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Appendix W3A: Search Strategy Appendix W3B: Excluded Studies Appendix W3C: Included Studies Appendix W3D: Funnel Plots

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Appendix W3A Search Strategy

We used as key words the terms “smoking cessation“ and (“myocardial infarction” or “heart disease“). By searching with subject headings we only got 90 citations in Medline, 16 in PsycInfo and none in PSYNDEX. Only 22 relevant primary studies could be identified when these three sources were combined. For this reason we decided to run additional free text searches (number of hits in parentheses) with database status between 1985 and 2000.

Medline search

Search terms for CHD:

cvd (590) or cardiovascular disorder? (179) or cardiovascular disease? (8157) or coronary (26039) or coronary* (26039) or myo?ard (23) or myo?ard* (24061) or mi (6193) or myo?ardial infarction (11753) or ami (1177) or angina (5164) or angina* (5273) or cad (1520) or pavk (10) or peripheral circulatory insufficiency (2)

(Sum 51665 hits, year 1985 to 2000 and age=adult).

Search terms for smoking cessation:

smoking (23677) or smoke* (11764) or cessation (5738) or tobacco (5012) or health behavio?r (3491)

(Sum 32408 hits, year 1985 to 2000 and age=adult).

And-combination of search results for CHD and smoking cessation. (4904 hits).

PsycInfo search

Search terms for CHD:

cvd (4103) or cardiovascular disorder? (4147) or cardiovascular disease? (4140) or coronary (2727) or coronary$ (2727) or myocard (1) or myocard$ (857) or mi (756) or ami (577) or

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angina (4706) or angina$ (4710) or cad (4741) or coronary artery disease (4725) or coronary artery lesion (1946) or pavk (0) or peripheral circulatory insufficiency (0)

(Sum 6981 hits, year 1985 to 2000 and human) Search terms for smoking cessation:

smoking (6608) or smoke* (5792) or cessation (5676) or tobacco (5126) or health behavio?r

(3594)

(Sum 11425 hits, year 1985 to 2000 and human)

And-combination of search results for CHD and smoking cessation (631 hits ) PSYNDEX search

For the PSYNDEX search the terms varied.

Search terms for CHD:

cvd (4) or cardiovascular disorder? (909) or cardiovascular disease? (57) or koronar (10) or koronar* (402) or coronar (0) or coronar* (322) or myo?ard (3) or myo?ard* (314) or Herzinfarkt (329) or KHK (20) or koronare Herzkrankheit? (43) or mi (278) or ami (7) or angina* (32) or cad (69) or pavk (0) or peripheral circulatory insufficiency (1) or

Verschlußkrankheit (0) or Koronarerkrankung (7) (Sum 1581 hits, year 1985 to 2000)

Search terms for smoking cessation:

smoking (565) or smoke* (155) or cessation (198) or tobacco (461) or health behavio?r (1078)

(Sum 1591 hits, year 1985 to 2000)

And-combination of search results for CHD and smoking cessation (153 hits).

Systematic reviews of the Cochrane Library

By searching with the term “smoking” 95 reviews can be identified.

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CCTR of the Cochrane Library

The terms “cardio*” and “smoking” were used and 603 primary documents were found.

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Appendix W3B: Studies Excluded from Meta-Analysis (References were added for papers not cited in the text) Table W3B.1: Excluded Studies Section Epidemiology

Bartholomew, H.C. & Knuiman, M.W. (1998). Longitudinal analysis of the effect of smoking cessation on cardiovascular risk factors in a community sample: the Busselton study. Journal of Cardiovascular Risk, 5, 263-271: This study has an epidemiological design. Changes in cardio- vascular risk factors are assessed as endpoints. Morbidity and mortality are not assessed, and no specific intervention was carried out.

Berglund, G., Eriksson, K.F., Israelsson, B., Kjellström, T., Lindgärde, F., Mattiasson, I., Nilsson, J.A. & Stavenow, L. (1996). Cardiovascular risk groups and mortality in an urban Swedish male population: the Malmö Preventive Project. Journal of Internal Medicine, 239, 489- 497: The influence of risk factors on cardiac morbidity and mortality was presented in

comparison. This comparison, however, only was carried out in the group without risk factors and the influence of smoking was not specifically investigated.

Calori, G., D´Angelo, A., Della Valle, P., Ruotolo, G., Ferini-Strambi, L., Giusti, C., Errera, A.

& Gallus, G. (1996). The effects of cigarette smoking on cardiovascular risk factors: a study of monozygotic twins discordant for smoking. Thrombosis and Haemostasis, 75, 14-18: Highly selective sample (n = 27), only twins with differing smoking status were included. Morbidity and mortality were not analysed as endpoints.

Dobson, A.J., Alexander, H.M., Heller, R.F. & Lloyd, D.M. (1991). How soon after quitting smoking does risk of heart attack decline? Journal of Clinical Epidemiology, 44, 1247-1253:

Case control study, which assesses cardiac mortality and morbidity as joint dependent / outcome measure.

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Freund, K.M., Belanger, A.J., D’Agostino, R.B. & Kannel, W. (1993). The health risks of smoking. The Framingham Study: 34 years of follow-up. Annals of Epidemiology, 3, 417-424:

FRAMINGHAM: The authors do not state how many of the polled people smoked. The reported Odds ratios cannot be converted due to lack of basic rate.

Grossarth-Maticek, R., Kanazir, D.T., Vetter, H. & Jankovic, M. (1983). Smoking as a risk factor for lung cancer and cardiac infarct as mediated by psychosocial variables. Psychotherapy and Psychosomatics, 39, 94-105: Statistical information in the regression model cannot be converted into bivariate correlations.

Herlitz, J., Karlson, B.W., Karlsson, T., Lindqvist, J. & Sjölin, M. (1998). Predictors of death during 5 years after hospital discharge among patients with a suspected acute coronary syndrome with particular emphasis on whether an infarction was developed. International Journal of

Cardiology, 66, 73-80 and Herlitz, J., Brandrup-Wognsen, G., Haglid, M., Karlson, B.W., Hartford, M. & Karlsson, T. (1998). Predictors of death during 5 years after coronary artery bypass grafting. International Journal of Cardiology, 64, 15-23: The authors merely report effects of the risk factor premorbid smoking on relapse. Information on reduction of tobacco use / smoking cessation are missing.

Herlitz, J., Karlson, B., Sjölin, M., Lindqvist, J., Karlsson, T.& Caidahl, K. (2000). Five year mortality in patients with acute chest pain in relation to smoking habits. Clinical Cardiology, 23, 84-90: This publication distinguishes between smoker and non-smoker without a differentiation between premorbid non-smokers and those who have meanwhile given up smoking.

