PMID: 9601624 [PubMed - indexed for MEDLINE]

㈽

片頭痛もちの人口サンプルにおける頭痛の疾患重症度測定法の信頼性について

173人の片頭痛もちが登録された．試験再試験相関係数は0.65〜0.93だった．

MeSH Terms:
•  Activities of Daily Living/classification
•  Adult
•  Female
•  Humans
•  Male
•  Maryland/epidemiology
•  Mass Screening
•  Middle Aged
•  Migraine/classification
•  Migraine/diagnosis*
•  Migraine/epidemiology
•  Pain Measurement/statistics & numerical data
•  Questionnaires
•  Reproducibility of Results
•  Research Support, Non-U.S. Gov't
•  Research Support , U.S. Gov't, P.H.S.
Severity of Illness Index*

2) Stewart WF, Lipton RB, Kolodner KB, Sawyer J, Lee C, Liberman JN.
　 Validity of the Migraine Disability Assessment (MIDAS) score in
　 comparison to a diary-based measure in a population sample of
　 migraine sufferers. Pain. 2000 Oct;88(1):41-52.

論文抄録

The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered questionnaire designed to quantify headache-related disability over a 3 month period. The MIDAS score has been shown to have moderately high test-retest reliability in headache sufferers and is correlated with clinical judgment regarding the need for medical care. The aim of the study was to examine the validity of the MIDAS score, and the five items comprising the score, compared to data from a 90 day daily diary used, in part, to record acute disability from headache. In a population-based sample, 144 clinically diagnosed migraine headache sufferers were enrolled in a 90 day diary study and completed the MIDAS questionnaire at the end of the study. The daily diary was used to record detailed information on headache features as well as activity limitations in work, household chores, and non-work activities (social, family and leisure activities). The MIDAS score was the sum of missed work or school days, missed household chores days, missed non-work activity days, and days at work or school plus days of household chores where productivity was reduced by half or more in the last 3 months. Validity was assessed by comparing MIDAS items and the MIDAS score with equivalent measures derived from the diary. The MIDAS items for missed days of work or school (mean 0.96, median 0) and for missed days of household work (mean 3.64, median 2.0) were similar to the corresponding diary-based estimates of missed work or school (mean 1.23, median 0) and of missed household work (mean 3.93, median 2.01). Values for missed days of non-work activities (MIDAS mean 2.6 and median 1 versus diary mean 2.22 and median 0.95) were also similar. Responses to MIDAS questions about number of days where productivity was reduced by half or more in work (mean 3.77, median 2.00) and in household work (mean 3.92, median 2.00) significantly overestimated the corresponding diary-based measures for work (mean 2.94, median 1.06) and household work (mean 2.22, median 0.98). Nonetheless, the overall MIDAS score (mean 14.53, median 9.0) was not significantly different form the reference diary-based measure (mean 13.5, median 8.4). The correlation between the MIDAS summary score and an equivalent diary score was 0.63. The group estimate of the MIDAS score was found to be a valid estimate of a rigorous diary-based measure of disability. The mean and median values for the MIDAS score in a population-based sample of migraine cases were similar to equivalent diary measures. The correlation between the two measures was in the low moderate range, but expected given that two very different methods of data collection were compared.

文献 PubMed−ID

PMID: 11098098

エビデンスレベル

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文献タイトル (日本語)

片頭痛もちの人口標本における MIDASスコアの妥当性

目的

MIDASスコアとスコアとなる5項目を90日間の頭痛日記から得られるデータと比較して妥当性を評価することである．

研究デザイン

Validation studies

研究施設

記載なし

研究期間

3 November 1997 and 10 December 1997 .

対象患者

メリーランド州ボルチモアの電話インタビューを受けた片頭痛もち 884名のうちランダムに選ばれた426名

介入

メリーランド州ボルチモアの住人に電話インタビュー（ clinically validated computer-assisted telephone interview ;CATI）を行い対象者を集め，同意を得た後に妥当性調査に参加させた．対象者は90日間の頭痛日記を記入後MIDAS質問票を記入する．

