EXAMPLES OF GRAPHICS TO SHOW FOOD VALUES
Permanent URL: salt.globe1234.com
B. Know where to look
C. Health organizations' advice
D. Results of high sodium diet: broken bones, stroke, kidney failure, weakness
E. How much sodium is OK?
G. Published Diets
A. Overview - Salt leads to broken bones, strokes, and kidney failure, besides raising blood pressure. Studies are in section D. Ordinary meals can vary from 400 mg sodium per day to over 4,000, depending on the exact foods eaten. Section B tells you where to find low sodium choices among the 43,000 items in an average supermarket. Reading thousands of labels is too arduous, and you can ask manufacturers to adopt graphic labels like these:
Section B tells you exactly where to look for low-sodium foods. Here are examples of how your meals could work out (click for a more detailed example).
LOW HIGH (Milligrams of sodium)
395 4,345 TOTAL
75 75 Egg or egg white
35 35 Milk, 2 ounces for cereal
0 Oatmeal or shredded wheat
290 Grape Nuts
50 920 Vegetable soup
45 340 Cottage cheese
0 440 Bread, two slices
0 95 Butter
10 350 Cheese, one slice
110 1,400 Turkey, two servings (sandwich & dinner)
60 60 Vegetables, 3 servings
10 10 Fruits, 2 servings
0 290 Buttered popcorn
0 40 Water, one liter
B. Know where to look. Look for the foods below. All these are far better than the FDA goals.
21. RESTAURANTS - When you go to restaurant chains, take this bar graph of outstanding food at each chain. Ask for their list of salt content, or look first at New York's list of many national chains, which you can sort to find low sodium. You can also check the chains' websites as I did.
22. REFERENCES include:
C. Health organizations' advice is to control salt in the diet to avoid high blood pressure. The advice usually omits crucial information:
D. Results of high sodium diet: broken bones, stroke, kidney failure, weakness.
E. How much sodium is OK?
G. Published Diets:
Most published diets have too much sodium, too little potassium, calcium and iron, according to Diet guidelines. The 4 sample menus below all have enough of the nutrients shown.
DAILY MENUS CALORIES SODIUM POTASSIUM CALCIUM IRON
Globe1234 1,500 420 5,300 1,000 18
Raw 2,440 846 11,401 1,660 24
"What I Eat" 3,104 1,404 6,050 1,070 22
NIH Low Salt #6 1,935 1,472 4,710 1,214
A list of 40 other sample menus and US dietary standards shows how the recommended diets fall short of the standards, which makes it hard for people to follow the standards. A spreadsheet version of the list also shows how many calories we need, according to our age and height.
Aside from one NIH diet, #6 listed above, all other diets from NIH, USDA, and the National Institute on Aging fail the standards, with excess sodium or shortfalls in other nutrients. US News and World Report lists 32 other diets, showing some of the same nutrients above; none of those diets has appropriate sodium (below 1,500) and potassium (above 4,700).
There is a software website, EatThisMuch, (or another version Swole.me)which will generate diets with your choice of calories, sodium, protein, fiber, carbohydrate, fat, cholesterol. It is very helpful and creative, though even that site usually does not give enough calcium, potassium or other micronutrients.
Gerber offers a menu planner for children up to 4 years old. Sometimes a screen asks whether you are a health care professional (undefined); "no" takes you away from the planner, "yes" lets you continue. Click "Generate" for a week of menus, with a mix of Gerber products and unbranded foods. Then click in the "Nutrition Details" box (upper right) to see daily totals of sodium and other nutrients. Finally click the column heading for each Day to see nutrients of each food. For example they averaged 1,000 mg/day sodium for a 4-year-old, but suggested one day withe 1,500 mg. Clicking on that day showed they included 724 mg from a sloppy Joe sandwich, 241 from a waffle and 164 from a tablespoon of Ranch dressing, so it wouldn't be hard to cut back.
Direct url: aaa.globe1234.com
WILL PEOPLE FOLLOW YOUR INSTRUCTIONS?
Medscape has a scary and pointed survey of how doctors decide what care to give:
They surveyed 17,000 US doctors and 4,000 European doctors.
Geriatricians say that "state statutes sharply restrict the circumstances in which clinicians may forgo life-sustaining treatment on the basis of a living will... Living will laws tend to assume that preferences expressed in advance may be changed in the event of dementia..."
A nationally representative survey in the US found that two thirds of people had advance directives before they died, but confirmed they were not always followed. Among incapacitated patients who had left instructions:
An earlier study tracked patients in one nursing home from 1986-87. The researchers asked mentally competent patients who agreed to participate about their care preferences, typed individual statements, read them back, changed further if needed, then put the signed statement in the nursing home file, with another copy in a prominent envelope in the file, for transfer to the hospital if needed.
Family members do not always follow instructions. Public radio quotes New Hampshire's "Long Term Care Ombudsman - basically the complaint department for New Hampshire nursing homes. He says what’s directed in the form doesn’t always get carried out. 'Younger folks take it upon themselves to say, "You know, I know Dad wants this, but I think this would be better for them." Well, that’s not their job.' "
Pregnant women's directives on withdrawing life support have limited or no effect under many state laws.
In a study of deaths in British hospitals from July-September 2015, 4% of patients had advance directives, and 91% were used. DNR orders were discussed with 36% of patients and 81% of patients' representatives. For 16% of patients there was no reason given why a discussion did not take place:
When a patient or representative disagrees with a hospital doctor's plan of care, either can appeal to the hospital's ethics committee, which has 1 or 2 people on call to listen and advise. If patients are in a hurry they need to decide whether to spend a few hours on this internal procedure or go straight to court, based on an attorney's advice.
Loyola University has 3 free video case studies, which use actors to train ethics committee members. Loyola says the committee should get the doctor's story first, and prepare the doctor before the meeting, "prepare any health-care team members for participation in the conference." No one prepares the patient or representative. In 2 of the 3 cases the doctors get what they want by their forceful arguments. Ethics committee members' goal seems to be getting a decision made and accepted by doctor and representative. Rubin says mediation by untrained mediators subverts ethics, and adds, "it would not be unexpected to find more disagreement than consensus surfacing as difficult cases are discussed in the ethics consultation process."
