Peritoneal Dialysis in the comfort of home - regain your independence

 Background

Chronic kidney disease (CKD) is a recognised healthcare problem across the world and afflicts 8 – 10 % of the population globally. The proportion of CKD cases is even higher in developing countries. In India, this number is estimated at 8-17% of the total population – propelled by an increased number of elderly people, changing lifestyle and other NCD risk factors. CKD is associated with increased risk of complications and mortality at all stages in its natural course. About 10-20% of those with CKD are expected to develop End Stage Renal Disease (ESRD) and will need some form of Renal Replacement Therapy (RRT). Over 2 million people worldwide receive treatment with dialysis or a kidney transplant, yet this number represents less than half of persons who need treatment to stay alive.

About 2.2 Lakh new patients of ESRD get added in India every year, resulting in an additional demand for 3.4 Crore dialysis sessions. Outcomes and “time on therapy” are poor now, but will get better with improving living conditions, better awareness, higher incomes, and reimbursement. This will put pressure on the dialysis infrastructure – and demand much more capacity creation.  

Peritoneal dialysis (PD) can, in part, relieve some of this pressure. PD can be done at home and can be cheaper than HD when scale is reached. PD does not need much infrastructure or technical manpower. It has been adopted as the preferred modality by many countries - Thailand, Hong Kong, New Zealand, and Australia, being the latest examples. Other countries like USA are pushing to increase the share of patients on peritoneal dialysis.

On 7th April 2016, the Ministry of Health and Family Welfare, Govt. of India, launched programme guidelines for hemodialysis under the Pradhan Mantri National Dialysis Programme (PMNDP) for implementation at District Level. Subsequently, the initiative was expanded to Peritoneal Dialysis to provide respite and better quality of life to kidney patients, particularly those who live in remote areas. An estimated 70-80% of kidney patients who start dialysis are forced to drop out due to a variety of reasons. While resource limitations are a prominent cause, access to dialysis centres and care-giver availability are huge problems too. Dialysis is hard to access for large number of patients living in remote rural areas and the introduction of home-based Peritoneal Dialysis will benefit these individuals by allowing greater flexibility and freedom in their treatment schedule.

According to the recently published Global Kidney Health Atlas, 63 out of the 124 countries surveyed provided free PD from public funds – compared to 52 that provided free HD. It is important for doctors and patients to make their Dialysis modality choice after a careful evaluation of all available options. Sadly, many patients today are not even offered PD before beginning dialysis.

According to current estimates, there are only 6,500 patients on PD in India. There are multiple reasons for low utilisation of PD - including the high cost of PD supplies, physician and provider bias, financial incentives, and higher professional earnings to physicians from HD, need for provider organisations to utilise existing HD capacity and lack of familiarity amongst physicians making them uncomfortable with the therapy.  There is a widespread but

unfounded belief that PD is associated with higher complication rates, in particular,

infection. It is felt that patients from low socio-economic group are not suitable for the self-management that PD warrants. Experience in PD first countries across the world bely these theories. Adoption of PD in India will need each one of these factors to be addressed and mitigated

Factors that will drive greater PD utilisation

1. Building the clinical case for PD. Doctor support, patient and care-giver education, PD infra in key hospitals, tele-medicine
2. Attracting large scale manufacturing of PD in India – and making the therapy more affordable
3. Building the clinical support – training, quality, social worker involvement, clinical protocols, condition monitoring, complications management

1.    Building the clinical / health economic case for PD

PD is the therapy of choice for remote dialysis patients, as a bridge to transplant, for independent patients seeking quality of life and for those with cardio-vascular insufficiencies. Moreover, 60 % of ESRD patients are suited for either dialysis form – HD being the choice of most treating physicians. It is necessary to put a formal program in place to counter-act the considerable negativity associated with PD - through education, demonstrated clinical evidence and outcomes. Some measures are elaborated below:

