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1.

BACKGROUND

Knowing a patient’s health literacy can help clinicians and researchers anticipate a patient’s ability to understand complex health regimens and deliver better patient-centered instructions and information. Poor health literacy has been linked with lower ability to function adequately in health care systems.

OBJECTIVE

We evaluated and compared three measures of health literacy and performance among older patients with diabetes.

DESIGN

Cross-sectional study utilizing in-person interviews conducted in participants’ homes.

PARTICIPANTS

A tri-ethnic sample (

MAIN MEASURE

Participants completed interviews and health literacy assessments using the Short-Form Test of Functional Health Literacy in Adults (S-TOFHLA), the Rapid Estimates of Adult Literacy in Medicine Short-Form (REALM-SF), or the Newest Vital Signs (NVS). Scores for reading comprehension and numeracy were calculated.

RESULTS

Over 90% completed the S-TOFHLA numeracy and approximately 85% completed the S-TOFHLA reading and REALM-SF. Only 73% completed the NVS. The correlation of S-TOFHLA total scores with REALM-SF and NVS were 0.48 and 0.54, respectively. Age, gender, ethnic, educational and income differences in health literacy emerged for several instruments, but the pattern of results across the instruments was highly variable.

CONCLUSIONS

A large segment of older adults is unable to complete short-form assessments of health literacy. Among those who were able to complete assessments, the REALM-SF and NVS performed comparably, but their relatively low convergence with the S-TOFHLA raises questions about instrument selection when studying health literacy of older adults.
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2.

Background

Health-related quality of life (HRQL) is an increasingly well-recognized measure of health outcome in cardiology. We examined HRQL as a predictor of unplanned rehospitalization for cardiac reasons in patients after coronary revascularization over a period of 3 years.

Patients and methods

Out of 791 patients enrolled in the study, 743 completed the MacNew HRQL questionnaire after coronary revascularization. MacNew HRQL scores were used as predictors of unplanned rehospitalization.

Results

Within the 3-year follow-up period, 125 patients (16.8?%) were rehospitalized. After adjustment for age, gender, and myocardial infarction as the initiating event, there were significant differences in unplanned rehospitalization rates between patients with low or moderate vs. high MacNew HRQL global scores (HR: 1.8, 95?% CI: 1.2–2.7) and both physical (HR: 2.2, 95?% CI: 1.4–3.5) and social (HR: 1.8, 95?% CI: 1.2–2.7) subscale scores.

Conclusion

Poor HRQL assessed after coronary revascularization appears to be a powerful predictor of rehospitalization over a 3-year period.
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3.

Background

Hypertension is a major risk factor for peripheral artery disease (PAD). Little is known about relative efficacy of antihypertensive treatments for preventing PAD.

Objectives

To compare, by randomized treatment groups, hospitalized or revascularized PAD rates and subsequent morbidity and mortality among participants in the Antihypertensive and Lipid-Lower Treatment to Prevent Heart Attack Trial (ALLHAT).

Design

Randomized, double-blind, active-control trial in high-risk hypertensive participants.

Participants

Eight hundred thirty participants with specified secondary outcome of lower extremity PAD events during the randomized phase of ALLHAT.

Interventions/events

In-trial PAD events were reported during ALLHAT (1994–2002). Post-trial mortality data through 2006 were obtained from administrative databases. Mean follow-up was 8.8 years.

Main Measures

Baseline characteristics and intermediate outcomes in three treatment groups, using the Kaplan-Meier method to calculate cumulative event rates and post-PAD mortality rates, Cox proportional hazards regression model for hazard ratios and 95 % confidence intervals, and multivariate Cox regression models to examine risk differences among treatment groups.

Key Results

Following adjustment for baseline characteristics, neither participants assigned to the calcium-channel antagonist amlodipine nor to the ACE-inhibitor lisinopril showed a difference in risk of clinically advanced PAD compared with those in the chlorthalidone arm (HR, 0.86; 95 % CI, 0.72–1.03 and HR, 0.98; 95 % CI, 0.83–1.17, respectively). Of the 830 participants with in-trial PAD events, 63 % died compared to 34 % of those without PAD; there were no significant treatment group differences for subsequent nonfatal myocardial infarction, coronary revascularizations, strokes, heart failure, or mortality.

