ABSTRACT
Background:
The Liverpool University Neuroleptic Side-Effect Rating Scale (LUNSERS) is a comprehensive self-report tool for assessing subjective adverse events during antipsychotic treatment.
Aim:
We aimed to translate LUNSERS into Hindi for its application in the Indian population.
Methods:
We followed the translation methodology provided by the World Health Organization (WHO) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2005 task force (English to Hindi). We completed the forward (n = 2) and back translation (n = 2), reconciliation by an expert panel (n = 5), and cognitive debriefing (20 participants). After suggested culturally relevant changes, the final version was drafted.
Results:
Participants included Hindi-speaking adult male participants on second-generation antipsychotics. Reported side effects included sedation, tiredness, tension, restlessness, difficulty concentrating, and memory problems. A total of eight items were revised following cognitive debriefing. The influence of “Hinglish” was a factor influencing a change in interpretation.
Conclusion:
The Hindi-translated self-report tool (LUNSERS) can help screen antipsychotic-related side effects in a busy Indian clinical setting.
Keywords: Antipsychotics, Hindi, LUNSERS, neuroleptics, schizophrenia, self-report, side effect, translation
INTRODUCTION
The use of antipsychotics has encountered a shift in recent decades.[1] Among other factors, side effects due to the use of antipsychotics guide the choice of the agent for treatment. Numerous tools exist to record antipsychotic side effects, which can help guide drug selection and dosing. Self-report tools can be easily filled out by patients while waiting for their consultation, saving crucial time during busy clinics.[2] The Liverpool University Neuroleptic Side-Effect Rating Scale (LUNSERS) is one such comprehensive self-report instrument for assessing and quantifying the subjective adverse events during antipsychotic treatment.[3] When required, it can also be administered by mental health workers if the client is unable to complete it. It is available in English, German, and Romanian.[3]
Hindi is a common language in the northern part of India.[4] There is limited availability of self-reported measures for antipsychotic side-effect rating in the Hindi language. The Glasgow Antipsychotic Side-Effect Scale (GASS) is available but limited to assessment of antipsychotic side-effects related to second-generation antipsychotics. Its official translated version is not readily available in the database.[5] LUNSERS provides a more comprehensive assessment, including side-effect domains related to first-generation antipsychotics as well. Additionally, it has “red-herring” items to monitor for overreporting during the assessment.[3] Translation of a patient-reported outcome measure into an Indian language has its own set of challenges, including low health and questionnaire literacy, cultural mediation of health expressions, response style biases, and requires a systematic approach.[6,7] To date, no validated or adapted Hindi version of LUNSERS exists, limiting its use in routine clinical practice in Northern India. Therefore, we planned this study with the aim of translating the LUNSERS scale into Hindi using standard translation methodology.
METHODS
The validity and reliability of LUNSERS are established.[3,8,9] It consists of 51 items, with each item scored on a five-point Likert rating scale of 0–4. For the purpose of cross-cultural adaptation of the LUNSERS, we adopted the methodology provided in the translation guidelines of the World Health Organization (WHO) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2005 task force.[10,11] The guidelines comprise several steps for adopting a translation of patient-reported measures. These include obtaining permission from the developers of the scale, constituting a bilingual expert panel, two forward translations into the target language (e.g., English to Hindi), two backward translations into the original language, and cognitive debriefing. The cognitive debriefing was conducted with a selected number of participants (e.g., 10) to check for cultural and linguistic acceptability. The final draft was compiled after reconciliation of inputs from cognitive debriefing and shared with the developers. The translation process was completed at a tertiary center in North India. The ethics approval for the study was obtained from the Institute Ethics Committee (IEC-409/02.07.21). The authors adopted the following steps for translation [Supplementary Figure 1 (711.6KB, tif) ]:
Phase 1: Forward and back translations of the LUNSERS
The authors of the original LUNSERS were contacted, and permission was obtained for the Hindi translation. A panel of five bilingual (proficiency in reading and writing both English and Hindi) experts working in the field of mental health was formed. Forward translations (English to Hindi) by two bilingual individuals were later compiled into a single draft (LUNSERS Hindi V1). This draft was given to two other bilingual people who had not seen the original scale before, and they back-translated it (Hindi to English). This was reviewed by the expert panel, and the final draft was made by consensus of all the experts (LUNSERS Hindi V2).
Phase 2: Cognitive Debriefing of the LUNSERS Hindi V2 draft
After the developers’ review and approval, the cognitive debriefing was conducted with the LUNSERS Hindi V2 draft. The questionnaire for the cognitive debriefing interview was developed to pre-test the instrument on the target population (10–15 participants) using in-depth personal interviews.[10]
For cognitive debriefing, 20 participants aged 18 to 60 years, of either sex, and currently on daily antipsychotic medications for greater than 2 weeks were recruited from the psychiatry outpatient clinic. Interviews for cognitive debriefing were conducted by a single interviewer who was fluent in both languages and was a psychiatrist familiar with the application of LUNSERS. We included participants having a history of any affective or non-affective psychotic illness as per ICD-10 criteria. Those with severe psychiatric or medical illness hindering the interview or unwilling to participate were excluded. Written informed consent was obtained from the patient or their family members. Participant data were collected cross-sectionally from December 2024 to February 2025.
