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When you see ‘Fraser Institute” on a report you must, must, must read the methodology section.The data for this issue of Waiting Your Turn were collected between January 4 and April 28, 2017. Survey questionnaires [4] were sent to practitioners in 12 medical specialties: plastic surgery, gynaecology, ophthalmology, otolaryngology, general surgery, neurosurgery, orthopaedic surgery, cardiovascular surgery, urology, internal medicine, radiation oncology, and medical oncology. This year, the overall response rate was 21% (table 1).This is not ‘wait times for medical care’. This is ‘wait times for specialist visits as estimated by 21% of specialists using “weeks” as the scale of measurement.’ When evaluating this I’d want to see a far more granular breakdown in the response rate by specialty and analysis done within each province (and within the health regions in each province), instead of nationally.Here’s the specific question used in the questionnaire1. From today, how long (in weeks) would a new patient have to wait for a routine office consultation with you? ____________ week(s)You MUST read a Fraser Institute report methodology section.You’ll notice as you read the report that there are significant regional disparities in wait times as well as significant disparities between specialties.As is normal, the Fraser Institute is taking noisy data, creating a convenience sample based on estimates and then making broad proscriptions for health policy.

I will cover the definition of FMT (Fecal Microbiota Transplant), why FMT is a challenge for regulatory agencies, the type and purpose of screening required for donors and recipients.What is FMT (Fecal Microbiota Transplant)?Commensal bacteria in the stool samples from healthy individuals are transplanted through colonoscopy, nasoduodenal tubes or enemas into the GI tract of patients with GI tract infections (1). Currently, FMT is most commonly done for drug-resistant Clostridium difficile infection (C.diff, CDI) patients, and not for other types of GI tract infections or issues. FMT introduces into their GI tract commensal microbes that outcompete the pathogenic C.diff for limited nutrients.FMT dataThe first randomized control trial for FMT (2), published in 2013, was so successful that they ended it ahead of time. What were the dramatically beneficial results that induced such an unusual step? 13 of 16 patients (81.3%) resolved C.diff with just one infusion of FMT compared to 4 of 13 (30.7%) treated with vancomycin, and 3 of 13 (23%) treated with vancomycin plus bowel lavage. Such an enhanced benefit has spurred great interest in making this treatment more widely available. Drawbacks of this 2013 study included small test size, which is inherently not representative, data collection was not blinded, and cross-over among subjects during study.A 2nd pilot controlled trial study (3) also reported very encouraging results, including resolution of diarrhea in 14 of 20 patients (70%) after one infusion.These results need to be reproduced using additional randomized control trials, with larger test sizes, in additional countries and for conditions other than recurrent GI C.diff infections. Further, though the treatment itself is simple, the material, human stool, offers unique challenges for regulatory agencies.Regulatory hurdles in making FMT use widespreadProper classification of human stool is a major regulatory dilemma, very complicated to say the least. Is it a tissue, akin to human tissue or is it a drug, akin to conventional drugs?Current regulatory agency definitions of human stool for the purpose of FMTThe latest (March 2014) FDA enforcement Policy states that it intends “to exercise enforcement discretion regarding the IND (Investigational New Drug) requirements for the use of FMT to treat C.diff infection not responding to standard therapies” (4). In other words, FMT can currently be done in USA without requiring any mandatory screening only for recurrent C. diff infections. All other uses of FMT require submission of INDs. Approval of INDs is very complicated and lengthy, making it a huge regulatory burden that discourages physicians from exploring it, and deters expanding its use. The term IND also implies the FDA considers human stool a drug. This is similar to the position of the French regulatory agency, ANSM (5).Austria, on the other hand, has gone the other way and considers FMT a therapeutic intervention and