主要評価項目とそれに用いた統計学的手法

MIDASの質問項目とスコアの妥当性を検討するため90日間の日記から得られるデータの平均値，中央値を算出

結果

仕事及び学校を休んだ日数およｂひ家事不能だった日数および仕事以外の活動が不能だった日数日記から得られた値と類似していた．仕事と家事の生産性が半減舌日数は MIDASスコアが日記スコアより過大評価されていた．全体のMIDASスコアは日記スコアと大きな差異は認められなかった．MIDASの合計スコアと日記から得られた合計スコアの相関は0.63だった．

結論

MIDASスコアで見積もられたグループは日記に基づいた支障度の計測値の見積もりと妥当であることが示された．人口ベース標本におけるMIDASスコアの平均値，中央値は日記の計測値と類似していた．

コメント

研究およびレポートの質は高い．

備考

Publication Types:　Validation studies
MeSH Terms:
•  Absenteeism
•  Adult
•  Comparative Study
•  Disability Evaluation*
•  Efficiency
•  Female
•  Human
•  Male
•  Medical Records*
•  Middle Aged
•  Migraine/physiopathology*
•  Questionnaires
•  Support, Non-U.S. Gov't

作成者

飯ｹ谷美峰

3) Bayliss MS, Dewey JE, Dunlap I, Batenhorst AS, Cady R, Diamond ML,
　 Sheftell F.A study of the feasibility of Internet administration of a
　 computerized health survey: the headache impact test (HIT). Qual Life
　 Res. 2003 Dec;12(8):953-61

論文抄録

BACKGROUND: Headache impact test (HIT) is a precise, practical tool that quantifies the impact of headache on respondents' lives. It is the first widely-available dynamic health assessment (DynHA). Applications of this brief, precise survey include population based screening for disabling headaches, tracking of individual patient scores over time, disease management programs and others. We use data from Internet HIT assessments during the fall of 2000 to (1) evaluate characteristics of respondents and assessments, (2) assess the utility of joint administration of HIT and the SF-8 Health Survey (SF-8) to screen for migraine and depression, and (3) explore associations between HIT scores and subsequent healthcare-related attitudes and behaviors. METHODS: We analyzed Internet HIT surveys completed between 9/1 and 11/30/2000 (n = 19,195). Subsamples include respondents who also completed (1) a 12-item Internet survey assessing severity, frequency, cause and management of headaches; (2) an e-mail survey measuring healthcare-related behaviors; (3) the SF-8; or (4) the website registration process, providing age and gender data. We used analysis of variance (ANOVA) to evaluate HIT score differences associated with age, gender, headache severity or frequency, and healthcare-related behaviors and attitudes and chi2 tests to assess the prevalence and comorbidity of migraine and depression. RESULTS: Three-quarters of respondents achieved a precise HIT score in < or = 5 items. Most had moderate/severe headaches; 65% had headaches at least monthly. HIT scores were directly related to headache severity and frequency. Most respondents were females, with significantly higher HIT scores than males. Most HIT respondents were between ages 25 and 54 (HIT scores were higher for younger respondents). Sixty four percent screened positive for migraine; 20% for depression. Both conditions were more prevalent among females than males. Comorbid migraine and depression was 50% more prevalent among females and increased with age until age 50. Patients with worse headache impact were more likely to seek care, discuss headaches with their providers and find HIT useful. CONCLUSIONS: It is feasible to use Internet-based dynamic assessments to measure health status. These data complement previous results showing that HIT differentiates respondents according to headache characteristics (severity and frequency). HIT plus SF-8 yields a practical screen for migraine and depression in headache patients and may lead to more effective treatment for patients with these conditions. Preliminary findings suggest that the experience of taking HIT on the Internet may motivate headache patients to seek care and discuss headaches with their providers.

