including initial selection of items and results of the expert feedback and patient–caregiver survey are detailed in the Supplementary Materials 3–6.
In the second phase of item development (TGI-3S), the MedDRA terminology served as the foundation. Progressive consolidation of the 27 MedDRA System Organ Classes yielded 20 and 12 intermediate domains, culminating in 10 clinically coherent domains that formed the scale at this stage (Table 1).
MedDRA domain consolidation overview
Table 1. Long description
The table consists of four columns representing different levels of domain consolidation.
Column 1 lists 27 MedDRA S O Cs including Blood and lymphatic system disorders, Cardiac disorders, Congenital, familial and genetic disorders, Ear and labyrinth disorders, Endocrine disorders, Eye disorders, Gastrointestinal disorders, General disorders and administration site conditions, Hepatobiliary disorders, Immune system disorders, Infections and infestations, Injury, poisoning and procedural complications, Investigations, Metabolism and nutrition disorders, Musculoskeletal and connective tissue disorders, Neoplasms benign, malignant and unspecified, Nervous system disorders, Pregnancy, puerperium and perinatal conditions, Product issues, Psychiatric disorders, Renal and urinary disorders, Reproductive system and breast disorders, Respiratory, thoracic and mediastinal disorders, Skin and subcutaneous tissue disorders, Social circumstances, Surgical and medical procedures, and Vascular disorders.
Column 2 consolidates these into 20 domains: Blood and lymph, Cardiac, Injury, General, Eye, Ear and labyrinth, Neurology, Psychiatry, Infections, Immune, Skin and subcutaneous tissue, Musculoskeletal, Reproductive system, Renal and urinary, Endocrine, Metabolism, Hepatobiliary, Gastrointestinal, Respiratory, and Vascular.
Column 3 further consolidates into 12 domains: Cardiovascular, Metabolic, Gastrointestinal, Respiratory, General sickness symptoms and signs, Sedation/insomnia, Alertness/arousal, Neuromotor, Skin and hair, Sexual health, Lab signs, and Sensory symptoms (eye, ear, labyrinth).
Column 4 shows the final 10 domains: Cardiovascular, Metabolic/Gastrointestinal, Respiratory, Neurological, Sleep and energy, Sensory, Sexual health, Immune/infection, and General/physical/lab composite.
Rating followed the same structure for each domain: respondents first indicated whether they had experienced any problems in that domain, then rated the severity of each relevant symptom using a 1–7 scale (1 = normal/not at all severe; 7 = extreme severity). For each domain, a “Highest Score” box captured the most severe rating assigned to any listed symptom, which could then be transferred to a visual map to generate a personal “heatmap” summarising areas of difficulty. To align with the structure of the TGI-P, each domain included both hyperactive and hypoactive expressions, representing either an elevation above or a reduction below normal physiological levels, and respondents could add unlisted symptoms in designated “other” fields. This pre-revision version is summarised in Table 2.
The initial version of TGI-3S
Table 2. Long description
The table consists of four columns and ten numbered rows. The columns are labeled Body area/function, Any problems? (with YES/NO options), Your impression – how severe? (listing specific symptoms), and Highest score (rated 1 for normal to 7 for extreme).
* Row 1. Heart and circulation: Overactive symptoms include fast heartbeat, pounding heart, high blood pressure, and chest tightness. Underactive symptoms include slow heartbeat, low blood pressure, and dizziness.
* Row 2. Weight and metabolism: Overactive symptoms include weight gain, increased appetite, high blood sugar, and high cholesterol. Underactive symptoms include weight loss, decreased appetite, and low blood sugar.
* Row 3. Sleep, alertness, and energy: Overactive symptoms include trouble falling asleep, restlessness, and irritability. Underactive symptoms include sleeping too much, feeling sleepy all day, and lack of energy.
* Row 4. Nerves and muscles: Overactive symptoms include tremors, muscle cramps, and nerve pain. Underactive symptoms include emotional or cognitive blunting, stiff muscles, and poor balance.
* Row 5. Sexual and reproductive health: Overactive symptoms include increased sexual drive and heavy periods. Underactive symptoms include low sexual interest and erection problems.