• Partnering with the ISN (Indian Society of Nephrology) and PDSI(Peritoneal Dialysis Society of India) to develop a PD clinical evidence series – clinical papers and outcomes from PD first countries; comparison of DALY adjusted for initial clinical condition, Quality of Life. Programs run by PD companies prove that, stripped of financial constraints and supply issues, patients can live many years on PD with a better quality of life. 
• Partnering with the ISN and PDSI on continuing Medical Education: Bringing strong PD practitioners alongside promising ones to help cross-learning of the nuances 
• Make it mandatory for all centres participating in government programs to offer PD along with HD. Reserving even 10 % of patients for PD will serve to ensure that HD centres are committed to the therapy; physicians are encouraged to learn and incorporate PD into their practice; and large-scale manufacture will reduce cost 
• Equating physician incentives on HD and PD – to build objectivity and eliminate any financial biases that could affect therapy choice.
• Build a “Total System Cost” model to compare PD and HD. Equate standards of dialysis adequacy across PD and HD – and build in the hidden costs eg. travel, opportunity cost of care-giver time and other out-of-pocket expenses

2.    Making it attractive for large scale manufacturing of PD in India

Manufacturing PD fluid and consumables is not a very complex operation – especially for a country like India that has established itself as a manufacturing hub for much more complex products. The components are predominantly plastic (PVC or PPE), filling is akin to large volume parenterels in aseptic conditions and the product is terminally sterilised by steam. The key task is to deliver adequate quality at a reasonable price – scale of manufacture has a very large part to play in this. 

Large manufacturing plants in PD “friendly” countries have demonstrated that the cost of bags and consumables can be cut down to the extent that therapy costs are comparable to that achieved by HD. To derive these economies of scale, though, a plant must produce over a crore bags annually – i.e., cater to the requirements of 10,000 patients. In initial years, while patient numbers are being ramped up, manufacturers will struggle to utilise their installed capacity and will need to be supported through incentives such as:

• Long term supply contracts 
• Production and Quality linked incentive schemes
• Capital credit
• Grants for research on better manufacturing methods and materials
• Subsidies and duty waiver on RM, PM and Capital goods that are needed to manufacture PD
• Tax benefits to extend existing large volume parental lines to accommodate PD

3.    Building the clinical support infrastructure 

HD has been the therapy of choice for several decades now – the collective patient experience is several hundred times that of PD. Clinical processes are mature, care standards well defined, patient review processes well charted and support systems for managing adverse events are in place. It is important that all these aspects are built in for PD too. Being a home care option, PD will need an additional layer of support from last mile PD coordinators, social workers, and caregivers. PD patients enjoy much higher degree of independence – the flip side of this a tendency to put off regular doctor visits until absolutely necessary. PD coordinators bridge this gap by engaging with patients on a more regular basis, keeping an eye for any decline in clinical condition, and feedback to the doctor. These need to be standardised, documented, and tracked for quality. 

Infection is a common problem in both PD and HD – though the nature of infection is different in each. Infections in PD patients are related to the PD catheter - peritonitis and exit site infection, whereas HD are at greater risk of vascular catheter related sepsis, bloodstream infections (bacteraemia), infective endocarditis and pneumonia. Vascular catheters are associated with higher infection as compared to AV fistula. In comparative studies, hospital admission rates due to infection are twice as high for HD as for PD.  Moreover, mortality due to peritonitis is much lower than the risk of death in the HD patients due to bacteraemia, sepsis and pneumonia. 

Infection management has achieved great prominence in a hospital setting. It must be given the same importance in a home setting for PD.  Patients and caregivers must be trained on proper techniques to minimise infection – this has been adopted very successfully elsewhere in the world. 

Standardised elements of PD therapy will include

• Independent counselling centres for non-biased explanation of therapy choices
• PD rooms in HD centres – as a necessary feature to support initiation, hand hold patients through the troublesome initial phases, provide educational content and manage complications, if any
• A patient home care manual (paper and online) where patients can record daily therapy information – exchanges, fluid status, diet, exercise, and medication.
• PD Coordinator formats that will report on patient status – through scheduled video and in-person evaluations. Evaluations to include clinical condition, fluid status, compliance with therapy, nutrition status, fatigue assessment and complications that will need escalation
• Essential training tools and schedule – on 6 step hand-washing, maintaining a safe environment for exchanges, safe disposal, what to watch out for, patient helpline etc. 

