• Imputation and bias-correction methods
• Differential verification
LCA: latent class analysis; CRS is composite reference standard. ROC is receiver operating characteristics; NGS is no gold standard
Fifty-one statistical methods were identified from the review that were developed to evaluate the diagnostic accuracy of index test(s) when the true disease status of some participants is not verified with the gold standard. These methods are divided into two subgroups:
This group includes algebraic methods developed to correct the estimated sensitivity and specificity of the index test when the sensitivity and specificity of the imperfect reference standard is known. There are seven statistical methods in this group described in five different articles [ 91 – 95 ]. The methods by Emerson et al [ 95 ] does not estimate a single value for sensitivity or specificity, unlike the other correction methods [ 91 – 94 ] but produces an upper bound value and a lower bound value for the sensitivity and specificity of the index test. These bounded values are used to explain the uncertainty around the estimated sensitivity and specificity of the index test.
A gold standard or accurate information about the diagnostic accuracy of the imperfect reference standard are often not available to evaluate the index test. In these situations, multiple imperfect reference standards can be employed to evaluate the index test. Methods in this group include:
This group includes methods that fit the inclusion criteria but could not be placed into the other three groups. They include study of agreement, test positivity rate and the use of an alternative study design such as analytical validation. Study of agreement and test positivity rate are best used as exploratory tools alongside other methods [ 152 , 178 ] because they are not robust enough to assess the diagnostic ability of the medical test. Validation of a medical test cut across different disciplines in medicine such as psychology, laboratory or experimental medicine. With this approach, the medical test is assessed based on what it is designed to do [ 191 ]. Other designs include case-control designs (where the participants are known to have or not have the target condition) [ 207 , 208 ], laboratory based studies or experimental studies which are undertaken with the aim to evaluate the analytical sensitivity and specificity of the index test [ 190 , 209 , 210 ].
The guidance flowchart ( Fig 5 ) is a modification and extension of the guidance for researchers flow-diagram developed by Reitsma et al [ 34 ].
Since, evaluating the accuracy measures of the index test is the focus of any diagnostic accuracy study, the flowchart starts with asking the first question “Is there a gold standard to evaluate the index test?” Following the responses from each question box (not bold); methods are suggested (bold boxes at the bottom of the flowchart) to guide clinical researchers, test evaluators, and researchers as to the different methods to consider.
Although, this review aims to provide up-to-date approaches that have been proposed or employed to evaluate the diagnostic accuracy of an index test in the absence of a gold standard for some or all of the participants in the accuracy study; some things researchers can consider when designing an accuracy study aside from the aim of their studies, are outlined in Box 1 ([ 26 , 211 – 218 ]).
Some guidelines and tools have been developed to assist in designing, conducting and reporting diagnostic accuracy studies such as the STARD [ 219 – 223 ] guidelines, GATE [ 224 ] framework, QUADAS [ 225 ] tools; which can aid the design of a robust test accuracy study.
This review sought to identify and review new and existing methods employed to evaluate the diagnostic accuracy of a medical test in the absence of gold standard. The identified methods are classified into four main groups based on the availability and/or the application of the gold standard on the participants in the study. The four groups are: methods employed when only a sub-sample of the participants have their disease status verified with the gold standard (group 1); correction methods (group 2); methods using multiple imperfect reference standards (group 3) and other methods (group 4) such as study of agreement, test positivity rate and alternative study designs like validation.
