Mobile Phones “Always There Always On” -mHealth Says Vikrant Patnaik

The new patient monitoring tool may not be quantifiable right now, but industry experts state that mobility is the next big thing to happen to the healthcare and medical research industry.

The healthcare and medical research field is experiencing rapid transitions. With continuous innovation in technologies, healthcare is bringing many better facets of treatment and patient care forward, giving the patients the best of healthcare experience that one could receive. With the growth and ease to access internet and other upcoming technologies, there have been a plethora of changes happening across industries and the healthcare and medical research industries are no exception to it.
As on today, the mere definition of healthcare initiatives for hospitals has broadened its horizons from just dispensing basic “treatment” to having more patient concentric services and thus, satisfaction. In this era, with technologies such as internet and mobiles playing a pivotal role in our lives, ensure that such services are within the reach of the common man and patients coming from different socioeconomic strata. Well, what we are talking about is bringing on board a smoother registration processes, better patient care in the hospital premises, improved preoperative observation and post operative care and a robust administration tool. It is a fact that hospital staff and doctors spend large amounts of time in capturing and accessing patient information, which can be reduced to a great extent using a combination of internet’s allied services and mobile technology. Getting quicker and accurate information for quick decision making and actions that are more “to the point” oriented are just some key advantages of mobility services in a healthcare environment and which is the need of the hour.
While the in-hospital service and experience is commendable today, there still is a large gap in terms of monitoring patients once prescribed to a particular treatment or discharged post treatment. It is quite a hassle for physicians and doctors to keep a track on patients’ health status and there is an innate requirement of continuously monitoring a patient’s health given the support that we can get from technology.
Although there are ways and means for keeping a check on the patient’s status of health, we must look at new and innovative ways that are not only simple to use but are omnipresent. If one gets to thinking, the only common denominator that exists across different societal levels is a mobile phone, from a vegetable vendor to an auto- rickshaw driver to a high flying business or corporate person; most of them carry at least one mobile device if not two.
Introduction to smart phones
With the different types of mobile phones available in the market, access and affordability has increased multifold. Mobile devices with the latest features such as touch, internet, applications and 3G have made it an extremely handy device that can perform almost everything at the push of a button or a mere “touch”. Healthcare and self care application can be developed allowing both patients and the medical fraternity to use it for multiple functions. Custom enterprise level applications can be developed for hospital staff for better hospital and patient management. With robust and secure back end web based functions to support, the turn around time can be improved by many folds. Mobile technology can be used in areas like patient monitoring, treatment adherence, geriatric care and wellness, post operative care and follow up, remote patient data capture, chronic disease management, ante natal and maternity care, rural health, stepping up from EMR (Electronic Medical Records) to MMR (Mobile Medical Records), hospital bed side monitoring systems using mobile technology and many more.
There are several areas where mobile technology can be used to improve efficiency, save time and costs in healthcare institutions and regulated research, including clinical trials. Some of the key areas that encompass the use of mobile and internet technologies with some business concepts and implementation techniques are discussed ahead.
Patient records in hospitals are an important source of information for medical practitioners and the hospital staff to take critical decisions. With primitive methods still being used largely to capture medical records, a systematic and compliant system to record, store and retrieve information is the need of the hour for instant and real time data capture and viewing by the medical staff. An instance of which would be, key patient records should be entered and found quickly in the doctor /nurse/ HOD‘s mobile phone and further can also be checked on their computers. Nurses can provide real time patient health status information to the doctors from the patient’s bed side using a mobile phone that allows every nurse to log in with a unique id thus keeping all patients information and transaction secure and audit trailed, thereby saving time on multiple rounds to all wards, resources, reducing logistics and space to store and keep all these paper based records. In multi-specialty hospitals, huge paper inventories are made on a day to day basis, which makes retrieval of records delayed and more tedious. Being aware of the fact that time is something that is most precious in a hospital environment; such delays make patient experience sour, making them frustrated. A simple and handy method of patient data collection such as using the mobile phone will save hospital staff from the burden of tedious pen and paper data capture, storage and retrieval. Since the security of patient data is important, the information can be stored in compliant server farms that follow global standards of compliance regulations and security guidelines.
It thus makes a lot of sense for a healthcare institution or an organisation to ramp up their turn around time in terms of internal operations etc.
At this point, our thoughts should be more oriented towards “Patient Care and the Patient” wherein the present day technology should be leveraged, to be at par with the fast approaching future and the growing competition globally.
Opportunity and its cost implications
Using latest trends and technologies in a sector that evades changes is a challenge. The benefits of technology can be explained and quantified with a credible ROI (Return on Investment). Patient Health is the most important fact on which the healthcare industry thrives is the patients’ health status and being, which directly or indirectly brings a cost value to the organization implementing such solutions. Better healthcare service and patient experience brings in belief and faith towards a particular institution and thereby more loyalty towards a particular brand – “building up Brand Equity”. Reminder systems and automatic storage of data in the central HIS servers would allow reduce logistics and administration and ensure quick retrieval of data as against a paper based approach, thereby saving on time and money both. Doctors can use their computer systems to track the compliance levels of the patients thereby being sure that their patient’s health is monitored on a regular basis. Reminders could also be sent as interventional messages and for doctors’ visits, which would ensure that the patient will come for his/her visit.
On the whole we are looking at a considerable return on investment for hospitals and healthcare institutions over a period of time.
Several other areas in the healthcare sector can benefit from mobile technology, some of which are widely known but less used. Industries globally have been using mobile technology and reaping benefits from it. Healthcare providers gain more while improving patient monitoring by providing them with our mobile competencies. It would be our primary motto and consistent effort to keep the healthcare fraternity educated and execute such advancements and initiatives towards making the patient’s health better