Jousilahti, P., Toumilehto, J., Vartiainen, E., Korhonen, H.J., Pitkaniemi, J., Nissinen, A. et al.

(1995). Importance of risk factor clustering in coronary heart disease mortality and incidence in eastern Finland. Journal of Cardiovascular Risk, 2, 63-70. and Jousilahti, P., Vartiainen, E.,

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Korhonen, H.J., Puska, P. & Toumilehto,J. (1999). Is the effect of smoking on the risk for coronary heart disease even stronger than was previously thought? Journal of Cardiovascular Risk, 6, 293-298: This study of the North Karelia sample was of no use because of missing data on the proportion of smokers.

Kambara, H., Kinoshita, M., Nakagawa, M. & Kawai, C. (1995). Gender differences in long- term prognosis after myocardial infarction – clinical characteristics in 1000 patients. Japanese Circulation Journal, 59, 1-10: Does not include separate analyses on mortality / morbidity dependent on smoking status.

Lam, T.H., Ho, S.Y., Hedley, A.J., Mak, K.H. & Peto, R. (2001). Mortality and smoking in Hong Kong: case-control study of all adult deaths in 1998. British Medical Journal, 323, 1-6: Case control study.

McElduff, P., Dobson, A., Beaglehole, R. & Jackson, R. (1998). Rapid reduction in coronary risk for those who quit cigarette smoking. Australian and New Zealand Journal of Public Health, 22, 787-791: Case control study.

Menotti, A., Blackburn, H., Seccareccia, F., Kromhout, D., Nissinen, A., Karvonen, M., Fidanza, F., Giampaoli, S., Buzina, R., Mohacek, I., Nedeljkovic, S., Aravanis, C. & Dontas, A. (1998).

Relationship of some risk factors with typical and atypical manifestations of coronary heart disease. Cardiology, 89, 59-67: Study includes multivariate analyses based on the Seven Countries Study, which do not allow a distinction between non-smokers and smokers.

Nursing Research, 15, 441-455.

Metayer, C., Coughlin, S.S. & Mather, F.J. (1996). Does cigarette smoking paradoxically increase survival in idiopathic dilated cardiomyopathy: the Washington D.C. Dilated

Cardiomyopathy Study. General Cardiology, 87, 502-508: Study only describes influence of

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premorbid smoking on medium-term course of the cardiac disease.

Moller, A.M., Villebro, N., Pederson, T. & Tonnesen, H. (2002). Effect of preoperative smoking intervention on postoperative complications: a randomised clinical trial. The Lancet, 359, 114- 117: Sample consists of patients who did not undergo surgery for cardiological reasons.

Negri, E., La Vecchia, C., D´Avanzo, B., Nobili, A. & La Malfa, R. G. (1994). Acute myocardial infarction: Association with time since stopping in Italy. Journal of Epidemiology and

Community Health, 48, 129-133: GISSI 2: This publication describes a case control study

(patients from GISSI vs. control group patients). The authors conclude that already after one year there is a risk reduction for abstinent patients.

Njølstad, I. & Arnesen, E. (1998). Preinfarction blood pressure and smoking are determinants for a fatal outcome of myocardial infarction: a prospective analysis from the Finnmark Study.

Circulation, 158, 1326-1332. The authors only present multivariate analyses with co-variables.

Ornish, D., Brown, S.E., Scherwitz, L.W., Billings, J.H., Armstrong, W.T., Ports, T.A., McLanahan, S.M., Kirkeeide, R.L., Brand, R.J. & Gould, K.L. (1990). Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. The Lancet, 336, 129-133: Because of the sample’s pre-selection only one person smoked and quit at the beginning of the study.

Parish, S., Collins, R., Peto, R., Youngman, L., Barton, J., Jayne, K., Clarke, R., Appleby, P., Lyon, V., Cederholm-Williams, S., Marshall, J. & Sleight, P. (1995). Cigarette smoking, tar yields, and non-fatal myocardial infarction: 14000 cases and 32000 controls in the United Kingdom. British Medical Journal, 311, 471-477: Case control study; mainly findings on the influence of the kind of tobacco use on morbidity / mortality.

Ramanathan, K.B., Zwaag, R.V., Maddock, V., Kroetz, F.W., Sullivan, J.M. & Mirvis, D.M.

(1990). Interactive effects of age and other risk factors on long-term survival after coronary

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artery surgery. Journal of the American College of Cardiology, 15, 1493-1499: The authors do not describe the effects of tobacco abstinence after a cardiac incident with regard to morbidity and mortality. Instead, they compare their study population with data from resident statistics.

Rosenberg, L., Palmer, J.R. & Shapiro, S. (1990). Decline in the risk of myocardial infarction among women who stopped smoking. New England Journal of Medicine, 322, 213-217: The examined sample was selected from the general population and had no cardiac conditions. The influence on cardiac conditions was analysed as dependent / outcome measure.

Stähle, E., Bergström, R., Holmberg, L., Edlund, B., Nyström, S.-O., Sjögren, I. & Hansson, H.- E. (1994). Survival after Coronary Artery Bypass grafting. European Heart Journal, 15, 1204- 1211: Study analyses importance of tobacco abstinence after CABG. Specification of indication in heterogeneous patients without previous cardiac incident (e.g. MI).

Taylor, H.A., Mickel, M.C., Chaitman, B.R., Sopko, G., Cutter, G.R. & Rogers, W.J. (1997).

Long-term survival of African Americans in the Coronary Artery Surgery Study (CASS). Journal of the American College of Cardiology, 29, 358-364: CASS: Publications that deal with the CASS-sample are mainly concerned with ethnical differences in risk behaviour and associated medical consequences.

Tomás-Abadal, L., Varas-Lorenzo, C., Bernades-Bernat, E. & Balaguer-Vintró, I. (1994).

Coronary risk factors and a 20-year incidence of coronary heart disease and mortality in a mediterranean industrial population. European Heart Journal, 15, 1028-1036: Include only data on “person years” corrected for age, which cannot be used for data entry.

Tzivoni, D., Keren, A., Meyler, S., Khoury, Z., Lerer, T. & Brunel, P. (1998). Cardiovascular safety of transdermal nicotine patches in patients with coronary artery disease who try to quit smoking. Cardiovascular Drugs & Therapy, 12, 239-244. Patients felt the desire to quit smoking

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at the beginning of the study already.

Wannamethee, S.G., Shaper, A.G., Whincup, P.H. & Walker, M. (1999). Role of risk factors for major coronary heart disease events with increasing length of follow up. Heart, 81, 374-379: The authors describe their sample with heterogeneous times of follow-up. There is no information on basic rates regarding smoking.