The case studies never address the financial incentives everyone has: the hospital (which employs committee members) is generally paid a flat fee for each hospital stay, based on the patient's main diagnosis, but not based on the length of his/her stay, so shorter treatment saves the hospital money, and death prevents future readmission penalties. Furthermore enrollment in hospice will remove the death from the hospital's death rate, as tracked by Medicare.
In all 3 of Loyola's training videos, the representative goes into a room with 3 hospital staff, and there's no discussion of getting a second opinion from an independent doctor. The representatives are tired from care-giving. One says she's been with her mother for 30 hours. The doctors are understandably in a hurry to get back to other patients. The ICU doctor has either left the ICU for the meeting, or has stayed for a meeting after the end of her 12-hour shift, and she'll have to take the decision back to the next doctor to carry out. To avoid medical errors, representatives are advised to keep someone in the patient's room at all times, so if the representative has an ally at the hospital, that ally is probably in the patient's room. For these life and death decisions, an representative really needs an ally who's been through the process before, like a former ethics committee member, a nurse-advocate, or a lawyer.
The chair of U of Michigan Medical Center's ethics committee describes how his committee works (starts at 2:15 minutes into the video and goes to 17:15 minutes). He says that two committee members discuss the issues with doctors and representatives or patients, then post their draft report on an internal website for other committee members to post comments.
Federal law requires: "42 CFR 489.102 (a) Hospitals, critical access hospitals, skilled nursing facilities, nursing facilities, home health agencies, providers of home health care... must maintain written policies and procedures concerning advance directives... and are required to:
"(1) Provide written information to such individuals concerning—
"(i) An individual's... right to accept or refuse medical or surgical treatment and the right to formulate, at the individual's option, advance directives... and
"(ii) The written policies of the provider or organization respecting the implementation of such rights...
"(4) ...The provider must inform individuals that complaints concerning the advance directive requirements may be filed with the State survey and certification agency"
A lawyer says this rule is almost never enforced.
TALKING WITH DOCTORS
"But most people die in the healthcare system. Indeed, most of them die as the result of a deliberate decision to stop medical treatment that might have prolonged their life" (Pope, 2011, Widener Law Review)
When a patient enters a hospital, s/he is sick, weak and/or in pain, and has often forgotten to wear hearing aids. Hospitals may not let the representative in the room at first. At that moment an unknown doctor asks orally whether the patient wants CPR, electric shocks or a breathing tube if the heart or breathing stops. The questioning occurs even if there is an advance directive, since the patient's choice might change. Miscommunication is possible.
Hospitals and doctors have trouble talking to patients about the end of life. This section gives examples from the American Medical Association, Los Angeles. and Canada.
Six professors and doctors from the University of Chicago, Johns Hopkins, Northwestern, St Luke's-Roosevelt and Massachusetts General say (J of the Am. Geriatric Soc. 1/2013), "clinicians lack sufficient understanding of the predictors of survival after CPR to assist in such discussions." There are ways to estimate life expectancy, accounting for patient health, but these are little better than chance.
The medical representative must deeply probe for possible treatments, probably by reading UpToDate, since many doctors do not offer complete options to older people.
Considering whether care is helpful or futile, AMA opposes "the concept of 'futility,' which cannot be meaningfully defined."
AMA has intricate rules for considering advance directives in "Ethics Opinion 2.037 - Medical Futility in End-of-Life Care." They expect sick patients in the hospital to negotiate for whether their wishes will be followed. AMA's background reports for this opinion show their thinking goes back to 1990 when CPR rarely succeeded. AMA says (emphasis added):
"give consideration to patient or proxy assessments of worthwhile outcome... [The] intent... should not be to prolong the dying process without benefit to the patient or to others with legitimate interests. They may also take into account community and institutional standards..."
"(1) All health care institutions… should adopt a policy on medical futility; and
"(2) Policies on medical futility should follow a due process approach. The following seven steps should be included…
"(a) …negotiate… on what constitutes futile care for the patient, and what falls within acceptable limits for the physician, family, and possibly also the institution.
"(b) Joint decision-making should occur between patient or proxy and physician to the maximum extent possible.
"(c) Attempts should be made to negotiate…
"(d) Involvement of an institutional committee such as the ethics committee should be requested if disagreements are irresolvable.
"(e) If the institutional review supports the patient’s position and the physician remains unpersuaded, transfer of care to another physician within the institution may be arranged.
"(f) If the process supports the physician’s position and the patient/proxy remains unpersuaded, transfer to another institution may be sought and, if done, should be supported by the transferring and receiving institution.
"(g) If transfer is not possible, the intervention need not be offered."
Unfortunately the AMA language about futility in End-of-Life Care dates to 1990 when CPR rarely succeeded for patients with certain diseases. The 1990 Report supporting this Ethics Opinion says,
An updated report in 2005 did not update the data on success of CPR.
Three professors from Columbia and Harvard recommend (JAMA 3/7/2012, emphasis added):
"Physicians should not offer CPR to the patient who will die imminently or has no chance of surviving CPR to the point of leaving the hospital."
A bioethicist for Mercy Health (4 hospitals in and near Philadelphia) notes (AMA J of Ethics May 2007 emphasis added):
"If agreement is not reached between the physician or hospital and the patient or surrogate, either party may seek injunctive relief from the courts, or the patient/surrogate may file medical malpractice action... the threat of litigation alone will deter some physicians from ever invoking a futility policy... a consensus among physicians can then be submitted as evidence in legal proceedings to demonstrate that the standard of care was not breached."
Nine major Los Angeles hospitals and medical groups issued a press release promising "shared-decision making with patients" at the end of life. They did not release the actual guidelines, so I got them from UCLA under California's Freedom of Information Act. The guidelines cover 33 hospitals, 10,000 doctors and 7,000,000 patients.
Surprisingly, the new guidelines call many standard treatments "non-beneficial," (emphasis added in all quotes in this section) and encourage doctors not to discuss them with patients. They say: "In patients with late-stage terminal illness, use of interventions such as
Problems with this Los Angeles guidance include:
(A) there is no definition of "late stage," and
(B) "terminal illness" is so broadly defined it covers most older people: "any disease affecting one or more organs whose progression is not preventable, and commonly leads or contributes to death or manifest deterioration (mental or physical) within a predictable timeframe" (footnote 3). This definition of terminal illness covers:
The Los Angeles guidelines apply during "late-stage terminal illness." This appears to include:
They are allowed to deny dialysis, tube feeding, CPR, ventilation or ICU, so the doctor earns Medicare rewards for saving money, and so patients don't survive to cause very expensive readmission penalties at the hospital.