In this review additional statistical methods have been identified that were not included in the earlier reviews on this topic by Reitsma et al [ 34 ] and Alonzo [ 25 ]. A list of all the methods identified in this review are presented in the supplementary material ( S1 Supplementary Information ). This includes a brief description of the methods and a discussion of their strengths and weaknesses and any identified case studies where the methods have been clinically applied. Only a small number of the methods we have identified have applied clinically and published [ 38 , 63 ]. This may be due to the complexity of these methods (in terms of application and interpretation of results), and/or a disconnection between the fields of expertise of those who develop (e.g. mathematicians or statisticians) and those who employ the methods (e.g. clinical researchers). For example, the publication of such method in specialist statistical journals may not be readily accessible to clinical researchers designing the study. In order to close this gap, two flow-diagrams (Figs (Figs3 3 and and4) 4 ) were constructed in addition to the modified guidance flowchart, ( Fig 5 ) as guidance tools to aid clinical researchers and test evaluators in the choice of methods to consider when evaluating medical test in the absence of gold standard. Also, an R package ( bcROCsurface ) and an interactive web application (Shiny app) that estimates the ROC surface and VUS in the presence of verification bias have been developed by To Duc [ 78 ] to help bridge the gap.
One of the issues not addressed in this current review was on methods that evaluate the differences in diagnostic accuracy of two or more tests in the presence of verification bias. Some published articles that consider this issue are Nofuentes and Del Castillo [ 226 – 230 ], Marin-Jimenez and Nofuentes [ 231 ], Harel and Zhou [ 232 ] and Zhou and Castelluccio [ 233 ]. This review also did not consider methods employed to estimate the time-variant sensitivity and specificity of diagnostic test in absence of a gold standard. This issue has recently been addressed by Wang et al [ 234 ].
In terms of the methodology, a limitation of this review is the exclusion of books, dissertations, thesis, conference abstract and articles not published in English language (such as the review by Masaebi et al [ 235 ] which was published in 2019), which could imply that there could still be some methods not identified by this review.
Regarding the methods identified in this review, further research could be carried to explore the different modification to the discrepancy analysis approaches to understand if these modifications reduce or remove the potential bias. In addition, further research is needed to determine if the different methods developed to evaluate an index test in the presence of verification bias are robust methods. Given the large numbers of statistical methods that have been developed especially to evaluate medical tests when there is a missing gold standard and the complexity of some of these methods; more interactive web application (e.g. Shiny package in R [ 236 ]) could be developed to implement these methods in addition to the Shiny app developed by To Duc [ 78 ] and Lim et al [ 237 ]. The development of such interactive web tools will expedite the clinical applications of these developed methods and help bridge the gap between the method developers and the clinical researchers or tests evaluators who are the end users of these methods.
Various methods have been proposed and applied in the evaluation of medical tests when there is a missing gold standard result for some participants, or no gold standard at all. These methods depend on the availability of the gold standard, its application to all or subsample of participants in the study, the availability of alternative reference standard(s), and underlying assumption(s) made with respect to the index test(s) and / or participants in the study.
Knowing the appropriate method to employ when analysing the data from participants of a diagnostic accuracy studies in the absence of gold standard, help to make statistically robust inference on the accuracy of the index test. This, in addition to data on cost-effectiveness, utility and usability of the test will support clinicians, policy makers and stake holders to decide the adoption of the new test in practice or not.
S1 checklist, s1 appendix, s1 supplementary information, acknowledgments.
The authors will like to acknowledge Professor Patrick Bossuyt from the Department of Clinical Epidemiology and Biostatistics, Academic Medical centre, University of Amsterdam, the Netherlands, for giving the consent to update his review, reviewing the protocol and his continued advice throughout this work. Also we will like to acknowledge the authors of the previous review, Dr Anne Rutjes in University of Bern, Switzerland; Professor Johannes Reitsma in the Department of Epidemiology, Julius Center Research Program Methodology UMC Utrecht, The Netherlands; Professor Arri Coomarasamy in the College of Medical and Dental Sciences, University of Birmingham, UK; and Professor Khalid Saeed Khan in Queen Mary, University of London for the guidance flowchart which was modified and extended. AJA, SG, and LV are supported by the National Institute for Health Research (NIHR) Newcastle In Vitro Diagnostics Co-operative. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
This work is supported by the Newcastle University Research Excellence; the School of Mathematics, Statistics and Physics Newcastle University; the Institute of Health & Society Newcastle University; and the National Institute for Health Research (NIHR) [NIHR Newcastle In Vitro Diagnostics Co-operative]. The view and opinions expressed are those of the authors and do not necessary reflect those of the NIHR Newcastle In Vitro Diagnostics Co-operative, Newcastle University and Newcastle upon Tyne NHS Foundation Trust, the NHS or Newcastle Research Academy. The views expressed are those of the authors and not necessarily those of the NIHR, the NHS or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Home > MAHE Student Work > KMCMLR
Theses/dissertations from 2021 2021.