Conclusions

Neither amlodipine nor lisinopril showed superiority over chlorthalidone in reducing clinically advanced PAD risk. These findings reinforce the compelling need for comparative outcome trials examining treatment of PAD in high-risk hypertensive patients. Once PAD develops, cardiovascular event and mortality risk is high, regardless of type of antihypertensive treatment.
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4.

Background

Obtaining cancer screening on patients with limited life expectancy has been proposed as a measure for low quality care for primary care physicians (PCPs). However, administrative data may underestimate life expectancy in patients who undergo screening.

Objective

To determine the association between receipt of screening mammography or PSA and overall survival.

Design

Retrospective cohort study from 1/1/1999 to 12/31/2012. Receipt of screening was assessed for 2001–2002 and survival from 1/1/2003 to 12/31/2012. Life expectancy was estimated as of 1/1/03 using a validated algorithm, and was compared to actual survival for men and women, stratified by receipt of cancer screening.

Participants

A 5 % sample of Medicare beneficiaries aged 69–90 years as of 1/1/2003 (n?=?906,723).

Interventions

Receipt of screening mammography in 2001–2002 for women, or a screening PSA test in 2002 for men.

Main Measures

Survival from 1/1/2003 through 12/31/2012.

Key Results

Subjects were stratified by life expectancy based on age and comorbidity. Within each stratum, the subjects with prior cancer screening had actual median survivals higher than those who were not screened, with differences ranging from 1.7 to 2.1 years for women and 0.9 to 1.1 years for men. In a Cox model, non-receipt of screening in women had an impact on survival (HR?=?1.52; 95 % CI?=?1.51, 1.54) similar in magnitude to a diagnosis of complicated diabetes or heart failure, and was comparable to uncomplicated diabetes or liver disease in men (HR?=?1.23; 1.22, 1.25).

Conclusions

Receipt of cancer screening is a powerful marker of health status that is not captured by comorbidity measures in administrative data. Because life expectancy algorithms using administrative data underestimate the life expectancy of patients who undergo screening, they can overestimate the problem of cancer screening in patients with limited life expectancy.
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5.

Background

Heart rate (HR) and heart rate variability (HRV) have been established in the last few years as a non-invasive method for recording the demands on the cardiovascular system. The development enables us today to measure the interbeat intervals with different technologies for calculating HR and HRV.

Materials and methods

This review is based on a systematic literature search in PubMed for validity of different measurement techniques and their pros and cons for the measurement of HR and the analysis of HRV.

Results

Measurement equipment for recording of interbeat intervals should have a high storage capacity and a sampling rate of 1000 Hz ideally. The quality criteria of freedom of feedback (small, little disruptive), robustness and a non-invasive measurement (e. g. freeze-electrodes or sensors) have to be fulfilled. In addition to the Holter ECG, several portable heart rate watch and chest belt systems provide adequate validity and good applicability.

Discussion

The Holter ECG is still the gold standard for the measurement of NN intervals and for the analysis of HRV. Modern heart rate watches show a good correlation with the conformance of freedom from discomfort, robustness and non-invasive measurement and are a good alternative due to the lower disturbance of test persons.
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6.

Background

Little is known about self-help associations and their possibilities. Obstacles often prevent early contacts between affected people.

Objectives

The psychosocial support given by self-help associations in different phases is evaluated.

Materials and methods

Based on the experience of the Deutsche ILCO and from cooperation with other organizations and institutions, various dimensions of self-help groups are investigated.

Results

On the professional side, there is a lack of knowledge and of attitude. Suitable structures are rare.

Conclusions

The removal of barriers and development of effective structures are overdue.
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7.
8.

RATIONALE

Adjuvant hormone therapy (HT) based on tamoxifen (TX) or aromatase inhibitors (AIs) has become the standard of care for treating hormone receptor -positive (HR+) breast cancer (BC) over the past 20 years. Based on clinical trial results, AI use is recommended by the American Society of Clinical Oncology for treatment of postmenopausal women with HR+ breast cancer. AIs, however, are significantly more expensive than TX, raising concerns about access and use of effective treatment among women of lower socio-economic status.