By not offering these standard treatments, doctors deny patients the choice of more time with family and friends. A single dialysis session can clean a patient's system, giving a few more days to make decisions on continuing care or to say goodbye. A single CPR has a 23% chance of success, and gives a median of 2 more years of life, in about the same state of health as before.
After a treatment is called non-beneficial California law lets a doctor be silent about it, except when a patient or representative directly instructs it be done. Then the doctor must give the treatment or offer to transfer the patient elsewhere. But patients almost never have independent advice to make such a direct instruction, so doctors are allowed to stay silent while shared decision-making and life disappear.
The Los Angeles guidelines say, "Decisions not to comply with a patient or legally recognized healthcare decision maker's request for medically non-beneficial treatment should be undertaken in accordance with California probate code sections 4734-4736" (footnote 5).
California probate code says, "4735. A health care provider or health care institution may decline to comply with an individual health care instruction or health care decision that requires medically ineffective health care or health care contrary to generally accepted health care standards applicable to the health care provider or institution."
Thus the effect of the new guidelines is to permit the silent denial of dialysis, tube feeding, CPR, ventilation and ICU whenever doctors want to deny them to patients with chronic illnesses.
The guidelines cover 33 hospitals, 10,000 doctors and 7,000,000 patients in southern California:
Canada distinguishes 3 types of patients:
SOME STATES' STANDARD WORDING
A few state forms show the kinds of choices people need to make, but none of the terms is defined, and there is no discussion of the choices. Bold type was added to simplify comparisons:
CALIFORNIA's Attorney General has a form which asks you to check (a) or (b) and optionally (2.2) and/or (2.3):
NEW YORK state's instructions provide model language to include on their form,
TEXAS form lets you choose:
If, in the judgment of my physician, I am suffering with a terminal condition from which I am expected to die within six months, even with available life-sustaining treatment provided in accordance with prevailing standards of medical care:
LAWYERS who draft a will or trust, often provide custom wording for advance directives too. However they are usually specialists in estate planning, not medical law, so they do not know all the choices which will occur in health care, and in any case patients' choices change with technology and increasing age.
CATHOLIC TEACHING ON TUBE FEEDING
US Catholic bishops asked the Pope's office about tube feeding, and the Pope's office answered,
"First question: Is the administration of food and water (whether by natural or artificial means) to a patient in a 'vegetative state' morally obligatory except when they cannot be assimilated by the patient's body or cannot be administered to the patient without causing significant physical discomfort?
Official Commentary: vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_20070801_nota-commento_en.html
Another article discusses the compatibility of this Catholic teaching with the Los Angeles guidelines, discussed above, which tell doctors they do not need to offer artificial feeding to certain patients, even if the patients need artificial feeding to live.
Below is a sample of some of the best research on the generally high skills of high-volume doctors. You can find older studies in their end notes, and each entry gives the newer studies which cite them. You can also find many more studies with searches for "surgeon volume" and "physician volume".
There is also a research study, discussed at the bottom of this article, on the two causes of high volume: more referrals to the best doctors, and practice makes perfect. Companion articles address training of doctors and how to find high-volume doctors.
CANCER, HEART AND ANEURYSM SURGERY
"Surgeon volume and operative mortality in the United States." Birkmeyer JD, Stukel TA, Siewers AE, Goodney PP, Wennberg DE, Lucas FL, N Engl J Med. 2003 Nov 27;349(22):2117-27. with comments Cited by 101 articles.
"Patients can often improve their chances of survival substantially, even at high-volume hospitals, by selecting surgeons who perform the operations frequently...
"Increasing surgeons’ volumes would require that administrators and leaders in the field of surgery actively manage the way in which selected operations are distributed within their hospitals — that is, by restricting them to a smaller number of surgeons. Although such efforts would no doubt encounter resistance, they may be more practical and less controversial than policies focusing exclusively on redistributing patients among hospitals."
Low-volume surgeons had 1 to 10 more deaths per 100 patients than high-volume surgeons. See table above.
All types of surgeons had similarly risky patients: "there were no clinically important differences in predicted mortality rates [patient risk] according to surgeon volume."
The study counted deaths within 30 days of the operation (or during the same hospital stay, even if longer than 30 days), based on 470,000 Medicare patients in 1998-99. Surgeon volume includes estimates of non-Medicare patients. These estimates can be fractions.
"Is volume related to outcome in health care? A systematic review and methodologic critique of the literature." Halm EA, Lee C, Chassin MR, Ann Intern Med. 2002 Sep 17;137(6):511-20. Cited by 160 articles.
"69% of studies of physician volume reported a statistically significant association between higher volume and better health outcomes. No study documented a statistically significant association between higher volume and worse outcomes."
"[T]he most striking differences in mortality rates between high- and low-volume surgeons were seen for pancreatic cancer, ruptured abdominal aortic aneurysm, and pediatric cardiac surgery (median differences of 3 to 14 deaths per 100 cases for the three procedures). Surgeon volume seemed to be a more important determinant of outcomes than hospital volume in the case of CABG, carotid endarterectomy, surgery for ruptured abdominal aortic aneurysm, and surgery for colorectal cancer."
"Increasing evidence shows that high-volume providers may more consistently use proven effective therapies, such as aspirin or beta-blockers in [heart attacks] or adjuvant [followup chemo, radiation, or hormones] therapy in breast cancer...
"We found a positive association between physician volume and outcome in 62% of studies with no risk adjustment, 68% of those with risk adjustment using administrative data, and 73% of investigations using clinical risk-adjustment models."
A summary article in 2007 quotes a British specialist that death rates are lowest at hospitals which treat 43 or more abdominal aortic aneurysms per year.
Newer articles include:
Verma V, Allen PK, Simone CB 2nd, Gay HA, Lin SH. Association of Treatment at High-Volume Facilities With Survival in Patients Receiving Chemoradiotherapy for Nasopharyngeal Cancer.JAMA Otolaryngol Head Neck Surg. 2017 Nov 2. doi: 10.1001/jamaoto.2017.1874. [Epub ahead of print] PMID: 29098291 DOI:10.1001/jamaoto.2017.1874
Chen YW, Mahal BA, Muralidhar V, et al. Association between treatment at a high-volume facility and improved survival for radiation-treated men with high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2016;94(4):683-690.