* Row 6. Stomach, digestion, kidney and bladder: Overactive symptoms include nausea, diarrhea, and too much urination. Underactive symptoms include dry mouth, constipation, and bloating.
* Row 7. Breathing and lungs: Overactive symptoms include fast breathing and asthma symptoms. Underactive symptoms include shallow breathing and snoring.
* Row 8. Skin and hair: Overactive symptoms include rash, itching, and sweating. Underactive symptoms include hair loss and change in hair texture.
* Row 9. Eyes, ears, and other senses: Overactive symptoms include enlarged pupils, double vision, and sensitivity to light or sound. Underactive symptoms include small pupils, blurred vision, and dry eyes.
* Row 10. Lab values and body temperature: Overactive symptoms include high white blood cell count, high prolactin, and fever. Underactive symptoms include decreased blood cells, underactive thyroid, and decreased body temperature.
Expert feedback
Across both expert rounds, reviewers agreed that the scales captured the intended constructs and included relevant content; however, concerns regarding clarity, comprehensibility, and cognitive burden became increasingly prominent in the second round. While early feedback already indicated that certain elements – particularly the hyper/hypo polarity axis and technically phrased items – might be challenging to interpret or apply consistently, these issues were reinforced and amplified as the review process progressed. By the second round, experts uniformly concluded that the draft TGI-3S remained too technical for patient self-report. Many items required medical or laboratory knowledge that most patients would not possess – for example, interpreting thyroid status, understanding an electrolyte imbalance, distinguishing migraine from other headaches, or recognising changes in eye pressure. Reviewers cautioned that such technical demands would likely impair comprehension, increase cognitive and interpretive load, and undermine the reliability of responses, even among highly educated individuals. Taken together, feedback from both rounds highlighted the need for substantial simplification to ensure that the instrument is accessible across a wide range of educational backgrounds, symptom presentations, and psychiatric diagnoses.
Concerns raised by the consultants provide the impetus for major revisions of the original draft. The hyperactive/hypoactive structure was removed, all wording was rewritten in plain language, and clinically complex items – including the entire laboratory-values domain – were eliminated or integrated elsewhere. The instrument was consolidated into a single version suitable for patients, caregivers, and clinicians alike by simplifying the language. Ten somatic domains were retained for conceptual coherence and alignment with user preferences for brevity, forming the final structure of the TGI-3S: (1) Heart & Circulation, (2) Weight & Metabolism, (3) Sleep, Alertness & Energy, (4) Nerves & Muscles, (5) Sexual & Reproductive Health, (6) Stomach, Digestion, Liver & Bile, (7) Breathing & Lungs, (8) Skin & Hair, (9) Eyes, Ears & Other Senses, and (10) Kidney, Bladder & Prostate. This refined version was then taken forward to the patient–caregiver usability survey.
Patient & caregiver feedback
Participant characteristics
In development round 2, 100 participants (50 patients, 50 caregivers) were evenly split between the UK and US (Table 3). Female participants represented 74% of the sample. Age distribution was broader than in round 1, with 26% aged 18–39 and 33% aged 50–59. Educational attainment remained high (65% university-educated). Household size showed similar variability, with 28% living alone and 38% in two-person households.
Participant characteristics of the patient and caregiver survey
Table 3. Long description
The table is organized into four columns: Characteristic, Total (n = 100), Patients (n = 50), and Caregivers (n = 50). Data is presented as n (%).
* Country: Split equally with 50 from the U K and 50 from the U S. Each group (Patients and Caregivers) has 25 participants from each country.
* Sex: 26% Male and 74% Female. This distribution is identical across both Patients and Caregivers.
* Age groups: The largest segment is 50 to 59 years (33% total). Caregivers are younger on average, with 34% in the 18 to 39 bracket compared to 18% of patients.
* Education: 65% of the total have a University education. This is higher in patients (76%) than caregivers (54%).
* Household size: The most common size is 2 people (38% total). 32% of patients live alone compared to 24% of caregivers.
* Diagnosis: Bipolar disorder is the most frequent diagnosis (47% total), followed by Major depression (28%) and Schizophrenia (25%). Among patients, 54% have Bipolar disorder, while caregivers support a more even distribution of the three conditions.