The PD Clinical Coordinator is an essential part of the PD ecosystem. It isn’t a specialised skill, though, and can easily be administered by a quasi-healthcare worker trained for the purpose.  ASHA workers and volunteers at the field level can be trained to play the role of the social worker – and ensure more regular contact with patients. An incentive model must be worked out for last mile healthcare workers. The proliferation of Home Care and Telemedicine represents a huge opportunity – drawing on these home care networks can provide the last mile touch points for patients and build in a feedback loop through telemedicine for remote attending physicians. A network of this nature is essential to build confidence amongst doctors and scale the therapy. 

Conclusion

In conclusion, as the RRT needs of the country grows, it is imperative to add PD to the basket of options available to the patient. However, bringing PD to the forefront required collaboration and concerted action by all stakeholders for the period of time it takes to embed the therapy into people’s mind and for it to become financially viable. 

Acknowledgements

This paper would not have been possible without the involvement, advice and critique of Prof. Vivek Jha, Director, The George Institute for Global Health, India. Most of the data and clinical references are derived from his work on PD over the last 2 decades.

A case for building immunity

 COVID-19 has disrupted our lives in ways that were unimaginable a year ago – and will possibly leave us with scars and lessons for an entire lifetime. Amongst other lessons, COVID-19 has exposed the weaknesses of the curative healthcare system to sort our healthcare problems. It is now evident that this pandemic isn’t going to leave in a hurry – and that we will need to learn to co-exist with it.

Not all people have reacted to the virus in the same fashion – a large majority appear to shrug it  off with ease – a small fraction have been hit very hard. Some have needed hospitalisation; and quite a few lives have been lost. The wide range of potential threats – and the seeming uncertainty about where and how it will strike has caused widespread paranoia and fear.

Why do different people react differently to this pandemic? What can we do to guard against it and, god forbid it strikes, blunt its sting

Pasted below is a link to a talk from a young Auckland doctor, Dr Sandhya Ramanathan -  spelling out her advice. As we know, New Zealand has been exceptionally successful in its fight against COVID. Her simple prescription - build immunity; reduce viral load; and strengthen lung capacity and respiratory function.

https://www.youtube.com/watch?v=2ZoBb-ngk5k

COVID isn’t the first super-bug to hit humanity – and will definitely not be the last. Increasing ease and opportunity for overseas travel and a global employment pool has led to the breaking down of country boundaries – making containment much more difficult than it was a couple of decades ago. So this might well be the universal recipe to guard against all the super-bugs that hit us in future.

1. Don’t take unnecessary chances – be on guard. The need to maintain personal hygiene, avoid unnecessary physical contact and minimise exposure to crowds is more important now than it ever was
2. Identify and strengthen your weak link(s) -  systematically assess your highest health risk factors and work on them, NOW!
3. Build immunity – the stronger you are overall, the less likely that any external bug can affect you

The first point is about reducing the viral load. It is now clear that COVID is very unlikely to be transmitted through a fleeting encounter with an affected person. It needs prolonged exposure. The virus is heavy and fragile – and is incapable of surviving long on most surfaces. So even the simplest measures of hand and face hygiene, isolation and irrigation of the nasal and throat packages can reduce the probability of getting infected dramatically

The second is about identifying and working on your health risks. Based on the data available so far, only a small fraction of the mortality associated with COVID can be attributed directly to it – these patients usually die of respiratory distress. After the initial surprise, the medical fraternity has geared up and is now able to very effectively fight COVID – with fairly simple tools and, in many cases, at home. This is the case with most diseases that have struck humanity – experience and the learning curve almost always results in simpler, and more effective, medical management. A much larger fraction succumbs to co-morbidities and to other underlying medical conditions that take advantage of the COVID weakened body.

That leads us to the third, and most interesting, point on “immunity”. A year ago, we thought of COVID as the mystery virus that the human race could not defend against. It is clear now that, notwithstanding the large death toll, different people have different levels of defence against the virus. A large number of people are not infected in spite of prolonged exposure; some show no symptoms but high levels of antibodies in their blood point to their recovery from COVID; some only show very mild symptoms and are treated at home; and some need hospitalisation. To understand this wide variation in how COVID affects people, it is important to understand the functioning of the human immune system.