Wenzlaff, P. & Amende, I. (1994). Progression der Koronarsklerose nach Einstellen des Zigarettenrauchens. Zeitschrift für Kardiologie, 83, 703-710: They do not specify any hard criteria as dependent / outcome measures, but also findings of the angiography.

Table W3B.2: Excluded Studies Section Intervention

Basler, H.-D., Brinkmeier, U., Buser, K. & Gluth, G. (1992). Nicotine gum assisted group therapy in smokers with an increased risk of coronary disease – evaluation in a primary care setting format. Health Education Research: Theory and Practice, 7, 87-95. Heterogeneous sample; no restriction to patients with CVD.

Bengtsson, K. (1983). Rehabilitation after myocardial infarction. Scandinavian Journal of

Rehabilitation in Medicine, 15, 1-9: Abstinence rates were presented in the text only, i.e. without frequencies.

Cupples, M.E. & McKnight, A. (1994). Randomised controlled trial of health promotion in general practice for patients at high cardiovascular risk. British Medical Journal, 309, 993-996:

Patients with angina pectoris complaints only.

Dunn, A.L., Marcus, B.H., Kampert, J.B., Garcia, M.E., Kohl, H.W. & Blair, S.N. (1997).

Reduction in cardiovascular disease risk factors: 6-month results from project Active. Preventive Medicine, 26, 883-892: No sample of patients with CVD.

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Horlick, L., Cameron, R., Firor, W., Bhalerao, U. & Baltzan, R. (1984). The effects of education and group discussion in the post myocardial infarction patient. Journal of Psychosomatic

Research, 28, 485-492: Insufficient presentation of the sample before and after the intervention.

Frequencies cannot be deduced.

Houston-Miller, N., Smith, P.M., DeBusk, R.F., Sobel, D.S. & Taylor, C.B. (1997). Smoking cessation in hospitalised patients. Archives of Internal Medicine, 157, 409-415: Heterogeneous sample of patients (CVD, cancer, respiratory diseases, etc.). Persons with MI are included in the study of DeBusk et al. (1994).

Ibrahim, M.A., Feldman, J.G., Sultz, H.A., Stainman, M.G., Young, L.J. & Dean, D. (1974).

Management after myocardial infarction: a controlled trial of the effect of group psychotherapy.

International Journal of Psychiatry in Medicine, 5, 253-268: No comparative analysis of the smoking status after the intervention.

Kristeller, J., Rossi, J., Ockene, J., Goldberg, R. & Prochaska, J. (1992). Processes of change in smoking cessation: a cross-validation study in cardiac patients. Journal of Substance Abuse, 4, 263-276. The sample overlaps with the CASIS study (cf. Ockene et al., 1992), which was already included in the meta-analysis.

Maiani, G., Callegari, S. & Sanavio, E. (1990). Smoking after myocardial infarction. New Trends in Experimental and Clinical Psychiatry, 6, 207-215: No hard endpoints (behaviour resp.

mortality analysed), only scales.

Mayou, R., MacMahon, D., Sleight, P. & Florencio, M.J. (1981). Early rehabilitation after myocardial infarction. The Lancet, 19, 1399-1401: Abstinence rates are not reported.

McSweeney, J.C. (1993). Making behavior changes after a myocardial infarction. Western Journal of Miller, M., Hemenway, D., Bell, N.S., Yore, M.M. & Amoroso, P.J. (2000). Cigarette

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smoking and suicide: a prospective study of 300,000 male active-duty army soldiers. American Journal of Epidemiology, 151, 1060-1063: Examined the intervention group only.

Miller, P., Wikoff, R., McMahon, M., Garrett, M.J. & Ringel, K. (1988). Influence of a nursing intervention on regimen adherence and societal adjustments postmyocardial infarction. Nursing Research, 37, 297-302: Did not assess behaviour, only attitude.

Mittag, O. & Ohm, D. (1992). Raucherentwöhnung durch Hypnose bei 21 Patienten mit

koronarer Herzkrankheit oder peripherer Verschlusskrankheit: Ergebnisse nach vier Jahren. Herz Kreislauf, 24, 408-411.: Examined the intervention group only.

Oldenburg, B., Allan, R. & Fastier, G. (1989). The role of behavioural and educational interventions in the secondary prevention of coronary heart disease. In P.F. Lovibond & P.H.

Wilson (Eds.), Clinical and abnormal psychology: Proceedings of the XXIV international congress of psychology of the international union of psychological science (pp. 429-438).

Sidney: Australia: Group sizes after randomisation not reported, only those of complete sample.

Perkins, K.A. & Scott, R.R. (1986). A low-cost environmental intervention for reducing smoking among cardiac inpatients. The International Journal of the Addictions, 21, 1173-1182: A mass communicative message and its effects on smoking behaviour in a cardiological clinic.

Observational study.

Pozen, M.W., Stechmiller, J.A., Harris, W., Smith, S., Fried, D.D. & Voigt, G.C. (1977). A nurse rehabilitators impact on patients with myocardial infarction. Medical Care, 15, 830-837: Data on abstinence exist only for one month after discharge.

Rankin-Esquer, L.A., Houston Miller, N., Myers, D. & Taylor, C.B. (1997). Marital status and outcome in patients with coronary heart disease. Journal of Clinical Psychology in Medical Setting, 4, 417-435: Examined the intervention group only.

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Rice, V.H., Fox, D.H., Lepczyk, M., Sieggreen, M., Mullin, M., Jarosz, P., & Templin, T.

(1994). A comparison of nursing interventions for smoking cessation in adults with

cardiovascular health problems. Heart & Lung, 23, 473-486: Heterogeneous sample of patients without acute diseases (CVD, peripheral vascular diseases, respiratory diseases).

Salonen, J.T., Hämynen, H., Heinonen, O.P. (1985). Impact of health education program and other factors on stopping smoking after heart attack. Scandinavian Journal of Social Medicine, 13, 103-108: No randomised allocation to rehabilitation programme. Besides, problems with comparability of the sample due to insufficient documentation in the publication.

Saner, H., Saner, B. & Stäubli, R. (1994). Erste Erfahrungen mit einem komprehensiven ambulanten Rehabilitationsprogramm für Herzpatienten. Schweizer Medizinische Wochenschrift, 124, 2075-2082: Examined the intervention group only.

Scott, R.R., Mayer, J.A., Denier, C.A., Dawson, B.L. & Lamparski, D. (1990). Long-term smoking status of cardiac patients following symptom-specific cessation advice. Addictive Behaviors, 15, 549-552. No allocation to EC and UC. Exclusively prospective study of cardiological patients.