Haque W, Verma V, Butler EB, Teh BS. Definitive chemoradiation at high volume facilities is associated with improved survival in glioblastoma. J Neurooncol. 2017. doi:10.1007/s11060-017-2563-0
"Relationship between annual volume of patients treated by admitting physician and mortality after acute myocardial infarction." Tu JV, Austin PC, Chan BT, JAMA. 2001 Jun 27;285(24):3116-22. Cited by 20 articles.
"Patients with AMI [heart attack] who are treated by high-volume admitting physicians are more likely to survive at 30 days and 1 year."
"The 30-day risk-adjusted mortality rate was 15.3% for physicians who treated 5 or fewer AMI cases per year (lowest quartile) compared with 11.8% for physicians who treated more than 24 AMI cases annually (highest quartile; P<.001). The 1-year risk-adjusted mortality rate was 24.2% for physicians who treated 5 or fewer AMI cases per year (lowest quartile) compared with 19.6% for physicians who treated more than 24 AMI cases annually (highest quartile; P<.001)...
"Physician volume is a well-established determinant of outcomes after invasive cardiac procedures. Previous studies have demonstrated an inverse relationship between annual surgeon volume of coronary artery bypass graft (CABG) procedures and in-hospital mortality and between annual cardiologist volume of percutaneous coronary interventions (PCIs) procedures and complication rates after the procedure. [notes 1- 3] These associations have led to development of American Heart Association/American College of Cardiology guidelines that recommend a minimum annual volume of procedures that should be performed by cardiac surgeons and invasive cardiologists...
"Physicians who treated the most patients on an annual basis had the lowest 30-day and 1-year patient mortality rates, even after adjusting for potential confounders. The impact of physician volume on outcomes of AMI [heart attack] patients was comparable with the impact of physician volume on outcomes of invasive cardiac procedures... The association between physician volume and mortality was robust and existed across physician specialties.
"The results of our study are consistent with a previous study conducted using Pennsylvania hospital discharge data from 1993 that demonstrated an inverse association between physician volume and in-hospital mortality after an AMI. That study demonstrated that patients of low-volume physicians who treated 1 to 6 AMI patients per year had a 43% higher in-hospital mortality rate than high-volume physicians, defined as those who treated 24 or more AMI patients per year... Physician volume was a stronger predictor of 30-day AMI mortality than was physician specialty in both our study and the Pennsylvania analysis...
"our results do suggest that significant reductions in AMI mortality could be achieved by shifting the primary responsibility for treating more AMI patients to a smaller number of high-volume physicians. Hospitals that have low-volume physicians could consider designating a few physicians to handle all of their AMI cases or they could mandate that low-volume physicians work with high-volume physicians when treating AMI patients."
The study counted deaths among 98,000 heart attack patients at Ontario hospitals from 1992-1998.
The graph below shows death rates decline steadily as the number of heart attack patients treated by a doctor rise from 1-2 to 34 or more per year:
"2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery" American College of Cardiology Foundation/American Heart Association, pp. 35-36
" 5.1.1... Class I - 1. All cardiac surgery programs should participate in a state, regional, or national clinical data registry and should receive periodic reports of their risk-adjusted outcomes..." Patients can ask for these "periodic reports" cited in the American Heart Association guideline 5.1.1
"Class IIb - 1. Affiliation with a high-volume tertiary center might be considered by cardiac surgery programs that perform fewer than 125 CABG procedures annually...
"In general, the best results are achieved most consistently by high-volume surgeons in high-volume hospitals and the worst results by low-volume surgeons in low-volume hospitals. (notes 793,794) However, many low-volume programs achieve excellent results, perhaps related to appropriate case selection; effective teamwork among surgeons, nurses, anesthesiologists, perfusionists, and physician assistants; and adoption of best practices derived from larger programs. (notes 833,834)
"As a quality assessment strategy, participation in a state, regional, or national clinical data registry that provides regular performance feedback reports is highly recommended for all cardiac programs. Random sampling variation is greater at low volumes... Ultimately, state or national regulatory authorities must decide whether the lower average performance of very small programs and the added difficulty in accurately measuring their performance are outweighed by other considerations, such as the need to maintain cardiac surgery capabilities in rural areas with limited access to referral centers."
They cite many studies on supplemental pages 33-39. Most address hospital volume, not surgeon volume.
"The role of surgeon volume on patient outcome in total knee arthroplasty: a systematic review of the literature" Rick L Lau, Anthony V Perruccio, Rajiv Gandhi, and Nizar N Mahomed. BMC Musculoskelet Disord. 2012; 13: 250. Cited by 3 articles.
"Mortality rate, survivorship and thromboembolic events [clots] were not found to be associated with surgeon volume [of knee replacements]. We found a significant association between low surgeon volume and higher rate of infection (0.26% - 2.8% higher), procedure time (165 min versus 135 min), longer length of stay (0.4 - 2.13 days longer [in hospital]), transfusion rate (13% versus 4%), and worse patient reported outcomes...
"After reviewing the available studies, we would identify a high surgeon volume as > 50 TKA [Total Knee Replacements] per year. Three studies identified a statistically significant relationship between low surgeon volume and higher infection rates (0.26% - 2.8% higher)...
"Early to midterm (up to 8 years) implant survivorship did not appear to be influenced by surgeon volume [notes 18,25,32]. Whether similar findings hold over the longer-term (i.e. >8 years) is unknown...
"In the one study which examined patient-reported outcomes, Katz et al (2007) reported a positive association between LV [Low Volume] surgeons and poorer TKA outcomes [in US Medicare, study summary below]...
"Evidence suggests that some patients would refuse to have surgery in an unfamiliar setting, preferring to attend a local health provider with lower procedure volume [notes 35,52]. In the US, the poor, less educated, elderly, as well as racial/ethnic minorities are more likely to undergo TKA at low volume centers [notes 11,36,38]. Regionalization of TKA to high volume centres and surgeons may further exacerbate existing disparities in the utilization of TKA and restrict access to some patients who would otherwise use a low volume provider for TKA, increasing the number of patients who decline or defer their elective TKA surgery with resultant poorer health outcomes [notes 2,11,53]. A regionalization program involving referral to high volume surgeons and hospitals might decrease the already low rate of perioperative complications at the cost of increasing arthritis related disability [note 11]. Evidence suggests that having TKA in low volume hospitals costs more and produces worse outcomes than having TKA in high volume centers, but having TKA in low volume centers is still more cost effective than not having TKA at all [note 35]. While these studies were specific to examining the role of hospital volume on cost effectiveness of TKA, it is possible that the same may hold true for surgeon volume and TKA."