Opinion about the TGI-3S scale
Overall, the revised TGI-3S was rated positively across all usability indicators (Table 4). Most respondents found the aim of the scale clear (96% very or somewhat clear) and the instructions easy to follow (87% very or easy to follow), with only 3% reporting any confusion. Confidence in completing the scale was high (99%), and 72% finished in less than 5 minutes. The TGI-3S was perceived as easy to complete by 91% of participants, and 92% reported no difficulties. Emotional and cognitive burden remained low, with 75% not at all overwhelmed, 77% not burdened, and 73% not triggered by the content. The revised plain-language item descriptions were well understood across domains, with only small proportions (2–8%) indicating uncertainty; notably, most wording challenges occurred in the Sexual & Reproductive Health and Nerves & Muscles domains, and these were reported primarily by caregivers. The detailed examples were widely appreciated (80% very helpful).
Results of the patient and caregiver survey
Table 4. Long description
The table presents survey data for 100 participants (50 patients and 50 caregivers) divided equally between the UK and U.S. (n = 25 per group). Key findings include:
* Understandability of aim: 60% found it very clear, 36% somewhat clear, and 4% not clear.
* Understandability of instructions: 66% found them very easy to follow, while only 3% found them confusing or very confusing.
* Confidence: 74% felt completely confident filling out the scale.
* Time: 72% completed the scale in less than 5 minutes.
* Easiness: 56% rated it very easy; 0% rated it difficult or very difficult.
* Difficulties: 92% reported no difficulties.
* Understandability of wording: For specific medical categories (Heart, Weight, Sleep, Nerves, Sexual, Stomach, Breathing, Skin, Eyes, Kidney), ‘No’ answers regarding clarity ranged from 2% to 8%.
* Evaluation of examples: 80% found detailed examples very helpful.
* Description preferences: 50% saw no need for shortening, while 38% preferred it somewhat shorter.
* Visual output: 58% found the visual output very helpful for understanding, and 62% found it very helpful for communicating with doctors.
* Future use: 72% intend to fill out the scale at every visit.
* Psychological impact: 75% were not at all overwhelmed, 77% found it not at all burdensome, and 73% were not at all triggered.
a only “No” answers displayed.
Compared with the earlier TGI-AE evaluation, the TGI-3S demonstrated several improvements. Confusion with instructions decreased, respondents showed even higher confidence when completing the scale, and comprehension of item wording improved following simplification and removal of the hyper/hypo structure. Requests for substantial shortening also declined, and the visual output remained strongly valued, with most participants finding it helpful for understanding symptoms and communicating with clinicians.
Spontaneous feedback supported these results. Altogether, 42% commented that everything was clear and understandable, and 38% described the scale as helpful, often highlighting the clearer explanations, intuitive layout, and usefulness of the visual output in recognising symptom patterns. Patients especially praised the visualisation, noting that “the graph makes it easier to know how your overall health changes over time,” that the “use of colour, clear scale and gradations” was helpful, and that the visuals “allowed me to see how I am doing” and “simplified completing the scale.” Caregivers similarly emphasised the simplicity and intuitiveness of the scale, explaining that the questions were easy to understand without being overwhelming and that the scale “gives you a feeling of completeness.” Challenges mainly concerned the link between scale items and the visual diagram, the desire for even simpler or more concise wording, and occasional issues with small screen size during digital completion. Participants suggested clarifying how the visual output reflects responses, simplifying descriptions where possible, and offering clearer guidance for non-applicable items.
Following the development round 2 patient–caregiver survey, no further refinements were made, as additional simplification was judged to risk loss of clinical clarity and participants were overall satisfied with the scale’s structure and usability.
The final TGI-3S scale
The final version of the TGI-3S consists of 10 somatic symptom and sign domains: Heart & Circulation, Weight & Metabolism, Sleep, Alertness & Energy, Nerves & Muscles, Sexual & Reproductive Health, Stomach, Digestion, Liver & Bile, Breathing & Lungs, Skin & Hair, Eyes, Ears & Other Senses, and Kidney, Bladder & Prostate.