The participants were interviewed systematically, using the cognitive debriefing questionnaire, which had questions for each item of the scale. The questions asked about their understanding of the item, rephrasing in their own words, their choice of answer, understanding of all words, any unacceptable or offensive words, and any alternative expressions. The responses were audio-recorded after taking consent. Written notes were also taken during the interview.
After the interviews, there was a cognitive debriefing review by the expert panel. The audio records were referred to where required. The questions for cognitive debriefing were organized into domains of understandability (yes/no), unacceptable words or phrases (yes/no), and suggested alternatives for expression. The data on specific domains were categorized based on the number of participants. The expert panel reviewed the responses and suggested alternatives, with the compilation of a final draft (LUNSERS Hindi V3) after discussion. Descriptive analysis was used to summarize the participant data.
RESULTS
The LUNSERS Hindi V2 was compiled after forward and backward translation and expert discussion regarding several items, as provided in Table 1 and Supplementary Tables S1 and S2. The participants for cognitive debriefing included adult males (median 30 years) (n = 14) belonging to middle socio-economic status (n = 13). Common diagnoses in the participants included bipolar disorder (n = 11) and schizophrenia (n = 7). All participants were receiving second-generation antipsychotics for a median of 6 months [Supplementary Table S3].
Table 1.
Item revision during reconciliation (only conflict items displayed)
| Ref | LUNSERS Original Questionnaire | Issues Encountered and Resolved During the Review |
|---|---|---|
| 1, 3, 4 | LUNSERS QUESTIONNAIRE Assessment No.: Assessment Date: |
“प्रश्नावली” is a more acceptable spelling. “क्रमांक” is better understood and more accurately back-translated. “दिनांक” is better understood and more accurately back-translated. |
| 5 | Please indicate how much you have experienced each of the following symptoms, in the last month, by ticking the appropriate boxes. | • “पिछले महीनें” back translates to “last month” hence chosen over “पिछले ३० दिनों “ • महसूस is more commonly used in spoken Hindi • “उपयुक्त बॉक्स में टिक करके बताएं।“ is more accurately back-translated. |
| 9 Q3, 10 Q4 | Runny nose Increased dreaming |
“नाक बहना” was accurately back-translated “आना” is literally translated to coming whereas “देखना“ is seeing. In review, “आना” was found to be more appropriate |
| 13 Q7 | Swollen or tender chest | “Tender chest” here means pain in the chest on palpation and not soft, thus “छाती में सूजन या दर्द” was selected in review. |
| 14 Q8 | Chilblains | No literal translation was found for “chilblains,” so translated as per meaning, and translation 1 was selected for review. |
| 15 Q9 | Difficulty in concentrating | “एकाग्रता में कठिनाई” was more accurately backtranslated. |
| 18 Q12, 19 Q13 | Urine darker than usual Period problems |
“गहरा” is accurately backtranslated to „darker“ “माहवारी” is more commonly used than “महीने/पीरियड” and is also more accepted. Discussed in review and finalised. |
| 22 Q16 | Feeling sick | “उल्टी जैसा लगना” was accurately backtranslated. |
| 23 Q17, 52 Q46 | Increased sex drive Reduced sex drive |
Although translation 2 was better backtranslated, translation 1 was selected as it was found to be more culturally appropriate in review. “शारीरिक सम्बन्ध बनाने” is accurately backtranslated. It also sounds culturally more appropriate in the final review. |
| 25 Q19, 40 Q34 | Muscle stiffness Muscle spasms |
“मांसपेशियों में जकड़न” more accurately back-translated “मांसपेशियां अकड़ जाना” is more accurately backtranslated |
| 26 Q20 | Palpitations | “दिल की धड़कन बढ़ना” accurately backtranslated, no Hindi word for palpitation, so it was translated as per meaning, selected in review. |
| 27 Q21 | Difficulty remembering things | “चीजों को याद रखने में कठिनाई” was more accurately backtranslated. |
| 29 Q23, 32 Q26 | Lack of emotions Depression |
“भावनाओं की कमी” is back-translated to “lack of emotions” more accurately “भावनाएं कम व्यक्त करना” was back-translated to “inability to express emotions”, whereas here it refers to both difficulty experiencing and expressing emotions. “उदासी” is more commonly used in spoken language than “विषाद” |
| 30 Q24 | Difficulty achieving climax | The word “कामोन्माद” is too literary and will not be understood by common people. It is also culturally less acceptable than “शारीरिक सम्बन्ध में सुख”. Although “शारीरिक सम्बन्ध में सुख” literally back-translates to “pleasure in sexual relations”. This question was difficult to translate as no literal translation for climax is available, which is commonly used in day-to-day language. |
| 35 Q29 | Slowing of movements | “धीरापन” is more commonly used for slowness than “धीमापन”. |
| 36 Q30 | Greasy skin | “चिकनी त्वचा” backtranslated as oily skin |
| 38 Q32, 57 Q51 | Difficulty passing water Passing a lot of water |
“दिक्कत” is more commonly used than “कठिनाई”. Although both can be used interchangeably and both are commonly used. “ज़्यादा पेशाब आना” backtranslated to “increased urination” which is accurate as per concept elaboration. |
| 41 Q35 | Sensitivity to sun | “धूप के कारण जलन या दाने” is used as there is no word for photosensitivity in Hindi. |
| 43 Q37 | Over-wet drooling mouth | “लार गिरना” is better understood for excessive or hypersalivation, although it literally backtranslates to “drooling of saliva” |
| 48 Q42 | Neck muscles aching | “गर्दन की मांसपेशियों में दर्द” is more accurately backtranslated. |
| 49 Q43, 54 Q48 | Shakiness Parts of body moving of own accord (For example foot moving up and down) |
“कम्पन महसूस करना” is more accurately backtranslated. “शरीर के अंग” translates to body parts. |
| 50 Q44 | Pins and needles | “हाथों पैरों में झनझनाहट लगना या सुई चुभना” is more accurately backtranslated |
| 53 Q47, 55 Q49 | New or unusual skin marks Itchy skin |
“त्वचा में कोई बदलाव” is more near in meaning to the concept elaboration. “खुजली होना” used commonly in spoken Hindi. |
Supplementary Table S1.