Our immune system protects us against a huge array of external pathogens – in the absence of an effective immune system, even the smallest of infections could kill us. The immune system’s first line of defence is an army of macrophages that engulf and destroy most pathogens that threaten us. This happens automatically, most times before the pathogens even get into our system. This constitutes the “Innate” immune system.

Some pathogens do elude this outer line of defence and get into our bodies. This breach is detected by dendritic cells that then collect information on the pathogen and pass them onto T Cells. The T Cells, in turn, instruct B cells to produce antibodies, or special weapons, against these specific pathogens – weapons that are then used by the macrophages to destroy the pathogens. This constitutes the “adaptive” immune system. The adaptive immune system learns from each experience and stores it into memory – so that it can respond very quickly to attacks from the same, or similar, pathogens in future.

When the pathogens manage to overwhelm both the innate and adaptive immune systems is when medical intervention is needed – starting with oral medication but progressing to hospitalisation as the fight becomes more intense.

This explains the variability in the way COVID affects people – and builds the case for boosting our innate immune system. There is no universal prescription for immunity development. There is enough evidence, fortunately, of what constitute the building blocks. At the core is leading a healthy lifestyle – eating right, exercising in moderation and giving up smoking. Too much exposure is dangerous – but so is too little exposure. Indians returning from long stints overseas find themselves more susceptible to even the simplest of bugs.  Nutritional supplements and medication can help – including Vitamin C, Vitamin D, Vitamin K, Zinc and natural supplements like amla, ginger, pepper and turmeric. One needs to be careful about not overdoing them, though – and seek guidance of a practitioner before embarking on a supplementation plan.

In summary, we will possibly see a lot of other pathogens over our lifetime – hopefully none as devastating as COVID. It is impossible to predict what will come next – but whatever does, we will have a better chance of overcoming it by building our immunity.   

A thought for Food

The day before yesterday, 16 October, was celebrated as World Food Day. Funny – I thought every day was that. Nothing gives as much pleasure as food – or creates as much confusion in our minds.

Every day we are assailed with completely conflicting messages – eggs are bad; no - eggs are good. Cholesterol is a problem; no - cholesterol is essential for a healthy body and mind. Milk is good – no, milk is bad. Tomatoes are good; no, tomatoes can cause cancer

How, in the face of such contradiction, can we even decide what is good for us? Would like to share my simple theory on this

A large part of the problem lies in the pace of evolution of the human species. We are no different than we were in the 17th century – 300 years is a mere blink of an eye in evolutionary terms. Our lifestyle has, however, changed tremendously -  automobiles, processed foods, supermarkets, air conditioning and desk jobs have served to make us much more rich, sedentary and overfed as a species. Our lives are programmed and routine but genetically, we are still omnivorous hunter gatherers who can’t be sure where our next meal will come from. 

Every diet we try attempts to trick our body into not absorbing the food we eat – eat only protein, eat only fat, separate the protein and fats, cut out carbs entirely. We lose weight dramatically while on the diet – only to put it all back and more when we go back to normal food. That is because the diet signals to the body that food is in short supply, and triggers the “thrifty gene” - that in turn conserves every scrap of food and uses it sparingly.

When we were young, we learned about 'balanced diets' – our bodies needed to be fed much like we would build a camp-fire. The heavy logs were at the bottom and the tinder and camphor were on the top. The camphor lights the tinder, the tinder lights the twigs and the twigs light the logs. A fire entirely of tinder would burn out too fast and not generate enough heat – one with only logs would be nigh impossible to light. Similarly, the simple sugars provide the energy to break down and digest the other carbohydrates that then start working on the heavier fats and finally, the proteins. By depriving our body of the carbs, we slow down digestion of the heavier nutrients and so feel full for longer. But is this the right approach? The real questions we should be asking are “Who are we fooling?” and “Should we be eating as much as we do in the first place?”

