Sequential Multiple Assignment Randomized Trial (SMART) to identify optimal sequences of telemedicine interventions for improving initiation of insulin therapy: A simulation study.

BACKGROUND: To examine the value of a Sequential Multiple Assignment Randomized Trial (SMART) design compared to a conventional randomized control trial (RCT) for telemedicine strategies to support titration of insulin therapy for Type 2 Diabetes Mellitus (T2DM) patients new to insulin. METHODS: Microsimulation models were created in R using a synthetic sample based on primary data from 63 subjects enrolled in a pilot study of a smartphone application (App), Diabetes Pal compared to a nurse-based telemedicine strategy (Nurse). For comparability, the SMART and an RCT design were constructed to allow comparison of four (embedded) adaptive interventions (AIs). RESULTS: In the base case scenario, the SMART has similar overall mean expected HbA1c and cost per subject compared with RCT, for sample size of n = 100 over 10,000 simulations. SMART has lower (better) standard deviations of the mean expected HbA1c per AI, and higher efficiency of choosing the correct AI across various sample sizes. The differences between SMART and RCT become apparent as sample size decreases. For both trial designs, the threshold value at which a subject was deemed to have been responsive at an intermediate point in the trial had an optimal choice (i.e., the sensitivity curve had a U-shape). SMART design dominates the RCT, in the overall mean HbA1c (lower value) when the threshold value is close to optimal. CONCLUSIONS: SMART is suited to evaluating the efficacy of different sequences of treatment options, in addition to the advantage of providing information on optimal treatment sequences.

Development and validation of a questionnaire to evaluate the impact of COVID-19 on lifestyle-related behaviours: eating habits, activity and sleep behaviour.

OBJECTIVE: This study was conducted to develop and validate a questionnaire to assess the impact of COVID-19 pandemic on lifestyle-related behaviour related to eating, activity and sleep pattern. DESIGN: Indexed study used a mixed method design. Phase I employed qualitative methods for development of questionnaire including literature review, focus group discussion, expert evaluation and pre-testing. Phase II used quantitative methods for establishing construct validity of the questionnaire via parallel factor analysis. PARTICIPANTS: Phase 1 involved participation of experts from different fields (Departments of Medicine, Nutrition and Clinical Psychology) and general adult population. For phase II, data were collected from 124 adult respondents (female = 57·26 %); mean age (36 ± 14·8 years) residing in an urban setting. RESULTS: The questionnaire consisted of three sections: (A) socio-demographic and anthropometric parameters, (B) twenty-four items each for investigating the changes in eating, activity and sleep behaviour before v. during COVID-19, (C) six items assessing COVID-19 specific reasons for lifestyle change. The Cronbach's α value of the questionnaire is 0·83 suggesting its good internal consistency. CONCLUSIONS: This appears to be a valid tool to assess the impact of COVID-19 on lifestyle-related behaviours with potential utility for public health researchers to identify these changes at community level and develop strategies to reinforce corrective behaviours.

Role of routine use of ultrasonographic guidance for performing lumbar punctures.

PURPOSE OF STUDY: Ultrasound (US) for lumbar puncture has seen the most success in obese patients and in patients with difficult to palpate landmarks. We aimed to elucidate the advantage of the use of routine US for performing lumbar punctures over the traditional landmark method. STUDY DESIGN: This was a prospective study with consecutive sampling with a sample size of convenience. Three residents were chosen to perform the lumbar punctures after a training session. Patients were assigned to either the US group or the landmark group. The outcomes studied were number of attempts at needle insertion, patient and physician anxiety, pain experienced, time to procedure, number of traumatic attempts and the difficulties faced during the procedure. RESULTS: A total of 77 patients were included in this study, of which 36 patients (46.8%) underwent landmark-based lumbar puncture and 41 (53.2%) underwent US-guided lumbar puncture. There was no statistically significant difference between the two groups among the following characteristics: number of attempts to a successful procedure, number of traumatic punctures, procedure time, preprocedure anxiety of the participants and physicians and pain score rating of the procedure. CONCLUSION: There was no significant difference between the landmark method and US-guided method for performing lumbar puncture in the number of successful attempts, number of traumatic punctures, procedure time and pain during the procedure. Further studies are required to elucidate the advantage of the use of ultrasonography in subsets of the population such as the low body mass index population.

Utility of Walk Tests in the Progression of Mild COVID-19 Infection at a Tertiary Hospital in North India.