Forward Translations of the Scale
| Ref | LUNSERS Original Questionnaire Wording | Hindi translation 1 | Hindi Translation 2 |
|---|---|---|---|
| 1 | LUNSERS QUESTIONNAIRE | लूनसर्स प्रश्नावली | लूनसर्स प्रश्नावली |
| 2 | Name: | नाम | नाम |
| 3 | Assessment No.: | क्रमांक | मूल्यांकन संख्या: |
| 4 | Assessment Date: | दिनांक | मूल्यांकन संख्या: |
| 5 | Please indicate how much you have experienced each of the following symptoms, in the last month, by ticking the appropriate boxes. | पिछले ३० दिनों में आपने ये लक्षण कितने ज़्यादा महसूस किये है , टिक कर के चिन्हित करे. | आपने पिछले महीनें में निम्नलिखित लक्षणों में से प्रत्येक का कितना अनुभव किया है? कृपया नीचे दिए गए उपयुक्त बॉक्स में टिक करके बताएं |
| 6 R1-51 | Not at all Very little A little Quite a lot Very much |
बिलकुल भी नहीं बहुत कम कम अधिक बहुत अधिक |
बिलकुल भी नहीं बहुत कम थोड़ा सा काफी बहुत ज्यादा |
| 7 Q1 | Rash | चक्कते या दाने | लाल चकत्ते |
| 8 Q2 | Difficulty staying awake during the day |
दिन के समय जगे रहने में दिक्कत |
दिन के दौरान जगे रहने में कठिनाई |
| 9 Q3 | Runny nose | नाक से पानी बहना | नाक बहना |
| 10 Q4 | Increased dreaming | ज़्यादा सपने आना | ज्यादा सपने देखना |
| 11 Q5 | Headaches | सरदर्द | सिर दर्द |
| 12 Q6 | Dry mouth | मुँह सूखना | मुँह सुखना |
| 13 Q7 | Swollen or tender chest | छाती/स्तन में सूजन या दर्द | सूजी हुयी या नरम छाती |
| 14 Q8 | Chilblains | बिवाई /ठण्ड में उँगलियों में सूजन | बिवाई |
| 15 Q9 | Difficulty in concentrating | एकाग्रता में कठिनाई | ध्यान केंद्रित करने में कठिनाई |
| 16 Q10 | Constipation | कब्ज़ | कब्ज |
| 17 Q11 | Hair loss | बाल झड़ना | बाल झड़ना |
| 18 Q12 | Urine darker than usual | पेशाब का रंग गाढ़ा होना | मूत्र का रंग सामान्य से अधिक गहरा होना |
| 19 Q13 | Period problems | महीने/पीरियड में दिक्कत | माहवारी की समस्याएं |
| 20 Q14 | Tension | तनाव महसूस करना | तनाव |
| 21 Q15 | Dizziness | चक्कर आना | चक्कर आना |
| 22 Q16 | Feeling sick | उलटी जैसा लगना | बीमार महसूस करना |
| 23 Q17 | Increased sex drive | ज़्यादा शारीरिक सम्बन्ध बनाने का मन करना | यौन-रूचि में वृद्धि |
| 24 Q18 | Tiredness | थकान महसूस करना | थकान |
| 25 Q19 | Muscle stiffness | मांसपेशिओं में खिंचाव | मांसपेशियों में जकड़न |
| 26 Q20 | Palpitations | दिल की धड़कन बढ़ना | तेज और अनियमित दिल की धड़कन |
| 27 Q21 | Difficulty remembering things | याद्दाश्त में दिक्कत | चीजों को याद रखने में कठिनाई |
| 28 Q22 | Losing weight | वज़न कम होना | वजन कम होना |
| 29 Q23 | Lack of emotions | भावनाएं कम व्यक्त करना | भावनाओं की कमी |