"Association of hospital and surgeon procedure volume with patient-centered outcomes of total knee replacement in a population-based cohort of patients age 65 years and older." Katz JN, Mahomed NN, Baron JA, Barrett JA, Fossel AH, Creel AH, Wright J, Wright EA, Losina E. Arthritis Rheum. 2007 Feb;56(2):568-74. Cited by 30 articles.
"The questionnaires assessed lower extremity functional status using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [notes 17,18]. The WOMAC contains... a 17-item scale that assesses lower extremity functional status...
"Scores <60 indicated poor outcome. Sixty is a typical preoperative score... WOMAC functional status scores <60 increased from 10% among patients of surgeons who performed >50 cases per year in the Medicare population to 20% among surgeons who performed ≤12 per year...
"Patients operated upon in higher volume hospitals by higher volume surgeons had the lowest rates of worse functional outcomes (WOMAC functional status score <60, unable to flex the knee 90 degrees, unable to extend knee fully), while patients operated upon by lower volume surgeons in lower volume centers had the highest rates of these poor functional outcomes...
The risk of a poor WOMAC score ranged from 8.4% for patients in the high-volume centers operated upon by a high-volume surgeon to 22.6% for patients in low-volume centers operated upon by low-volume surgeons... The finding of a volume effect on function and range of knee motion, but not on pain or satisfaction, suggests possible mechanisms. In high- and low-volume settings, the pain generator, the arthritic knee, is removed during surgery in all patients. Thus, pain relief is generally excellent. However, low-volume surgeons in low-volume centers may be less skilled at soft tissue balancing required to achieve the normal motion necessary for full function."
The study used questionnaires from a random sample of 906 Medicare patients 2 years after their total knee replacements, which were in 2000. These provided a 58% response rate among those sampled and invited.
"Early failures of total hip replacement: effect of surgeon volume." Losina E, Barrett J, Mahomed NN, Baron JA, Katz JN. Arthritis Rheum. 2004 Apr;50(4):1338-43. Cited by 30 articles.
"Clinicians should consider surgeon volume among the factors influencing their referrals for elective THR." [Total Hip Replacement]
"Patients of low-volume surgeons have higher rates of revision THR than patients of high-volume surgeons, particularly within the first 18 months postoperatively."
15,000 elective Medicare hip replacements were done in 1995 by surgeons who did less than 12 Medicare hip replacements that year. 4.5% of these needed to be redone (revised) within 4 years, usually within 18 months. Among the 42,000 hip replacements done by surgeons who did 12 or more, 3.5% needed to be redone. This is a noticeable difference if you are in the 1% who avoided a second hip replacement. See graph below.
"Our definition of THR failure was simply the occurrence of a revision THR. Clearly, patients can have a poor outcome of THR yet not receive revision surgery, either because they prefer not to have surgery or because they are poor surgical candidates...
"Medicare population represent at least 67% of the total number of THRs performed in the US."
"Proficiency of surgeons in inguinal hernia repair: effect of experience and age." Neumayer LA, Gawande AA, Wang J, Giobbie-Hurder A, Itani KM, Fitzgibbons RJ Jr, Reda D, Jonasson O; CSP #456 Investigators. Ann Surg. 2005 Sep;242(3):344-8; discussion 348-52. Cited by 5 articles
"Surgeon's inexperience and older age were significant predictors of recurrence in laparoscopic herniorraphy [repair]... This analysis demonstrates that surgeon's age of 45 years and older, when combined with inexperience in laparoscopic inguinal herniorraphies, increases risk of recurrence... We found a significantly higher recurrence rate in the laparoscopic group (10%) than in the open group (5%). Surgeons reporting experience with more than 250 laparoscopic herniorraphies before the beginning of the study, however, had recurrence rates with laparoscopic repair equivalent to that with open repair (5%)." Both types of repairs in this study placed mesh in the patient.
This study reports the experience of the "attending" or teaching surgeon. 96% of the operations also had an intern or resident, as discussed in the Training section.
Attending "Surgeons 45 years and older at the beginning of our study would have learned these [laparoscopic] techniques after completion of a surgical residency through a variety of means, including short courses and formal or informal preceptorships... The inadequacy of effective learning programs was sharply evident when experience was lacking... The methods of teaching older surgeons new techniques may need to be modified."
This study reported higher recurrence for experienced young attending surgeons than for inexperienced; there were only 2 experienced young attending surgeons.
Much higher volumes of hernia repair are done at the specialist Shouldice Hospital in Ontario, where each surgeon repairs 600-800 hernias per year. Furthermore the assistant surgeons are not interns or residents. They have 1% recurrence (based on 65,000 cases in 1993-2007), compared to 5% in other Ontario hospitals (170,000 cases), and 5-10% in the US.
"If the operations had all been recorded, the situations where error occurred could be identified... This would lead to more specific courses of instruction, which should improve outcomes. It almost certainly would shorten the average learning curve from 250 cases to a more practical number... A commitment to making video records a routine aspect of future trials on surgical technique has much to recommend it...
"Hernias are traditionally one of the first operations that surgeons assist junior residents during surgery training... We believe in the majority of open repairs, that the resident was on the side of the hernia, and presumably was the person making the cut and putting the stitches in.
Association of Surgical Volume With Perioperative Outcomes for Esophagomyotomy for Esophageal Achalasia, JAMA Surgery, Dec. 20, 2017
TWO CAUSES OF HIGH VOLUME
"The volume-outcome relationship: practice-makes-perfect or selective-referral patterns?" Luft HS, Hunt SS, Maerki SC. Health Serv Res. 1987 Jun;22(2):157-82. ncbi.nlm.nih.gov/pmc/articles/PMC1065430/ Cited by 50 articles.
A common explanation of good work with high volume is the, " 'practice-makes-perfect' hypothesis. An alternative explanation is that physicians and hospitals with better outcomes attract more patients - the "selective-referral pattern" hypothesis. Using data for 17 categories of patients from a sample of over 900 hospitals... both explanations are valid, and that the relative importance of the practice or referral explanation varies by diagnosis or procedure, in ways consistent with clinical aspects of the various patient categories."