Sippel, J.M., Osborne, M.L., Bjornson, W., Goldberg, B. & Buist, S. (1999). Smoking cessation in primary care clinics. Journal of General Internal Medicine, 14, 670-676: Heterogeneous sample of patients; no restriction to patients with CVD.

Smith, S.C. (1998). Risk reduction therapies for patients with coronary artery diseases: a call for increased implementation. American Journal of Medicine, 104, 23S-26S: Contains no primary data.

Taylor, C.B., Houston-Miller, N., Herman, S., Smith, P.M., Sobel, D., Fisher, L. & De Busk, F.

(1996). A nurse-managed smoking cessation program for hospitalized smokers. American

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Journal of Public Health, 86, 1557-1560: Heterogeneous sample of patients, no restriction to patients with CVD.

Toobert, D.J., Glasgow, R.E., Nettekoven, L.A. & Brown, J. (1998). Behavioral and

psychosocial effects of intensive lifestyle management for women with coronary heart disease.

Patient Education and Counseling, 35, 177-188: Only multivariate analyses without tobacco abstinence as endpoint.

Wewers, M.E., Bowen, J.M., Stanislaw, A.E. & Desimone, V.B. (1994). A nurse-delivered smoking cessation intervention among hospitalized postoperative patients-influence of a

smoking-related diagnosis: a pilot study. Heart & Lung, 23, 151-156: Heterogeneous sample of patients, no restriction to patients with CVD.

Whitlock, E.P., Hollis, J.F., Vogt, T.M. & Lichtenstein, E. (1997). Does gender affect response to a brief clinic-based smoking intervention? American Journal of Preventive Medicine, 13, 159- 166: Heterogeneous sample of patients, no restriction to patients with CVD.

Working Group for the Study of Transdermal Nicotine in Patients with Coronary Artery Disease (1994): Aim of this study was the description of side effects in patients with cardio-vascular diseases and not the estimation of effectiveness. Only 5-weeks-follow-up.

Young, D.T., Kottke, T.E., McCall, M.M. & Blume, D. (1982). A prospective controlled study of in-hospital myocardial infarction rehabilitation. Journal of Cardiac Rehabilitation, 2, 32-40: Do not report the basic rates, only the relative reduction in UC or EC.

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Appendix W3C: Studies excluded from Meta-Analysis Table W3C.1: Allen (1996)

Effects of a multicomponent intervention for life-style modification offered by nurses (AHA self-help videotape). Feedback on health improvement and achievement of objectives after one month. Subsequently one contact by telephone.

METHODS COMMENT

Design:

Randomised allocation to

1) experimental condition (EC): multicomponent programme

2) control condition = usual care (UC): one-time patient-education, care continued by GP.

Assessment time points:

Before the intervention and after one year.

Utilised measures / documented criteria:

Smoking status assessed in first examination (smoking status in the last 6 months) and at 12-month follow-up (current smoking status).

Participants:

174 consecutive patients after first coronary artery bypass grafting (CABG), 138 of these agreed to

• Restricted to female participants

• “intention to treat” analysis not possible, description restricted to those patients who were available for the follow-up

• Intervention strategies do not focus on smoking cessation only, eating and exercise behaviour also analysed

• Quality of the intervention not controlled for, no information on providers of intervention

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participate in study. 116 available after 12 months.

Analysis:

Fisher’s Test for differences between non-smokers and smokers, McNemar for changes within the group.

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Table W3C.2: DeBusk, Houston Miller, Superko et al. (1994)

Effects of a specific intervention after MI. Records of patients' behaviour (eating, exercise, etc.) are analysed and progress was reported to patients. Intensive aftercare by nurse (on the phone and face-to-face).

METHODS COMMENT

Design:

Randomised allocation to

1) EC: feedback on self-reports and care for 12 months

2) UC: standard care, in terms of health counselling with one-year catamnesis.

Assessment schedule:

(Smoking) Baseline, after 6 and 12 months; further criteria (cholesterol) also after 3, 6, 12 months.

Utilised measures / documented criteria:

Smoking status (cessation, confirmed by carbon monoxide measurements), missing data as well as patients using NRT are categorised as smokers.

Participants:

585 patients after MI: intervention group (n=293), usual care (n=292). Age M=57; 79%

• Elaborate programme including considerable social control during follow- up leads to a change in health behaviour of patients with MI. Also, positive influence on cholesterol and physical capacity.

• Problems with generalisability of results, as intervention relatively elaborate (up to 26 contacts in 12 months).

• Methods result in slight distortion- effects (pre-test), because persons in usual care group complain about angina pectoris more often. Also, drop-out rate after 12

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male; second infarction 15%; smokers 43%.

Analysis:

Not described regarding cessation, presumably chi square test.

months in EC higher than in UC group (15,4% vs. 11,6%).

• Effects confounded by higher proportion of patients using NRT in the EC group (10% vs. 2%).

• "Intention to treat analysis” not possible.

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Table W3C.3: Burt, Thornley, Illingworth et al. (1974)

Examination of the effects of an intervention after MI: Patients received detailed education on smoking cessation with insistent counselling by nurse. This was reinforced by written advice and motivation was continued in a follow-up clinic.

METHODS COMMENT

Design:

Randomised allocation to:

1) EC: education programme, reinforced by insistent, determined advice to stop smoking (by nurse and GP).

2) UC: education programme with conventional counselling and without aftercare clinic.

Assessment time points:

In clinic, after one year or later (1-3 years, not specified), assessment by nurse.

Utilised measures / documented criteria:

Smoking habits, smoking status: cessation- or reduction-rates or change to pipe smoking recorded in interview

Participants:

• Randomisation at day of

admission, which was considered an external method. Resulting

difference in sample size between EC and UC groups is a problem.

• For time of follow-up no

reduction in sample size mentioned, although that should have been expected.

• The intervention concept seems hardly standardised, hence arising

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Survivors of acute MI, intervention group (n=160, 125 of these smokers), UC group (n=120, 98 of these smokers).

Analysis:

Not specified, descriptive statistics, percentages.

problems with the study’s transferability.

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Table W3C.4: Campbell, Ritchie, Thain et al. (1998)

Examination, whether nurse run clinics in GP practices improve secondary prevention for patients with CHD. This experiment includes basic diagnostics, motivation for the use of aspirin, blood pressure, and blood lipids are controlled, and medication is provided if necessary. Assessment of risk behaviour and recommendation of change is provided.