OBJECTIVES

To examine the relationship between adjuvant HT modality and experience of financial hardship among a cohort of older BC survivors. Also, to examine the extent to which financial concerns affect the probability of switching between adjuvant HT modalities.

DESIGN

Population-based, prospective survey study.

PARTICIPANTS

Elderly (65+) women who had an incident BC surgery in 2003 and who reported receiving adjuvant HT during the first 12 months post-surgery.

METHODS

Multivariate regression models.

RESULTS

Use of AIs was associated with a significantly higher probability of financial hardship. Women who had taken only an AI were more likely to experience financial difficulty than women who took only TX (OR?=?1.4; 95% CI: 1.1–1.7), but women who switched between TX and AI were not more likely to experience financial difficulty. Breast cancer survivors with no drug coverage (OR?=?4.5; 95% CI: 3.3–5.9) or partial drug coverage (OR?=?3.6; 95% CI: 2.8–4.5) were more likely to experience financial difficulty compared to those with full coverage. Lack of drug coverage was also the main factor associated with the likelihood that BC survivors did not switch adjuvant HT modalities.

CONCLUSIONS

Adjuvant HTs have important economic consequences for BC survivors. These consequences are ameliorated by full, but not partial, drug coverage.
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9.

Aim

This paper is aimed at providing practical recommendations for the management of acute hepatitis C (AHC).

Methods

This is an expert position paper based on the literature revision. Final recommendations were graded by level of evidence and strength of the recommendations.

Results

Treatment of AHC with direct-acting antivirals (DAA) is safe and effective; it overcomes the limitations of INF-based treatments.

Conclusions

Early treatment with DAA should be offered when available.
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10.

Purpose

To determine the predictive value of qSOFA (quick Sequential Organ Failure Assessment) in Malawian patients with suspected infection.

Methods

Prospective observational study in a tertiary referral hospital in Malawi.

Results

Predictive ability of qSOFA was reasonable [AUROC 0.73 (95% CI 0.68–0.78)], increasing to 0.77 (95% CI 0.72–0.82) when classifying all patients with altered mental status as high risk. Adding HIV status as a variable to the qSOFA score did not improve predictive value.

Conclusion

qSOFA is a simple tool that can aid risk stratification in resource-limited settings.
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11.

Background

Physicians spend significant time outside of regular office visits caring for complex patients, and this work is often uncompensated. In 2015, the Centers for Medicare & Medicaid Services (CMS) introduced a billing code for care coordination between office visits for beneficiaries with multiple chronic conditions.

Objective

Characterize use of the Chronic Care Management (CCM) code in New England in 2015.

Design

Retrospective observational analysis.

Participants

All Medicare fee-for-service beneficiaries in New England continuously enrolled in Parts A and B in 2015.

Intervention

None.

Main measures

The primary outcome was the number of beneficiaries with a CCM claim per 1000 eligible beneficiaries. Secondary outcomes included the total number of CCM claims, total reimbursement, mean number of claims per beneficiary, and beneficiary characteristics independently associated with receiving CCM services.

Key results

Of the more than two million Medicare fee-for-service beneficiaries in New England, almost 1.7 million were potentially eligible for CCM services. Among eligible beneficiaries, 10,951 (0.65%) had a CCM claim in 2015. Massachusetts had the highest penetration of CCM use (9.40 claims per 1000 eligible beneficiaries); Vermont had the lowest (0.54 claims per 1000 eligible beneficiaries). Mean reimbursement per physician was $1745.98. Age, race/ethnicity, dual-eligible status, income, number of chronic conditions, and state of residence were associated with receiving CCM services in an adjusted model.

Conclusions

The CCM code is likely underutilized in New England; the program may therefore not be achieving its intended goal of encouraging consistent, team-based chronic care management for Medicare’s most complex beneficiaries. Or practices may be foregoing reimbursement for care coordination that they are already providing. Recently implemented revisions may improve uptake of CCM services; it will be important to compare our results with future utilization.
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12.

