Tatsuyoshi Ikenoue

Majority of systematic reviews published in high-impact journals neglected to register the protocols: a meta-epidemiological study

OBJECTIVESnTo describe the registration of systematic review (SR) protocols and examine whether or not registration reduced the outcome reporting bias in high-impact journals.nnnSTUDY DESIGN AND SETTINGnWe searched MEDLINE via PubMed to identify SRs of randomized controlled trials of interventions. We included SRs published between August 2009 and June 2015 in the 10 general and internal medicinal journals with the highest impact factors in 2013. We examined the proportion of SR protocol registration and investigated the relationship between registration and outcome reporting bias using multivariable logistic regression.nnnRESULTSnAmong the 284 included reviews, 60 (21%) protocols were registered. The proportion of registration increased from 5.6% in 2009 to 27% in 2015 (P for trend <0.001). Protocol registration was not associated with outcome reporting bias (adjusted odds ratio [OR] 0.85, 95% confidence interval [CI] 0.39-1.86). The association between Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) adherence and protocol registration was not statistically significant (OR 1.09, 95% CI 0.59-2.01).nnnCONCLUSIONSnSix years after the launch of the PRISMA statement, the proportion of protocol registration in high-impact journals has increased some but remains low. The present study found no evidence suggesting that protocol registration reduced outcome reporting bias.

Patient experience of primary care and advance care planning: a multicentre cross-sectional study in Japan

BackgroundnAdvance care planning (ACP) is becoming increasingly important in the primary care setting because of its positive impact on the end-of-life care.nnnObjectivenWe aimed to investigate the relationship between patient experience of primary care and ACP.nnnMethodsnThis cross-sectional study was conducted in 28 primary care clinics in Japan. We assessed patient experience of primary care using a Japanese version of Primary Care Assessment Tool (JPCAT), which comprises six domains: first contact, longitudinality, coordination, comprehensiveness (services available), comprehensiveness (services provided) and community orientation. The primary outcome measures were ACP discussion between patients and primary care providers and completion of advance directives (AD). We used a generalized linear mixed model to adjust clustering within clinics and individual covariates.nnnResultsnData were analysed for 535 primary care patients. After adjustment for patients sociodemographic and health characteristics, the JPCAT total score was found to be significantly associated with ACP discussion [odds ratio (OR) per 1 SD increase = 4.33; 95% confidence interval (CI), 2.53-7.47] but not with completion of AD (OR per 1 SD increase = 1.42; 95% CI, 0.94-2.12). All domains of JPCAT, which represent attributes of primary care, had positive associations with ACP discussion. First contact and comprehensiveness (services provided) domain scores were significantly associated with completion of AD.nnnConclusionsnWe found that better patient experience of primary care was strongly associated with ACP discussion. Our findings reinforce the significance of patient experience in primary care as part of quality end-of-life care.

Influence of Staff Encouragement on Perceived Burden of Dietary Restriction among Patients Living Alone.

To help relieve the burden of dietary restrictions experienced by many hemodialysis (HD) patients, dialysis staff may encourage patients, with no consideration to the degree of family support. Here, we clarified the effect of staff encouragement and living conditions on the burden of dietary restrictions in HD patients. This retrospective cohort study was conducted using data from the Dialysis Outcomes and Practice Patterns Study (DOPPS) I and III. We enrolled patients aged 18–75 years on HD therapy for at least 3u2009months. We categorized patients into four groups based on combinations of level of staff encouragement (high or low) and living condition (alone or with family) at baseline survey. Patients who felt they received high staff encouragement and lived with their family were set as the control. The main outcome was increase in patients perceived burden of dietary restriction after 1u2009year. 1377 (69.1%) felt they received high staff encouragement, and 176 (9.1%) were living alone. After 1u2009year, 537 (26.9%) patients reported feeling an increased burden of dietary restriction. A low level of staff encouragement did not increase the burden in any patients, regardless of living situation. However, a high level of staff encouragement did increase the burden in patients living alone (adjusted odds ratio: 1.57, 95% confidence interval: 1.05–2.36). We observed an unexpected association between high staff encouragement and increased burden of dietary restriction among patients living alone. Staff encouragement may not relieve patients burden with respect to dietary restriction and may in fact exacerbate it.