METHODS COMMENT

Design:

Randomised control study in 19 GP practices:

1) EC: nurse-run clinics help on medical and lifestyle aspects and offer follow-up- examinations.

2) UC: standard care.

Assessment time points:

Baseline and after one year.

Utilised measures / documented criteria:

Aspirin use, blood pressure, lipids, physical activity, fats and smoking status after 6 months, further on quality of life, psychological stress (anxiety and depression).

Participants:

• Significant difference in smoking status between respondents and non- respondents (18% of respondents; 28%

of non-respondents).

• Despite the possibility of a

conservative analysis authors undertake optimistic estimation.

• Smoking cessation was no central part of the overall intervention.

• Low proportion of smokers in analysed sample.

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1173 patients (683 male, 488 female) under the age of 80 diagnosed with CHD. No end- stage disease, dementia, or confined indoors (EC: 593 persons; UC: 580 persons), in EC 102 smokers, in UC 98 smoker.

Analysis:

Number of points regarding preventive behaviour was accumulated, logistic regression, t- tests of independent samples, covariance analyses.

• Concept of intervention is described insufficiently.

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Table W3C.5: Carlsson, Lindberg, Westin & Israelsson (1997)

After five-week care by nurse resp. cardiologist and participation in a physical training programme for the increase of physical capacity, patients are offered additional treatment. Authors examine the effects of an education intervention in individual and group sessions offered by nurses (smoking, dietary education, exercise behaviour). Additionally, physical training 2-3 times per week for 12 weeks.

METHODS COMMENT

Design:

Randomised allocation to

1) EC: continuous attendance by cardiologist and nurse (12 months) plus additional training for 3 months

2) UC: visits to GP after 2 and 6 months.

Assessment time points:

In hospital and after one year.

Utilised measures / documented criteria:

Smoking status assessed in questionnaire by means of 5 possible answers: (1) never smoked, (2) ex-smoker, (3) ex-smoker until 3 months ago, (4) occasional smoker (at

• The study does not show any significant effect (chi square test) of the intervention on abstinence.

• No information on quality control of the intervention and qualification of medical attendant of EC group.

• Smoking cessation was not the only primary aim of the intervention, but also eating behaviour and physical activity.

• Randomisation not specified

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parties only) (5) smoker. 4 and 5 were considered smokers, 1-3 non-smokers.

Participants:

Consecutively admitted patients with MI, 168 of 273patients were included in the study, age > 50

Analysis:

Dichotomization: smoker vs. non-smoker and chi square test.

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Table W3C.6: Coronary Artery Smoking Intervention Study (CASIS) Ockene et al. (1992); Rosal et al. (1998)

Effects of a multicomponent smoking cessation programme: inpatient counselling (30 min.; 100%1), outpatient counselling visits (80%), outpatient visits to hospital (50%), and phone calls (90%). Phone calls after 1 and 3 weeks, those who stopped smoking were called after 3 months, those who started smoking again after 2 and 4 months. On average about 90 min contact per person. All patients were advised not to smoke and given basic information on the benefits of non-smoking for one’s health (10 min).

METHODS COMMENT

Design:

Patients of 3 clinics were randomised:

1) EC: additional programme 2) UC: medical advice.

Assessment time points:

At admission; 1, 6 and 12 months after beginning of study as well as after 5 years (Rosal et al., 1998).

Utilised measures / documented criteria:

Stages of readiness to change (TTM), smoking (self-report, report by others and

• The studies present good descriptions of the intervention and innovative approaches to classification of smokers with TTM; the

intervention was conceptually independent of the status of motivation of treated persons.

• Long follow-up history of 5 years is beneficial to study.

• High drop-out rate in agreement could cause a problem, refusers characterised by less

1 percentages describe proportion of participants in respective interventions

(26)

validation by test), self-efficacy, somatic parameters.

Participants:

Patients scheduled for arteriography or catheterisation in clinic, of 1128 smokers 557 were eligible, 267 of these agreed to participate, consequently following sample groups: EC=135 and UC =132.

Analysis:

Calculation of continuous abstinence and current abstinence, both publications present descriptive findings and regression models regarding abstinence.

education, higher age, higher use of tobacco and, contrary to the hypothesis, a greater expectation, to be able to quit smoking on their own (Ockene et al, 1992), the resulting participants thus seem to make up a group that may be easier to treat.

• A further problem is caused by distortion effects in the availability of patients after 5 years;

those available for follow-up history stand out by higher education and a more beneficial

motivation and readiness (more persons in stage

“action”).

(27)

Table W3C.7: Dornelas, Sampson, Gray, Waters & Thompson (2000)

Examination of effects of an intervention programme based on the trans-theoretical model. Principal components: increase of motivation and relapse prevention.

METHODS COMMENT

Design:

Randomised study:

1) EC: counselling according to TTM (20 min) including follow-up phone calls (after 1, 4, 8, 12, 16, 20 and 26 week(s)).

2) UC: AHA videotape as well as brief individual counselling by psychologist.

Assessment time points:

Baseline and after 6 and 12 months.

Utilised measures / documented criteria:

Fagerström Test (nicotine tolerance); Smoking Cessation Self-Efficacy

Questionnaire, previous attempts at quitting; smoking status in phone interviews (validated by information from partner).

• Sophisticated study in content as regards the intervention (diagnostics based on TTM). The description does not allow for an exact estimation of the application of both intervention strategies (increase of motivation vs. relapse prevention). In contemplation phase both strategies are applied, no quality control of intervention.

• The authors also calculate conservative effect-estimates and classified unavailable persons as smokers. This holds for EC and UC, which might lead to a distortion of the EC-effect,

(28)

Participants:

Patients after MI, no age restriction given, 164 patients included, after exclusion of non-eligible patients allocation to EC (54) or UC (46).

Analysis:

Chi square test regarding abstinence, drop-outs classified as smokers.

especially if the drop-out rate in the EC group is higher than in UC group (here: EC 54 – 40; UC 46 – 40).

(29)

Table W3C.8: Engblom, Rönnemaa, Hämäläinen et al. (1992)

Effects of additional rehabilitation after CABG. Two days before surgery education on surgery in groups. After 6-8 weeks rehabi- litation for 3 weeks. Components: education on risk factors, dietary education, physical training

METHODS COMMENT

Design:

Randomised allocation to:

1) EC: inpatient courses in rehabilitation clinics approx. 2 weeks before surgery (2 days), approx. 6 weeks after surgery (3 weeks) as well as after approx. 8 months (2 days).

2) UC: standard care of the clinic including contacts with patients after 2, 6 and 12 months, brief education of patients and controlling of risk factors.

Assessment time points:

Smoking: before surgery, 6 and 12 months after surgery.

