Participation in introductory APIB training at the Colorado NIDCAP Center-Report on the training and its applicability to future studies-

本研修の目的は,新生児・早産児行動評価(Assessment of Term and Preterm Infant Behavior:APIB 1))を研究に活用するため,その具体的な方法を学ぶことであった.今回,国際NIDCAP®連盟(Newborn Individualized Developmental Care and Assessment Program FederationInternational:NFI)が認定する公式のトレーニング施設,Colorado NIDCAPセンターにおいて,2013年9月7日～8日の2日間,APIBの導入研修に参加する機会を得た.NFIは米国マサチューセッツ州ボストンに本部を置き,北米,南米,ヨーロッパに20のトレーニング施設を認定し,包括的で質の高いトレーニングとコンサルテーションの機会を提供している.APIBは,正期産児を対象とする新生児行動評価(Neonatal Behavioral Assessment Scale:NBAS 2))を,早産児と発達上のリスクを持つ新生児に適合するように開発された評価法であり,新生児と観察者の相互作用を通して,中枢神経系の組織化の状態と受け入れられる刺激を評価し,発達の評価や発達支援の方策を考案するために用いられている.APIBを研究に活用する際は,評価者としての認定が必要であり,トレーニングは「準備の段階」「導入トレーニング」「自主トレーニングおよび指導者との調整(中間評価)」「信頼性の評価」の4段階からなる.今回参加した導入研修では,APIBの基盤となる理論と実際の評価法を学び,評価の進め方とスコア化の基準を理解するとともに,早産児の現在の状態と受け入れられる刺激を評価することの重要性を知ることができた.本稿では,研修内容および今後の研究への活用性について報告する

Consort 2010 checklist.

ObjectiveHypokalemia is associated with increased risk of arrhythmias and it is recommended to monitor plasma potassium (p-K) regularly in at-risk patients with cardiovascular diseases. It is poorly understood if administration of potassium supplements and mineralocorticoid receptor antagonists (MRA) aimed at increasing p-K also increases intracellular potassium.MethodsAdults aged≥18 years with an implantable cardioverter defibrillator (ICD) were randomized (1:1) to a control group or to an intervention that included guidance on potassium rich diets, potassium supplements, and MRA to increase p-K to target levels of 4.5–5.0 mmol/l for six months. Total-body-potassium (TBK) was measured by a Whole-Body-Counter along with p-K at baseline, after six weeks, and after six months.ResultsFourteen patients (mean age: 59 years (standard deviation 14), 79% men) were included. Mean p-K was 3.8 mmol/l (0.2), and mean TBK was 1.50 g/kg (0.20) at baseline. After six-weeks, p-K had increased by 0.47 mmol/l (95%CI:0.14;0.81), p = 0.008 in the intervention group compared to controls, whereas no significant difference was found in TBK (44 mg/kg (-20;108), p = 0.17). After six-months, no significant difference was found in p-K as compared to baseline (0.16 mmol/l (-0.18;0.51), p = 0.36), but a significant increase in TBK of 82 mg/kg (16;148), p = 0.017 was found in the intervention group compared to controls.ConclusionsIncreased potassium intake and MRAs increased TBK gradually and a significant increase was seen after six months. The differentially regulated p-K and TBK challenges current knowledge on potassium homeostasis and the time required before the full potential of p-K increasing treatment can be anticipated.Trial registrationwww.clinicaltrials.gov (NCT03833089).</div

POTCAST study protocol.

ObjectiveHypokalemia is associated with increased risk of arrhythmias and it is recommended to monitor plasma potassium (p-K) regularly in at-risk patients with cardiovascular diseases. It is poorly understood if administration of potassium supplements and mineralocorticoid receptor antagonists (MRA) aimed at increasing p-K also increases intracellular potassium.MethodsAdults aged≥18 years with an implantable cardioverter defibrillator (ICD) were randomized (1:1) to a control group or to an intervention that included guidance on potassium rich diets, potassium supplements, and MRA to increase p-K to target levels of 4.5–5.0 mmol/l for six months. Total-body-potassium (TBK) was measured by a Whole-Body-Counter along with p-K at baseline, after six weeks, and after six months.ResultsFourteen patients (mean age: 59 years (standard deviation 14), 79% men) were included. Mean p-K was 3.8 mmol/l (0.2), and mean TBK was 1.50 g/kg (0.20) at baseline. After six-weeks, p-K had increased by 0.47 mmol/l (95%CI:0.14;0.81), p = 0.008 in the intervention group compared to controls, whereas no significant difference was found in TBK (44 mg/kg (-20;108), p = 0.17). After six-months, no significant difference was found in p-K as compared to baseline (0.16 mmol/l (-0.18;0.51), p = 0.36), but a significant increase in TBK of 82 mg/kg (16;148), p = 0.017 was found in the intervention group compared to controls.ConclusionsIncreased potassium intake and MRAs increased TBK gradually and a significant increase was seen after six months. The differentially regulated p-K and TBK challenges current knowledge on potassium homeostasis and the time required before the full potential of p-K increasing treatment can be anticipated.Trial registrationwww.clinicaltrials.gov (NCT03833089).</div

Baseline characteristics for patients in the intervention (n = 7) and control group (n = 7).