文献 PubMed−ID

PMID: 14651414

エビデンスレベル

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文献タイトル (日本語)

インターネットで行なうコンピュータ化された健康調査の実用性についての研究； Headahce Impact Test(HIT)

目的

インターネット HITからのデータをもとに㈰回答者とそのHIT内容の特徴を評価する．㈪片頭痛とうつのスクリーニングとしてHITとSF-8の連結評価の有用性を検討する．㈫HITスコアと体調に基づく行動の関連性を検討する．

研究デザイン

Internet survey

研究施設

不明

研究期間

2000年9月1日〜11月30日

介入

19195名に電話調査を行った．
Internet Study;12項目の重度，頻度，原因，頭痛管理，を評価
Email Survey：ヘルスケア関連の行動の測定（SF8）
Analysis of Variance(ANOVA)

主要評価項目とそれに用いた統計学的手法

年齢・性別・頭痛の重度と頻度，ヘルスケア関連行動に関連した HITスコアの違いを評価．
Chi2 test：片頭痛とうつの有病率とcomorbidityを評価する．

結果

中等度から十度の片頭痛はほとんどの症例．
65％は少なくとも連日の頭痛を有していた．

結論

健康状態を計測するためインターネットベースの評価法と HITは実用可能である．

備考1

MeSH Terms:
•  Adolescent
•  Adult
•  Aged
•  Computer Systems
•  Feasibility Studies
•  Female
•  Headache/physiopathology*
•  Humans
•  Internet*
•  Male
•  Middle Aged
•  Psychometrics
•  Quality of Life
•  Questionnaires*
•  Sickness Impact Profile*

備考２

HITへのアクセス
www.amIhealthy.com , www.headachetest.com ,

作成者

飯ｹ谷美峰

4) Kosinski M, Bayliss MS, Bjorner JB, Ware JE Jr, Garber WH, Batenhorst
　 A, Cady R, Dahlof CG, Dowson A, Tepper S. A six-item short-form
　 survey for measuring headache impact: the HIT-6. Qual Life Res. 2003
　 Dec;12(8):963-74.

文献 PubMed−ID

PMID: 14651415

エビデンスレベル

㈽

文献タイトル (日本語)

頭痛のインパクトを計測するための 6項目のショートフォーム調査：HIT-6

目的

臨床研究や診療において患者のスクリーニングやモニタリングに使用しうる信頼性，妥当性を有する簡潔で幅広い内容を持った頭痛インパクトを評価する HIT-6の開発をする．

介入

HIT-6能項目は既存の54項目と臨床かによって提案された35項目から選択された．選択項目は妥当性，項目反応セオリー（IRT）情報機能，内的整合性，スコアの配分，言語的分析に基づいて修正された．HIT-6はアメリカオンライン（AOL）のメンバーからなる1103名の頭痛患者のインターネット調査で評価された．14日後の540名に対して追跡調査を行なった．

結果

HIT-6の内的整合性；0.89，交替配列型0.90，試験再試験信頼度0.80であった．

結論

頭痛のインパクトを計測するために広く用いられている項目を見積もる IRTモデルは，患者の成果をスクリーニングしたりモニタリングするための，有効で信頼性と妥当性を有するショートフォーム（HIT-6）を構築するのに有用であった．

備考

MeSH Terms:
•  Adult
•  Calibration
•  Headache/physiopathology*
•  Humans
•  Internet*
•  Psychometrics
•  Quality of Life
•  Questionnaires*
•  Sickness Impact Profile*
•  United States

作成者

飯ｹ谷美峰

6) Davies GM, Santanello N, Gerth W, Lerner D, Block GA. Validation of a
　 migraine work and productivity loss questionnaire for use in migraine
　 studies. Cephalalgia. 1999 Jun;19(5):497-502.