Clinical Trials in India- Where are we going ! Take preventive actions

With the way things are going in the Indian Clinical Trial space is not only saddening but also coming in as a threat for most of the sponsor companies who have made India their homes. The Indian Government is not too happy with the way patients/subjects are treated during clinical trials and as a result of which are becoming victims to SDRs (Severe Drug Reactions) and SAEs (Severe Adverse Events).

With over 1500 subjects becoming victims to the wrath of illegal and unethical clinical trial practices over the past 28 months, it is very important for us, as experts to ensure the right norms and procedures and followed. Times of India quotes - "This blatant violation of norms and ethics while conducting clinical trials is largely because of lax rules and absence of provisions for effective monitoring during each stage of the trial."

"There is no mechanism to monitor clinical trials," says Dr C. M. Gulati, editor, Monthly Index of Medical Specialities.

What is the solution to this ? In principal we need to look at robust monitoring mechanisms and better patient monitoring that can best be provided using mobile technology. Mobile technology can play a pivotal role in getting the right information from patients, ensure that they are compliant to their medication and site visits. With a validated mobile based system, the ethics committees and other governing bodies can drill down using audit trails and monitor the complete system.

Patients' even today come from rural areas but there is a ray of hope - All patients are aware and use mobile devices. Mobile devices can be used as a convenient medium for reminding patients and get them to be more compliant to their clinical trial protocol.

It is very important to have our basics right. Lets drill down to see whats wrong. We all are aware where the problem lies - A couple of pointers are:
1. Ensuring the trials are ethical
2. Ensuring that the trials are valid with the right approvals
3. Patients are compliant to their trial protocol
4. Patients safety is taken very seriously by the organization that is conducting the trial
5. Getting the right information from the patients in terms of QOL and other assessments

I still think there are huge gaps in the way things are done. And this is my request to the officials that they must look ahead in time, make tighter regulations for trials to be conducted as per the guidelines and bring in more automation for better results.

The Information Technology Advantage in Life Sciences and Healthcare

THE INFORMATION TECHNOLOGY ADVANTAGE

A clinical trial is largely dependent on the data provided by the subjects enrolled into the trial, who consume the drug under question. A drug for it to be launched in the market after extensive research takes anywhere around 15 to 20 years. Also millions of dollars are spent each year by Sponsors on clinical trials. With such a lot of effort, time and money going into trials, the success of the trial becomes very essential. This success can largely be achieved by the right data reported within the right frame of time by the patient.

Till date most trials have this data (PRO) captured by using the paper based system wherein all the questionnaires are administered by means of paper. With the modernization of the world and tremendous development of technology, time has come where all the players of the clinical research industry should use the features of information technology for improved results.

