How to recruit patients for clinical trials?


Last week I was a patient participant at the #CVCT18 – The conference for Cardio Vascular Clinical Trialists. It was very interesting and we did have a lot of discussions and conversations. One question was about the best way to recruit a diverse group of trial patients.

One cardiologist made a convincing argument. She said that patients need someone they can trust when it comes to participating. That was why she always asked the patients she wanted to include herself.

“When you participate, I am going to adopt you. You will become my family. Nobody will do anything to you without discussing with me first. And you will have a team on your side. Your nurses will be your guardian angels. They will support you, monitor you, protect you and contact me when things are not going the way they should. Would you like to participate?”

It was a very sincere plea and if I were her patient I would join immediately.

Also there was a discussion about online recruitment for trials. That way you can recruit patients you otherwise would not have seen. Yet how will patients trust the trial when they have no personal connection to the doctor?

I learned that – no matter whether you are in the control group or the experimental group – your medical care during a trial is better than regular medical care, according to the doctors who presented this statement.

It was an interesting session with patients, doctors, the FDA and the industry. An open discussion. I really was happy I was able to participate.

Thanks to #Faied Zannad for inviting me!


Transfer issues

fax rip

The Rehab Center:
The rehab specialist arrived on Thursday to run some tests and ask some questions:

Him:                                                                                             Me:
Can you stand?                                                                     Only briefly
Raise your leg?                                                                      No
Fetch something with your left hand?                     No
Do anything with your left-hand side?                    Raise one finger 3mm

“I propose to have you admitted to the rehab center,” he told me with a smile. “You will improve more there than anywhere else.”
That sounded good to me. I knew I had a lot to work on because I couldn’t do anything in my current state.
“It’s hard work, though, in a rehab center,” he warned me, which I thought was a peculiar remark. As a CVA patient, everything I did was hard work. Just getting out of bed was more difficult for me than mountain climbing would be for you. I needed the agility of an acrobat just to put my pants on in the morning.
Later on I learned from other patients at the rehab center that it wasn’t made available to every CVA patient. One gentleman, who was my age and paralyzed on the left side as well, was first sent to an old-folks home. He lived there like a plant for three months before the doctors acknowledged that he’d progress more at the rehab center. I considered myself lucky to be sent directly there, and I thanked the universe that an available space was open for me at that time.
Another lady came to visit me to ask whether I would participate in the Explicit Research Project. She explained how its research would measure the effectiveness of different treatments on young CVA patients. I knew how hard it was to get appropriate candidates for research, so I was happy to oblige. The lady provided me with a leaflet, and she said she would follow up at the rehab center.
The doctor in training stopped by. She was working hard to have my transfer file ready before I left the next day due to its importance. She told me to stop by the secretary before I left and ask for my file if it wasn’t brought to me beforehand.
The next morning two paramedics were waiting to take me with them. I was rolled onto a stretcher and wrapped up in blankets before being strapped to it. Suddenly, I realized I didn’t have my transfer file yet, and I told the paramedics that we needed to get it from the secretary before we left. They agreed.
The secretary was enjoying a cup of coffee when we showed up. When I asked her for my file, she pretended to look around her desk briefly, then told me she couldn’t find it.
“It’s not a problem,” she assured me. “We will fax your papers to the rehab center.”
I couldn’t believe what I was hearing. Faxing? What century did we live in? And who spread the myth that information via fax was confidential and safer than email?
I repeated that the doctor in training had moved heaven and earth to have my transfer file ready so that I could take it with me. I wanted her to retrieve it for me now. The secretary pretended to put forth another fake effort to look for my file. Her body language spoke louder than words, telling me she didn’t want to find the file. This was her territory, and she was in charge. Period.
I realized I wouldn’t win this battle and told the paramedics we could go. Just when we were past the doors, I heard high heels clicking in the hallway. It was the doctor in training who came by to see if I got my transfer file. When I told her I didn’t get it despite multiple requests, she hurried back and plucked my file from a pile on the top of the secretary’s desk. If looks could kill, the secretary would have been dead by now.
“Here you are,” the doctor told me as she passed me the file. “This way you’ll have all the information you’ll need in the rehab center.”
The paramedics saw the entire episode, but they kept a neutral expression on their faces. They whisked me off to the ambulance and loaded me inside. One paramedic sat next to me as we travelled, and I asked his opinion of what he just witnessed.
“Well,” he replied, “patient transfers usually have flaws, but this is a big one. One cannot change the system by themselves.”
The Large Organization is back.
We discussed what we do, and it turned out this paramedic was also a trainer in healthcare. I told him about my plans to share my experiences with managers and directors in healthcare in order to get the opportunity to improve things — in this hospital, for instance. He thought that was a great idea, and when we arrived at the rehab center (in record speed), we exchanged contact information just in case. Hubby always carried some of my business cards for networking instances like these. The next day we found each other on Linkedin.

Cardiology and the ECG (electrocardiogram)


There is a fresh baker with a thriving business in the town I live in. He bakes an assortment of delicious, wonderful things. At times, when the queue management system broke down, chaos reined at his establishment. When I saw how the queue management system was run in Cardiology, I was reminded of my home-town bakery during a chaotic episode.