not a pharmaceutical drug. “The Austrian Federal Office for Safety in Health Care, which executes federal policy in areas of infectious disease control and pharmaceuticals, sees FMT as a therapeutic intervention which should not be considered a pharmaceutical drug and therefore not be regulated by the Austrian Medicines Act. FMT is also not subject to the Medical Devices Act or to the Austrian Transplantation Act” (6).The European Medicines Agency has not yet openly stated its position with respect to FMT (7).UK's National Institute of Care and Excellence (NICE) complicates the regulatory stance further by stating that it does not consider FMT to be a transplant in the regular sense of the word, “The Committee recognised that the enteric infusion of donor faeces is not a transplant in the usual sense of transplanting body tissues, but it accepted that faecal microbiota transplant has become an accepted term to describe this procedure” (8).Problems with classifying human stool as a drugHuman stool contains gut microbiota (bacteria, viruses, fungi), mucus, metabolites and human cells. Even from the same person, it is different in composition each time, i.e. it is inherently variable and irreproducible. This makes it manifestly different from what we typically consider a drug where we use stringent quality control measures to minimize batch-to-batch or lot-to-lot variations.Further, in contrast to a conventional drug, donor stool provides therapeutic benefit not just by alleviating the C. diff infection but also by not transmitting any infection itself.Classifying human stool as a drug also places it under the purview of hospital pharmacies, requiring that they store it (9). I don't see how this could ever happen in practice. All the stakeholders from pharmacists and doctors to patients would be up in arms.Is human stool is a tissue instead?Mark B.Smith, a co-founder of OpenBiome argues human stool is a tissue (10). However, as Megerlin et al convincingly rebut (7) human stool is not a human tissue either. After all, we can call human stool a tissue only metaphorically. This definition does not withstand close scrutiny when we ask if is a human tissue. Rather, Megerlin et al consider the stool donor as a bioreactor producing “the faecal substrate of therapeutic interest”, and from this standpoint, they call human stool a sui generis (singlular/stand-alone product) drug.From a regulatory standpoint, human stool shares many properties with human blood and milk, with the additional caveat that unlike the ways in which we use the latter, with FMT, the explicit goal is to transfer live micro-organisms. This makes it a unique product requiring novel regulatory guidelines. Thus, devising proper regulatory classification of human stool is not just a stomachache but rather the mother of all stomachaches!Current human donor and stool screening processIn USA, current FDA stipulations (4) dictate the following: “(1) the licensed health care provider treating the patient obtains adequate informed consent from the patient or his or her legally authorized representative for the use of FMT products; (2) the FMT product is obtained from a donor known to either the patient or to the licensed health care provider treating the patient; and (3) the stool donor and stool are qualified by screening and testing performed under the direction of the licensed health care provider for the purpose of providing the FMT product to treat his or her patient”.OpenBiome is a public stool bank that offers frozen, pre-screened and filtered human stool preparations. In a Jan 2015 interview (Fecal Transplants Are On The Rise—Meet 2 Guys Who Make Poop Their Lives) their founders say, “We have a multiple stage screening program. The first stage is sitting down with a nurse to go through your medical history. Any conditions linked to the biome—gastrointestinal, neuropsychiatric, anyone who's taken antibiotics recently, recent travel to any countries with high risk to waterborne infections—and you're out. It's a 107-point questionnaire. If you pass, the next step is a blood sample and stool sample. We run it through 27 tests, looking for pathogens like HIV, hepatitis, syphilis, white and red blood cell counts, E. coli, salmonella, and any parasites”, and that “Less than 20% of people end up becoming donors”.At a minimum, screening should rule out HIV, hepatitis (A, B, C), syphilis, enteric pathogens (e.g. Salmonella). Both serum and stool of the potential donor