I would like to advocate an approach that has been serving me well for the last 15 years

• Don’t embark on a diet that you cannot sustain – lifelong! Remember the rebound effect – if you can’t sustain the diet, the weight will all come back
• Eat what is natural and seasonal. Nature inevitably has a purpose for what it does – for the watermelon in summer, and apples in winter.
• Keep away from the processed foods - processed foods are possibly the biggest evil we encounter in our day to day existence. As a rule, stay away from the 4 whites – white bread, processed sugar, salt and white flour. Some add milk to this list – I have benefited by keeping milk out of my diet, preferring yoghurt and old cheeses. Carbonated beverages are high on my list of “dont’s” – recent evidence suggests that even diet drinks can mess with your metabolism and effect your health. Eat whole fruit instead of fruit juice. Don’t hurry to throw away the skin – often the largest source of nutrients and fibre.
• Exercise – as much as you can. A 10 minute walk is better than none at all. A gentle walk post a meal helps the digestion and works the body. Build exercise into your routine and chores – that is the only way of incorporating it into your life. Even the slightest exercise is a stimulus - it pumps up the metabolism and keeps you well-oiled
• Control the portions. Eat a variety of foods. Watch how much you eat though – 'how much' is more important than 'what' where diets are concerned
• Work with a dietician who understands your needs. Overlay all advice with a strong dose of common sense

Disregard everything I have just said if you have an existing medical condition. Your doctor is the best judge of what you need to do to put you back on the health path.

Happy World Food day to all my fellow foodies – better late than never. The intention was not to throw you off your food – love my food too much to do that! I do hope, though, that I have given you something to think about when you next reach for something – or abstain from something. Remember, maintaining a balance will allow you to enjoy your food for as long as you live

I am 50 – going on………… 35!

Yes – you read that right!!

We are all obsessed with chronological age – celebrating anniversaries, blowing candles, cutting cakes. But look around you – has everyone around you aged uniformly?

Twenty years ago, I was a fairly unhealthy 35 year old. A freak soccer accident played havoc with my right knee – needing reconstructive surgery. My exercise levels dropped, and I quickly put on 10 kgs.

Things changed for the better when I turned 40. I re-discovered my passion for the outdoors and learnt to play tennis.  I will never climb Mt. Everest and will never win even my condo tennis tournament – but that doesn’t dampen my enthusiasm. A recent high point was when an online test declared my health age at 35 years! There are large numbers of self-administered online tests that estimate your health age based on your physical characteristics, activities and lifestyle – you might like to try one just for fun.

Analytics today have evolved to the extent of scientifically predicting your chance of having a cardiac event in the next 5 years. Several “Risk Assessment” algorithms have been put out by some of the best names in medicine  - Johns Hopkins’s ACG, the Framingham panels, the Minnesotta Tiering methodology, Charlson Comorbidity measures, Kaiser’s Archimedes etc. Each of them puts a number to your health risk – some translate the risk into money. The algorithms are extremely complex, but most recognise that over 80 % of the controllable risk can be attributed to 5 factors – excess body weight (BMI), Lipid Profile, uncontrolled diabetes and hypertension, stress and smoking.

The George Institute for Global Health (TGI) is a 4 - country organisation headquartered in Australia. The institute is known for its research into population health and clinical excellence. In 2015, it was ranked among the leading ten research institutions in the world for research impact by the SCImago Institutions Rankings World Reports. TGI has developed a proprietary risk stratification and management methodology and has embedded it into a computer tool called “Healthtracker”. Healthtracker is a part of a suite of tools developed by TGI that, together, can link to medical records, extract data, dialogue with users and provide end-to-end solutions. Healthtracker quantifies cardiovascular risk and allows the individual to take charge, in consultation with his doctor. A dial allows an individual to set goals for diet, exercise, medication compliance and smoking cessation – and to see how this helps dial down their healthcare risk. Healthtracker paints some amazing pictures – for example, just cutting off smoking reduces cardiac risk by 30 %. This is just a glimpse of what Articial Intelligence and Machine learning tools can do to improve healthcare

A word of caution though - these tools only work when they are correctly adapted to the health system / individual context. Most times, results are more directional than accurate - so the movement over time and action plans for sustained outcomes are more important than the absolute numbers.