Each domain includes a list of examples of commonly experienced symptoms/signs phrased in plain language, rated on a 7-point severity scale consistent with the TGI-P and CGI-S (1 = normal/not at all severe to 7 = extreme severity) (Table 5). The TGI-3S is designed for use by multiple respondent types. Patients and informants rate symptoms based on lived experience or observation, whereas clinician ratings may integrate patient report together with available objective or medical information (e.g., physical examination findings, laboratory values, or documented diagnoses). Accordingly, the inclusion of signs reflects clinically meaningful indicators that may not be directly perceived by patients, but that could also have been elicited clinically and shared with the patient or caregiver. Moreover, it is not uncommon for patients to track their own blood pressure, pulse, body temperature, or blood sugar, especially if having a chronic physical disorder for which self-monitoring such signs is relevant. Additionally, it is not required for patients or informants to recognise or rate every example within a domain. Respondents indicate whether they perceive or know about any problems within each domain, rate the severity of relevant symptoms and/or signs appropriate to their role, and transfer the highest rating score per domain onto the symptom map to generate a visual map (Figure 1).
The finalised Transdiagnostic Global Impression–Somatic Symptoms and Signs scale
Table 5. Long description
A radial diagram, also known as a spider or radar chart, used to map a clinical footprint of somatic health.
At the center of the web is a score of 1, representing normal or not at all. Concentric rings expand outward to a maximum score of 7 at the perimeter, representing extreme severity.
Ten symptom domains are positioned as axes around the circle. Starting from the top and moving clockwise, they are:
* Heart and circulation
* Weight and metabolism
* Sleep, alertness and energy
* Nerves and muscles
* Sexual and reproductive health
* Stomach, digestion, liver and bile
* Breathing and lungs
* Skin and hair
* Eyes, ears and other senses
* Kidney, bladder and prostate
Each axis contains tick marks for scores 1 through 7, allowing a user to mark a point on each axis and connect them to visualize a global somatic health profile.
a 1 – normal/not at all; 2 – minimal; 3 – mild; 4 – moderate; 5 – marked; 6 – severe; 7 – extreme.
The finalised Transdiagnostic Global Impression–Somatic Symptoms and Signs map. 1 = normal/not at all; 2 = minimal; 3 = mild; 4 = moderate; 5 = marked; 6 = severe; 7 = extreme.
Figure 1. Long description
The diagram consists of seven concentric circles intersected by nine radial lines.
Concentric Structure:
From the center moving outward, the circles are numbered 1 through 7 along the bottom vertical axis.
- Level 1 is the innermost circle, representing normal or not at all.
- Level 2 represents minimal.
- Level 3 represents mild.
- Level 4 represents moderate.
- Level 5 represents marked.
- Level 6 represents severe.
- Level 7 is the outermost perimeter, representing extreme.
Radial Categories:
Starting from the top vertical axis and moving clockwise, the categories are:
- Kidney, Bladder and Prostate (dark purple)
- Eyes, Ears and Other senses (blue)
- Skin and Hair (cyan)
- Breathing and Lungs (green)
- Stomach, Digestion, Liver and Bile (teal)
- Sexual and Reproductive Health (brown)
- Nerves and Muscles (orange)
- Sleep, Alertness and Energy (light purple)
- Weight and Metabolism (red)
- Heart and Circulation (pink)
The final version of the TGI-3S for clinicians, patients, and caregivers is available in Supplementary Material 7.
Discussion
The TGI-3S scale is a promising, novel, anamnesis-embedded, user-based tool for everyday psychiatric practice. If validated, it would offer a comprehensive, yet brief framework for assessing somatic symptoms and signs that can be related to both physical comorbidities and medication-related adverse events. It could serve as a front-end, screening tool, which is most relevant to psychiatric populations but might also have applicability in patients followed in general medical care [Reference Kolappa, Henderson and Kishore1, Reference De Hert, Cohen, Bobes, Cetkovich-Bakmas, Leucht and Ndetei3–Reference Correll, Detraux, De Lepeleire and De Hert5, Reference Lawrence, Hancock and Kisely12, Reference Nordentoft, Wahlbeck, Hällgren, Westman, Ösby and Alinaghizadeh13, Reference Di Bonaventura, Gabriel, Dupclay, Gupta and Kim22, Reference Tandon, Lenderking, Weiss, Shalhoub, Barbosa and Chen23, Reference Fagiolini and Goracci28, Reference Marder, Essock, Miller, Buchanan, Casey and Davis29].