Association Between Subjective Sleep Quality and Future Risk of Falls in Older People: Results From LOHAS

BackgroundnInadequate sleep is correlated with morbidity and mortality among older adults. However, the longitudinal relationship between subjective sleep quality and risk of falls in the elderly population remains to be clarified.nnnMethodsnStudy participants were from Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS) sites (1,071 community-dwelling people ≧65 years of age, mean: 71 years). Subjective sleep quality was measured by the Pittsburgh Sleep Quality Index (PSQI). Occurrence of falls (defined as experiencing at least one fall) during the subsequent year was ascertained by a self-reported questionnaire.nnnResultsnMean global PSQI score was 4.3 (SD 3.2), with 28.9% of participants rating their sleep quality as poor (PSQI > 5). A total of 210 participants (19.6%) fell at least once in the year following sleep examination. Multivariable analysis revealed that participants reporting worse subjective sleep quality had significantly higher odds of experiencing falls during the 1-year follow-up period (adjusted odds ratio [AOR] = 1.50 for each three-point increase in global PSQI score; 95% confidence interval [CI] = 1.20, 1.89). Participants in the highest global PSQI score (PSQI > 5) quartile had significantly increased odds of experiencing falls compared to those in the lowest global score quartile (PSQI < 2; AOR = 2.14; 95% CI = 1.09, 4.22). This association was similarly significant in subgroup analyses for older men and women, nonusers of sleep medication, and those without a history of falls at baseline.nnnConclusionnSubjective poor sleep quality, as measured by the PSQI, is longitudinally associated with greater risk of experiencing falls in community-dwelling older adults.

Association between post-dialysis hemoglobin level and the survival of vascular access

Introduction: Although a few dialysis facilities conduct a complete blood cell count for some patients at post-dialysis, including hemoglobin, clinical findings supporting the interpretation of results are scarce. The aim of this study was to investigate the association between post-dialysis hemoglobin level and vascular access failure with clinical data. Methods: Study design: Case crossover design. Setting: Japanese dialysis facilities, which routinely take post-dialysis blood samples, including complete blood cell counts at least once a month. Participants: Hemodialysis patients who experienced vascular access failure in January 2010 until December 2014. Exposure: Post-dialysis hemoglobin level. Main outcome: Vascular access failure treated with endovascular treatment or operation. Statistical analysis: Self-matched odds ratios and 95% confidence intervals were estimated by comparing post-dialysis hemoglobin just before events (“case”) with levels at 6 and 12 months before events (“control”) using conditional logistic regression, and presented with restricted cubic spline. Results: Two hundred and thirty hemodialysis patients with vascular access failure were identified. Mean post-dialysis hemoglobin level before the failure was 11.8 g/dL (standard deviation 1.7). The spline curve showed that higher post-dialysis hemoglobin levels above 11.8 g/dL had a greater odds ratio for vascular access failure. Post-dialysis hemoglobin levels and odds ratios (95% confidence interval) for vascular access failure relative to the reference value (Hb 11.8 g/dL) were Hb 12.0 g/dL, 1.1 (1.0-1.1); Hb 14.0 g/dL, 1.4 (1.0-2.0); and Hb 16.0 g/dL, 2.1 (1.1-4.3). Conclusions: A higher post-dialysis hemoglobin level was associated with vascular access failure. Higher post-dialysis Hb could be a factor that triggers vascular access failure.