So, fellow 50 year olds – take heart. With some effort you can go back to feeling the way and doing the things you did 20 years ago. Only you can take charge of your own health; adopt some simple mantras

• Eat right; avoid processed foods, watch those lipids and your blood sugar
• Exercise regularly; stay light on your feet
• Find and practice your way to beat stress. Laugh; have fun; develop a hobby; make friends – it is never too late
• Stop smoking – NOW

Watch yourself grow younger –  go on that magical hike, play a game with the kids or finally indulge your love for outdoor photography. Life can be fun – again!

Only Dreamers can be Doctors

If there is one thing I regret in life, it is not studying to be a doctor. I am not usually the regretting kind –but I have enormous respect for those that heeded the calling and chose this profession.

There are a number of reasons I could possibly give for my not choosing to be a doctor – but below all that is a lack of courage. I simply lacked the courage to withstand the trauma and the gore. I lacked the commitment it takes to work endless hours. I doubted my ability to go those long hours without sleep and still be available, when needed, to address the next, inevitable, crisis. I wasn’t sure that I could cope with the expectation – to be that model citizen who unselfishly puts others’ interests ahead of his/her own.

Fourteen years ago, I made amends in a small way by committing myself to a career in healthcare – to support these wonderful people in their quest to keep people healthy. 

A few years ago, I was discussing a mutual passion in music with a doctor friend. The conversation veered to affordable player options and I talked about my latest acquisition, a Bose Sound Dock. My friend laughed and said “Rs 13,500/- isn’t a small sum of money on an associate professor’s salary, Harish”.  I came out of the room very embarrassed by my lack of sensitivity and suitably chastised. The incident also got me reflecting on the cost economics of becoming a doctor.

A little known fact is that a professor in a Government Academic Centre of Excellence takes home a salary comparable to that of the Company Medical Representative across the table from him. The figure could multiply several fold if they choose to move to the private sector - a fact that every doctor is aware about. This begs the question “Why do these doyen of the medical profession choose to stick to their government careers?” “Why do they resist the large financial incentives to jump ship?” and “Will this last?”

Medicine is amongst the most expensive educations one can pursue. Even in a relatively less expensive country like India, the cost of qualifying as a doctor can top Rs 1 Crore ($ 150,000) – in terms of facilities, equipment, teaching faculty and support staff. It also takes significantly longer to qualify – there is the 4 year undergraduate course, residency and a possible 3 year post graduation. Doctors often earn their first salaries when other professionals have bought a car and are planning their first child. The starting salary for a General Practitioner in India averages ~ Rs 7 lacs per year. This is only marginally higher than that of an office assistant – and significantly lower than an executive’s starting pay. Most start as duty doctors manning the toughest shifts and the worst timings – or are left to fend for themselves in the uncertain world of private practice.

Layer on top of this the huge gap in the availability of qualified doctors to manage the health of a population as large as ours. The WHO norm for is 2.5 doctors per 1000 population – a number that several developed nations have reached and exceeded. China and Brazil have 1.8 doctors per 1000 population. The corresponding figure in India is 0.7 doctors per 1000. Given the amazing range of professional choices available to an aspiring youngster in our country, will this gap ever be covered? I, for one, have my serious doubts.

What, then, is the recourse available to us? How do we continue as a country to march towards Universal Healthcare, the Sustainable Development Goals and delivering on the promises an “emerged” nation needs to make to its citizens. I have listed out my list of “must do’s” below :

1.          Value our doctors – they chose to be where they are so they can serve us. Value their time and respect their inputs
2.          Support every healthcare professional to work at their highest capability level
3.          Use technology to free up precious doctor time
4.          Empower patients to take care of themselves
5.          Focus on prevention and early intervention

Each of these is a complex problem in its own right – and each deserves to be dealt with in detail as I hope to do in my future writings.

For the moment, though – I would like to end with a salute to our doctors. You are truly an inspiration. We might not always show our appreciation but we depend on you to keep us healthy and happy!