Utilised measures / documented criteria:

Smoking status assessed in questionnaire, group of smokers in Baseline includes persons who quit smoking in the last month.

• The description of results does not contain details on the effect of the smoking intervention.

Study was assigned to optimistic estimation, due to insufficient presentation, however, the effect could only be roughly estimated.

• Overall low proportion of smokers in the study.

• Patients older than 65 years of age were excluded.

(30)

Participants:

228 patients with CABG (EC: n=119; UC: n=109). age M=55; 90% male; more than 50% damages of three blood vessels; 20% smokers.

Analysis:

Chi square test regarding tobacco abstinence.

(31)

Table W3C.9: Erdmann & Duivenvoorden (1983)

Effects of an aftercare intervention for patients with MI. Multidisciplinary team of cardiologists, psychologists, social workers and nurses. Intervention mainly consists of physical training. Additional education group on risk factors and their modification.

METHODS COMMENT

Design:

Randomised allocation to two groups:

1) EC: day hospital with described aftercare methods 2) UC: received booklet as well as care by GP.

Assessment time points:

Smoking in retrospect and after 3 and 6 months.

Utilised measures / documented criteria:

Smoking status in questionnaire plus scale charts on psychological traits (e.g.

anxiety, rigidity).

Participants:

Consecutively admitted patients with MI younger than 65 years of age. Exclusion of patients, with whom this method of intervention was counterindicated. Of

• The training programme leads to an

improvement of tobacco abstinence (only half of EC group smoke).

• Overall, the insufficient presentation of the study is to be criticised. There is no information on the randomisation or on problems with randomised persons without consent. It remains unclear, in which way the dependent / outcome measures were assessed, neither is there a description of the

quality of the intervention.

• Moreover, this is a highly selective sample (criterion for participation in study: married men)

(32)

originally 328 patients only 80 were included in study, 40 patients in each group.

However, due to drop-out, data of only 32 patients was evaluated.

Analysis:

Not specified, comparison of first to third measurement time point.

with a high drop-out of 20% in the last assessment.

• The generalisability of the findings is very questionable.

(33)

Table W3C.10: Fridlund, Högstedt, Lidell & Larsson (1991)

Examination of the effects of a rehabilitation programme on somatic and psychosocial criteria.

METHODS COMMENT

Design:

Randomised study with

1) EC: rehabilitation with two intervention strategies (lifestyle resp. life circumstances and social support). During inpatient stay every second day individual counselling by nurse. After discharge from hospital weekly 2h visits for 6 months (relaxation, exercise behaviour, lifestyle).

2) UC: standard care, counselling approx. 3 times in 12 months and recording of laboratory results.

Assessment time points:

Before discharge, after 6 and 12 months.

Utilised measures / documented criteria:

WHO-questionnaire for documentation of medical conditions, health behaviour, etc. including a dichotomous documentation of smoking status.

• Comprehensive intervention study with an exact documentation and adequate sample reduction (good generalisability), design and assessment time points chosen and implemented well.

• Problematic description of the intervention strategy:

no quality control (adherence) carried out.

• The comparability of the EC and UC groups is limited, as regards the problem dealt with: the proportion of smokers: EC (56%) vs. UC (42%); also higher

proportion of workers in UC (n.s.).

• The result regarding tobacco abstinence does not show an effect of the intervention, although a greater effect should be expected because of tendency towards

(34)

Participants: Patients after MI, younger than 65 and living self-

dependently. 178 persons included and after randomisation allocated to intervention group (87) or control group (91). Reduction of sample size by death (19), cardiac/cerebral disorders (28), lack of given consent (15), EC (53) vs. UC (63).

Analysis:

ANOVA with co-variables (sex, age, education).

the middle.

• Method of analysis questionable, as a variance analysis requires an interval-scaled variable.

(35)

Table W3C.11: Hedbäck & Perk (1987)

Effects of an additional rehabilitation programme for patients after MI. The intervention consisted of patient education and, particularly, training of physical fitness. The training was offered for at least 2 years (70% of the patients participated).

METHODS COMMENT

Design:

Comparison of treatment in two hospitals:

1) EC: clinic with rehabilitation 2) UC: clinic without rehabilitation.

Assessment time points:

Baseline, as well as annual measurements for 5 years.

Utilised measures / documented criteria:

Unclear whether smoking status was assessed by interviews or questionnaire.

Participants:

Consecutively admitted patients with MI, younger than 65 years of age;

intervention group n=147; control group n=158, exclusion of those patients

• This measure proves to have long-term effects in the reduction of tobacco use of patients after MI.

• The question whether both clinics are comparable is answered by the statistical comparison at the time of the first measurement. This does not show any significant differences in risk factors and socio-economic factors between both partial samples. It is, however,

questionable whether the medical treatments (independent of the existence of a rehabilitation programme) are comparable. The medicinal prescriptions vary to a great extent.

• Possibly the effect of the treatment is caused by the

(36)

with whom training might have caused complications.

Analysis:

Statistical methods not described.

long-lasting connection to one institution and not by the inpatient treatment concept.

(37)

Table W3C.12: Heller, Knapp, Valenti & Dobson (1993) Effects of the additional offer of mail-out information

METHODS COMMENT

Design:

Approx. one week after discharge from hospital patients were randomised.

1) EC: information by GP (diet, exercise, smoking); monthly sending of information by mail (prescriptions, booklets, etc.)

2) UC: no intervention.

Assessment time points:

At inclusion in study and after 6 months.

Utilised measures / documented criteria:

Smoking status assessed (method inexplicit); somatic (cholesterol, CABG, medication, etc.) as well as psychological parameters (quality of life).

Participants:

Of 635 persons with MI, 450 were included (EC: 213; UC: 237).

Analysis:

• Difference in drop-out between EC (- 21%) and UC (-13%) groups at time of follow-up after 6 months.

• Abstinence quote was estimated because result presentation was insufficient; overall, barely meaningful analysis due to the calculation of difference values

• Cost-effective, standardised intervention after cardiac incident.

• The evaluation of the methodological quality shows an overestimation of the quality of the study.

(38)

Pre-post difference values between groups (EC vs. UC) were calculated (with CI).

(39)

Table W3C.13: Linden (1994)

Examination of the effects of a booklet resp. of relaxation tapes and the implementation of an exercise programme.

METHODS COMMENT

Design:

Patients of one hospital were randomised:

1) EC: specific booklet (Heart Manual) including instructions on relaxation, exercise behaviour, etc.

2) UC: unspecific booklet.

Both groups were surveyed after 1, 3, and 6 weeks.

