Effect on Postpartum Hemorrhage of Prophylactic Oxytocin (10 IU) by Injection by Community Health Officers in Ghana: A Community-Based, Cluster-Randomized Trial.


Background

Oxytocin (10 IU) is the drug of choice for prevention of postpartum hemorrhage (PPH). Its use has generally been restricted to medically trained staff in health facilities. We assessed the effectiveness, safety, and feasibility of PPH prevention using oxytocin injected by peripheral health care providers without midwifery skills at home births.

Methods and Findings

This community-based, cluster-randomized trial was conducted in four rural districts in Ghana. We randomly allocated 54 community health officers (stratified on district and catchment area distance to a health facility: ≥10 km versus <10 km) to intervention (one injection of oxytocin [10 IU] one minute after birth) and control (no provision of prophylactic oxytocin) arms. Births attended by a community health officer constituted a cluster. Our primary outcome was PPH, using multiple definitions; (PPH-1) blood loss ≥500 mL; (PPH-2) PPH-1 plus women who received early treatment for PPH; and (PPH-3) PPH-2 plus any other women referred to hospital for postpartum bleeding. Unsafe practice is defined as oxytocin use before delivery of the baby. We enrolled 689 and 897 women, respectively, into oxytocin and control arms of the trial from April 2011 to November 2012. In oxytocin and control arms, respectively, PPH-1 rates were 2.6% versus 5.5% (RR: 0.49; 95% CI: 0.27–0.88); PPH-2 rates were 3.8% versus 10.8% (RR: 0.35; 95% CI: 0.18–0.63), and PPH-3 rates were similar to those of PPH-2. Compared to women in control clusters, those in the intervention clusters lost 45.1 mL (17.7–72.6) less blood. There were no cases of oxytocin use before delivery of the baby and no major adverse events requiring notification of the institutional review boards. Limitations include an unblinded trial and imbalanced numbers of participants, favoring controls.

Conclusion

Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some contexts, home births.

Discussion

This community-based, cluster-randomized trial of prophylactic oxytocin (10 IU) administered via Uniject by peripheral health care providers without midwifery skills showed statistically significant reductions of 51% in the risk of PPH for blood loss ≥500 mL and 66% for blood loss ≥500 mL or with gushing and large blood clots. Results for severe PPH (≥1,000 mL) were not statistically significant. All secondary outcomes suggested the intervention was safe.

The magnitude of protective effect for blood loss ≥500 mL in this trial is similar to results shown for community-based prophylactic misoprostol (600 mcg) versus placebo in rural India (47% reduction in PPH) [10] and to a meta-analysis of health facility–based prophylactic use of intramuscular and intravenous oxytocin versus no uterotonics in high-income countries (50% reduction in PPH defined as ≥500 mL blood loss; 95% CI: 0·43–0·59) [9]. PPH reduction in this study was greater than trial results shown for prophylactic misoprostol (600 mcg) versus placebo in rural Pakistan (24% reduction in PPH) and in Guinea Bissau (11% non-significant reduction in PPH) . Mean blood loss among both oxytocin and control women in this trial was lower than that reported in these community-based misoprostol trials. Our results show mean blood loss of 185.5 mL and 229.2 mL among oxytocin and control deliveries, respectively, as compared to results from India (214.3 mL versus 262.3 mL), Pakistan (337 mL versus 366 mL), and Guinea Bissau (443 mL versus 496 mL) . Lower blood loss in this trial is expected, as early treatment of PPH with an additional injection of oxytocin (10 IU) in both our trial arms likely reduced ultimate blood loss among all PPH cases.

Several limitations of this study warrant discussion. The ratios of numbers of women in oxytocin and control arms of the trial range from 0.68 at the identification of eligible pregnancies to 0.77 at enrollment. Prior to randomization, CHO catchment areas were stratified by distance to emergency obstetric care, but not by population size, as these data were only available for Kintampo North and South. In these two districts, the ratio of population in the oxytocin versus control catchment areas is 0.88, explaining some, but not all, of the imbalance. As shown inTable 2, fertility between study arms is similar. There was no evidence that field workers in the oxytocin arm systematically missed identifying more pregnant women than in the control arm. However, if they did, it is unlikely that these women would have substantially different characteristics than the homogenous group that provided initial consent for the study (and which represented 99% of all identified pregnancies in both groups).