Four "Procedures and diagnoses... exhibit high volumes resulting in lower death rates, but there is no measurable influence of outcomes on volume; that is, the practice-makes-perfect effect predominates. All four of these, acute myocardial infarction [heart attack], stomach operations, intestinal operations, and cholecystectomy [remove gallbladder], are usually managed by the family physician or a general surgeon, perhaps in consultation with local cardiologists or gastroenterologists. There is little reason to seek outside specialty consultations, so referrals to centers with particularly good outcomes are unlikely."
For four others "the selective-referral effect predominates. Volume has no effect on death rates, but hospitals with low death rates attract patients with abdominal aortic aneurysm, fracture of the femur... transurethral resection of the prostate, and coronary artery bypass graft...
"Insurers are developing preferred provider organizations with financial incentives for enrollees to use selected hospitals... if only the practice-makes-perfect hypothesis is applicable, then the selection criterion is irrelevant. Regionalization efforts will improve outcomes in the selected hospitals-and perhaps worsen them in those that lose patients.
"However, if selective-referral patterns are" important, outcomes "may worsen markedly if the higher-quality settings are excluded and if increased volume in the selected hospitals does not improve outcomes sufficiently to offset the loss of the better providers... the possibility that unmeasured, but nonetheless important, physician and hospital factors influence outcomes and that existing referral patterns may already reflect such factors. Policymakers and insurance companies must also be cautious, because the results suggest that the roles of practice, referral, and other factors vary across diagnoses and procedures."
"If primary physicians initially choose specialists at random, then switch referrals after one "bad outcome," patients eventually are directed away from providers with outcomes truly worse than average. Furthermore, even if the majority of patients go to the nearest hospital or otherwise make decisions independent of perceived outcomes, a minority seeking or referred to the "best provider in town" (or referred away from "poor-quality providers") will result in a selective referral pattern for specific diagnoses and procedures... The question, therefore, is whether some patients are influenced in their choice of physicians and hospitals by relative performance, not whether all patients are so influenced...
[H]igher-than-expected volumes for a specific procedure or diagnosis may, in fact, be the best single indicator of exceptionally good outcomes... As an analogy, consider the situation of a new visitor to a city... indication of relative quality might be the number of patrons in each [restaurant]. Our visitor would probably be wise to avoid places that are nearly empty and, if there is no hurry, a long line would be not only a measure of popularity but perhaps the best single indicator of good food within a given price range."
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Initial Training, and Re-training Senior Doctors
Complications, A Surgeon's Notes on an Imperfect Science, by Atul Gawande, published by Henry Holt, 2002. find library or excerpts or buy
" 'Hello, I'm Dr. Gawande. I'm one of the surgical residents, and I'll be assisting your surgeon'... Yet to say I just assisted remains a kind of subterfuge. Otherwise, why did I hold the knife? Why did I stand on the operator's side of the table? Why was it raised to my six-feet-plus height?...
"When an attending physician brings a sick family member in for surgery... a first-timer is certainly not going to do it. Conversely, the ward services and clinics where residents have the most responsibility are populated by the poor, the uninsured, the drunk, and the demented...
"You do get good at certain things, my father [a urologist] tells me, but no sooner than you do, you find what you know is outmoded, New technologies and operations emerge to supplant the old, and the learning curve starts all over again. 'Three-quarters of what I do today I never learned in residency,' he says. On his own, fifty miles from his nearest colleague... he has learned to put in penile prostheses, to perform microsurgery, to reverse vasectomies, to do nerve-sparing prostatectomies, to implant artificial urinary sphincters. He's had to learn to use shock-wave lithotripters, electrohydraulic lithotripters, and laser lithotripters (all instruments for breaking up kidney stones); to deploy Double J ureteral stents and Silicone Figure four coil stents and Retro-Inject Multi-Length stents (don't ask); to maneuver fiber-optic ureteroscopes...
When an important new device or procedure comes along, as they do every year, surgeons start out by taking a course about it -- typically a day or two of lectures by some surgical grandees with a few film clips and step-by-step handouts. We take a video home to watch... But there's not much by way of hands-on training. Unlike a resident, a visitor cannot scrub in on cases, and opportunities to practice on animals or cadavers are few and far between. (Britain, being Britain, actually bans surgeons from practicing on animals.) ... Patients do eventually benefit -- often enormously -- but the first few patients may not and may even be harmed... you can't train novices without compromising patient care...
"Do we ever tell patients that because we are still new at something, their risks will inevitably be higher, and that they'd likely do better with others who are more experienced? Do we ever say that we need them to agree anyway? I've never seen it. Given the stakes, who in their right mind would agree to be practiced upon?...
"I noticed on the expert's desk a picture of his child, born just a few months before... 'So did you let the resident deliver?'... 'No,' he admitted. 'We didn't even allow residents in the room.'...
"If you're going to do nothing but fix hernias or perform colonoscopies, do you really need the complete specialists' training (four years of medical school, five or more years of residency) in order to excel?"
Limited Quality of First Training
"Does resident post graduate year influence the outcomes of inguinal hernia repair?" Wilkiemeyer M, Pappas TN, Giobbie-Hurder A, Itani KM, Jonasson O, Neumayer LA. Ann Surg. 2005Jun;241(6):879-82; discussion 882-4. Cited by 7 articles
"Despite the presence of an attending surgeon, open hernia repairs performed by junior residents were associated with higher recurrence rates than those repaired by senior residents."
96% of hernia repair operations in the study had interns or surgical residents doing or helping with the operation. Interns and 2nd year residents had a recurrence rate on open hernia repairs (not laparoscopic) of 6.4%, 3rd year residents had 3.0%, and 4th or later year residents had 1.1%.
All levels averaged 9.8-11.5% recurrence on laparoscopic hernia repairs. "Only when the attending surgeon and the resident are highly experienced in laparoscopic repair techniques, are recurrence rates for laparoscopic repairs reduced."
"Hands-on instruction and graded clinical responsibility are integral components of surgical education in North America... One variable that could have affected the results seen in this study is degree of attending surgeon supervision. Fallon et al (note 11) have reported that, when surgical procedures were performed with low levels of attending surgeon supervision, complication levels and mortality were raised...