| 30 Q24 | Difficulty achieving climax | शारीरिक सम्बन्ध में सुख ना महसूस होना. | कामोन्माद पर पहुँचने में कठिनाई |
| 31 Q25 | Weak fingernails | कमज़ोर नाखून | कमजोर नाखून |
| 32 Q26 | Depression | उदास रहना | डिप्रेशन/ विषाद |
| 33 Q27 | Increased sweating | ज़्यादा पसीना आना | अधिक पसीना आना |
| 34 Q28 | Mouth ulcers | मुँह के छाले | मुंह में छालें आना |
| 35 Q29 | Slowing of movements | हाथ-पैर चलाने में धीरापन | गति का धीमा होना |
| 36 Q30 | Greasy skin | चेहरे पे चिकनाई आना | चिकनी त्वचा |
| 37 Q31 | Sleeping too much | ज़्यादा सोना | बहुत ज्यादा सोना |
| 38 Q32 | Difficulty passing water | पेशाब करने में दिक्कत | पेशाब करने में कठिनाई |
| 39 Q33 | Flushing of face | चेहरा लाल हो जाना | चेहरा लाल होना |
| 40 Q34 | Muscle spasms | मांसपेशियां अकड़ जाना | मांसपेशियों में ऐंठन |
| 41 Q35 | Sensitivity to sun | धूप के कारण जलन या दाने | सूर्य के प्रति संवेदनशीलता |
| 42 Q36 | Diarrhoea | दस्त | दस्त |
| 43 Q37 | Over-wet drooling mouth | ज़्यादा थूक आना | मुँह अधिक गीला गीला रहना |
| 44 Q38 | Blurred vision | धुंधला दिखाई देना | धुंधली दृष्टि |
| 45 Q39 | Putting on weight | वज़न बढ़ना | वजन बढाना |
| 46 Q40 | Restlessness | बेचैनी | बेचैनी |
| 47 Q41 | Difficulty getting to sleep | नींद आने में दिक्कत | सोने में कठिनाई होना |
| 48 Q42 | Neck muscles aching | गर्दन में दर्द | गर्दन की मांसपेशियों में दर्द |
| 49 Q43 | Shakiness | कम्पन महसूस करना. | कम्पन |
| 50 Q44 | Pins and needles | हाथों पैरों में झनझनाहट लगना / सुई चुभना | चुभता हुआ दर्द |
| 51 Q45 | Painful joints | जोड़ों में दर्द | जोड़ों में दर्द |
| 52 Q46 | Reduced sex drive | शारीरिक सम्बन्ध बनाने का मन ना करना | यौन-रूचि में कमी |
| 53 Q47 | New or unusual skin marks | त्वचा में कोई बदलाव | त्वचा पर नये या असामान्य निशान |
| 54 Q48 | Parts of body moving of own accord (For example foot moving up and down) | हाथ-पैर खुद ही हिलना | शरीर के अंगों का अपने हिसाब से चलना (उदाहरण के लिए- पैर का ऊपर-नीचे होना ) |
| 55 Q49 | Itchy skin | खुजली होना | त्वचा में खुजली |
| 56 Q50 | Periods less frequent | महीने /पीरियड ना आना | माहवारी में कमी |
| 57 Q51 | Passing a lot of water | ज़्यादा पेशाब आना | बहुत ज्यादा पेशाब होना |
| 58 | Please check that you have given your answer to all the statements. | एक बार देख ले की आपने सारे सवालों के जवाब टिक कर दिए है | कृपया जांच लें कि आपने सभी कथनों के लिए अपने उत्तर दिये है। |
| 59 | Thank you for your time in completing this questionnaire. | धन्यवाद | इस प्रश्नावली को पूरा करने में समय देने के लिए आपको धन्यवाद। |
Supplementary Table S2.