Two CHO behaviors differed by arm of the trial. First, control CHOs initiated blood-loss measurement (i.e., unfolded the drape) on average one minute later than oxytocin CHOs following delivery, possibly leading to an underestimate of blood loss in the control group. However, if delayed unfolding of the drape by control CHOs reduced blood loss measures, it would underestimate impact of oxytocin on outcomes. Second, CHOs in the oxytocin group referred women prior to delivery more frequently (17.3%) than control CHOs (12.5%), possibly indicating that the analyzable sample in the oxytocin group excluded a larger pool of women having a difficult delivery and thus potentially at higher risk of PPH. Data extracted from hospital records for referred women did not, however, indicate a higher risk (6 PPH cases among 198 referred women in the oxytocin group = 3.0%).

In an un-blinded study, differential measurement errors across arms of the trial are possible and thus, lack of blinding constitutes a study limitation. However, in this study the intervention was provided by CHOs who were not birth attendants. They were not responsible for managing the births nor were they responsible for the birth outcome, two issues which we believe would decrease the chances that they influenced the study outcome. The CHO’s job was to respond to the call, to give (or not give) the injection and measure blood. They had no previous experience with birth, or visual blood loss estimation and possible associations with bad maternal outcomes.

This trial provides evidence that administration of intramuscular prophylactic oxytocin in Uniject by peripheral health care providers without midwifery skills can effectively decrease the risk of PPH at home births under research conditions. Furthermore, none of the secondary outcomes reflecting safety suggested that this intervention was unsafe. Across trial arms, service was successfully provided to three-quarters of all calls requesting CHO assistance. However, CHO compliance varied widely, and was likely due to CHOs working alone in their catchment area per trial protocol; that is, they were on call 24 hours per day for 19 months. In a scaled-up program, additional staffing or the ability to refer calls to a neighboring CHO would be required to increase and sustain CHO compliance. There is no evidence that the intervention decreased health facility–based births. However, 17% of pregnant women (n = 5919) chose to deliver at home without a CHO and research is needed to understand the barriers to reaching these women. Another concern was the frequent lack of compliance with free referral to hospital for PPH cases. Refusal of referrals was unexpected and underscores the importance of providing community-based early treatment to women reluctant to seek care outside the home.

Cost is an important component of intervention feasibility. Oxytocin in Uniject is currently commercially available only in a few Latin American countries and thus its eventual market-driven cost is unknown. The United Nations Commission on Life-Saving Commodities for Women and Children includes oxytocin among 13 medicines unavailable to women due to issues such as cost or supply because they are not subsidized by global bulk purchase agreements or advance market commitments. The Commission has developed specific recommendations to address these issues as well as to promote oxytocin in a Uniject-type device [24]. It is anticipated that oxytocin in Uniject will cost US$1.00 or less, and potentially substantially less once sustained demand is established. The oxytocin in Unijects used in this study, were purchased on a non-commercial basis at a cost of $1.40 per dose. A commercial price for the product, should sustainable demand emerge, could be lower as economies of scale play a significant role in the cost of producing pharmaceutical products.

These results also raise additional questions. For example, if oxytocin in Uniject is not an option, could providers entrusted to vaccinate children and provide other injections use a traditional syringe and ampoule for oxytocin administration? The skills required are the same as are issues regarding needle disposal. As a cost-saving measure, could a time/temperature indicator be placed on a flat of oxytocin ampoules (versus individual ampoules), since ampoules within a flat are generally exposed to the same environmental conditions? This issue is mentioned in the UN Commission on Life-Saving Commodities for Women and Children and will likely be determined by the willingness of pharmaceutical companies to allow it. Regarding the duration that oxytocin can remain out of the cold chain in hot climates, additional analyses from this trial are currently underway to assess the number of days that oxytocin can remain out of the cold chain under field conditions in central Ghana prior to indication by the time/temperature indicator that the device should be discarded. Such information will serve health care planners in determining the required resupply schedule and the feasibility of this schedule locally. Could a lay provider safely and effectively use oxytocin in Uniject? (A randomized trial assessing use of oxytocin in Uniject by traditional birth attendants to prevent PPH is underway in Senegal now; clinicaltrials.gov: NCT01713153.) Is the BRASSS-V calibrated plastic drape used here necessary or could a simplified drape that indicates only when treatment and referral are needed (versus a quantitative blood loss measure), or other PPH detection pads suffice? This choice will be determined by the objectives of local health planners and the ability to easily obtain or import supplies. In Ghana, local manufacture of the blood loss measurement drape is considered a priority for scaled-up use.

While the move towards use of skilled birth attendants is gathering global momentum, poverty and inequity—particularly in selected areas in countries—will remain issues for the foreseeable future. Prophylactic use of uterotonics to prevent PPH, the biggest killer of women during childbirth, is a key intervention and use of oxytocin as the drug of choice should be considered where its use is feasible. It is unhelpful to pose this issue as oxytocin versus misoprostol. The more appropriate question is: Where and under what circumstances can each of these proven effective drugs be used? Ultimately, decisions regarding the balance of advantages and disadvantages of using oxytocin or misoprostol for PPH prevention at home births will depend on local conditions, human resources, infrastructure, and national policies.