thus need to be screened. For example, in Austria, they screen serum for Hepatitis B and C, HIV, Treponema pallidum, CMV, and they screen stool for C. diff, Salmonella, Campylobacter, EHEC, Shigella, Yersinia, Giardia lamblia, Cryptosporidium, norovirus and rotavirus (6).Detailed medical histories should include information about high risk sexual behaviors, known exposure to infectious diseases and inflammatory bowel disease, history of autoimmunity, and travel to regions endemic for diarrheal diseases. Human stool thus requires intensive screening. This adds considerable laboratory costs (11).The Atlantic magazine reviewed current practices and the FDA guidelines here:The Problem of DIY Fecal TransplantsWhen Feces Is the Best MedicineOther useful web-sites:WelcomePage on shea-online.orgControversies in Hospital Infection Preventionhttp://thepowerofpoop.comBibliographyVyas, Dinesh, Apoorva Aekka, and Arpita Vyas. "Fecal transplant policy and legislation." World journal of gastroenterology: WJG 21.1 (2015): 6. Page on nih.gov.van Nood, Els, et al. "Duodenal infusion of donor feces for recurrent Clostridium difficile." New England Journal of Medicine 368.5 (2013): 407-415. Page on uchc.edu.Youngster, Ilan, et al. "Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study." Clinical Infectious Diseases 58.11 (2014): 1515-1522.Page on fda.govPage on ansm.sante.frKump, Patrizia K., et al. "Faecal microbiota transplantation—the Austrian approach." Clinical Microbiology and Infection 20.11 (2014): 1106-1111.Megerlin, F., et al. "Faecal microbiota transplantation: a sui generis biological drug, not a tissue." Annales pharmaceutiques françaises. Vol. 72. No. 4. Elsevier Masson, 2014. Page on researchgate.netPage on nice.org.ukMoore, Thomas, Andres Rodriguez, and Johan S. Bakken. "Fecal microbiota transplantation: a practical update for the infectious disease specialist." Clinical infectious diseases 58.4 (2014): 541-545.Smith, Mark B., Colleen Kelly, and Eric J. Alm. "Policy: How to regulate faecal transplants." Nature 506.7488 (2014): 290-291. Page on nature.comAllen-Vercoe, Emma, et al. "A Canadian Working Group report on fecal microbial therapy: microbial ecosystems therapeutics." Canadian Journal of Gastroenterology 26.7 (2012): 457. Page on nih.gov

It appears that yes, some doctors will empower their patient and give them the option to insert the speculum, but not swab for the sample.On the horizon? Eliminating the Pap smear, the gown, table, stirrups and speculum altogether for women who meet the medical requirements. Women will be able to self swab for HPV cervical cancer screening and or provide a urine sample in the privacy and comfort of their own home. Thank you science and technology.See the details of the studies in the links below.Self-sampling for cervical cancer screening: Empowering women to lead a paradigm change in cancer controlPutting Off Your Pap Smear? Do It from HomeUrinary HPV Testing May Be an Alternative to Pap SmearFor Many Women, Cervical Cancer Screening May Get A Lot SimplerNew DIY alternative to pap smears will save lives, doctors sayThere's a DIY alternative to Pap smears. But not everyone is eligible.Also, there is a new technology (the Callascope) to examine the cervix, which eliminates the need for a speculum in most cases, and allows for self insertion of a tampon like cylinder that contains a camera. What a brilliant idea!Most importantly, women should know that it’s no longer required for healthy women to have annual pelvic exams and pap smears.I never bought into the go every single year, after year after year routine that’s been pushed on us for the past 60 years.* Why Some Doctors Allow Patients to Take a Hands-On Approach During a Pap Smear“Would you like to insert the speculum?”BY CASS BALZERNOVEMBER 14, 2019Nothing unites those of us with vaginas like the universal hatred of a Pap smear. We might put off visiting the gynecologist for varied reasons; it’s awkward, uncomfortable, and sometimes traumatic. But shifts in gynecological practice are allowing vagina owners to take parts of the procedure into their own hands — quite literally.I experienced this myself last May while visiting my local Planned Parenthood for an annual exam and Pap smear. Lying on the exam table, I could feel my heart racing as the practitioner assembled a range of plastic tools on a metal tray. Then, she asked: “Would you like to insert the speculum?”I sat up, confused. The practitioner explained she had been offering all patients the option to insert speculums themselves, a gesture that conveyed her respect for their autonomy and self-knowledge. The offer, she continued, made an otherwise uncomfortable moment slightly more tolerable.