Baseline characteristics for patients in the intervention (n = 7) and control group (n = 7).</p

Supplementary appendix.

ObjectiveHypokalemia is associated with increased risk of arrhythmias and it is recommended to monitor plasma potassium (p-K) regularly in at-risk patients with cardiovascular diseases. It is poorly understood if administration of potassium supplements and mineralocorticoid receptor antagonists (MRA) aimed at increasing p-K also increases intracellular potassium.MethodsAdults aged≥18 years with an implantable cardioverter defibrillator (ICD) were randomized (1:1) to a control group or to an intervention that included guidance on potassium rich diets, potassium supplements, and MRA to increase p-K to target levels of 4.5–5.0 mmol/l for six months. Total-body-potassium (TBK) was measured by a Whole-Body-Counter along with p-K at baseline, after six weeks, and after six months.ResultsFourteen patients (mean age: 59 years (standard deviation 14), 79% men) were included. Mean p-K was 3.8 mmol/l (0.2), and mean TBK was 1.50 g/kg (0.20) at baseline. After six-weeks, p-K had increased by 0.47 mmol/l (95%CI:0.14;0.81), p = 0.008 in the intervention group compared to controls, whereas no significant difference was found in TBK (44 mg/kg (-20;108), p = 0.17). After six-months, no significant difference was found in p-K as compared to baseline (0.16 mmol/l (-0.18;0.51), p = 0.36), but a significant increase in TBK of 82 mg/kg (16;148), p = 0.017 was found in the intervention group compared to controls.ConclusionsIncreased potassium intake and MRAs increased TBK gradually and a significant increase was seen after six months. The differentially regulated p-K and TBK challenges current knowledge on potassium homeostasis and the time required before the full potential of p-K increasing treatment can be anticipated.Trial registrationwww.clinicaltrials.gov (NCT03833089).</div

Study protocol.

ObjectiveHypokalemia is associated with increased risk of arrhythmias and it is recommended to monitor plasma potassium (p-K) regularly in at-risk patients with cardiovascular diseases. It is poorly understood if administration of potassium supplements and mineralocorticoid receptor antagonists (MRA) aimed at increasing p-K also increases intracellular potassium.MethodsAdults aged≥18 years with an implantable cardioverter defibrillator (ICD) were randomized (1:1) to a control group or to an intervention that included guidance on potassium rich diets, potassium supplements, and MRA to increase p-K to target levels of 4.5–5.0 mmol/l for six months. Total-body-potassium (TBK) was measured by a Whole-Body-Counter along with p-K at baseline, after six weeks, and after six months.ResultsFourteen patients (mean age: 59 years (standard deviation 14), 79% men) were included. Mean p-K was 3.8 mmol/l (0.2), and mean TBK was 1.50 g/kg (0.20) at baseline. After six-weeks, p-K had increased by 0.47 mmol/l (95%CI:0.14;0.81), p = 0.008 in the intervention group compared to controls, whereas no significant difference was found in TBK (44 mg/kg (-20;108), p = 0.17). After six-months, no significant difference was found in p-K as compared to baseline (0.16 mmol/l (-0.18;0.51), p = 0.36), but a significant increase in TBK of 82 mg/kg (16;148), p = 0.017 was found in the intervention group compared to controls.ConclusionsIncreased potassium intake and MRAs increased TBK gradually and a significant increase was seen after six months. The differentially regulated p-K and TBK challenges current knowledge on potassium homeostasis and the time required before the full potential of p-K increasing treatment can be anticipated.Trial registrationwww.clinicaltrials.gov (NCT03833089).</div

CONSORT flow-chart of patient inclusion and follow-up.

CONSORT flow-chart of patient inclusion and follow-up.</p

Difference in changes between groups from baseline (reference) at six-weeks, and six-months with 95% intervals of confidence from a mixed linear random effects regression model.

Difference in changes between groups from baseline (reference) at six-weeks, and six-months with 95% intervals of confidence from a mixed linear random effects regression model.</p