Source:PLOS

HIV Occupational Exposure: USPHS Updates Guidelines.


After any occupational exposure to HIV, healthcare personnel (HCP) should immediately receive a postexposure prophylaxis (PEP) regimen containing at least 3 antiretroviral drugs, according toupdated guidelines published in the September issue of Infection Control and Hospital Epidemiology. The current recommendations from the United States Public Health Service (USPHS) update the 2005 guidelines for management of HCP with occupational HIV exposure and use of PEP.

A major change in the recommendation refers to the number of drugs included in the PEP regimen. The previous guidelines recommended evaluating the risk level associated with specific exposures to help determine the optimal number of antiretroviral drugs for PEP. In contrast, the current recommendations call for consistent use of a combination of 3 or more drugs for all occupational exposures to HIV.

“Preventing exposures should be the leading strategy to prevent occupational HIV infections,” guidelines author David Kuhar, MD, a medical epidemiologist from the Centers for Disease Control and Prevention‘s Division of Healthcare Quality Promotion, said in a Society for Healthcare Epidemiology of America news release. “However, when an exposure occurs, it should be considered an urgent medical concern and a PEP regimen should be started right away, ideally within hours of the potential exposure.”

An interagency USPHS working group, including members from the Centers for Disease Control and Prevention, National Institutes of Health, US Food and Drug Administration, and the Health Resources and Services Administration, developed these guidelines with input from an external expert panel.

To improve compliance and completion of the full PEP regimen, many of the revised recommendations aim to improve tolerability of the PEP regimen. Drugs in the currently recommended regimens are better tolerated than those previously recommended.

Specific Recommendations

  • The guidelines emphasize primary prevention strategies and prompt reporting and management of occupational exposures.
  • If possible, the HIV status of the exposure source patient should be determined to guide the need for HIV PEP.
  • Initiating PEP should be the first priority and should not be delayed pending expert consultation, which is also recommended.
  • PEP regimens should contain 3 (or more) antiretroviral drugs for 4 weeks.
  • Follow-up appointments should begin within 72 hours of HIV exposure and should include follow-up HIV testing, monitoring for drug toxicity, and counselling.
  • HIV testing should generally continue for 6 months after exposure.
  • HIV testing may be concluded at 4 months, provided a newer fourth-generation HIV antigen/antibody combination test is used for follow-up testing.
  • The updated guidelines should be distributed to emergency physicians and other providers as needed, because many HCP exposures occur outside of normal office hours. Emergency physicians or other providers who are not experts in HIV treatment or in the use of antiretroviral therapy medications often oversee initial management of HIV exposure in emergency medical service personnel, dental personnel, laboratory personnel, autopsy personnel, environmental maintenance personnel, nurses, nursing assistants, physicians, technicians, therapists, pharmacists, students, and trainees.

“To ensure timely postexposure management and administration of HIV PEP, clinicians should consider occupational exposures as urgent medical concerns, and institutions should take steps to ensure that staff are aware of both the importance of and the institutional mechanisms available for reporting and seeking care for such exposures,” the guidelines authors write.

Source:medscape.com

Sixty Percent of Doctors Refuse to Get Flu Shots. Why?


According to a 2008 survey, only about 4 out of 10 healthcare professionals chose to get a flu shot last year. The next time a physician recommends a treatment to you, especially if it has potentially hazardous side effects (as most do in modern medicine), you might ask them if they would do the same if they were the patient, and if not, why not. If you are fortunate enough to have an open relationship with your provider — as we all should — he or she may just take off the “doctor” hat and tell you person to person their own true opinion, rather than what the HMO, drug company, or medical board often tutor them to say.

Our own wellness, and that of our family’s, is something each of us should be personally responsible for. It is up to us to proactively learn how to best maintain our health and avoid disease. Part of this plan should include a relationship with a healthcare professional that knows us and knows what course is most beneficial for our specific needs. It is best to work with someone who shares your own healthcare philosophy — hopefully one that focuses on prevention through the use of nutrition and other wellness-related lifestyle choices.

Sixty Percent of Doctors Refuse to Get Flu Shots

by Mike Adams, the Health Ranger, December 9, 2008

If flu shots are so good for you, then why do sixty percent of doctors and nurses refuse to get them? ABC News is reporting that only forty percent of health care professionals opted to be vaccinated against the flu last year.

It’s yet another case of health professionals telling patients to do one thing while they do something entirely different themselves. For example, according to surveys published earlier this year, most oncologists would never undergo chemotherapy.