Association between spinal immobilization and survival at discharge for on-scene blunt traumatic cardiac arrest: A nationwide retrospective cohort study

INTRODUCTIONnSpinal immobilization has been indicated for all blunt trauma patients suspected of having cervical spine injury. However, for traumatic cardiac arrest (TCA) patients, rapid transportation without compromising potentially reversible causes is necessary. Our objective was to investigate the temporal trend of spinal immobilization for TCA patients and to examine the association between spinal immobilization and survival.nnnMETHODSnWe conducted a retrospective cohort study using the Japan Trauma Data Bank 2004-2015 registry data. Our study population consisted of adult blunt TCA patients encountered at the scene of a trauma. The primary outcome was the survival proportion at hospital discharge, and the secondary outcome was the proportion achieving return of spontaneous circulation (ROSC). We examined the association between spinal immobilization and these outcomes using a logistic regression model based on imputed data sets with the multiple imputation method to account for missing data.nnnRESULTSnAmong 4313 patients who met the inclusion criteria, 3307 (76.7%) were immobilized. The proportion of patients that underwent spinal immobilization gradually decreased from 82.7% in 2004-2006 to 74.0% in 2013-2015. 1.0% of immobilized and 0.9% of non-immobilized patients had severe cervical spine injury. Spinal immobilization was significantly associated with lower survival at discharge (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.42 to 0.98) and ROSC by admission (OR, 0.48; 95%CI, 0.27 to 0.87). There was no significant sub-group difference of the association between spinal immobilization and survival at discharge by patients with or without cervical spine injury (p for interaction 0.73).nnnCONCLUSIONnSpinal immobilization is widely used even for blunt TCA patients, even though it is associated with a lower rate of survival at discharge and ROSC by admission. According to these results, we suggest that spinal immobilization should not be routinely recommended for all blunt TCA patients.

Computed tomography during initial management and mortality among hemodynamically unstable blunt trauma patients: a nationwide retrospective cohort study

BackgroundAlthough many hemodynamically unstable trauma patients undergo computed tomography (CT) to identify a source of bleeding, this practice is currently only recommended by a few guidelines. To clarify whether CT has harmful effects among these patients, we examined the association between CT during initial management and mortality among unstable blunt trauma patients.MethodsThis was a retrospective cohort study based on Japan Trauma Data Bank 2004–2014 registry data. Study population was adult blunt trauma patients with hypotension on arrival. The primary outcome was the in-hospital mortality. Two types of analyses were performed to adjust for confounding factors including propensity score inverse probability of treatment weighted (IPTW) and instrumental variable (IV) analysis.ResultsAmong 5,809 patients who met inclusion criteria, 5,352 (92.1%) underwent CT. The No CT group was more likely to have severe physiological conditions and lower probability of survival than those of the CT group. In IPTW analysis adjusting for measured confounders, we found a significant protective effect of undergoing CT on in-hospital mortality (excess deaths: −20.6 per 100 patients, 95% CI −26.2 to −14.9). In IV analysis adjusting both for measured and unmeasured confounders, the association between CT and mortality was not statistically significant (excess deaths: −4.1 per 100 patients, 95% CI −23.1 to 14.8).DiscussionWe did not find clinically meaningful harmful effect of CT on survival for unstable blunt trauma patients even after adjusting both for measured and unmeasured confounders.Conclusions Our results did not support the recommendation of current guideline. We suggest physicians should consider CT as one of the diagnostic options even when patients are unstable.

Multimorbidity patterns in relation to polypharmacy and dosage frequency: a nationwide, cross-sectional study in a Japanese population

In the present study, we aimed to identify multimorbidity patterns in a Japanese population and investigate whether these patterns have differing effects on polypharmacy and dosage frequency. Data was collected on 17 chronic health conditions via nationwide cross-sectional survey of 3,256 adult Japanese residents. Factor analysis was performed to identify multimorbidity patterns, and associations were determined with excessive polypharmacy [concurrent use ofu2009≥u200910 prescription or over-the-counter (OTC) medications] and higher dosage frequency (u2009≥u20093 doses per day). Secondary outcomes were the number of concurrent prescription medications and the number of concurrent OTC medications. We used a generalized linear model to adjust for individual sociodemographic characteristics. Five multimorbidity patterns were identified: cardiovascular/renal/metabolic, neuropsychiatric, skeletal/articular/digestive, respiratory/dermal, and malignant/digestive/urologic. Among these patterns, malignant/digestive/urologic and cardiovascular/renal/metabolic patterns showed the strongest associations with excessive polypharmacy and the number of concurrent OTC medications. Malignant/digestive/urologic, respiratory/dermal, and skeletal/articular/digestive patterns were also associated with higher dosage frequency. Multimorbidity patterns have differing effects on excessive polypharmacy and dosage frequency. Malignant/digestive/urologic pattern may be at higher risk of impaired medication safety and increased treatment burden, than other patterns. Continued study is warranted to determine how to incorporate multimorbidity patterns into risk assessments of polypharmacy and overall treatment burden.