論文抄録

Migraine symptoms and therapy side effects cause significant functional disability that can result in work and productivity losses. Effective, well-tolerated migraine therapy with rapid onset of relief could decrease work and productivity losses. The Migraine Work and Productivity Loss Questionnaire (MWPLQ) evaluates the impact of migraine and migraine therapy on paid work. Data from a randomized, open-label extension study were collected over 3 months. Migraineurs were randomized to either rizatriptan (5HT1B/1D receptor agonist) or their usual migraine therapy. Data were analyzed from 164 patients who experienced at least one work-related migraine. Internal consistency (Cronbach's alpha) for the work difficulty domains ranged from 0.80 to 0.95. Work loss and work difficulty were moderately correlated (r = 0.39-0.58) with migraine severity and functional ability. Differences were found favoring rizatriptan for absenteeism (1.3 vs 2.4 h), effectiveness at work (62% vs 49%), and difficulty with work-related tasks (p < 0.01). The MWPLQ demonstrated favorable measurement characteristics in this study and could be an important research tool for future evaluations of migraine-related work disability.

文献 PubMed−ID

PMID: 10403065

エビデンスレベル

Ib

文献タイトル (日本語)

片頭痛研究に用いるための労働と生産性の減損質問票の妥当性評価

目的

片頭痛による労働と生産性の損失質問票（ MWPLQ）の測定法としての特徴（内的一貫性，妥当性）を決定する

研究デザイン

Randomized Controlled studies

研究施設

記載なし

研究期間

記載なし

対象患者

片頭痛患者 313人のうち265人がオープンラベル延長相に登録された．

介入

登録された頭痛患者を再ランダム化してリザトリプタン 10mg
内服群とこれまでどおりの治療継続群にわけた．労働に関連して生じた片頭痛が 1回はあった164例からデータは解析された．

主要評価項目とそれに用いた統計学的手法

仕事の損失のフォーミュラ：有給労働の損失時間＋ (1.00分％有効性/100)×片頭痛とともに働いた時間＝仕事が不能となった時間　として計算した．Spearmanの相関係数を用いてランダムに選んだ頭痛の重症度と機能的支障を評価した．

結果

内的整合性（ Cronbach　α）は0.80から0.95であった．
仕事の喪失と仕事の困難さは片頭痛の重症度と機能的能力と適度な相関がみられた (r=0.39-0.58) ．
データは，リザトリプタンを用いた場合の長期欠勤率（ 1.3時間対2.4時間），労働についての有効性（62％対49％）と仕事に関連した課題（ｐ＜0.01）の困難さにおいて差異が認められた．

結論

本研究により MWPLQの測定法としての有用性が示された．MWPLQは片頭痛によって生じる労働障害の見通し評価のための重要な調査ツールとなりうる．

備考１

MeSH Terms:
•  Absenteeism*
•  Adult
•  Disability Evaluation*
•  Female
•  Humans
•  Male
•  Middle Aged
•  Migraine/diagnosis
•  Migraine/drug therapy
•  Migraine/epidemiology*
•  Reproducibility of Results
•  Serotonin Agonists/adverse effects
•  Serotonin Agonists/therapeutic use
•  Sickness Impact Profile*
•  Triazoles/adverse effects
•  Triazoles/therapeutic use

備考２

Publication Types:
•  Clinical Trial
•  Randomized Controlled Trial

備考 3

Substances:
•  Serotonin Agonists
•  Triazoles
•  rizatriptan

作成者

飯ｹ谷美峰

7) Cramer JA, Silberstein SD , Winner P. Development and validation of
　 the Headache Needs Assessment (HANA) survey.Headache. 2001
　 Apr;41(4):402-9.

論文抄録

OBJECTIVE: To develop and validate a brief survey of migraine-related quality-of-life issues. The Headache Needs Assessment (HANA) questionnaire was designed to assess two dimensions of the chronic impact of migraine (frequency and bothersomeness). METHODS: Seven issues related to living with migraine were posed as ratings of frequency and bothersomeness. Validation studies were performed in a Web-based survey, a clinical trial responsiveness population, and a retest reliability population. Headache characteristics (eg, frequency, severity, and treatment), demographic information, and the Headache Disability Inventory were used for external validation. RESULTS: The HANA was completed in full by 994 adults in the Web survey, with a mean total score of 77.98 +/- 40.49 (range, 7 to 175). There were no floor or ceiling effects. The HANA met the standards for validity with internal consistency reliability (Cronbach alpha =.92, eigenvalue for the single factor = 4.8, and test-retest reliability = 0.77). External validity showed a high correlation between HANA and Headache Disability Inventory total scores (0.73, P<.0001), and high correlations with disease and treatment characteristics. CONCLUSIONS: These data demonstrate the psychometric properties of the HANA. The brief questionnaire may be a useful screening tool to evaluate the impact of migraine on individuals. The two-dimensional approach to patient-reported quality of life allows individuals to weight the impact of both frequency and bothersomeness of chronic migraines on multiple aspects of daily life.