Background

Evidence is lacking to inform providers’ and patients’ decisions about many common treatment strategies for patients with end stage renal disease (ESRD).

Methods/design

The DEcIDE Patient Outcomes in ESRD Study is funded by the United States (US) Agency for Health Care Research and Quality to study the comparative effectiveness of: 1) antihypertensive therapies, 2) early versus later initiation of dialysis, and 3) intravenous iron therapies on clinical outcomes in patients with ESRD. Ongoing studies utilize four existing, nationally representative cohorts of patients with ESRD, including (1) the Choices for Healthy Outcomes in Caring for ESRD study (1041 incident dialysis patients recruited from October 1995 to June 1999 with complete outcome ascertainment through 2009), (2) the Dialysis Clinic Inc (45,124 incident dialysis patients initiating and receiving their care from 2003–2010 with complete outcome ascertainment through 2010), (3) the United States Renal Data System (333,308 incident dialysis patients from 2006–2009 with complete outcome ascertainment through 2010), and (4) the Cleveland Clinic Foundation Chronic Kidney Disease Registry (53,399 patients with chronic kidney disease with outcome ascertainment from 2005 through 2009). We ascertain patient reported outcomes (i.e., health-related quality of life), morbidity, and mortality using clinical and administrative data, and data obtained from national death indices. We use advanced statistical methods (e.g., propensity scoring and marginal structural modeling) to account for potential biases of our study designs. All data are de-identified for analyses. The conduct of studies and dissemination of findings are guided by input from Stakeholders in the ESRD community.

Discussion

The DEcIDE Patient Outcomes in ESRD Study will provide needed evidence regarding the effectiveness of common treatments employed for dialysis patients. Carefully planned dissemination strategies to the ESRD community will enhance studies’ impact on clinical care and patients’ outcomes.
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13.

BACKGROUND

Low organ donation rates remain a major barrier to organ transplantation.

OBJECTIVE

We aimed to determine the effect of a video and patient cueing on organ donation consent among patients meeting with their primary care provider.

DESIGN

This was a randomized controlled trial between February 2013 and May 2014.

SETTING

The waiting rooms of 18 primary care clinics of a medical system in Cuyahoga County, Ohio.

PATIENTS

The study included 915 patients over 15.5 years of age who had not previously consented to organ donation.

INTERVENTIONS

Just prior to their clinical encounter, intervention patients (n?=?456) watched a 5-minute organ donation video on iPads and then choose a question regarding organ donation to ask their provider. Control patients (n?=?459) visited their provider per usual routine.

MAIN MEASURES

The primary outcome was the proportion of patients who consented for organ donation. Secondary outcomes included the proportion of patients who discussed organ donation with their provider and the proportion who were satisfied with the time spent with their provider during the clinical encounter.

KEY RESULTS

Intervention patients were more likely than control patients to consent to donate organs (22 % vs. 15 %, OR 1.50, 95%CI 1.10–2.13). Intervention patients were also more likely to have donation discussions with their provider (77 % vs. 18 %, OR 15.1, 95%CI 11.1–20.6). Intervention and control patients were similarly satisfied with the time they spent with their provider (83 % vs. 86 %, OR 0.87, 95%CI 0.61–1.25).

LIMITATION

How the observed increases in organ donation consent might translate into a greater organ supply is unclear.

CONCLUSION

Watching a brief video regarding organ donation and being cued to ask a primary care provider a question about donation resulted in more organ donation discussions and an increase in organ donation consent. Satisfaction with the time spent during the clinical encounter was not affected.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01697137
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14.

Background

Although older adults are disproportionately affected by painful musculoskeletal conditions and receive more opioid analgesics than persons in other age groups, insufficient evidence is available regarding opioid harms in this age group.

Objective

To examine longitudinal relationships between opioid use and falls, clinical fractures, and changes in physical performance. We hypothesized that opioid use would be associated with greater risks of falling and incident clinical fractures and greater declines in physical performance.