“The Impact of Self-Stigma of Seeking Help and Perceived Social Support on Burnout among Clinical Psychologists” , Aavrita A
The impact of self-stigma of seeking help &percieved social support on burnout among clinical psychologists. , Aavrita .
Immediate Effects of Novel Hand Rehabilitation Board on Fine Motor Skills in Children with Cerebral Palsy. , Romita Fernandes. Abraham
"COMPARISON OF THREE SCORING CRITERIA TO ASSESS RECOVERY FROM GENERAL ANAESTHESIA IN THE POST-ANAESTHESIA CARE UNIT- A LONGITUDINAL OBSERVATIONAL STUDY " , Shagun Aggarwal
Comparative predictive validity of Alberta Infant Motor Scale and Infant Neurological International Battery in Low Birth Weight Infants- A Prospective Longitudinal Study. , Polisetti Siva Sai Anand
Antagonistic Asynchrony in Muscle Recruitment Pattern of Forward Reach Movement In Children With Cerebral Palsy. , Sanya Anklesaria
Muscle fatigue response of rotator cuff muscles in sitting and standing postures , Lisanne Aranha
Effectiveness of static weight bearing versus modified constraint induced movement therapy on improving hand function in hemiplegic cerebral palsy- A Randomized Clinical Trial. , Ruth Bavighar
How informed are our patients about generic medicines? – A study from coastal South India , Darshan BB
Morphological variants of the human spleen, a cadaveric study , Murlimanju BV
Association between cervical breast cancer and Diabtetes mellitus among women seeking health care in tertiary hospitals od south India: A cross sectional study , Pratik Kumar Chatterjee
Carcinoma Breast in among Women with Diabetes Mellitus: A Case Control Study , Pratik Kumar Chatterjee
Perception of Empathy among medical students: A cross sectional study , Pratik Kumar Chatterjee
CLINICOMYCOLOGICAL PROFILE OF DERMATOPHYTOSIS IN A TERTIARY CARE HOSPITAL IN SOUTH INDIA , Adyashree Dalai
Study of outcome of Ponseti technique of management for idiopathic clubfoot in a tertiary center in south India , Lulu Damsas
Comparative study of emotional labour &burnout on life satisfaction among school teachers across different educational settings , Meghana Dharampalan
“Comparative Study of Emotional Labor and Burnout on Life Satisfaction Among School Teachers Across Different Educational Settings” , Meghana V. Dharmapalan
“Relationship Between Sexual Fantasy, Sexual Communication, Personality Traits and Sexual Satisfaction in Married Individuals” , Rhea Dhir
Comparing the efficacy of USG guided supraclavicular brachial plexus block with or without intercostobrachial nerve block for forearm surgeries – an observational study , DIKSHA D’MELLO
Does Quality of Sitting influence Functional Mobility in Cerebral Palsy? A cross-sectional study , Kaiorisa N. Doctor
Factors effecting gait velocity in osteoarthritis knee-An observational study. , Lisha Gretal D’silva
Effect of Inspiratory Muscle Training on Pulmonary Function, Functional Capacity, Quality Of Life And Length Of Stay in individuals undergoing Cardiac Surgery , Fiona Verdine Dsouza
Relationship of Academic Resilience with Self-Efficacy, and Perceived Social Support; Among Civil Service Aspirants , Neha Eldho
EFFICACY, FEASIBILITY, AND SAFETY OF PERCUTANEOUS IMAGE-GUIDED CATHETER DRAINAGE OF THORACIC, ABDOMINAL, AND PELVIC FLUID COLLECTION , Aishwarya Gadwal
Comparison of efficacy of two different bolus doses of norepinephrine as prophylac-tic to prevent post-spinal hypotension during elective caesarean section , PRANATHI GARAPATI
Trends in Frailty and its Associated factors in Community Dwelling Elderly Indian Population during COVID-19 Pandemic- A Prospective Analytical Study , Karan Gautam