“It’s about as easy as inserting a tampon,” she said. “A cold, hard tampon.”“OB/GYNs probably have ( perform ) one of the most invasive exams,” said Huma Farid, MD., an OB/GYN and instructor in obstetrics and gynecology at Harvard Medical School…Farid said she has not traditionally offered patients the option to place the speculum themselves, but she does ask whether they want to insert transvaginal ultrasound probes. “I think control is the most important thing that we can give back to our patients… but if they really have concerns about it, I will let them try."“I know how to get [the speculum] in there in a way that won’t shock or hurt me,” said Shelby Holte, 25. “If the option to insert the speculum were a standardized offer, it would give any patient the peace of mind that comes with knowing that, no matter who else in the room, she is in charge of what takes place.”Farid said …“Once you give a woman control of her own body during the exam, you’re telling her that this is a safe space. I really emphasize their control over the exam rather than me doing something to them. It is something in which we are participating together.”Farid encourages them to ask about ways in which they can participate in the process. “There used to be this patriarchal culture of medicine. The doctor knew what was best, and they gave orders for patients to follow,” she said. “But now, there’s more of an attitude of reciprocity. This shared decision-making allows doctors and patients to arrive at conclusions together, allowing the patient to feel more actively involved in their healthcare and the doctor to better understand what the patient needs.”* From midwife Stephanie Tillman,Speculum self-insertion: People for whom the speculum exam is a feared visit or is uncomfortable and the exam itself is absolutely necessary for their care, there are many things I do to try to increase comfort (send them home with a few speculums and lube to allow them time to practice at home and get used to it, for example). Another method is that they insert the speculum on their own (similar to how ultrasonographers offer people the opportunity to insert a trans-vaginal probe on their own). With stirrups as the default position, people are unable to navigate the body maneuvers (hands, torso, legs) needed to position oneself to insert the speculum and then lay down for the provider to complete the exam. The extended table allows this process to happen much more easily.* A Novel, Versatile Speculum-free Callascope for Clinical Examination and Self-Visualization of the CervixA Novel, Versatile Speculum-free Callascope for Clinical Examination and Self-Visualization of the CervixView ORCID ProfileMercy N. Asiedu, Júlia S. Agudogo, Mary Elizabeth Dotson, Marlee S. Krieger, John W. Schmitt, View ORCID ProfileMegan Huchko, Gita Suneja, View ORCID ProfileRae Jean Proeschold-Bell, Jennifer S. Smith, Deborah Jenson, Wesley Hogan, Nirmala RamanujamRegardless of the setting, the duckbill speculum is used to visualize the cervix whether it is for a Pap smear, VIA or colposcopy. This is a significant factor in women avoiding cervical cancer screening, largely due to anxiety, fear, discomfort, pain, embarrassment, and/or vulnerability during the procedure.4-7In a longitudinal study of sexually active young women, poor compliance with return screening for Pap smears is again associated with perceptions of pain.8These barriers to screening are echoed globally. In Australia, a study seeking to determine women’s attitudes towards physician versus self–insertion of the standard speculum found that 91% of 133 women would choose selfinsertion over physician insertion, and that women felt discomfort, embarrassment and vulnerability from having another person insert a device and examine their cervix.We have previously published work on a low-cost, speculum-free, cervical visualization device, the Callascope.30We have also developed an android-based mobile application HIPPA (Health Insurance Portability and Accountability Act of 1996)-compliant image capture and cloud storage. The Callascope consists of an inserter and a 2-megapixel (MP) off-the-shelf camera (Supereyes Y002) that fits in a channel in the inserter to enable image capture.The Callascope inserter, referred to as the Calla, has a slim tubular body the size of a small tampon, and a funnel-like curved tip, shaped like a Calla Lily that is used to part only the vaginal walls closest to the cervix, with a lip for cervix manipulation to center the osFigure 1.a) Standard-of-care speculum inserted into vagina with tilted uterus, b) Speculum bill centering the cervix for imaging, c) Callascope inserted into the vagina with tilted uterus, d) Callascope lip centering the cervix for imaging...questionnaire responses from volunteers indicated that > 92% of them preferred the Calla compared to the traditional speculum. 