"Under these circumstances, the results we describe raise important questions about the effectiveness of supervision of inexperienced surgery residents. While it is understandable that the instruction of an inexperienced resident will take longer and lengthen the operative time, why were recurrences more common when junior residents were involved? Should not the supervising surgeon corrected [sic] any errors in technique and achieved the same outcome as if the attending surgeon had performed the operation?"
The attending surgeons knew they were part of a study where results would be measured. Would they do even worse normally?
"If experience is required of a closely supervised surgery resident to achieve optimal patient outcomes, how is it possible to begin the educational process for a surgeon-in-training and still safeguard each patient’s welfare?... Which points in each procedure are most vulnerable to inexperience? What must the attending surgeon do to confirm accomplishment of maneuvers critical to the outcome of the procedure?... None of these questions has been adequately addressed by surgical educators...
"Hopefully, the future will include better training tools for teaching surgical procedures outside of the operating room...
"Should only senior residents do hernias? I think the answer is clearly no. I think we have to be better at teaching interns and second-year residents how to do these operations."
One question in the discussion published with the paper asked, "do you plan to change anything based on patient informed consent, given the data in this study?" No further discussion of patient information or consent was given.
Weaknesses of Senior Doctors, Benefits of Simulators
"Expertise in Medicine and Surgery" Norman, Eva, Brooks, Hamstra, chapter in Cambridge Handbook of Expertise and Expert Performance, edited by Ericsson. Charness, Feltovich, Hoffman. Cambridge University Press, 2006. cited by 133 studies.
"Systematic consideration of the causes of poor performance in older physicians suggests that premature closure (i.e., excessive reliance on one’s early impressions of a case) may be the primary source of difficulty for those with more experience (Caulford et al., 1994). In other words, more-experienced physicians appear more likely to accurately diagnose using pattern recognition, but as a result of increased reliance on this strategy, they also run the risk of being less flexible, failing to give due consideration to competing diagnoses (Eva, 2002). Historical work into the cost of experience confirms that the more one relies on automatic processing, the harder it is to exert cognitive control when problem solving (Sternberg & Frensch, 1992). More recently, Hashem, Chi, and Friedman (2003) have presented data supporting this idea, showing that medical specialists have a tendency to pull cases towards the domains in which they have the most experience."
"Several studies (Anastakis et al., 1999; Matsumoto et al., 2002; Grober et al., 2004) have now shown that technical skills acquired on low-fidelity bench models transfer to improved performance on higher-fidelity models (such as human cadavers), as well as live patients in the operating room, both in laparoscopic surgery (Scott et al., 2000) and anaesthesia (Naik et al., 2001)." This finding suggests that volume can be obtained in training, without putting humans at risk.
Studies published since 2006 show the continuing need for bench training, such as a 2014 plan for $100 laparoscopic simulators for constant home practice, not just $2,000 simulators for occasional practice at a hospital: "the laparoscopic approach is quite different and different skills are needed. The first is the ability to perform actions in three dimensions when only two can be observed on the monitor. The second is that the difference of depth perception, spatial relationship and long surgical instruments requires perfect eye-hand coordination. Moreover, the arms of the tools act as levers with a fulcrum at the site of the skin incision, and hence the real action with the tool handles is a mirror of the movement of the tool tips seen on the monitor."
Simulation can include live animals, cadavers, artificial materials and virtual reality with tactile feedback. Some authors are concerned there is not enough time to train since residents are limited to 80 working hours/week in the US and 48 in the UK.
A 2013 synthesis commented that with the rise in laparoscopic training, "the open operative experience of current surgical residents has decreased significantly. This deficit poses a potentially adverse impact on both surgical training and surgical care. Simulation technology, with the potential to foster the development of technical skills in a safe, nonclinical environment, could be used to remedy this problem...
"This is particularly true with regard to skills required to competently perform technically challenging open maneuvers under urgent, life-threatening circumstances. In an era marked by a decline in open operative experience, there is a need for simulation-based studies."
Another 2013 overview says simulation should be required in surgical training and asks why it is not, "simulation is still not a mandatory component of all surgical training...
"The role of simulation is not to replace conventional training in the operating room but rather to augment it. By training in a simulation laboratory, a surgeon can acquire the necessary cognitive, technical, and nontechnical skills to shorten his or her learning curve in the operating room."
They even recommend simulated operating rooms to teach group work. Current training fails "to address such nontechnical skills as communication, teamwork, situational awareness, decision making, and leadership. This failure to address nontechnical skills is not acceptable, given the evidence that communication breakdown and failures in leadership and teamwork might be the root cause in up to 60% of major perioperative complications."
The Medical Director and Chief Academic Officer at Carolinas HealthCare System: "Bullard and Hall say the $1 million [simulation] program has paid off by helping doctors and nurses respond to sepsis in the simulation center, rather than relying on real-time cases to learn the procedure. 'It used to be that you saw one, did one, and then taught one. But those days are gone,' Bullard says. 'It's no longer safe to practice that way. Residents learn better in experiential learning environments.' "
Benefits of High Volume per Year, Weaknesses of Older and Senior Doctors
"Prestige of training programs and experience of bypass surgeons as factors in adjusted patient mortality rates." Hartz AJ, Kuhn EM, Pulido J, Med Care. 1999 Jan;37(1):93-103. Cited by 10 articles.
Findings on Annual Volume and Lower Deaths:
"As with previous studies, we found that the more operations a surgeon performed [per year], the lower the mortality rate. notes 8-11 This association may result because a greater number of surgeries may improve physician performance. It is also possible that the best surgeons may be referred the most cases."
The study covered deaths among 83,500 patients in 1990-92 in Pennsylvania (46,000), New York (38,000), Wisconsin (3,000). Each NY surgeon had treated 200+ patients in 3 years. Each Pennsylvania surgeon had treated 30+ patients per year. The Wisconsin patients were only from Medicare, and only from 1 year, mostly 1990, and included surgeons who treated any number of patients.
Findings on Years of Experience, Academic Rank and Higher Deaths:
"Mortality ratios... increased with years of experience, age and academic rank." See graph below left.
"A higher mortality ratio was significantly associated with more years in practice." as shown in the graph above right. The fewest deaths were for the 66 surgeons 5-10 years after training.
The ratio of actual deaths to deaths expected based on patient traits increased with higher academic rank:
0.79 for the lowest academic rank, instructors (death rate 21% less than average)
0.95 for assistant professors
0.99 for associate professors
1.19 for full professors (death rate 19% more than average)
"There was no evidence that surgeons with higher academic ranks had higher risk patients. An explanation for this finding is that the mortality ratio of senior academic surgeons may be increased because more of their operations are performed by residents or fellows."