Design

We analyzed data from the Osteoporotic Fractures in Men Study (MrOS), a large prospective longitudinal cohort study. Participants completed baseline visits from 2000 to 2002 and were followed for 9.1 (SD 4.0) years.

Participants

MrOS enrolled 5994 community-dwelling men ≥ 65 years of age. The present study included 2902 participants with back, hip, or knee pain most or all of the time at baseline.

Main Measures

The exposure of interest was opioid use, defined at each visit as participant-reported daily or near-daily use of any opioid-containing analgesic. Among patients, 309 (13.4 %) reported opioid use at one or more visits. Participants were queried every 4 months about falls and fractures. Physical performance scores were derived from tests of grip strength, chair stands, gait speed, and dynamic balance.

Key Results

In the main analysis, the adjusted risk of falling did not differ significantly between opioid use and non-use groups (RR 1.10, 95 % CI 0.99, 1.24). Similarly, adjusted rates of incident clinical fracture did not differ between groups (HR 1.13, 95 % CI 0.94, 1.36). Physical performance was worse at baseline for the opioid use group, but annualized change in physical performance scores did not differ between groups (?0.022, 95 % CI ?0.138, 0.093).

Conclusions

Additional research is needed to determine whether opioid use is a marker of risk or a cause of falls, fractures, and progressive impairment among older adults with persistent pain.
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15.

Incidence of diabetic kidney diseases

In some European countries the incidence of end-stage renal disease (ESRD) has remained relatively constant or even fallen over the past years despite an increasing prevalence of chronic kidney diseases (CKD). This possibly indicates an improvement in long-term treatment; however, by 2015 a further increase in the prevalence of CKD is expected.

Diagnostics

In the diagnostics, the micro-ribonucleic acids (μRNA) have reached the stage of clinical trials. Among the many other suggestions for new biomarkers urinary podocalyxin and angiotensinogen appear to show promise.

Renin-angiotensin-aldosterone blockade

On the subject of simple versus dual renin-angiotensin-aldosterone (RAAS) blockade important meta-analyses were published, that levelled the problems of hyperkalemia and acute renal failure for dual blockade. Surprisingly, in a new meta-analysis no single antihypertensive agent could effectively influence the overall mortality of diabetes patients with diabetic nephropathy. In particular, the onset of ESRD was significantly delayed by dual RAAS blockade.

New substances: finerenone and patiromer

In a pilot study the new non-steroidal aldosterone antagonist finerenone showed a reduction in proteinuria without resulting in the known side effects of hyperkalemia and acute renal failure. The new oral potassium binder patiromer is suitable for long-term administration for the reduction of potassium and can effectively prevent the occurrence of hyperkalemia that occurred under conventional aldosterone antagonists.
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16.

Background

End stage renal disease (ESRD) patients receiving hemodialysis (HD) have a higher risk of peptic ulcer bleeding (PUB).

Aims

Whether ESRD patients receiving peritoneal dialysis (PD) also carries a higher risk of PUB has not been studied.

Methods

This was a cohort study using Taiwan’s National Health Insurance research database, whereby 11,408 patients, including 2,239 PD, 2,328 HD, 2,267 chronic kidney disease (CKD) and 4,574 controls with age–sex matching were recruited. The log-rank test was used to analyze differences in accumulated PUB-free survival rates between groups. Cox proportional hazard regression was performed to evaluate independent risk factors for PUB in all the enrollees.

Results

During the 7-year follow-up, PD and CKD patients had a significantly higher rate of PUB than matched controls. The risk of PUB between PD and CKD was not significantly different. Moreover, patients receiving HD carried a higher risk of PUB than those receiving PD, with CKD and controls (p all <0.05, by log-rank test). Cox proportional hazard regression analysis showed that CKD (HR 3.99, 95 % CI 2.24–7.13), PD (HR 3.71, 95 % CI 2.00–6.87) and HD (HR 11.96, 95 % CI 7.04–20.31) were independently associated with an increased risk of PUB. Being elderly, male, having hypertension, diabetes, cirrhosis, and nonsteroidal anti-inflammatory drugs and steroid use were other independent risk factors of PUB in all enrollees.