INTRODUCTION: There have been 214 million confirmed cases of COVID-19 worldwide, with a total death tally of 4.4 million. The current study aims to determine the predictive value of various scores in the assessment of progression of mild COVID-19 infection at a tertiary care hospital in North India. METHODS: The study population consisted of adults (age more than 18 years) with a confirmed diagnosis of COVID-19 by RT-PCR on nasopharyngeal specimens. Patients with only mild illness were enrolled. After the patients were admitted to the isolation ward, the presenting history, comorbidity status, vital signs and laboratory parameters were recorded. The 3 and 6 minutes walk test was performed daily from admission till discharge or progression of the severity of COVID- 19, and it was used to calculate Borg Dyspnoea Score (BDS) and National Early Warning Score (NEWS2) scores. RESULTS: Our study consisted of 50 patients with 34 (68%) males, and the mean (SD) age of the patient population was 28.1 (6.4) years. The most common symptoms were fever, sore throat, and cough. All laboratory parameters were within normal ranges for all the patients. 96% recovered without progression, while only 4% of them progressed to moderate illness. Results of the 3 and 6 minutes walk tests, BDS and NEWS2 scores showed improvement over the course of the hospital stay. CONCLUSION: Although the walk tests and the scores improved over time, they failed to predict the disease progression.

Comprehensive Treatment Module for Medically Unexplained Physical Symptoms - A Guide for General Practitioners.

PURPOSE: This study was aimed to develop a comprehensive treatment module that the general physician can use to manage patients with Medically Unexplained Physical Symptoms (MUPS) at a primary care level.  Methods: This comprehensive module was developed after a literature review followed by its validation by a two-step Delphi technique with experts from internal medicine, psychiatry, and clinical psychology. RESULTS: The developed module for the patients with MUPS includes case diagnosis, initial evaluation, strategy for referral, and a comprehensive treatment module. The comprehensive treatment module includes symptom discussion, rapport establishment, physical health counselling, stress management, cognitive strategies for symptom control, comorbidities treatment, and medical management.  Conclusion: The developed module has unique features, such as intensive sessions with these patients, a patient-specific treatment strategy, and a holistic approach incorporating pharmacological and non-pharmacological interventions. General Practitioners across the world can use this comprehensive treatment module for the management of patients with MUPS.

What Indians Think of the COVID-19 vaccine: A qualitative study comprising focus group discussions and thematic analysis.

BACKGROUND AND AIMS: The study aims to interpret current knowledge, attitude, perceptions and concerns regarding COVID-19 vaccine in the Indian population. METHODS: Eight focus group discussions were conducted. Participants were recruited via purposive sampling. Discussions were recorded and transcribed verbatim. Key themes were extracted using thematic analysis method. RESULTS: There were 19 males and 24 females, with a mean age of 36 ± 11 years. Sub-themes identified were knowledge, attitude, perception and concerns regarding COVID-19 vaccine, leading to the main theme, i.e., views about the COVID-19 vaccine. CONCLUSION: People have mixed perceptions regarding COVID-19 vaccine. Channelling correct messages may improve people's willingness to get vaccinated.

A short questionnaire to assess changes in lifestyle-related behaviour during COVID 19 pandemic.

BACKGROUND AND AIMS: The lasting impact of COVID 19 pandemic and associated restrictions are bound to be significant on lifestyle-related behaviour including diet, physical activity and sleep which is one of the important components in the management of diabetes mellitus and metabolic syndrome. This study was conducted to develop and validate a questionnaire to assess changes in individual's lifestyle-related behaviour during COVID 19 pandemic. MATERIALS AND METHODS: The questionnaire was developed through a standardised methodology including literature review, focus group discussion, expert evaluation, pre-testing and validation. The face validity and content validity of the questionnaire were analysed. A cross-sectional survey was carried out on 103 participants to validate the questionnaire that used a 5-point Likert scale for the response option. Exploratory factor analysis was performed to establish construct validity. Cronbach's alpha was calculated to test the internal consistency of the whole questionnaire. RESULTS: A questionnaire with 20 items to assess the lifestyle-related behaviour of people was developed. The questionnaire shows a satisfactory validity and a good internal consistency with the Cronbach's alpha value of 0.72. CONCLUSION: The developed tool is valid and reliable to assess the changes in lifestyle-related behaviour of individuals during COVID 19 pandemic.