"Neither the observed mortality, predicted mortality, nor mortality ratio differed significantly between physicians who trained in the most prestigious medical school, residency, or fellowship programs, and physicians who trained in the other programs."
However, "Physicians were more likely to be identified as best doctors [in lists of 'best doctors'] if they trained in prestigious residencies (P<0.01) or fellowships (P<0.05), or if they had an academic appointment (P<0.05) or 15 or more years of experience (P<0.001)."
"Conclusions. Training at a prestigious institution was associated with identification as a "best" doctor but not with lower mortality ratios.
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CONTENTS: factsheet Direct url: privacy.globe1234.com
Targets of threats
Other medical staff
Family & friends when relevant to their involvement or payments
People at risk of communicable disease
Public health agencies (including foreign)
Social services agency to help victims of abuse
Discovery requests (e.g. divorce)
Emergency preparedness (NYTimes story)
Military commanders (about service members)
Prisons (about prisoners)
Police and any other law enforcement
Researchers on anonymous data, or onsite, or on the dead, or locally approved
Workers' compensation purposes
Food and drug businesses approved by FDA (to monitor side effects)
Employer for "medical surveillance of the workplace and work-related illnesses" if employer requested any care
All medical records can be subpoenaed, as explained by ABA, Massachusetts Bar, Iowa Medical Society, and a liability insurer. Electronic records are cheaper to subpoena than paper records, since copying is cheaper.
Federal rules of evidence do not protect doctor-patient confidentiality in federal courts, though most state courts do. Federal prosecutors use their access to private health care data in prosecutions.
Disclosures have the same limits for 50 years after death.
The following organizations do not have to follow the Privacy and Security Rules for data they have. A good poster and study show how hundreds of data brokers buy this health information and spread it widely.
- online shopping sites (know what health items you bought)
- credit card companies
- social networks (know your messages about your and your friends' health)
- life insurers
- workers compensation carriers
- most schools and school districts
- many state agencies like child protective service agencies
- most law enforcement agencies
- many municipal offices
- health care providers small enough that they don't electronically send health insurance claims and eligibility to insurance companies
Disclosure rules are also strict on mental illness, and the government plans to loosen them to keep mental patients from access to guns.
An article shows practical barriers to carrying out the law and suggests more access for relatives. A longer explanation of medical privacy is at the Privacy Rights Clearinghouse.
HHS lets information be released if the following are removed: patient/relatives/employers' names, ID numbers, addresses except state or 3-digit zip with 20,000+ people, IP addresses, URLs, equipment numbers, months and days of any event, and years over 90 years ago (so people 90 and older are grouped), biometric identifiers (e.g. finger/voice prints), "full-face photographs and any comparable images, Any other unique identifying number, characteristic, or code," such as dental charts. Even these can be released if a statistical expert certifies a "very small" risk of identifying people. Lawyers say the expert approach is common, though I cannot imagine an expert saying that releasing more is safe. Even the HHS list does not protect privacy: it allows records with your age, doctor names, and diagnoses by year, which data brokers can compare to your social media postings. Movers can be identified by a series of 3-digit zip codes.
Medicare itself releases individual patient records to researchers who get approval and sign a data use agreement. The data use agreement refers to other documents for computer security, does not specifically cover access to, or deletion of backup systems, locking of offices and cars, etc.
E. Damages and Alternatives
An extensive article in Politico says hackers can sell medical records for hundreds of dollars, and people use them to get prescription drugs for resale. A 2013 article in Wired said companies with big business outside health care, like Google were leaving the business of patient data to avoid liability when things go wrong. A 2015 article said 2 Google subsidiaries were producing health care inventions.
The government rarely imposes penalties for privacy breaches, and it is hard for individuals to sue for damages, though they may claim deceptive privacy statements, or other grounds.
A legal review points out, "Trusted insiders often are granted access to an organization’s most sensitive data without a proper understanding of the information security policies and procedures that govern usage... Employees should be aware of common attack vectors specific to their industry, and they should be provided with examples of attempted or successful attacks on their company and on similar organizations... Putting employees through regular mock breach scenarios can be a good way to determine the adequacy of response times and to evaluate existing procedures."
An ID company warns about keeping your purse or wallet secure when you strip for a medical procedure, by giving it to a friend or asking for it to be locked up, or entrusting it to a staff member you trust
In Dominica each patient carries his/her own medical record, creating an incentive to maximize involvement, availability and security.
F. Comparison of Lists of Data Breaches
- All lists omit the many breaches, large and small, which companies fail to report.
- As noted above the federal HHS list covers medical breaches affecting 500 or more people and does not yet include cases which are still under investigation.
- National lists (pdf) of medical and non-medical breaches as soon as they are reported by government or press, and no matter what the size, are at the ID Theft Resource Center, sponsored by a company which sells services for ID theft prevention and recovery. Each year the "Breach Stats Report" is a compact list of key facts on each breach, while the "Breach Report" has more detail when available. Often the initial listing from press reports does not show the number of people affected, but the site inserts it later if the number becomes available in followup reports or the HHS site. Breaches which appear on the CA Attorney General site must be over 500, but the ID Theft Resource Center site does not update with just that information.
- The CA Attorney General, lists all breaches which affect 500 or more Californians, as soon as a notification letter is sent to people affected. It includes many national breaches, which affect 500 Californians. It does not always show who caused the breach, for example when a bank tells people that a merchant lost credit credit card data, it shows the bank, not always the merchant.
- Massachusetts lists all breaches which affected any Massachusetts residents since Nov 2007. It shows whether the breach included social security number, driver's license, account number, and if data were encrypted (almost never). Like other lists it does not show whether the breach happened at the place which reported it, or for example at a merchant losing credit card data. It is incomplete, because there is no enforcement.
- Washington State lists breaches which affect 500 or more Washington residents.
- Oregon lists breaches which affect 250 or more Oregon residents.
Click for a helpful Checklist for emergencies: It suggests preparing for unexpected sickness by having information ready at hand for your caregivers and advocates to use. For fires, floods and storms it focuses on having copies and backups of your important papers offsite, long before the emergency. It suggests actions to prepare for pandemics, and has notes on quakes, evacuations, chemical and nuclear contamination.