LUNSERS Hindi V1 and Backward Translations of The Scale
| Ref | LUNSERS Hindi V1 | English back translation 1 | English back translation 2 |
|---|---|---|---|
| 1 | लूनसर्स प्रश्नावली | LUNSERS Questionnaire | Lunsers questionnaire |
| 2 | नाम | Name | Name |
| 3 | क्रमांक | Valuation Number | Number |
| 4 | दिनांक | ValuationNumber | Date |
| 5 | पिछले ३० दिनों में आपने ये लक्षण कितने ज़्यादा महसूस किये है , टिक कर के चिन्हित करे. | How much symptoms of the below mentioned points did you experience during the last month. Please tick the appropriate box given below | Tick and mark the symptoms based on their severity in the last thirty days |
| 6 | बिलकुल भी नहीं बहुत कम कम अधिक बहुत अधिक |
Not at all Very Less Nominal Sufficient Very high |
Absolutely not Very less Less Quite much Very much |
| 7 | चक्कते या दाने | Red spots | Spots or dots |
| 8 | दिन के समय जगे रहने में दिक्कत | Difficulty being awake during the day | Difficulty in staying awake during daytime. |
| 9 | नाक से पानी बहना | Running nose | Watery secretions from nose |
| 10 | ज़्यादा सपने आना | Having a lot of dreams | Excessive dreaming |
| 11 | सरदर्द | Headache | Headache |
| 12 | मुँह सूखना | Dry mouth | Dry mouth |
| 13 | छाती/स्तन में सूजन या दर्द | Swelled or soft chest | Pain or discomfort in chest/breast |
| 14 | बिवाई /ठण्ड में उँगलियों में सूजन | Heel cracks | Swelling in fingers during winters |
| 15 | एकाग्रता में कठिनाई | Difficulty in foussing attention | Difficulty in concentration |
| 16 | कब्ज़ | Constipation | Constipation |
| 17 | बाल झड़ना | Hairfall | Hair fall |
| 18 | पेशाब का रंग गाढ़ा होना | Urine darker than normal | Dark coloured urine |
| 19 | महीने/पीरियड में दिक्कत | Menstruation problems | Menstrual difficulties |
| 20 | तनाव महसूस करना | Stress | Feeling tensed |
| 21 | चक्कर आना | Dizziness | Dizziness |
| 22 | उलटी जैसा लगना | Feeling sick | Urge to vomit |
| 23 | ज़्यादा शारीरिक सम्बन्ध बनाने का मन करना | Increased sexual desire | Experiencing increased desire for sexual relations |
| 24 | थकान महसूस करना | Tiredness | Feeling tired |
| 25 | मांसपेशिओं में खिंचाव | Muscle stiffness | Muscle pulls |
| 26 | दिल की धड़कन बढ़ना | Fast or irregular heart beat | Increased heart rate |
| 27 | याद्दाश्त में दिक्कत | Difficulty in remembering things | Difficulty in recollection |
| 28 | वज़न कम होना | Weight loss | Weight loss |
| 29 | भावनाएं कम व्यक्त करना | Less emotions or feelings | Inability to express emotions |
| 30 | शारीरिक सम्बन्ध में सुख ना महसूस होना. | Difficulty in achieving climax | Dissatisfaction in sexual relations |
| 31 | कमज़ोर नाखून | Weak nails | Brittle nails |
| 32 | उदास रहना | Depression | Feeling sad |
| 33 | ज़्यादा पसीना आना | Excessive sweating | Increased sweating |
| 34 | मुँह के छाले | Mouth ulcers | Ulcers in mouth |
| 35 | हाथ-पैर चलाने में धीरापन | Slowing down | Slowing of hand or limb movements |
| 36 | चेहरे पे चिकनाई आना | Smooth skin | Oily face |
| 37 | ज़्यादा सोना | Sleeping a lot | Increased sleep |
| 38 | पेशाब करने में दिक्कत | Difficulty urinating | Difficulty in urination |
| 39 | चेहरा लाल हो जाना | Red face | Redness over face |
| 40 | मांसपेशियां अकड़ जाना | Muscle cramps | Tightness in muscles |
| 41 | धूप के कारण जलन या दाने | Sensitivity to the sun | Burning or dots experienced in sunlight |
| 42 | दस्त | Diarrhea | Diarrhoea |
| 43 | ज़्यादा थूक आना | Mouth remians very wet | Increased salivation |
| 44 | धुंधला दिखाई देना | Blurred vision | Blurring of vision |
| 45 | वज़न बढ़ना | Weight gain | Weight gain |
| 46 | बेचैनी | Restlessness | Restlessness |
| 47 | नींद आने में दिक्कत | Difficulty sleeping | Difficulty in falling asleep |
| 48 | गर्दन में दर्द | Neck muscle pain | Neck pain |
| 49 | कम्पन महसूस करना. | Shivering | Experiencing tremors |
| 50 | हाथों पैरों में झनझनाहट लगना / सुई चुभना | Stinging pain | Pin prick or lightening sensation in hands and feel |
| 51 | जोड़ों में दर्द | Joint pain | Pain in joints |
| 52 | शारीरिक सम्बन्ध बनाने का मन ना करना | Decreased sexual interest | Loss of desire for sexual relations |
| 53 | त्वचा में कोई बदलाव | New or unusual scars on the skin | Any changes in skin |
| 54 | हाथ-पैर खुद ही हिलना | Body parts working on their own (For example, foot going up and down) |
Involuntary movements of hands and feet |
| 55 | खुजली होना | Itchy skin | Itching |
| 56 | महीने /पीरियड ना आना | Menstrual reduction | Absence of menstrual cycles |
| 57 | ज़्यादा पेशाब आना | Excessive urination | Increased urination |
| 58 | एक बार देख ले की आपने सारे सवालों के जवाब टिक कर दिए है | Please check that you have provided your answers to all the statements. | Recheck that all questions have been answered |
| 59 | धन्यवाद | Thank you for taking the time to complete this questionnaire. | Thank you |
Supplementary Table S3.