文献 PubMed−ID

PMID: 11318888

エビデンスレベル

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文献タイトル (日本語)

頭痛の要求評価票（ HANA）の開発と妥当性調査

目的

片頭痛に関連した問題の簡潔な調査票を開発し妥当性評価する．

研究デザイン

Validation studies

研究施設

記載なし

研究期間

1999年8月までにウェブ登録を完了

対象患者

ウェブサイトにアクセスした 1800人以上の登録者のうちHANAの質問をすべて完了した994名が対象となった．

介入

片頭痛とともに生活することの 7つの問題が頭痛頻度と頭痛のわずらわしさを格付けして提示された．妥当性評価はウェブに基づく調査，臨床試験反応人口と再試験信頼性人口で行なわれた．頭痛の特徴（例；頻度，重症度，治療），人口統計学的情報とHeadache Disability Inventoryが外的妥当性評価に用いられた．

結果

ウェブ調査で 994名の成人がHANAを行ない，平均の合計スコアは77.98±40.49（範囲　7から175）だった．底効果や天井効果HANAは内的整合性信頼性（Cronbach=0.92，1因子の固有値＝4.8，試験再試験信頼性＝0.77）評価において基準を満たしていた．外的妥当性はHANAとHeadache Disability Inventoryの合計スコア間で高い相互関係を示し（0.73，P<0.001），疾患と治療特徴の相関も高かった．

結論

HANAには心理測定的特性を有すことが示された．簡潔なアンケートは片頭痛の個人へのインパクトを評価するために役立つスクリーニングツールである可能性がある．患者のQOLへの2方向からのアプローチは日常生活のいろいろな局面において慢性的な片頭痛の頻度とわずらわしさのインパクトの重み付けを可能とする．

備考１

MeSH Terms:
•  Activities of Daily Living
•  Adolescent
•  Adult
•  Aged
•  Female
•  Health Status
•  Humans
•  Internet
•  Male
•  Middle Aged
•  Migraine*/classification
•  Migraine*/complications
•  Migraine*/psychology
•  Needs Assessment
•  Psychometrics
•  Quality of Life*
•  Questionnaires*/standards
•  Reproducibility of Results
•  Research Support, Non-U.S. Gov't
•  United States

備考２

Headache Needs Assessment（HANA） Questionnaire
In the past month,･･･
Problem1: I have felt anxious or worried (tense, wound-up, frightened) about having another severe headache.
Problem 2; I have felt depressed, discouraged about my headache.
Problem 3; I have felt that I am not in control of myself because of my headaches.
Problem 4; I have had less energy; I am more tried than I should have been because of my headaches.
Problem 5;I functioned and worked (attention, concentration, etc.) at lower level than I should have because of my headaches.
Problem 6; I have felt that my family and social activities were limited because of my headaches.
Problem 7; I have felt that my life centered or revolved around my headaches.

作成者

飯ｹ谷美峰

8) Iigaya M, Sakai F, Kolodner KB, Lipton RB, Stewart WF. Reliability and
　 validity of the Japanese Migraine Disability Assessment (MIDAS)
　 Questionnaire. Headache. 2003 Apr;43(4):343-52.