Integrating structured, rapid somatic screening into mental-health care is essential to advance individualised, and holistic measurement-based care [Reference Marder, Essock, Miller, Buchanan, Casey and Davis29, Reference Reddy and Rado35, Reference Mitchell, Delaffon, Vancampfort, Correll and De Hert52–Reference Firth, Siddiqi, Koyanagi, Siskind, Rosenbaum and Galletly56]. Existing guidelines emphasise the need for regular metabolic, cardiovascular, neurological, and endocrine monitoring in patients receiving antipsychotic, mood stabiliser, or antidepressant medication [Reference Marder, Essock, Miller, Buchanan, Casey and Davis29, Reference Reddy and Rado35], yet uptake in clinical practice remains low [Reference Mitchell, Delaffon, Vancampfort, Correll and De Hert52–Reference Solmi, Fiedorowicz, Poddighe, Delogu, Miola and Høye54], as in the absence of routine screening, many of these aspects are unlikely to enter the clinical focus. Multiple instruments exist to assess physical health or medication side effects, but each occupies a relatively narrow niche. Movement-disorder scales such as the BARS, SAS, AIMS, and ESRS provide detailed clinician-rated assessments of specific neurological adverse effects but require training and are not designed for broad somatic screening [Reference Barnes43–Reference Chouinard and Margolese46]. Broader side-effect scales (e.g., UKU, LUNSERS, GASS, and ASEC) capture a wider range of psychotropic-related symptoms but are comparatively lengthy, medication-specific, or research-oriented, making them challenging to use routinely in busy outpatient settings [Reference Lingjærde, Ahlfors, Bech, Dencker and Elgen32–Reference Yahya34, Reference Day, Wood, Dewey and Bentall48, Reference Waddell and Taylor49]. Meanwhile, general health surveys such as PHQ-15, PROMIS Global Health, and the SF-36 assess global symptoms, functioning, or well-being but do not prioritise psychotropic-relevant domains or provide the domain-level clinical granularity needed to guide medication decisions [Reference Katzan and Lapin50, Reference Ware, Snow, Kosinski and Gandek51]. As such, current tools tend either to be too narrow (focused on one adverse-event cluster) or too broad or generic to support treatment decisions in psychiatry. Additionally, available tools are typically too lengthy or impractical for routine use within the limited time of a standard clinical encounter.
The TGI-3S was designed to fill this gap by offering a concise, transdiagnostic, trans-medication, anamnesis-embedded tool that is specifically designed for easy integration into everyday clinical workflows. The TGI-3S is not intended to replace or compete with established, domain-specific validated scales; rather, it offers a pragmatic complementary tool for routine use, with the explicit recognition that increased brevity entails a trade-off with clinical granularity and precision. Further clarification may be required to differentiate whether reported symptoms and signs within a specific domain entail a pathological or burdensome abundance or shortage of physiologically present or normal domain functioning (e.g., sedation vs agitation; insomnia vs hypersomnia, or both. Conceptually, the scale complements the TGI-P and follows the tradition of global-impression measures (e.g., the CGI) that provide clinically intuitive, severity-anchored ratings suitable for real-world use [Reference Correll, Dombi, Barabássy, Németh, Brevig and McIntyre36, Reference McIntyre, Dombi, Barabassy, Brevig, Németh and Correll37]. The TGI-3S extends this framework to somatic domains central to psychotropic tolerability/safety and overall somatic health. By integrating these domains into a single 10-domain map with a harmonised 7-point scale, the TGI-3S will allow clinicians, patients, and caregivers to generate a shared, visually intuitive overview of the current presence and severity of the somatic burden within minutes [Reference Correll, Detraux, De Lepeleire and De Hert5, Reference Di Bonaventura, Gabriel, Dupclay, Gupta and Kim22].
This positioning has important implications. First, even prior to full psychometric validation, the use of a structured approach may represent an incremental improvement over unstructured assessments alone, particularly in domains that are known to be under-reported unless systematically queried (e.g., sexual dysfunction, metabolic symptoms, or neuromotor adverse effects) [Reference Montejo and Rico-Villademoros47]. Accordingly, the potential value of the TGI-3S should be interpreted in relation to current clinical practice rather than in comparison to fully validated research instruments alone. While formal psychometric validation remains essential and is underway, the present data support the feasibility of integrating a structured somatic assessment into routine psychiatric encounters in a manner that aligns with real-world workflows.