Many doctors take vitamins and nutritional supplements, but they won’t tell their patients to do the same because state medical boards have made it illegal for doctors to recommend nutritional therapies.

Thus, much of what medical professionals tell patients stands in contradiction to what they actually believe is best for their health. Flu shots have become the mad cry of quackery in modern medicine, which believes that the human immune system is useless to prevent infectious disease and must be artificially hijacked by invasive medical procedures (a shot) in order to function correctly.

Interestingly, related research just announced today reveals that half a flu shot produces the same results as a full flu shot. But they didn’t test the “no flu shot but extra vitamin D” option, which would have been ever better.

Flu shots are pure quackery combined with clever hucksterism. And if you don’t believe me, just check the medical records of the doctors themselves: Most of them aren’t getting flu shots in the first place. Doctors aren’t stupid people. If they’re not getting flu shots, that tells you probably they think it’s a waste of time.

Sources: oawhealth.com

Telehealth Follow-up in Lieu of Postoperative Clinic Visit for Ambulatory Surgery.


Importance  Telehealth encounters can safely substitute for routine postoperative clinic visits in selected ambulatory surgical procedures.

Objective  To examine whether an allied health professional telephone visit could safely substitute for an in-person clinic visit.

Design  Prospective case series during a 10-month study period from October 2011 to October 2012 (excluding July and August 2012).

Setting  University-affiliated veterans hospital.

Patients  Ambulatory surgery patients who underwent elective open hernia repair or laparoscopic cholecystectomy during the 10-month study period.

Interventions  Patients were called 2 weeks after surgery by a physician assistant and assessed using a scripted template. Assessment variables included overall health, pain, fever, incision appearance, activity level, and any patient concerns. If the telephone assessment was consistent with absence of infection and return to baseline activities, the patient was discharged from follow-up. Patients who preferred a clinic visit were seen accordingly.

Main Outcomes and Measures  Percentage of patients who accepted telehealth follow-up and complications that presented in telehealth patients within 30 days of surgery.

Results  One hundred fifteen open herniorrhaphy and 26 laparoscopic cholecystectomy patients had attempted telehealth follow-up. Seventy-eight percent (110) of all patients were successfully contacted; of those, 70.8% (63) of hernia patients and 90.5% (19) of cholecystectomy patients accepted telehealth as the sole means of follow-up. Complications in the telehealth patients were zero for cholecystectomy and 4.8% (3) for herniorrhaphy. Nearly all patients expressed great satisfaction with the telephone follow-up method.

Conclusions  Telehealth can be safely used in selected ambulatory patients as a substitute for the standard postoperative clinic visit with a high degree of patient satisfaction. Time and expense for travel (7-866 miles) were reduced and the freed clinic time was used to schedule new patients.

Delivery of surgical care that is more efficient and cost-effective and has a high degree of patient satisfaction with excellent outcomes is a necessary evolution of the current surgical practice model. An in-person postoperative clinic evaluation is the “gold standard” throughout the United States. Some practices such as Kaiser Permanente use allied health care providers in lieu of surgeons to see the postoperative patients (N. Baril, MD, oral communication, December 12, 2012). The Veterans Health Care System provides care to eligible patients who come from sizeable catchment areas. The patients often must travel significant distances, which represent an investment on their part of time, missed work, and travel costs for a postoperative clinic visit that is typically quite brief. Therefore, as a quality initiative, we examined whether an allied health professional telephone visit could safely substitute for an in-person clinic visit.

For this pilot study, we defined a telehealth visit as a telephone call performed by a trained allied health care provider. This alternative has not been extensively studied, but a review of the literature demonstrates good patient satisfaction without compromise of overall patient care.1– 4 Several studies have shown that patients appreciate the ability to speak with their physicians or a physician’s surrogate by telephone and are highly satisfied with this mode of communication.1– 4 Advantages of telephone contact are the omission of clinic wait times and the elimination of the costs associated with traveling for an in-person clinic visit.2 Studies using telephone follow-up have been conducted in acute and chronic medical and surgical settings,4outpatient anorectal surgery,5 outpatient laparoscopic cholecystectomy,6 and pediatric adenotonsillectomy.7 These reports demonstrate that telephone encounters are safe for the patient and give the opportunity to provide advice and education and selectively identify individuals in need of actual in-person postoperative visits.2,4,8

Elective open hernia repairs and laparoscopic cholecystectomies are ambulatory procedures where potential complications are well characterized and infrequent.9– 10 The majority of postoperative clinic visits are often perfunctory with patients not having substantive issues that need acute medical attention. When there are complications, many of these patients present outside of the clinic visit with either a telephone call to the surgeon or to the emergency department. Therefore, these patients seemed to be the ideal cases that could be used for a pilot study before expanding to other ambulatory cases such as laparoscopic hernia repairs. Advantages to the patient would be convenience, no need to travel, and no loss of time. Advantages to the surgical service would be increased clinic access slots for new patients and decreased cost in the delivery of care.