Assessment time points:

Before intervention and after intervention.

Utilised measures / documented criteria:

Smoking presumably enquired for in interview; assessment of state of health and physical fitness, HADS.

Participants:

Patients after MI. No further criteria for inclusion, 41 patients included, 17 of these in EC and

• Intervention in EC group well standardised, however, hardly

information on treatment of UC group.

• EC and UC differ because of small sample size in numerous parameters.

• A blinding of the interviewers is not mentioned and self-reports of smoking status are not available.

(40)

UC each at last time of measurement.

Analysis:

Descriptive.

(41)

Table W3C.14: Lisspers, Sundin, Hofman-Bang et al. (1999)

Effects of a multicomponent programme after PTCA. Initially inpatient stay (4 weeks) including education as well as behaviour training. Afterwards out-patient phase with self-monitoring and possibility of contact with a “personal coach”.

METHODS COMMENT

Design:

Patients of a cardiological clinic were randomised 1) EC: in- and outpatient treatment

2) UC: basic diagnostics and treatment by GP.

Assessment time points:

1-2 weeks after surgery as well as 12 months after inclusion in study.

Utilised measures / documented criteria:

Smoking status assessed in questionnaire, health behaviour, type-A-behaviour, physical capacity and somatic endpoints.

Participants:

Patients after PTCA younger than 65, who were employed and did not show somatic co- morbidity. 151 patients included; remaining under EC = 46 and in UC = 41.

• Extensive intervention for the EC group that deals with diverse particulars.

• Relatively small proportion of smokers in EC and UC groups (15% vs. 12%), note that in UC more people smoke after the intervention than at time of first assessment (coded as 0 non-smokers ). The definition of smoking status (in the first assessment) is thus questionable, or possibly to be ex- plained by dissimulation.

• Restriction to persons with good social integration results in problems with

(42)

Analysis:

ANCOVA with results of pre-measuring as co-variates.

generalisability.

(43)

Table W3C.15: Marra, Paolillo, Spadaccini & Angelino (1985)

Effects of a rehabilitation programme after MI. Particularly, exercise programme of 30 sessions within 4 weeks (each for approx. 120 minutes including pauses).

METHODS COMMENT

Design:

Patients of a cardiological clinic were randomised:

1) EC: exercise programme

2) UC: recommendation of more exercise.

Assessment time points:

Two physical examinations per year and annual x-rays for 5 years.

Utilised measures / documented criteria:

Physical diagnostics described, however, no standardised procedures to assess risk behaviour mentioned

Participants:

Patients after MI younger than 65. Exclusion in case of severe hypertension, cardiac defects, etc. Initially 294 patients, randomised EC=84 and UC =83.

• The long duration of data collection is advantageous.

• Exclusion of patients after intensive screening phase.

• Effects were evaluated by authors, who were also members of the team as well. They explicitly mention the

renunciation of blinding for “practical and ethical reasons”.

• A description of the procedure of data collection is missing.

(44)

Analysis:

Chi square and t-test.

(45)

Table W3C.16: Mitsibounas, Tsouna-Hadjis, Rotas, Sideris (1992)

Effects of a one-year group programme on risk factors. Interviews were lead by physicians and were supposed to elaborate solutions for pre-morbid conflicts with the patients. Instructions on relaxation and fortnightly ECG.

METHODS COMMENT

Design:

Patients of a cardiological clinic were randomised

1) EC: fortnightly one-hour group meetings with 5-7 participants 2) UC: monthly ECG.

Medication provided, if necessary, in EC and UC.

Assessment time points:

At 1, 3, 6 and 12 months.

Utilised measures / documented criteria:

Physical measures (weight, cholesterol, etc.) and risk behaviour (smoking, triglyceride levels, etc.).

Participants:

Patients after MI, younger than 70 years of age, who were interested in participating in

• Possibly highly selective samples, as there is no information on the number of people who were not interested in participation.

• The intervention remains obscure, no precise concept is depicted (only given information: one year duration).

• At the beginning of the study there were more women in the intervention group and this group was noticeably younger (M (EC)

= 50; M (UC) = 56).

(46)

study (incl. regular sessions), randomised EC=23 and UC =20.

Analysis:

Chi square and t-test.

(47)

Table W3C.17: Rigotti, McKool & Shiffman (1994)

Effects of a programme of the American Lung Association (“In Control“) for patients with CABG. In addition to counselling

(cessation techniques) videotapes were used and families invited to counselling by nurse (for up to 60 min). After discharge one phone call from nurse. Alongside, predictors abstinence were calculated.

METHODS COMMENT

Design:

Patients of a cardiological clinic were randomised 1) EC: additional programme

2) UC: advice not to smoke by GP and in clinic.

Assessment time points:

At admission, 2, 4, 8 and 12 months after discharge, 5-year follow-up history.

Utilised measures / documented criteria:

Smoking status (life-time, actual, attempts at giving up), social support regarding non- smoking, attitudes, somatic parameters, abstinence was validated

Participants:

Patients before CABG, who quit smoking less than six months ago or did smoke. 152

• Methodologically sophisticated study in- cluding an extremely long follow-up history of five years.

• Quality assurance of intervention critical (therapist adherence); use of videotape, how- ever, allows for a communicative standard- isation.

• Internal randomisation without control of clinical parameters, yet no sample differences in pre-test. Nevertheless, a deliberate

allocation to different groups by investigators

(48)

patients were eligible, 120 of these fulfilled all criteria and were randomised after agreement (n=93). Due to cancelled surgery and death resulting sample sizes: EC=44 and UC =43.

Analysis:

“Intention to treat” - analysis by authors, chi square.

cannot be precluded.

(49)

Table W3C.18: Sivarajan, Newton, Almes et al. (1983)

Effects of an exercise programme (3 months) and weekly visits to hospital (30-minute talks on state of health, not risk factors). A further intervention group attended additional weekly sessions (which lasted 60 minutes) on risk factors, coping with the disease, social support, etc.

METHODS COMMENT

Design:

Patients of a cardiological clinic were randomised:

1) EC1: additional exercise programme

2) EC2: additional exercise programme and group talks 3) UC: medical attendance only during inpatient stay.

Assessment time points:

At admission; 3 and 6 months after discharge.

Utilised measures / documented criteria:

Smoking, eating behaviour, exercise behaviour, weight.

Participants:

Patients after MI < 70 years of age; original sample not specified, randomised allocation

• The study describes a possible intervention after MI. There is no

information on the original sample and the data collection is insufficiently reported.

This is due to the fact that tobacco use is only one criterion among numerous others.

• The EC2 group (maximal intervention) is compared to the control group by meta- analytic data analysis.