Speech Sound acquisition in some south Indian Dravidian languages: A systematic review , Jesica George
Comparison of Femoral nerve block with Dexmedetomidine and Adductor canal block with Dexmedetomidine for postoperative analgesia for Total Knee Arthroplasty . , NEHA GEORGE
Assessment Of Cardiovascular Risk Factors In Patients With Osteoarthritis Knee , Sagar Goel
Effectiveness of Intermittent Cervical Traction with and without Neural Mobilization in Discogenic Cervical Radiculopathy , Aditi Goyal
Study of maternal and cord blood vitamin B12 levels with anthropometry in term neonates born to normal and malnourished mothers: a hospital based cross sectional study , Sugapradha a. GR
Development of a Questionnaire to Determine the Intervention and Service Delivery Practices of Speech-Language Pathologists for Children with Speech Sound Disorders in India , Shaily Gupta
Relationship between Physical Activity, Objective Sleep Parameters and Circadian Rhythm in Patients with Head and Neck Cancer receiving Chemoradiotherapy- A Longitudinal Study , Rachita Gururaj
“Emotional Contagion, Perceived Stress and Coping Strategies Among Nurses” , Saumya Hariharan
Assessment of knowledge and belief about stuttering among undergraduate medical students , Anushree Harihar
Association of serum lipid levels and other systemic risk factors with retinal hard exudates in diabetic retinopathy patients. , Harshita Mukesh Hiran
Assessment of risk of Diabetes Mellitus by using Indian Diabetes Risk Score among Housekeeping staff , Ramesh Holla
“Emotional Intelligence, Self-compassion, and Life-Satisfaction In Clinical Psychologists” , Vania Jacob
UPPER-CROSSED SYNDROME AND DISABILITY IN SHOULDER ADHESIVE CAPSULITIS. , Aishwarya Jaideep
Study to assess the role of doppler ultrasound in evaluation of arteriovenous hemodialysis fistula and the complications of hemodialysis access , Ishank Jain
Relationship between burnout compassion fatigue, work environment & mindfulness in medical residents , Pranay Javeri
“Relationship Between Burnout, Compassion Fatigue, Work Environment and Mindfulness in Medical Residents” , Pranay Harichandra Javeri
“Dating Anxiety in Emerging Adults” , Jisha V. Jayaprakash
“Relationship Between Tolerance for Disagreement and Mindfulness in Married Males and Married Females” , Jahnavi Jha
Antibiotic usage and susceptibility patterns in Uncomplicated UTI in a Tertiary Hospital in South India , Christy John
Association of bed rise difficulty scale with trunk impairment and functional scales among stroke patients , Leena G. John
Is there a correlation between Pediatric Berg Balance Scale and Centre of Pressure Excursion measured through Dual Axis Static Force Plate™ to assess Balance in Children with Spastic Cerebral Palsy and Typically Developing? , Niharika Joshi
Comparison of Sensory Processing Responses in Cerebral Palsy Subtypes and Typically Developing Children (7-36 months): A Cross Sectional Study. , Archana Antony K
‘A study on the Role of Learned Helplessness, Selfefficacy and Perceived Social Support in Determining Resilience in Parents of Children with Neurodevelopmental Disorders’ , Benaisha Khurshed Katrak
A study of correlation of maternal serum zinc levels with breast milk and cord blood of late preterm neonates , Rashmi Katti
Correlation of histopathology and direct immunofluorescence findings in clinically diagnosed prurigo nodularis , Haritha K
Difference in proximal femur loading due to muscle activity during partial weight bearing and NWB standing- A cross-sectional study. , Smital Kshirsagar
Effect of Sesamol on neurobiochemical changes in diet induced (DIO) obesity model of Zebra fish (Danio rerio) , Rashmii K.S.