It is important to note, however, that the present development work only supports the feasibility, usability and acceptability of the TGI-3S, not the validity or reliability [Reference De Hert, Cohen, Bobes, Cetkovich-Bakmas, Leucht and Ndetei3–Reference Correll, Detraux, De Lepeleire and De Hert5, Reference Di Bonaventura, Gabriel, Dupclay, Gupta and Kim22, Reference Tandon, Lenderking, Weiss, Shalhoub, Barbosa and Chen23]. The present findings demonstrate strong face validity, usability, and acceptability among both patients and caregivers. Across iterative usability rounds, patients and caregivers consistently understood the scale, completed it rapidly, and endorsed the clarity of plain-language revisions. This emphasis on clear wording is consistent with best practices for patient-reported outcome (PRO) development, which highlight the importance of minimising cognitive burden and avoiding technical terminology to ensure reliability across diverse literacy levels. Early expert concerns regarding complexity and the hyper/hypo structure were addressed through substantial simplification, which improved usability without sacrificing face validity. Taken together, these findings align with MBC literature showing that tools must be brief, interpretable, and easily repeatable to be successfully implemented in routine care [Reference Guo, Xiang, Xiao, Hu, Chiu and Ungvari25, Reference DeSimone and Hansen26].
Limitations
The development of the TGI-3S scale is not without limitations. First and foremost, the psychometric testing of the TGI-3S scale is not yet complete – psychometric validation is underway. Second, the current findings do not constitute full feasibility testing in routine psychiatric settings. To date, support for the scale’s validity is based on expert consensus and caregiver and patient survey data rather than real-world clinical implementation. Further evaluation in routine practice settings is therefore warranted and planned as part of the continued psychometric validation. Third, the usability survey sample was restricted to participants from the UK and US, which may limit generalisability. Patients and caregivers were not matched, precluding direct comparisons between respondent groups, and psychiatric diagnoses were self-reported, which may affect diagnostic accuracy. In addition, the relatively high educational level of participants may have contributed to more favourable perceptions of clarity and usability. Finally, while respondents frequently indicated a preference for shorter formats in usability feedback, further reduction in length would likely compromise the clinical breadth and informational value of the instrument, which already employs intentionally broad domains.
Future research
The most important next step is the psychometric testing of the TGI-3S, with an adequate number of participants with different diagnoses and in different psychiatric settings. This Phase III step is planned for the TGI-3S scale as well as for all other TGI scales that are either previously published or in development [Reference Correll, Dombi, Barabássy, Németh, Brevig and McIntyre36, Reference McIntyre, Dombi, Barabassy, Brevig, Németh and Correll37]. A prospective, multicentre, observational cohort study is planned, enrolling in- and outpatients with major psychiatric disorders across the psychosis–mood spectrum. The primary aims are to assess key psychometric properties, including convergent and divergent validity, cross-cultural validity, known-groups validity, internal consistency, test–retest reliability, responsiveness to change, and feasibility. These evaluations will ensure that the TGI-3S is reliable, valid, and suitable for use across diagnostic groups and clinical settings. Furthermore, longitudinal data collection would be essential to understand the scale’s sensitivity to change. Given the limitations of the survey, particularly the reliance on self-reported psychiatric diagnoses, non-matched patient–caregiver samples, restriction to UK/US populations, and the relatively high educational attainment of participants (65% university educated), future validation efforts should address these factors and be conducted in more representative samples to enhance generalizability [Reference Di Bonaventura, Gabriel, Dupclay, Gupta and Kim22, Reference Tandon, Lenderking, Weiss, Shalhoub, Barbosa and Chen23]. Finally, further research is needed to evaluate how integrating the TGI-3S into routine care visits may benefit psychiatric and physical health outcomes – potentially through enhanced patient satisfaction, improved medication adherence, or the selection of more appropriate and acceptable treatment options. It is important to note that the authors explicitly intend the TGI-3S scale to be a free tool that can be used by clinicians and patients/caregivers without any licensing restrictions.