The ePRO(Electronic patient reported outcomes) and mPRO(Mobile Based Patient Reported Outcomes) provide an edge over the traditional paper based system allowing:

· Rapid data capture,

· Avoidance of data entry errors,

· Ability to trigger alerts/notifications for specific responses of concern

· Elimination of double data entry processes

· Real-time tracking of survey and compliance

· Reduction in missing information as compared to with paper administration

· Increase in patients’ willingness to report sensitive information

· Secure data storage in a compliant environment

· Easy access and storage of data -it omits the problem of data archival which is a huge problem with data storage as the regulations require the data to be stored for a minimum of 15 years after the start of the trial and 3-5 years after the drug has obtained marketing approval.

Treatment Adherence

Treatment Adherence refers to how closely a patient follows a prescribed treatment regimen. Different types of therapeutic areas need different treatment methodologies and schedules of the prescribed medication dosage. Treatment adherence plays an important role in clinical as well as behavioural treatment in patients. While in certain cases of illness adherence to a health condition may not be critical, some illnesses need extremely high adherence and compliance to the treatment regimen. Treatment adherence could imply on behavioral treatment such as adhering to an exercise routine or a particular diet plan whilst being critical in cases of terminal diseases, oncology (cancer), CVD (Cardio-Vascular Diseases) etc wherein the patient needs to take their medication at a particular time( under pre-defined circumstances). Ensuring that the patient has taken his/her medication on time and by acknowledging the intake, the clinical fraternity( Doctors/Physicians/Nurses/Caregivers) can monitor their patients in a better way. Keeping a track of their patients and their medication intake compliance, they can zero in on to various health conditions applying to the patient.

From a Patient's standpoint, there are several reasons for them to become non compliant or non adherent to their medication intake/treatment schedule such as forgetfulness, busy work schedules, multiple medication intake and schedules, ignorance, severe health conditions, age etc. As a result of which they are not able to do due diligence and are subject to prolonged illnesses. It therefore is mandatory for the patient to be sticking to his medication/treatment regimen for better and quicker recovery.

While for the patient it means better health, for a healthcare institution it means better point of care, treatment adherence initiatives, close monitoring of the patients.

Use of Mobile Technology for treatment adherence in Cancer Treatment/Trials

Cancer, the mere term that can shake up a perfectly healthy person’s life, let alone of those who are diagnosed of it. Any type of carcinogenic disease detection changes the course of a person’s life and it becomes extremely important for us to make use of modern techniques to cure or prevent cancer from spreading, especially in the initial stages.

Estimations given by global research firms’ state that there are more than 9.0 Million people diagnosed with cancer and about 4.5 million people succumb to different types of cancer every year. According to a WHO report we are expecting these numbers to escalate to 27 Million and 17 Million respectively, by 2030. It is a concern and we have to take the right steps towards mitigation of this lethal physical condition.

Knowing cancer as it is, it becomes critically important not only to be diagnosed and treated on time but more importantly to be adherent to the medication and treatment for those who have been detected with malignant carcinogenic cells.

Research on treatment and treatment adherence for people suffering from cancer has been going on for many years and several measures have been adopted towards improving patient care at different levels. Patient care and their treatment regimen are of utmost importance during the treatment of cancer. Until recent times’ technology only empowered physicians to monitor patients and their treatment regimen but today, we certainly can improve the same by allowing the patients to be a part of the doctors’ job and proactively manage their medication intake, be compliant to the treatment regimen, follow strict site visit schedules etc.

The internet certainly has played a very important role in giving a new dimension to the way things were and how they are today, however, with the advent and prevalence of mobile phones, there is a new dimension that can be explored and benefited from. Today we can achieve higher compliance ratios, better treatment follow up and intervention especially in Cancer treatment and trials using mobile technology. Global statistics show that there are more than 4 billion mobile phone users across the globe which constitutes of 2/3 rd of the world’s population, which is three times that of the internet users.

The mobile technology today give physicians an option to closely monitor their patients in treatment and trials by providing scheduled reminders and alerts for some of the key activities that the patient must perform at his end. Some of them are as follows:

1. Medication intake reminders
2. Follow ups
3. Site visit reminders and alerts
4. Interventional messages
5. Patient data capture – Mobile based electronic diaries
6. Alerts for caregivers
7. Patient recruitment (clinical trials)
8. Patient retention and monitoring (clinical trials)
9. Monitoring patient compliance
10. Reaching out to patients in their own language
11. AE and SAEs reporting using mobile technology
12. Audit trail maintenance for every action made/done by patients or clinical staff.