Importance of integration of medical ethics with undergraduate medical curriculum- Instructors and student’s perspectives. , Rashmii K.S.
Long-term potentiation (LTP): A simple yet powerful cellular process in learning and memory , Rashmii K.S.
Parkinson's Disease Overview: Alternative Potential Curcumin Treatment, Current Treatment and Prevalence Among Ethnic Groups , Rashmii K.S.
Smart brain of India vs. tricky drugs , Rashmii K.S.
The Role of Professionalism and Ethics Training: Instructor’s and Student’s perspectives in a medical College , Rashmii K.S.
Violence Against Doctors: A Qualitative Study On This Rising Predicament , Rashmii K.S.
Morphometric study of the gracilis muscle and its pedicles , Chettiar Ganesh Kumar
Comparative study of bed side tests to assess difficult airway in paediatric patients , S.Abinandha Kumar
Euphorbia thymifolia (Linn.)- A review on ethno pharmacological properties , Vasavi Kumblekar
COMPARISON OF KNOWLEDGE, ATTITUDE, AND PRACTICE TOWARDS THE USE OF SUNSCREEN IN DAILY LIFE BETWEEN FIRST -AND THIRD -YEAR MEDICAL STUDENTS , Aarushi Lall
‘Feminist Identity, Socio-cultural Attitude Towards Appearance, and Body Images issues in Emerging Adult Women’ , Sheena Lonappan
A novel approach to quantify the Dynamic Windlass Mechanism , Ishita Mahajan
METFORMIN VERSUS INSULIN IN THE MANAGEMENT OF GESTATIONAL DIABETES , Varikuti Manogna
Cognitive abilities among employed and unemployed middle-aged women – a systematic review , Aswini M
‘Emotional Intelligence, Job Satisfaction and Psychological Well-being Among Nurses’ , Chetna M
RELATIONSHIP OF COMPUTER AIDED DESIGN(CAD)-BASED PHOTOGRAMMETRY FOR FACIAL DYSFUNCTION WITH FACIAL GRADING SYSTEMS FOR BELL’S PALSY: A PROSPECTIVE OBSERVATIONAL STUDY , Ankita Mehendale
“Effect of Sensation Seeking and Anxious Traits on Suicidal Ideation Among Adults by Birth Order” , Haripriya G. M
Clinical & radiological assessment of intertrochanteric fractures treated with PFN A2 , Harish M
Effect of a home-based pulmonary rehabilitation programme on respiratory function, functional capacity, and quality of life in patients with chronic obstructive pulmonary disease , Vaibhavi Mhatre
Profiling Communication Characteristics of Individuals with Acquired Neuro-communication Disorder in a Tertiary Care Setup , Nikita Subudhi M
Relationship between weight bearing symmetry, trunk control and fear of fall amongst subjects with stroke: A cross sectional study , VIVIAN NEHAL MONIS
Lower extremity muscle recruitment pattern during sit to stand transfer in children with cerebral palsy as compared to typically developing children- a cross sectional study. , Kiran P. Nadgauda
Knowledge, attitudes and practices of Indian classical singers towards vocal healthcare , Raveena Muralidharan Nair
"Perspectives of Indian Speech Language Pathologists on Adolescent Language Assessment" , Rohana Muralidharan Nair
Effect Of Yoga On Perceived Stress And Pulmonary Function In High Stressed Postmenopausal Women , Vinodini NA
Refractory errors, blood groups & diabetes mellitus: A corrleative study in south Indian population , Vinodini NA
Comparison of Functional outcomes for displaced extra-articular distal radius fractures managed by Conservative versus Operative methods: A Prospective cohort study , Muhammed Ehsan Nazeer