Numerous patients had to go to the Cardiology department to have their heart checked since that organ was involved in most diseases. It’s natural to assume that a substantial number of those people would arrive in a wheelchair. I expected a state-of-the-art system that would manage the walking and wheelchair-bound patients at the same time. Unfortunately, that was not the case.

When we entered the hospital, we had to take a lift. There were six elevators spread out over a short distance, and it was a game to see which door would open first. As one slid open, my husband had to practically sprint to push me and my wheelchair into the elevator before the door closed.

We ascended to the Cardiology department and rolled to a stop at the counter in the reception area. My nose barely cleared the counter due to its height, which was not really a good start for equal communication. I was given a number and instructed to move on to the waiting room.

The waiting room was way too overcrowded to allow me to maneuver with my wheelchair. I was the only wheelchair-bound patient at present, but what if more showed up? Through a little force, my husband was able to create a space for me at the end of the line; although, it prevented anyone from getting past me. After a short while, I was asked to move along, but where could I go when I was hemmed in like I was?

Eventually, my number showed up on the electronic board. A beaming nurse dodged through the crowd to collect me.

“Hello,” she said. “My name is Blonde. Jane Blonde.”

Jane Blonde came to collect us for the ECG (ElectroCardioGram). She escorted us to a row of tiny cubicles which were set aside for the ECG patients as a changing area. Today, I was the only patient there.

Jane pointed at one of the cubicles and said, “please undress your upper body and lie on the bed. I’ll be with you shortly.”

A couple of minor details seemed to have escaped Jane’s awareness. First, my modestly proportioned wheelchair could not fit into any of the cubicles. Second, my entire left side was paralyzed and could not walk, much less undress and lie down.

Hubbie had to drag me onto the narrow table. Afterward, my left leg and hand fell off. Hubbie tucked both back onto the table, and I laid on my arm to ensure it stayed put.

Jane squeezed herself between my husband and the computer, blocking the screen from my view.

“What’s your name again?” Jane asked. As I told her, she typed it into the computer.

Suction cups were stuck to various parts of my upper body, and Jane asked me to relax and stay calm. Once the reading was complete, a printout was made from the ECG.

Mrs. Blonde continued to be oblivious and said, “you may dress yourself and get off the bed now.” My paralysis hadn’t vanished in the last thirty minutes, so I had to rely once again on Hubbie to dress me and get me back into my wheelchair.

Jane gave me a copy of the ECG printout … which had the wrong name on it. Apparently, Jane incorrectly typed my name wrong into the system. When we pointed this out to her, she responded cheerily, “oh, you can tell it to administration.”

The administration officer seemed shocked by the name error on the ECG printout. She ended up erasing my misspelt name with some white-out and wrote the correct spelling over top with a ballpoint pen.

“Please give this to the cardiologist,” she instructed, then handed it back to me.

This was the only aspect of the ordeal I had confidence would go right — I could trust myself to deliver the ECG printout in its correct state to the cardiologist. But suppose I had something to gain by changing some data? A little white-out and a ballpoint pen would suffice.


During my time in the world of Biotech, I got acquainted with GMP (Good Manufacturing Practices). These practices consisted of procedures that, if followed precisely, would ensure minimal mistakes and optimal work efficiency. Mistakes in these procedures could cost millions of dollars — or worse, human lives.
One of GMP’s principles was a “Single Point of Entry.” Basically, this meant that all data would be collected only once at the outset, then forwarded to all the parties who would need it.
The most optimum means to effectuate this concept in a hospital setting would be for the patient to enter his or her personal information (name, address, insurance, etc) into the system, then the administration officer or nurse would verify its veracity by comparison with a passport and insurance card. The system itself would be programmed to automatically pass the information on to all doctors, nurses, and other personnel that had need of it.
In the Emergency room the staff seemed to take the opposite of GMP’s approach. My husband had to give my information to the doctor; then, later, he had to re-give it to a nurse. Once we entered the Medium-Care unit at the Neurology ward, my husband was once again asked to provide my date “just to be safe.” I must admit that their lack of communication did not make me feel safe; on the contrary, it made me feel worried.
When I was moved to the regular ward in Neurology, I noticed a large blue binder with my name on it attached to my bed. I wouldn’t be me if I didn’t check its contents. To my astonishment, I saw the staff had a completely different General Practitioner listed as my doctor. The listed doctor’s name wasn’t even close to my GP’s name, nor did he live in the same area of town as me.
This sparked an intense desire to have multiple questions answered, and I wanted those questions answered NOW. Who was getting the information of my whereabouts? Was my medical information and status being forwarded to the proper people? The secretary was not in the building, and none of the nurses I talked to were very helpful.
In Holland there was a lot of hassle about the security of electronic medical data being breached and made available to the public. There was more emphasis on people’s privacy than on accuracy and efficiency. I appreciate the fact that my doctors worry about my digital privacy; however, I would appreciate more the administrative security of The Large Organization (TLO) making sure that these simple mistakes did not occur.

My husband called our GP, and she wasn’t even aware of my current situation. It took over three weeks before she got a perfunctory letter with no informative value letting her know I had been in the hospital with a CVA and was now in a rehab center. In the city of The Hague, 20 km from my hometown, the GPs are informed within a day by email when something happens to one of their patients.
From that moment on I made sure to check everything that was written about me both on paper and in the computer.
To be continued!