Sociodemographic and Clinical Characteristics of the Participants (n=20)
| Variable | Frequency (percentage) | Median (IQR) |
|---|---|---|
| Age (years) | 30 (35-26) | |
| Sex | ||
| Male | 14 (70) | |
| Female | 6 (30) | |
| Marital Status | ||
| Married | 5 (25) | |
| Unmarried | 15 (75) | |
| Occupation | ||
| Student | 4 (20) | |
| Homemaker | 3 (15) | |
| Skilled worker | 1 (5) | |
| Unemployed | 12 (60) | |
| Socio-economic status | ||
| Upper | 3 (15) | |
| Middle | 13 (65) | |
| Lower | 4 (20) | |
| Primary diagnosis | ||
| Schizophrenia | 7 (35) | |
| Psychosis unspecified | 1 (5) | |
| Bipolar type 1 – Mania with Psychotic symptoms | 3 (15) | |
| Bipolar type 1 – Depression with Psychotic symptoms | 3 (15) | |
| Bipolar type 1 – Mixed episode with Psychotic symptoms | 5 (25) | |
| Depression with psychotic symptoms | 1 (5) | |
| Duration on current antipsychotics (months) | 6 (10.5–2.25) | |
| Current antipsychotic drug | ||
| First-generation antipsychotic | 0 | |
| Second-generation antipsychotic | 16 (80) | |
| Clozapine | 4 (20) | |
| Other Psychotropics | ||
| SSRI | 6 (30) | |
| SNRI | 3 (15) | |
| Other antidepressants | 1 (5) | |
| Lithium | 4 (20) | |
| Valproate | 1 (5) |
The recorded self-reported side effects by most of the patients on the LUNSERS Hindi V2 draft commonly included constipation, palpitations, sleeping too much, restlessness, difficulty in concentrating, tension, tiredness, difficulty remembering things, and depression, as detailed in Supplementary Table S4.
Supplementary Table S4.
LUNSERS Hindi V3 Draft Self-Report Scores
| Hindi-translated LUNSERS item number | Frequency of participants with Likert rating of “A little” or higher (out of 20) |
|---|---|
| No items | None |
| Item 1, 3, 7, 8, 13, 17, 24, 25, 28, 32, 33, 35, 36, 46, 47, 49, 50 | 1-5 participants |
| Item 2, 4, 5, 6, 11, 12, 15, 16, 19, 22, 23, 27, 29, 30, 34, 37, 38, 39, 41, 42, 43, 44, 45, 48, 51 | 6-10 participants |
| Item 10, 20, 31, 40 (constipation, palpitations, sleeping too much, restlessness) | 11-15 participants |
| Item 9, 14, 18, 21, 26 (difficulty in concentrating, tension, tiredness, difficulty remembering things, depression) | 16-20 participants |
More than 25% of the participants had difficulty understanding a total of eight items (15.69%). This included item numbers 15, 19, 29, 30, 31, 36, 39, and 56, which were difficulty in concentrating (n = 10), period problems (n = 8), lack of emotions (n = 8), difficulty achieving climax (n = 7), weak fingernails (n = 6), greasy skin (n = 14), flushing of face (n = 7), and periods less frequent (n = 8), respectively. Item 36 (greasy skin) was misunderstood by most participants (70%), followed by item 15 (difficulty in concentrating). No participants reported any unacceptable or offensive words or phrases in the scale. For some items, the participants were more familiar with certain English terms than the classical Hindi translated versions. Supplementary Tables S5–S7, along with Figure 1, provide a more detailed account of this.
Supplementary Table S5.
Cognitive Debriefing - Understandability: Participant Frequency
| Cognitive debriefing item number | Frequency of participants with difficulty in understanding (out of 20) |
|---|---|
| Item 1, 3, 4, 5, 6, 9, 11, 12, 17, 21, 24, 28, 32, 33, 34, 37, 38, 44, 45, 46, 47, 51, 53, 57, 58, 59 | No difficulty in understanding |
| Item 2, 7, 8, 10, 13, 14, 16, 18, 20, 22, 23, 25, 26, 27, 35, 40, 41, 42, 43, 48, 49, 50, 52, 54, 55 | 1-5 participants had difficulty |
| Item 15, 19, 29, 30, 31, 39, 56 | 6-10 participants had difficulty |
| Item 36 | 11-15 participants had difficulty |
| No items | 16-20 participants had difficulty |
Supplementary Table S7.