DISCUSSION

Telehealth follow-up has been investigated and reviewed in various medical settings.1– 5,7– 8 Despite its demonstrated efficacy, there has not been widespread adoption in surgical practices. Our pilot study successfully demonstrates that patients who underwent elective open herniorrhaphy and laparoscopic cholecystectomy can be followed up safely by telehealth. Moreover, this approach has demonstrated acceptable complication assessment rates. Complications will occur after surgical procedures but the critical question to ask is whether there were any delays in diagnosis or worsened outcomes because of the lack of an in-person clinic visit. All but 1 of the hernia complications within 30 days were minor wound issues; the single serious complication of hematoma presented acutely and represented to the emergency department a second and third time even while being closely followed up in the clinic. No missed morbidity or mortalities were found on 30-day medical record review.

This pilot project was received very positively by our surgical staff and convincingly demonstrated to them that the vast majority of selected ambulatory patient follow-up could be done by telephone, with referral to the clinic based on the telephone evaluation. In the pilot, we learned that a process was necessary to facilitate completion of return-to-work or disability forms outside of a clinic visit. Our hospital is trying to expand the role of telehealth in the care of patients in our large catchment area. The director of the hospital telehealth program now recommends that a formal telehealth appointment be scheduled to set patients’ expectations. The 110 clinic slots that were opened up by use of this program were able to be used for new patients and helped improve clinic access and wait-time issues. We cannot provide any hospital cost data but a 10-minute physician assistant telephone call compared with a 5- to 10-minute surgeon visit in the clinic would most likely show a cost savings. More important is the savings of the patient’s time and resources to drive to the hospital for a brief and often cursory visit. In the cohort that accepted the telehealth visit, 51% had a round-trip driving distance of greater than 100 miles and 71% had a greater than 1 hour total commute.

Greater than 70% of patients contacted via telehealth willingly accepted this mode of communication for their postoperative care and no complaints were received. The observed low complication rate, none of which were directly tied to the lack of a postoperative clinic visit, helps demonstrate that patient care and outcomes were not compromised. It is our belief that this is applicable to non–veterans hospital practices. In general, people appreciate respecting their time, and elimination of a low-impact clinic visit while still maintaining patient contact through a telephone call should result in overall high patient satisfaction.

A potential weakness is the inference of cost savings to the system because a formal cost analysis was not performed. Since this was a pilot program, we can only infer conclusions about the true impact on health care costs. Overall, patients expressed satisfaction for our telehealth services, saving them from driving long distances and clinic wait times.

In conclusion, this pilot study demonstrated that a scripted telehealth visit by an allied health professional can be safely and effectively used for the postoperative care of open herniorrhaphy and laparoscopic cholecystectomy patients. There were no complications that resulted from the substitution of telehealth for a “gold standard” clinic visit. Expansion of telehealth follow-up to other selected procedures with low morbidities will be expanded within our service. The net results of increased clinic slots for new patients; patient satisfaction with avoiding travel; hospital cost savings by not using clinic space, resources, and staffing; and cost shifting the follow-up care from a physician to an allied health professional should all positively impact the cost of care for both the patient and the hospital. Evolution of care needs to continue with the aim of providing outstanding outcomes, at the lowest cost, and with a high degree of patient satisfaction. This program appears to satisfy all of these goals and is a direction that should be considered by other high-volume ambulatory practices, with care taken to select the correct mix of procedures.

 

Source: JAMA

New Evidence about an Old Drug — Risk with Codeine after Adenotonsillectomy.


During the past 10 years, efforts in pharmacogenomics have generated insights into the efficacy and safety of drugs, enhancing our understanding of the safety profile of even some of the oldest drugs, such as codeine sulfate, an opioid analgesic first approved in 1950 for relief of mild or moderate pain. Simultaneously, an increased awareness of the value of both personalized medicine and the reporting of rare adverse outcomes has resulted in the publication of information on adverse events that previously might not have been reported. These developments, in turn, led the Food and Drug Administration (FDA) to reanalyze the safety of — and ultimately restrict — codeine use in patients after adenotonsillectomy.