(50)

to EC1=88; EC2=86 and UC=84, approx. 50% of each were smokers.

Analysis:

Descriptive findings.

(51)

Table W3C.19: Taylor, Houston-Miller, Haskell & DeBusk (1988)

Effects of an intervention for the modification of exercise behaviour after MI. Training was held individually or in groups.

METHODS COMMENT

Design:

2 weeks after MI randomised allocation to 4 groups:

1) EC1: treadmill exercise testing and later home physical training 2) EC2: treadmill exercise testing and following medically supervised group training

3) EC3: treadmill exercise testing without subsequent training 4) UC: first treadmill exercise testing after 6 months.

Assessment time points:

Smoking in retrospect and after 6 months.

Utilised measures / documented criteria:

• The intervention is described in detail and four groups are differentiated. The merger in analysis is advantageous for expressiveness of test, yet results in a disadvantage for the generalisability of the findings.

• Authors validate self-reports of examined patients.

Unfortunately, they do not specify rates of abstinence for validated findings, nor do they give details on specificity and sensitivity of the test result. That is why the

dependent / outcome measure has not been regarded more positively in the quality rating of this study.

2 Number after slash = number of smokers in the respective group. In training-group 10 persons did not report anything. In the control group missing data regarding tobacco use of 8 patients.

(52)

Smoking status assessed and validated.

Participants:

Consecutively admitted patients with MI younger than 70 years of age.

Exclusion of patients for whom this intervention method was counter- indicated. Initially 203 patients included, five of theses excluded after first assessment. 160 of these patients suffered from no complications until time of second assessment. Group 1 (54), Group 2 (53), Group 3 (26), Group 4 (27); in training 97/42; no training 45/262.

Analysis:

Statistical method not explicated. Mergers of groups 1 and 2 as well as groups 3 and 4.

(53)

Table W3C.20: Taylor, Houston-Miller, Killen, & DeBusk (1990)

Effects of a specific smoking cessation intervention offered by nurses. Patients in EC receive manual „Staying Free“, tapes, phone calls (about 6) as well as additional individual counselling for relapsed patients.

Design:

After MI randomised allocation in 2 groups:

1) EC: specific intervention (six months)

2) UC: treadmill exercise testing and subsequently medically supervised group training.

Assessment time points:

Before intervention, after intervention, and six months after completion of intervention.

Utilised measures / documented criteria:

Smoking status in self-report and validate; patients obtain $ 25 for examination . Participants:

Consecutively admitted patients with MI younger than 70. 235 smoking patients were eligible. Because of lacking language skills and missing informed consent

• Greatest problem of this study is the selective return after 12 months. Of 86 persons in EC 72 were available for follow-up. Only 58 of 87 patients remained in UC. This difference is inde- pendent of lethal cardiac incidents. An “intention to treat“ analysis carried out by the authors inevit- ably leads to an overestimation of the effect of the intervention, as all non-respondents were con- sidered relapsed. We therefore abstained from a meta-analytical evaluation of this study.

(54)

reduced to 173 patients. Further reduction to persons available in follow-up:

EC=86; UC=87.

Analysis:

Chi square test to monitor abstinence. “Intention to treat” and optimistic estimation; however, distortion effect!

(55)

Table W3C.21: van Elderen, Maes, Seegers et al. (1994a) [van Elderen GROUP]

Effects of an education measure. The intervention is based on a model by Ellis [ABCDE] and aims at an identification and modification of irrational. 9 90-minute sessions with about 5-8 participants.

METHODS COMMENT

Design:

After CHD randomised allocation to two groups:

1) EC: specific intervention

2) UC: physical training and medical care.

Assessment time points:

Before intervention, after intervention, and six months after completion of the intervention.

Utilised measures / documented criteria:

Smoking status in self-report.

Participants:

Consecutively admitted patients with CHD (MI, CABG, PTCA, etc.). 477 patients were eligible, only 258 agreed to participate. After first assessment further 41

• The problem of this study is the allocation of patients to EC and UC via clusters of 2 months each, i.e. for two months patients for EC and then for the next two months patients for UC were re- cruited at a time. We cannot rule out the

possibility that the investigators selected patients due to heterogeneous criteria. Although there is no detectable distortion effect regarding somatic criteria, motivational differences cannot be excluded.

• Before the intervention patients in EC showed increased levels of exhaustion and depression.

(56)

patients were lost. EC = 102 and UC = 102. Roughly 60% of these were smokers.

Further reduction to those available for follow-up: EC = 86; UC = 87.

Analysis:

Chi square test to monitor abstinence. However, only those available for follow-up were analysed.

This fact was not considered a distortion effect, as it contradicts the prevailing hypothesis.

• More persons in UC did not want to participate after randomisation.

(57)

Table W3C.22: van Elderen, Maes & van den Broek (1994b) [van Elderen PHONE]

Effects of an education intervention with subsequent telephone counselling.

METHODS COMMENT

Design:

After MI randomised allocation to two groups:

1) EC: specific intervention 2) UC: standard care Assessment time points:

Before intervention, after intervention, and six months after completion of intervention.

Utilised measures / documented criteria:

Smoking status by self-report in interview in presence of a person of social surroundings Further variables on health behaviour.

Participants:

Patients with MI younger than 70. All of 60 eligible patients participated in the study. EC = 30 and UC = 30.

• The problem of this study is the allocation of patients to EC and UC groups in two-week clusters, i.e.: for two weeks

patients were recruited for EC only and then for two weeks patients for UC only. In contrast to the study described in table E 21 there is no reduction in sample size during recruiting.

Nevertheless, further differences in the treatment procedures cannot be excluded.

• Another problem results from the reduction of sample size in follow-up (initially 30 persons examined in each group).

Only 22 persons remained in EC (3 dead, 5 refusals), 26 in UC (1 dead, 3 refusals).

• It comes as a surprise that all eligible patients also participated in the study.

(58)

Analysis:

Chi square test for monitoring of abstinence. However only analysed for those persons available for follow-up.

• It was impossible to evaluate whether all patients were interviewed in the presence of another person of their social surroundings. There are no reports of missing data concerning this fact (i.e. interview with patient alone).

(59)

Appendix W3D: Funnel Plots

Figure W3D.1: Funnel Plot: influence of abstinence from tobacco on mortality of CHD (N=9).

(60)

Figure W3D.2: Funnel Plot: Efficacy of interventions on abstinence from smoking; follow- up studies (N=17)

(61)

Figure W3D.3: Funnel plot: Efficacy of interventions on abstinence from smoking;

intention to treat model (N=10).

References

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