COMPARATIVE STUDYOF THE EFFECTIVENESS OF VAPOCOOLANT SPRAY VERSUS EMLA®® CREAM IN REDUCING PAIN DURING INTRAVENOUS CANNULATION IN ADULT POPULATION , Sisla Nazer P
Assessment of attitude among public towards stuttering in a coastal city of Southern Karnataka , Prithvi N
"Severity assessment of acute pancreatitis using ct severity index and modified ct severity index: association with clinical outcomes and ranson’s criteria. " , GEETANJALI PARMAR
“The Effect of Culture Shock on Adjustment and Psychological Wellbeing Among College Going Students” , Akanksha Patra
‘Effect of Religiosity on Attitude Towards Euthanasia in Medical Students’ , Sumedha Pawar
Development Of A Questionnaire To Determine The Clinical Assessment Practices Of Speech-Language Pathologists For Children With Speech Sound Disorders In India , Prasila Elsa Philip
Correlation of oxidised LDL with oxidant and antioxidant enzymes in subjects with elevated LDL levels , Pooja p
Association of emotional intelligence of primigravida mothers with breastfeeding self efficacy in the early postpartum period and exclusive breastfeeding rates up to 6 months. , Priyanka Reddy p
Morphometric study of the Sartorius muscle and its vascular pedicles , M.D. Prameela
Comparison of the analgesic duration using ultrasound guided popliteal sciatic nerve block between diabetics with neuropathy and non-diabetics without neuropathy , GANESH PRASAD
Early follicular and Mid-luteal phase associated changes in Lower extremity Muscle strength , length and Agility in amateur female athletes – a Prospective Analytical study , Vishnu Priya
Assessment of mobile device based educational intervention on breastfeeding technique in multigravida mothers and its effect on early infant feeding pattern- A randomized controlled trial. , Keerthi Raj
THERMAL ULTRASOUND, MANIPULATION AND EXERCISE ON PAIN AND MOUTH OPENING IN CHRONIC TEMPOROMANDIBULAR JOINT DISORDER: A CASE REPORT , Suchita S. Rao
Correlation of Histopathology and Direct Immunofluorescence: Findings in clinically diagnosed Prurigo nodularis in a Tertiary care hospital , Haritha Reddy
EFFECT OF POSITIONING ON THE PAIN RESPONSE OF INFANTS VACCINATED WITH IPV AND PENTAVALENT (dtwp-HEPATITIS B-HEMOPHILUS INFLUENZA B) VACCINES , Sontosh Reddy
Assessment of the acceptable length of Right internal jugular central venous catheters. , Nivedhitha R
PRELEVANCE OF WORK RELATED DERMATOLOGICAL SYMPTOMS IN HEALTH CARE WORKERS IN COVID-19 ERA , Rana R
COMPARISON OF TWO ROUTINE FACIAL EXERCISE PROTCOLS FOR BELL’S PALSY- A RANDOMIZED CONTROLLED TRIAL , Stephanie Santiago
Profiling selected speech characteristics in individuals with Chronic Cough , Nawal Palakkal Sathar
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Stigmatizing language (SL) is widespread throughout medical documentation. 1 It is more likely to be found in the records of Black patients, 2 , 3 patients with public insurance, 2 and patients with certain comorbidities. 3 We investigated associations between SL, errors in the diagnostic process, and demographics for hospitalized patients.
Brooks KC , Raffel KE , Chia D, et al. Stigmatizing Language, Patient Demographics, and Errors in the Diagnostic Process. JAMA Intern Med. 2024;184(6):704–706. doi:10.1001/jamainternmed.2024.0705
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