The activity of codeine depends on its conversion to morphine by the cytochrome P-450 isoenzyme 2D6 (CYP2D6); morphine is subsequently metabolized to the active morphine-6-glucuronide by means of UDP-glucuronosyltransferase 2B7. The gene encoding CYP2D6 has many genetic variations that affect the amount of codeine that is converted to an active form and that result in the drug’s variable effect. Patients with a normal range of CYP2D6 activity represent 75 to 92% of the population and are called extensive metabolizers. At the low end of the activity spectrum are poor metabolizers (approximately 5 to 10% of the population), who have no functional alleles and therefore receive little to no morphine or analgesia from codeine. At the high end of the CYP2D6 activity spectrum, ultrarapid metabolizers have two or more functional alleles, and their bodies can convert codeine into large amounts of morphine. The prevalence of ultrarapid metabolism varies by ethnic group: it is lower than 1% among Chinese and Japanese patients but potentially higher than 15% among Middle Eastern and North African patients. Clinically significant toxic effects related to opioid excess have been reported in ultrarapid metabolizers, which suggests that the risk of toxic effects from codeine depends, in part, on genotype.1

In April 2012, a case series was published reporting two deaths and one case of respiratory depression in children 3 to 5 years of age who had received typical doses of codeine after tonsillectomy, adenoidectomy, or both performed because of obstructive sleep apnea.2 The two deaths occurred in children who had evidence of being ultrarapid metabolizers, and the postmortem morphine levels in these children were substantially higher than the therapeutic range. The third child was an extensive metabolizer. Signs of morphine toxicity developed within 1 to 2 days after codeine treatment began.

In response to that publication, the FDA initiated an evaluation of the safety of codeine in children. This assessment included a comprehensive review of the literature and case reports that were submitted to the FDA’s Adverse Event Reporting System (AERS, now known as FAERS) between 1969 and May 1, 2012. This search identified 13 cases, including 10 deaths and 3 cases of life-threatening respiratory depression associated with therapeutic codeine use. Seven of these 13 cases (including the 3 from the case series mentioned above) had been reported in the medical literature. Patients ranged in age from 21 months to 9 years. Most of the patients had undergone adenotonsillectomy (eight patients) or had a respiratory tract infection (three patients), and they appeared to receive appropriate doses of codeine. Of the seven children described in the published cases, three were characterized as ultrarapid metabolizers, three as extensive metabolizers, and one as a probable ultrarapid metabolizer. A search of the medical literature and AERS for cases of pediatric death or life-threatening respiratory depression with therapeutic use of hydrocodone, oxycodone, or morphine was also conducted and did not identify robust cases of unexplainable or unconfounded death or life-threatening respiratory depression after the use of these drugs.

In late 2011, the Patient Safety and Quality Improvement Committee of the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) was also becoming concerned about adverse events, particularly respiratory depression, after adenotonsillectomy. Such events have been described informally for decades but rarely reported. In 2012, the committee conducted a nationwide, anonymous survey of otolaryngologists to learn more about these events. When the FDA announced its investigation (www.fda.gov/Drugs/DrugSafety/ucm313631.htm), the committee reached out to share prepublication results with the agency. Limited information was available; however, two children (a 3-year-old and a 12-year-old) with obstructive sleep apnea who died after adenotonsillectomy were confirmed (by genotype) to be ultrarapid metabolizers or suspected (because of high postmortem blood morphine levels) of being ultrarapid metabolizers.3

The only well-documented cases of death or respiratory arrest after codeine treatment in ultrarapid-metabolizing children have involved patients who have just undergone adenotonsillectomy. That does not mean that the risk is not present in other situations, but currently available evidence suggests that the risk is most substantial in children after they have undergone tonsillectomy, adenoidectomy, or both. Many such children have sleep-disordered breathing, and children with sleep-disordered breathing are known to be more sensitive to opioids.4

Therefore, the FDA recently required that the manufacturers of all codeine-containing products add a boxed warning to the labeling of their product that describes the risk posed by codeine after a child has undergone tonsillectomy or adenoidectomy. A contraindication will be added to restrict codeine use in such patients. The “Warnings/Precautions,” “Pediatric Use,” and “Patient Counseling Information” sections of the labeling will also be updated.

Performing routine genotyping before prescribing codeine was not recommended for several reasons. Some of the patients who died or in whom respiratory depression developed were genetically extensive metabolizers, so patients with “normal” genotyping results may still be at risk. Also, since the number that would need to be screened to prevent such a rare toxic effect would be very high, and since preoperative laboratory assessments are not routine before adenotonsillectomy, the practicality of genotyping is questionable.

Although it did not participate in the FDA’s decision process, the AAO-HNS supported the labeling changes because of the increasing evidence that these extremely rare but catastrophic events can be related to codeine use, because codeine is ineffective in some patients (poor metabolizers), and because of emerging clarity that a variety of other drugs (e.g., some nonsteroidal antiinflammatory drugs) are safe to use and do not increase the risk of bleeding.5 The AAO-HNS informally surveyed opinion leaders in academic medicine, private practice, and pediatric otolaryngology and reached a consensus that the availability of other analgesic agents and the risk of catastrophic events outweighed the value of codeine.