Increased Mortality Rate after Hospitalization Among Chronic Hemodialysis Patients: A Prospective Cohort Study

Background/Aims: Hemodialysis patients are at high risk of hospitalization and their condition may worsen with repeated hospitalization. The aim of this study was to evaluate the impact of the cumulative number of hospitalizations on post-discharge mortality. Methods: This study was a prospective cohort study. We examined 3,359 adult patients on hemodialysis for at least 90 days who participated in the Japanese Dialysis Outcomes and Practice Patterns Study phases 3 and 4 (2005–2012). The patients hospitalized within 3 months before enrollment were excluded. The main exposure was the time-varying cumulative number of hospitalizations during the follow-up period. Hazard ratios (HRs) for all-cause mortality rate after discharge were estimated by time-dependent Cox regressions after adjusting for potential confounders. Results: The median follow-up time was 2.7 years, and 873 (26%) patients experienced at least 1 hospitalization during follow-up. The hospitalization rate was 0.23 per person-year and the mortality rate was 0.036 per person-year. The HR and 95% CI for post-discharge mortality increased as the cumulative number of hospitalizations increased: once, 1.41 (0.99–2.00); and twice or more, 2.27 (1.59–3.23). The cause-specific hospitalization categories, “infectious disease” and “cancer,” affected post-discharge mortality HRs in a similar manner: 2.41(1.32–4.41) and 2.70 (1.23–5.93), respectively. Conclusion: A higher cumulative number of hospitalizations is associated with increased post-discharge mortality in chronic hemodialysis patients. The cause-specific hospitalizations category of “infectious disease” showed an impact on mortality similar to that of hospitalization for “cancer.” Therefore, physicians should pay more attention to reducing preventable hospitalizations.

Effect of Patient Experience on Bypassing a Primary Care Gatekeeper: a Multicenter Prospective Cohort Study in Japan

BackgroundTo discuss how best to implement the gatekeeping functionality of primary care; identifying the factors that cause patients to bypass their primary care gatekeepers when seeking care should be beneficial.ObjectiveTo examine the association between patient experience with their primary care physicians and bypassing them to directly obtain care from higher-level healthcare facilities.Design and MethodsThis prospective cohort study was conducted in 13 primary care clinics in Japan. We assessed patient experience of primary care using the Japanese version of Primary Care Assessment Tool (JPCAT), which comprises six domains: first contact, longitudinality, coordination, comprehensiveness (services available), comprehensiveness (services provided), and community orientation. The primary outcome was the patient bypassing their usual primary care physician to seek care at a hospital, with this occurring at least once in a year. We used a Bayesian hierarchical model to adjust clustering within clinics and individual covariates.Key ResultsData were analyzed from 205 patients for whom a physician at a clinic served as their usual primary care physician. The patient follow-up rate was 80.1%. After adjustment for patients’ sociodemographic and health status characteristics, the JPCAT total score was found to be inversely associated with patient bypass behavior (odds ratio per 1 SD increase, 0.44; 95% credible interval, 0.21–0.88). The results of various sensitivity analyses were consistent with those of the primary analysis.ConclusionsWe found that patient experience of primary care in Japan was inversely associated with bypassing a primary care gatekeeper to seek care at higher-level healthcare facilities, such as hospitals. Our findings suggest that primary care providers’ efforts to improve patient experience should help to ensure appropriate use of healthcare services under loosely regulated gatekeeping systems; further studies are warranted.