30Conclusion The Callascope is more comfortable and provides similar visualization to the speculum. The Callascope can be used by medical providers for clinical exams while also enabling home self-screening for cervical cancer and promoting a better understanding of one’s cervix to increase awareness of cervical screening needs. The Callascope may increase cervical cancer screening rates through reducing barriers including cost, discomfort, lack of awareness and stigma.* The Gynecological Exam Is Finally Getting a Makeoverhttps://link.medium.com/3SYvYaTSv7Even if the pelvic exam is eliminated from gynecological check-ups (or becomes less frequent), there are still parts of the appointment that will remain, although not every year. For example, unfortunately: the need to use a speculumAt Duke University, a group of researchers are developing a technology that could potentially turn the speculum into an obsolete apparatus. Their prototype is a slim tubular object with a tampon-inspired design that houses a mini-camera able to capture images of the cervix and transmit them to a mobile phone or a computer... “In this case, patients could insert the camera themselves, under the nurses’ guidance, and actually see their cervix on a tablet screen. They realized it wasn’t uncomfortable at all and got really excited about seeing their own cervix.”In addition to new technologies for examining the cervix, finally, the ACOG has come to it’s senses and admitted that annual pelvic exams and Pap smears are not required for healthy women.Expert panel says healthy women don't need yearly pelvic exam - Harvard Health BlogPhasing out the annual pelvic exam mirrors a similar change for men. Doctors once routinely did rectal exams to check the prostate gland, a common site of cancer in men. But evidence that it isn’t a very effective way to detect prostate cancer, and may have caused more harm than good (sound familiar?) led experts to recommend against it being done every year.I have to admit that as a doctor and as a man, I was happy about that change. I called a couple of my female physician colleagues to get their personal and professional reactions to the news about phasing out routine pelvic exams. Question: “Will you miss not having regular pelvic exams?” Response (paraphrased): “Are you serious? No way will I miss them!”*Teen Girls Don't Need Routine Pelvic Exams. Why Are Doctors Doing So Many?Teen Girls Don't Need Routine Pelvic Exams. Why Are Doctors Doing So Many?… the high percentage of possibly unnecessary exams sends a message to physicians and educators that "we have a lot of educating to do." He hopes that the study will cause physicians to "be a little shocked — and then be reflective about their own practice."*For Many Women, Cervical Cancer Screening May Get A Lot SimplerFor Many Women, Cervical Cancer Screening May Get A Lot SimplerWomen ages 30 to 65 may decide how often they want to get screened for cervical cancer depending on the test they choose, according new draft recommendations for cervical cancer screening from the U.S. Preventive Services Task Force. Testing every three years requires a Pap smear, and testing every five years requires a test for human papillomavirus (HPV), the virus that causes nearly all cervical cancers.*Pelvic Exams No Longer Recommended For Well-Woman VisitsPelvic Exams No Longer Recommended For Well-Woman VisitsThe American College of Physicians announced a major change to their screening guidelines Healthy women should no longer receive pelvic exams during their annual well-woman visits.“It’s an intrusive test, it’s a test women don’t like, and there’s no evidence that we should be doing it,” says Dr. Hanna Bloomfield, associate chief of staff of research at the Minneapolis VA Healthcare System, who conducted the evidence review that led to the new recommendation.Hallelujah.