Even old and commonly used drugs may cause rare but catastrophic events that will not be recognized without a vigorous effort by the profession to share information in the literature. In the case of codeine, a combination of case reporting and our evolving understanding of genetic influences on drug response has clarified the need to avoid this drug after adenotonsillectomy.

Source: NEJM

 

Communication skills training for healthcare professionals working with people who have cancer. .


This is an updated version of a review that was originally published in the Cochrane Database of Systematic Reviews in 2004, Issue 2. People with cancer, their families and carers have a high prevalence of psychological stress which may be minimised by effective communication and support from their attending healthcare professionals (HCPs). Research suggests communication skills do not reliably improve with experience, therefore, considerable effort is dedicated to courses that may improve communication skills for HCPs involved in cancer care. A variety of communication skills training (CST) courses have been proposed and are in practice. We conducted this review to determine whether CST works and which types of CST, if any, are the most effective.

OBJECTIVES: To assess whether CST is effective in improving the communication skills of HCPs involved in cancer care, and in improving patient health status and satisfaction. SEARCH
METHODS: We searched the following electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL) Issue 2, 2012, MEDLINE, EMBASE, PsycInfo and CINAHL to February 2012. The original search was conducted in November 2001. In addition, we handsearched the reference lists of relevant articles and relevant conference proceedings for additional studies.
SELECTION CRITERIA: The original review was a narrative review that included randomised controlled trials (RCTs) and controlled before-and-after studies. In this updated version, we limited our criteria to RCTs evaluating `CST` compared with `no CST` or other CST in HCPs working in cancer care. Primary outcomes were changes in HCP communication skills measured in interactions with real and/or simulated patients with cancer, using objective scales. We excluded studies whose focus was communication skills in encounters related to informed consent for research.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials and extracted data to a pre-designed data collection form. We pooled data using the random-effects model and, for continuous data, we used standardised mean differences (SMDs).
MAIN RESULTS: We included 15 RCTs (42 records), conducted mainly in outpatient settings. Eleven studies compared CST with no CST intervention, three studies compared the effect of a follow-up CST intervention after initial CST training, and one study compared two types of CST. The types of CST courses evaluated in these trials were diverse. Study participants included oncologists (six studies), residents (one study) other doctors (one study), nurses (six studies) and a mixed team of HCPs (one study). Overall, 1147 HCPs participated (536 doctors, 522 nurses and 80 mixed HCPs).Ten studies contributed data to the meta-analyses. HCPs in the CST group were statistically significantly more likely to use open questions in the post-intervention interviews than the control group (five studies, 679 participant interviews; P = 0.04, I(2) = 65%) and more likely to show empathy towards patients (six studies, 727 participant interviews; P = 0.004, I(2) = 0%); we considered this evidence to be of moderate and high quality, respectively. Doctors and nurses did not perform statistically significantly differently for any HCP outcomes.There were no statistically significant differences in the other HCP communication skills except for the subgroup of participant interviews with simulated patients, where the intervention group was significantly less likely to present `facts only` compared with the control group (four studies, 344 participant interviews; P = 0.01, I(2) = 70%).There were no significant differences between the groups with regard to outcomes assessing HCP `burnout`, patient satisfaction or patient perception of the HCPs communication skills. Patients in the control group experienced a greater reduction in mean anxiety scores in a meta-analyses of two studies (169 participant interviews; P = 0.02; I(2) = 8%); we considered this evidence to be of a very low quality.
AUTHORS’ CONCLUSIONS: Various CST courses appear to be effective in improving some types of HCP communication skills related to information gathering and supportive skills. We were unable to determine whether the effects of CST are sustained over time, whether consolidation sessions are necessary, and which types of CST programs are most likely to work. We found no evidence to support a beneficial effect of CST on HCP `burnout`, patients` mental or physical health, and patient satisfaction.