The presence and usage trends of mobile technology across the globe in different socio-economic strata, allows us to look at a larger spectrum of patient population now to be catered to. With easy to use dashboards and metrics for reporting, the clinical staff can closely monitor patients and keep track of their health status remotely and be assured that the patient is following the treatment regimen.

Taking this forward:

It is important that the industry experts understand this requirement and take action to implement such available technology services for treating patients suffering from chronic and terminal illnesses. Oncologists across the globe must take the initiative of using cost effective methods to monitor their patients.

PaDiSys-mPRO and PaDiSys mTA

PaDiSys mPRO and PaDiSys mTA is the next wave in the clinical trials industry. Using the power of mobile phones to keep patients enrolled in clinical trials compliant to the trial protocol is the idea behind this initiative. Taking clinical trials to the next level from Paper PRO to ePRO to the present generation techniques of mPRO, the PaDiSys Solution is going to make things easy for every one participating in the trial.

The PaDiSys Solution allows Clinical Staff, Sponsors and CROs to monitor patients through a synchronized mechanism between the mobile phone being used by a patient and the web interface provided to them.

PaDiSys solution has been built from ground up following international development guidelines such as the GAMP 4/5 and regulatory guidelines such as that of FDA, EMEA, 21 CFR PART 11 etc.

The solution brings the following features to be used in a clinical trial:

** Medication Intake Adherence

i. Medication Intake Reminders

ii. Medication Intake Alerts

iii. Medication Intake Follow-up

** Site Visit Adherence

i. Site visit Reminders

** Miscellaneous Reminders

i. Blood Draw

ii. Blood Pressure Check

iii. Blood Sugar Check

iv. Instructional or Intervention messages

** Localization capability for patient's compatible mobile devices

** Real time - Patient wise Trial adherence monitoring system - Web interface for Site Investigators and Clinical Staff

** Reports and Analytics on various parameters

** Multilingual Support / Call centre

Where is the foresight ! Why Sponsors must look beyond ePRO?

With the advent of technology and access to internet, there has been a plethora of changes happening across industries. The life sciences and clinical trials not an exception to it, have also been drastically affected by the features of the web and the applications that reside on it.

Until very recent times, patient information capture in the life sciences and clinical trials area was being done through paper (PRO) and the industry has kind of become used to the process of using paper to gather information, peruse it, comprehend and derive results. With risks of incomplete data, illegible handwriting, non compliance of medication intake and the parking lot syndrome, the whole idea of research was going for a toss. In addition to a whole lot of monetary outflow and inconsistent data, the tracking of patient’s medication regimen was getting severely affected. Although to the rescue came the electronic format of the PRO, better known as the ePRO - brining in radical changes in the quality and consistency of data, a major lacunae was seen in untimely medication intake by the patients. Sponsors, CROs and their vendors have been struggling to ensure that their patients are in the closest compliance with the guidelines of the trial to give the most optimum results. No doubts about the fact that the overall performance of the trials per say has got better with patients getting more and more techno-savvy and aware of technological development around them. All said and done – the ePRO and EDC have created magic for the clinical trials and medical research domain- but what now? Are we getting stagnant here? Is not any one looking ahead of time… Has not any one thought of the thing that you can't live with out anymore.. Your Cellphone or mobile phone !!

Mobility solutions for Life sciences and healthcare, better known as mHealth is going to be the next big thing... And some of us just know how big it is going to be

Institutions like that of DIA, FDA, mHealth Alliance and WHO must look ahead to make use of the vision and revolution that mobile technology for health care ( mHealth) or life sciences can bring in…

My indication here is towards the fast developing mobile technology and a foresight to take advantage of it in terms of:
1. The pace of mobile technology development
2. Modes of quick communication
3. To get better in terms of compliance, quality and research results
4. People across the globe keeping themselves abreast with the changing times and technology
5. The world getting smaller
6. The MOBILE REVOLUTION in Life Sciences and Medical Research
7. Mobile Healthcare -mHEALTH