Summary table for changes made
| Cognitive debriefing item number* | Item description | Number of participants reporting the issue | Suggested alternative modes of expression by the participants (verbatim) | Changes made after discussion with the expert panel |
|---|---|---|---|---|
| 15 Q9 | एकाग्रता में कठिनाई | 10 | “focus” “ध्यान देने में कठिनाई” “किसी चीज़ में focus करने में दिक्कत” “ध्यान लगाने में दिक्कत” |
ध्यान देने में कठिनाई |
| 19 Q13 | माहवारी में दिक्कत | 8 | “Periods” “महीने” “Date/Periods” “Periods/महीने” |
पीरियड्स में दिक्कत |
| 29 Q23 | भावनाओं की कमी | 8 | “ख़ुशी की बात से खुश नहीं होना या दुःख की बात से दुखी” “Happiness से Happy feel नहीं करना” “ख़ुशी गम का अहसास पहले जितना नहीं होना” |
भावनाओं की कमी |
| 30 Q24 | शारीरिक सम्बन्ध में सुख न महसूस होना. | 7 | “Sex life अच्छी है या बुरी” “Sex के time मज़ा” |
शारीरिक सम्बन्ध में सुख न महसूस होना |
| 31 Q25 | कमज़ोर नाखून | 6 | “नाखून टूट तो नहीं रहे” “नाखून टूट जाना” “नाखून टूट तो नहीं जाते” |
नाखून कमज़ोर हो जाना |
| 36 Q30 | चिकनी त्वचा | 14 | “Oily skin” “Oily/त्वचा चिप चिप होना” “चिप चिप होना” “त्वचा Oily होना” “Oily त्वचा” “त्वचा पर तेल जैसा लगना” |
चिपचिपी तवचा |
| 39 Q33 | चेहरा लाल हो जाना | 7 | “चेहरे में लालपन” Misinterpreting as a proverb – “गुस्सा करना” |
चेहरे में लालपन हो जाना |
| 56 Q50 | माहवारी में कमी | 8 | “Periods” “महीने” “Date/Periods” “Periods/महीने” |
“पीरियड्स में कमी” |
*Only items with frequent understandability issues among participants are displayed
Figure 1.

Cognitive debriefing–understandability matrix representation. @ Rows represent cognitive debriefing test item numbers, and columns represent participants. * Green represents “yes”, and red represents “no” for understandability
Supplementary Table S6.
Cognitive Debriefing—Final Changes After Discussion
| Ref | LUNSERS Items | Issues in Review |
|---|---|---|
| 1 | LUNSERS QUESTIONNAIRE | “प्रश्नावली” is a more acceptable spelling. |
| 2 | Name: | Same in both translations. |
| 3 | Assessment No.: | “क्रमांक” is better understood and more accurately backtranslated. |
| 4 | Assessment Date: | “दिनांक” is better understood and more accurately backtranslated. |
| 5 | Please indicate how much you have experienced each of the following symptoms, in the last month, by ticking the appropriate boxes. | • “पिछले महीनें” backtranslates to “last month” hence chosen over “पिछले ३० दिनों” • महसूस is more commonly used in spoken Hindi • “उपयुक्त बॉक्स में टिक करके बताएं।“ is more accurately backtranslated. |
| 6 R1-51 | Not at all Very little A little Quite a lot Very much |
Final version accepted after review, so that it is framed like a Likert scale. |
| 7 Q1 | Rash | Same in both translations. |
| 8 Q2 | Difficulty staying awake during the day | Same in both translations. |
| 9 Q3 | Runny nose | “नाक बहना” was accurately backtranslated |
| 10 Q4 | Increased dreaming | “आना” is literally translated to coming whereas “देखना” is seeing in review, आना was found to be more appropriate. |
| 11 Q5 | Headaches | Same in both |
| 12 Q6 | Dry mouth | Same in both |
| 13 Q7 | Swollen or tender chest | “Tender chest” here means pain in the chest on palpation and not soft, thus “छाती में सूजन या दर्द” was selected in review. |
| 14 Q8 | Chilblains | No literal translation was found for “chilblains,” so translated as per meaning, and translation 1 was selected for review. |
| 15 Q9 | Difficulty in concentrating | “एकाग्रता में कठिनाई” was more accurately backtranslated. |
| 16 Q10 | Constipation | Same in both |
| 17 Q11 | Hair loss | Same in both |
| 18 Q12 | Urine darker than usual | “गहरा” is accurately backtranslated to “darker” |
| 19 Q13 | Period problems | “माहवारी” is more commonly used than “महीने/पीरियड” and also more accepted. Discussed in review and finalised. |
| 20 Q14 | Tension | Same in both |
| 21 Q15 | Dizziness | Same in both |
| 22 Q16 | Feeling sick | “उल्टी जैसा लगना” was accurately backtranslated. |
| 23 Q17 | Increased sex drive | Although translation 2 was better backtranslated, translation 1 was selected as it was found to be more culturally appropriate in review. |
| 24 Q18 | Tiredness | Same in both |
| 25 Q19 | Muscle stiffness | “मांसपेशियों में जकड़न“ more accurately back-translated |
| 26 Q20 | Palpitations | “दिल की धड़कन बढ़ना” accurately backtranslated, no Hindi word for palpitation so it was translated as per meaning , selected in review. |
| 27 Q21 | Difficulty remembering things | “चीजों को याद रखने में कठिनाई“ was more accurately backtranslated. |
| 28 Q22 | Losing weight | Same in both |
| 29 Q23 | Lack of emotions | “भावनाओं की कमी” is backtranslated to “lack of emotions” more accurately “भावनाएं कम व्यक्त करना” was backtranslated to „inability to express emotions“, whereas here it refers to both difficulty experiencing and expressing emotions. |
| 30 Q24 | Difficulty achieving climax | The words “कामोन्माद“ is too literary and will not be understood by common people. It is also culturally less acceptable than “शारीरिक सम्बन्ध में सुख”. Although “शारीरिक सम्बन्ध में सुख” literally backtranslates to “pleasure in sexual relations”. This question was difficult to translate as no literal translation for climax is available, which is commonly used in day-to-day language. |
| 31 Q25 | Weak fingernails | Same in both |