Conclusion
The TGI-3S represents a promising and novel tool for the systematic assessment of physical health problems and pharmacotherapy-related adverse effects in patients with psychiatric disorders, designed for use in routine clinical settings without imposing an undue time burden. Use of the TGI-3S by clinicians, patients, and caregivers may support the extension of measurement-based care beyond psychiatric symptoms and facilitate a more integrated triangle-of-care approach. Following successful validation, incorporation of the TGI-3S into routine practice could enable clinicians to more consistently address physical health and adverse effects within shared decision-making consultations, supporting the development of more comprehensive treatment plans and potentially improving treatment adherence and overall clinical outcomes.
Supplementary material
The supplementary material for this article can be found at http://doi.org/10.1192/j.eurpsy.2026.12252.
Data availability statement
Data are available upon request.
Acknowledgements
During the preparation of this work the author(s) used ChatGPT and Copilot to organise the language editing and text flow improvements. After using this tool/service, the author(s) reviewed and edited the content as needed and take(s) full responsibility for the content of the published article.
Financial support
The studies described in the manuscript were funded by Gedeon Richter Plc.
Competing interests
C.U.C. has been a consultant and/or advisor to or has received honoraria from: AbbVie, Alkermes, Allergan, Angelini, Aristo, Autobahn, Boehringer-Ingelheim, Bristol-Meyers Squibb, Cardio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Darnitsa, Delpor, Denovo, Draig, Eli Lilly, Eumentis Therapeutics, Gedeon Richter, GH, Hikma, Holmusk, IntraCellular Therapies, Jamjoom Pharma, Janssen/J&J, Karuna, LB Pharma, Lundbeck, MedInCell, MedLink, Merck, Mindpax, Mitsubishi Tanabe Pharma, Maplight, Mylan, Neumora Therapeutics, Neuraxpharm, Neurocrine, Neurelis, NeuShen, Newron, Noven, Novo Nordisk, Orion Pharma, Otsuka, PPD Biotech, Recordati, Relmada, Response Pharmaeutical, Reviva, Rovi, Saladax, Sanofi, Seqirus, Servier, Sumitomo Pharma America, Sunovion, Sun Pharma, Supernus, Tabuk, Takeda, Teva, Terran, Tolmar, Vertex, Viatris, and Xenon Pharmaceuticals. He provided expert testimony for Janssen, Lundbeck, Neurocrine, and Otsuka. He served on a Data Safety Monitoring Board for Compass Pathways, IntraCellular Therapies, Relmada, Reviva, and Rovi. He has received grant support from Boehringer-Ingelheim, Janssen, and Takeda. He received royalties from UpToDate and is also a stock option holder of Cardio Diagnostics, Kuleon Biosciences, LB Pharma, MedLink Global, Mindpax, Quantic, and Terran.
Zs.B.D., Á.B., Gy.N., and T.B. are employees of Gedeon Richter Plc.
S.L. has received honoraria for advising/consulting and/or for lectures and/or for educational material in the last 3 years from Angelini, Apsen, Bristol-Myers-Squibb, Boehringer-Ingelheim, Gedeon-Richter, Johnson and Johnson, Karuna, Kynexis, Mitsubishi, Neurotorium, Novo Nordisk, Orionpharma, Otsuka, ROVI, SunPharma, TEVA.
P.G. received during the last 5 years fees for presentations at congresses or participation in scientific boards from Biogen, Janssen, Lundbeck, MindMed, MS Pharma, Newron, Otsuka, Richter, Vita, and Viatris.
P.D.H. has received fees or travel reimbursements from.
Alkermes, Boehringer-Ingelheim, Bristol-Myers Squibb, Kynexis, and Neurocrine. He has received a grant from IntraCellular Therapies and is chief scientific officer of iFunction, Inc. He has received royalties from WCG Endpoint Solutions.
K.D. is a member of the Neurotorium Editorial Board, Lundbeck Foundation, and has received honoraria from Janssen Inc., and ROVI.
R.S.M. has received research grant support from CIHR/GACD/National Natural Science Foundation of China (NSFC) and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Neurawell, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, Abbvie, and Atai Life Sciences.
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