Conclusions

Patients with CKD and ESRD receiving PD or HD carried a higher risk for PUB. They should be screened for risk factors for PUB and receive some protective measures to prevent PUB.
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17.

Background

For patients with type 2 diabetes and chronic kidney disease (CKD), high-quality evidence about the relative benefits and harms of oral glucose-lowering drugs is limited.

Objective

To evaluate whether mortality risk differs after the initiation of monotherapy with either metformin or a sulfonylurea in Veterans with type 2 diabetes and CKD.

Design

Observational, national cohort study in the Veterans Health Administration (VHA).

Participants

Veterans who received care from the VHA for at least 1 year prior to initiating monotherapy treatment for type 2 diabetes with either metformin or a sulfonylurea between 2004 and 2009.

Main Measures

Metformin and sulfonylurea use was assessed from VHA electronic pharmacy records. The CKD-EPI equation was used to estimate glomerular filtration rate (eGFR). The outcome of death from January 1, 2004, through December 31, 2009, was assessed from VHA Vital Status files.

Key Results

Among 175,296 new users of metformin or a sulfonylurea monotherapy, 5121 deaths were observed. In primary analyses adjusted for all measured potential confounding factors, metformin monotherapy was associated with a lower mortality hazard ratio (HR) compared with sulfonylurea monotherapy across all ranges of eGFR evaluated (HR ranging from 0.59 to 0.80). A secondary analysis of mortality risk differences favored metformin across all eGFR ranges; the greatest risk difference was observed in the eGFR category 30–44 mL/min/1.73m2 (12.1 fewer deaths/1000 person-years, 95% CI 5.2–19.0).

Conclusions

Initiation of metformin versus a sulfonylurea among individuals with type 2 diabetes and CKD was associated with a substantial reduction in mortality, in terms of both relative and absolute risk reduction. The largest absolute risk reduction was observed among individuals with moderately–severely reduced eGFR (30–44 mL/min/1.73m2).
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18.

Background

Naloxone is a life-saving opioid antagonist. Chronic pain guidelines recommend that physicians co-prescribe naloxone to patients at high risk for opioid overdose. However, clinical tools to efficiently identify patients who could benefit from naloxone are lacking.

Objective

To develop and validate an overdose predictive model which could be used in primary care settings to assess the need for naloxone.

Design

Retrospective cohort.

Setting

Derivation site was an integrated health system in Colorado; validation site was a safety-net health system in Colorado.

Participants

We developed a predictive model in a cohort of 42,828 patients taking chronic opioid therapy and externally validated the model in 10,708 patients.

Main Measures

Potential predictors and outcomes (nonfatal pharmaceutical and heroin overdoses) were extracted from electronic health records. Fatal overdose outcomes were identified from state vital records. To match the approximate shelf-life of naloxone, we used Cox proportional hazards regression to model the 2-year risk of overdose. Calibration and discrimination were assessed.

Key Results

A five-variable predictive model showed good calibration and discrimination (bootstrap-corrected c-statistic?=?0.73, 95% confidence interval [CI] 0.69–0.78) in the derivation site, with sensitivity of 66.1% and specificity of 66.6%. In the validation site, the model showed good discrimination (c-statistic?=?0.75, 95% CI 0.70–0.80) and less than ideal calibration, with sensitivity and specificity of 82.2% and 49.5%, respectively.

Conclusions

Among patients on chronic opioid therapy, the predictive model identified 66–82% of all subsequent opioid overdoses. This model is an efficient screening tool to identify patients who could benefit from naloxone to prevent overdose deaths. Population differences across the two sites limited calibration in the validation site.
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19.
20.

Purpose

We report on a kidney transplant recipient treated with fecal microbiota transplantation (FMT) for recurrent urinary tract infections.

Methods

FMT was administered via frozen capsulized microbiota. Before and after FMT, urinary, fecal and vaginal microbiota compositions were analyzed.

Results

The patient remained without symptoms after FMT.

Conclusions

Underlying mechanisms of action need to be addressed in depth by future research.
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