| 32 Q26 | Depression | “उदासी” is more commonly used in spoken language than “विषाद” |
| 33 Q27 | Increased sweating | Same in both translations |
| 34 Q28 | Mouth ulcers | Same in both translations |
| 35 Q29 | Slowing of movements | “धीरापन” is more commonly used for slowness than “धीमापन”. |
| 36 Q30 | Greasy skin | “चिकनी त्वचा“ backtranslated as oily skin |
| 37 Q31 | Sleeping too much | Same in both |
| 38 Q32 | Difficulty passing water | “दिक्कत” is more commonly used than “कठिनाई”. Although both can be used interchangeably and both are commonly used. |
| 39 Q33 | Flushing of face | Same in both |
| 40 Q34 | Muscle spasms | “मांसपेशियां अकड़ जाना” is more accurately backtranslated |
| 41 Q35 | Sensitivity to sun | “धूप के कारण जलन या दाने” is used as there is no word for photosensitivity in Hindi . |
| 42 Q36 | Diarrhoea | Same in both |
| 43 Q37 | Over-wet drooling mouth | “लार गिरना” is better understood for excessive or hypersalivation, although it literally backtranslates to “drooling of saliva” |
| 44 Q38 | Blurred vision | Same in both |
| 45 Q39 | Putting on weight | Same in both |
| 46 Q40 | Restlessness | Same in both |
| 47 Q41 | Difficulty getting to sleep | Same in both |
| 48 Q42 | Neck muscles aching | “गर्दन की मांसपेशियों में दर्द” is more accurately backtranslated. |
| 49 Q43 | Shakiness | “कम्पन महसूस करना” is more accurately backtranslated. |
| 50 Q44 | Pins and needles | “हाथों पैरों में झनझनाहट लगना या सुई चुभना” is more accurately backtranslated |
| 51 Q45 | Painful joints | Same in both |
| 52 Q46 | Reduced sex drive | “शारीरिक सम्बन्ध बनाने” is accurately backtranslated. It also sounds culturally more appropriate in final review. |
| 53 Q47 | New or unusual skin marks | त्वचा में कोई बदलाव is more near in meaning to the concept elaboration. |
| 54 Q48 | Parts of body moving of own accord (For example, foot moving up and down) |
शरीर के अंग translates to body parts. |
| 55 Q49 | Itchy skin | “खुजली होना” used commonly in spoken Hindi. |
| 56 Q50 | Periods less frequent | “माहवारी” more culturally appropriate as per reviewer. |
| 57 Q51 | Passing a lot of water | “ज़्यादा पेशाब आना” backtranslated to “increased urination” which is accurate as per concept elaboration. |
| 58 | Please check that you have given your answer to all the statements. | “कृपया जांच लें कि आपने सारे प्रशनों के उत्तर दे दिये है।“ is accurately back translated |
| 59 | Thank you for your time in completing this questionnaire. | Same in both |
DISCUSSION
We translated the LUNSERS into Hindi. During our cognitive debriefing, we found that several participants had difficulty understanding the translated terms used to describe “periods” and “difficulty achieving climax.” This could be related to the hesitancy surrounding the discussion of topics related to sexual health.[12] The language or “slang” used to describe various sexual terms differs from the classical Hindi terminologies.[12]
Another important highlight was the suggestion of English language terms by the participants for better expression of certain translated terms in the LUNSERS Hindi V2 draft. An example is the term “concentrating,” where several participants suggested the use of the term “focus” in place of the Hindi-translated word “ekagrata”. This could possibly be due to the uncommon use of the more formal and complex Hindi language terminologies and integration of adopted words from English literature into the Hindi language.[13] It also reflects the integration of English literature with the Hindi language in day-to-day communication for the general population. Recent literature supports this notion, highlighting the rise of “Hinglish” speaking individuals.[13]
The strength of our study is that we followed the WHO and ISPOR 2005 task force guidelines and frequently requested inputs from the developers. The study limitations include having no psychometric validation, with a small, single-center sample, and difficulties in generalizability to all Hindi-speaking individuals. This translated version requires further validation research.
This study provides a perspective on the translation of a self-reported instrument. We selected LUNSERS for translation into Hindi after considering its comprehensive nature, clinical relevance, reliability, validity, and relevance of the translated language to the population of our region. This translated self-report tool can help screen antipsychotic-related side effects in a busy clinic and inform clinicians about the side effects experienced by individuals at a glance. Future work on this translated version could elaborate further on other psychometric properties and improve the validity of the Hindi translated version of LUNSERS.
Declaration regarding the use of generative AI
The author(s) attest that there was no use of generative artificial intelligence (AI) technology in the generation of text, figures, or other informational content of this manuscript.
Supplementary material
This article has supplementary material and can be accessed at this link. Supplementary Material at https://links.lww.com/IPSY/A23.
Conflicts of interest
There are no conflicts of interest.
Stepwise summary of the translation process
Funding Statement
Nil.
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Supplementary Materials
Stepwise summary of the translation process