論文抄録

OBJECTIVE: This study was designed to assess the test-retest reliability, internal consistency, and validity of a Japanese translation of the Migraine Disability Assessment (MIDAS) Questionnaire in a sample of Japanese patients with headache. BACKGROUND: Previous studies have demonstrated that the English-language version of the MIDAS Questionnaire is a reliable and valid instrument for the assessment of migraine-related disability. Any translations of the MIDAS Questionnaire must also be assessed for reliability and validity. METHODS: Study participants were recruited from the patient population attending either the Neurology Department of Kitasato University or an affiliated clinic. Participants were eligible for study entry if they had 6 or more primary headaches per year. For reliability testing, participants completed the MIDAS Questionnaire on 2 occasions, exactly 2 weeks apart. To assess validity, patients were also invited to participate in a 90-day daily diary study. Composite measures from the 90-day diaries were compared to equivalent MIDAS measures (ie, 5 questions on headache-related disability and 1 question each on average pain intensity and headache frequency in the last 3 months) and to the total MIDAS score obtained from a third MIDAS Questionnaire completed at the end of this 90-day period. RESULTS: One hundred one patients between the ages of 21 and 77 years were recruited (81 women and 20 men). Ninety-nine patients (80 women and 19 men) participated in the diary study. At baseline, 46.5% of patients were MIDAS grade I or II (minimal, mild, or infrequent disability), 22.2% were MIDAS grade III (moderate disability), and 31.3% were MIDAS grade IV (severe disability). Test-retest Spearman correlations for the 5 disability questions and the questions on average pain intensity and headache frequency ranged from 0.59 to 0.80 (P<.0001). The test-retest Spearman correlation coefficient for the total MIDAS score was 0.83 (P<.0001). The degree to which individual MIDAS questions correlated with the diary-based measures ranged from 0.36 to 0.88. The correlation between the total MIDAS score and the equivalent diary-based measure was 0.66. In general, the mean and median values for the MIDAS items and total MIDAS score were similar to the means and medians for the diary-based measures. However, the mean MIDAS scores for the number of days on which headache was experienced and the number of missed workdays were significantly different compared to the diary-based estimates for these items (P<.05). In addition, the mean MIDAS score for the number of days of missed housework was significantly higher than the corresponding diary-based estimate (P<.01). CONCLUSIONS: The results from this study show that the Japanese translation of the MIDAS Questionnaire is comparable with the English-language version in terms of reliability and validity.

文献 PubMed−ID

PMID: 12656705 [PubMed - indexed for MEDLINE

エビデンスレベル

Ib

文献タイトル (日本語)

MIDAS質問票日本語版の信頼性及び妥当性

目的

米国で開発された MIDAS質問票の日本語版を作成し，その有効性と信頼性を確立すること

研究デザイン

Validity study

研究施設

北里大学病院神経内科外来

研究期間

2000年7月から2000年11月までに患者を登録

対象患者

年間 6回以上の1次性頭痛を有する患者．

介入

信頼性テスト：患者に 2週間隔でMIDAS質問票を2回記入してもらう．
妥当性テスト： 3ヶ月間毎日頭痛の日記を記載してもらう．日記の作成が終了する90日目患者はに再びMIDAS質問票を記入する．これより日記から算出したMIDASスコアと90日後のMIDAS質問票から得られたスコアを比較検討する．

主要評価項目とそれに用いた統計学的手法

•  試験再試験信頼性評価
•  妥当性評価

結果

信頼性テスト；患者は 21歳から77歳までの101名(男性22名，女性81名　妥当性テスト：そのうち99人が日記調査に参加した．重症度分類ではグレード1および2は46.5％，グレード3は22.2％，グレード4は31.3％．テスト-再テスト試験における頭痛強度のスピアマン相関係数は0.59〜0.80（P<0.0001），MIDASスコアのスピアマン相関係数は0.83（P<0.0001）だった．個々の質問項目に関して係数は0.36-0.88の幅があった．妥当性テストにおいて日記とMIDASの総スコアの相関は0.66であった．

結論

本研究により MIDAS質問票日本語版の信頼性と妥当性が示された．

備考

Publication Types: Validation Studies
MeSH Terms:
・Adult
・Aged
・Disability Evaluation*
・Female
・Human
・Japan
・Language
・Male
・Middle Aged
・Migraine/classification
・Migraine/complications*
・Questionnaires/standards*
・Reproducibility of Results
・Translations
・Work

作成者

飯ヶ谷美峰