Source: Cochrane

Routine Propofol Sedation Increases Risk During Colonoscopy In a large database study, anesthesia assistance was associated with an elevated risk for perforation, splenic injury, or aspiration pneumonia. The use of anesthesiologist-administered propofol sedation for colonoscopy is increasing in the U.S. (JW Gastroenterol April 13 2012 and JW Gastroenterol Feb 17 2012). Propofol use during colonoscopy is associated with shorter recovery time and higher patient satisfaction but also an estimated 20% increase in health care costs. Whereas most studies on the use of propofol sedation during colonoscopy have focused on its economic cost, researchers now explore another possible disadvantage — increased risk for complications. Using a database of linked U.S. Medicare and cancer registry data, investigators identified patients without cancer who underwent diagnostic colonoscopy between 2000 and 2009, assessed whether they received anesthesiology services, and determined whether they were hospitalized during the 30 days following colonoscopy for perforation, splenic injury, or aspiration pneumonia. Data on the type of anesthetic agent used were unavailable, but investigators assumed that anesthesiologist-administered propofol was used most often. Of 165,527 colonoscopy examinations in 100,359 patients, 35,128 procedures (21.2%) were performed with anesthesia assistance. Complications of aspiration, perforation, or splenic injury occurred more frequently in patients who received anesthesia assistance than in those who did not (0.22% vs. 0.16%, P<0.001; odds ratio, 1.46; 95% confidence interval, 1.09–1.94). This difference was mostly attributable to the difference in risk for aspiration (0.14% vs. 0.10%; P=0.02). The risks for perforation and splenic injury were similar between groups. Other independent risk factors for these complications were older age, male sex, increased comorbidity, and undergoing the procedure in a hospital. Comment: Although the overall rate of complications was very low, the use of anesthesia services for diagnostic colonoscopy resulted in a higher risk for complications. These findings might result in part from confounding if patients who received anesthesia assistance were sicker or more prone to complications and were chosen to receive anesthesia for those reasons. Also, the data were from a period when propofol was sometimes administered by trained nurses rather than anesthesiologists, and the relative safety of this approach compared to anesthesia-administered services cannot be determined. Finally, these findings might be more pronounced in the types of patients included in this trial ( 65 years old), and whether the observed increased risk is present in younger or more healthy patients remains to be determined.


In a simulation study, percent adequate chest compressions performed by in-hospital providers fell below 70% within 120 seconds in child and adult manikins.

 

The American Heart Association defines effective chest compression during cardiopulmonary resuscitation (CPR) as >100 compressions per minute at a depth >38 mm. In a prospective randomized crossover study, investigators compared quality of compressions and the work required to perform them on a 5-year old manikin and an adult manikin. Forty-five in-hospital healthcare providers performed single-rescuer continuous compressions for up to 10 minutes on both the child and adult manikins. A HeartStart MRx Monitor/Defibrillator was used to quantify compression rate and compression depth at 30-second intervals.

Mean chest compression rate remained above 100 per minute for both manikins. Mean compression depth decreased over the 10-minute period for both the child (41 to 34 mm) and adult (42 to 36 mm) manikins. Measured energy expended during CPR was comparable to that expended during running or swimming, and was about 15% greater for the adult than the child manikin. Over the 10-minute period, the percentage of adequate compressions fell from 85% to less than 40% for both manikins. Fewer than 70% of compressions were adequate by 90 seconds in the child and 120 seconds in the adult. Self-reported fatigue during the first 2 minutes was low in comparison to the decrease in compression quality.

Comment: Whether due to fatigue, declining vigilance, or other causes, providers perform high-quality CPR for only a brief period of time. These data support switching the person providing chest compressions every 2 minutes during resuscitation in adults and children.

 

Source: Journal Watch Emergency Medicine

 

Understanding the Effect of Healthcare Workers’ Hand Hygiene.


Using a novel method, investigators revealed marked heterogeneity in healthcare worker interactions and in the potential consequences of their hand hygiene.

Attempts to understand disease transmission in healthcare settings have generally assumed that healthcare workers (HCWs) move and interact uniformly. However, observational studies have suggested the possibility of peripatetic “superspreaders” who have greater-than-average mobility and interactivity — and thus more opportunity to spread infection. In a recent study conducted in the medical intensive care unit of a university hospital, researchers assessed this possibility.

The researchers used small electronic badges worn by HCWs, together with fixed-position beacons, to determine patterns of HCW movement and interactions within this 20-bed unit. They then used these data to mathematically model the effect of HCW hand hygiene on pathogen transmission.

During the 48-hour period of analysis, the average number of contacts (HCW–HCW and HCW–patient) per HCW was 80.1 for day shifts and 76.1 for night shifts. However, a few HCWs were responsible for a disproportionately large share of the contacts. Modeling the effect of hand-hygiene activity on disease transmission showed that spread of a pathogen would be significantly greater with noncompliance of a few high-contact staff members than with noncompliance of an equal number of low-contact workers.

Comment: Hand hygiene is a central tenet of infection control, yet since the original work of Semmelweis, there has been relatively little research on the direct effects of hand-hygiene behavior on disease transmission. Hornbeck and colleagues have provided new insights into HCW contacts, which can help us to understand the role of hand hygiene in preventing nosocomial spread of pathogens and thus to develop more-sophisticated approaches for improving its efficacy.

Source: Journal Watch Infectious Diseases