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1.  Prognosis in patients with recent onset low back pain in Australian primary care: inception cohort study 
BMJ : British Medical Journal  2008;337(7662):154-157.
Objective To estimate the one year prognosis and identify prognostic factors in cases of recent onset low back pain managed in primary care.
Design Cohort study with one year follow-up.
Setting Primary care clinics in Sydney, Australia.
Participants An inception cohort of 973 consecutive primary care patients (mean age 43.3, 54.8% men) with non-specific low back pain of less than two weeks’ duration recruited from the clinics of 170 general practitioners, physiotherapists, and chiropractors.
Main outcome measures Participants completed a baseline questionnaire and were contacted six weeks, three months, and 12 months after the initial consultation. Recovery was assessed in terms of return to work, return to function, and resolution of pain. The association between potential prognostic factors and time to recovery was modelled with Cox regression.
Results The follow-up rate over the 12 months was more than 97%. Half of those who reduced their work status at baseline had returned to previous work status within 14 days (95% confidence interval 11 to 17 days) and 83% had returned to previous work status by three months. Disability (median recovery time 31 days, 25 to 37 days) and pain (median 58 days, 52 to 63 days) took much longer to resolve. Only 72% of participants had completely recovered 12 months after the baseline consultation. Older age, compensation cases, higher pain intensity, longer duration of low back pain before consultation, more days of reduced activity because of lower back pain before consultation, feelings of depression, and a perceived risk of persistence were each associated with a longer time to recovery.
Conclusions In this cohort of patients with acute low back pain in primary care, prognosis was not as favourable as claimed in clinical practice guidelines. Recovery was slow for most patients. Nearly a third of patients did not recover from the presenting episode within a year.
doi:10.1136/bmj.a171
PMCID: PMC2483884  PMID: 18614473
2.  Secular trends in self reported sexual activity and satisfaction in Swedish 70 year olds: cross sectional survey of four populations, 1971-2001 
BMJ : British Medical Journal  2008;337(7662):151-154.
Objective To study secular trends in self reported sexual behaviour among 70 year olds.
Design Cross sectional survey.
Settings Four samples representative of the general population in Gothenburg, Sweden.
Participants 1506 adults (946 women, 560 men) examined in 1971-2, 1976-7, 1992-3, and 2000-1.
Main outcome measures Sexual intercourse, attitudes to sexuality in later life, sexual dysfunctions, and marital satisfaction.
Results From 1971 to 2000 the proportion of 70 year olds reporting sexual intercourse increased among all groups: married men from 52% to 68% (P=0.002), married women from 38% to 56% (P=0.001), unmarried men from 30% to 54% (P=0.016), and unmarried women from 0.8% to 12% (P<0.001). Men and women from later birth cohorts reported higher satisfaction with sexuality, fewer sexual dysfunctions, and more positive attitudes to sexuality in later life than those from earlier birth cohorts. A larger proportion of men (57% v 40%, P<0.001) and women (52% v 35%, P<0.001) reported very happy relationships in 2000-1 compared with those in 1971-2. Sexual debut before age 20 increased in both sexes: in men from 52% to 77% (P<0.001) and in women from 19% to 64% (P<0.001).
Conclusion Self reported quantity and quality of sexual experiences among Swedish 70 year olds has improved over a 30 year period.
doi:10.1136/bmj.a279
PMCID: PMC2483873  PMID: 18614505
3.  Routine care of peripheral intravenous catheters versus clinically indicated replacement: randomised controlled trial 
BMJ : British Medical Journal  2008;337(7662):157-160.
Objective To compare routine replacement of intravenous peripheral catheters with replacement only when clinically indicated.
Design Randomised controlled trial.
Setting Tertiary hospital in Australia.
Participants 755 medical and surgical patients: 379 allocated to catheter replacement only when clinically indicated and 376 allocated to routine care of catheter (control group).
Main outcome measure A composite measure of catheter failure resulting from phlebitis or infiltration.
Results Catheters were removed because of phlebitis or infiltration from 123 of 376 (33%) patients in the control group compared with 143 of 379 (38%) patients in the intervention group; the difference was not significant (relative risk 1.15, 95% confidence interval 0.95 to 1.40). When the analysis was based on failure per 1000 device days (number of failures divided by number of days catheterised, divided by 1000), no difference could be detected between the groups (relative risk 0.98, 0.78 to 1.24). Infusion related costs were higher in the control group (mean $A41.02; £19.71; €24.80; $38.55) than intervention group ($A36.40). The rate of phlebitis in both groups was low (4% in intervention group, 3% in control group).
Conclusion Replacing peripheral intravenous catheters when clinically indicated has no effect on the incidence of failure, based on a composite measure of phlebitis or infiltration. Larger trials are needed to test this finding using phlebitis alone as a more clinically meaningful outcome.
Registration number Australian New Zealand Clinical Trials Registry ACTRN12605000147684.
doi:10.1136/bmj.a339
PMCID: PMC2483870  PMID: 18614482
4.  Bullous pemphigoid and pemphigus vulgaris—incidence and mortality in the UK: population based cohort study 
BMJ : British Medical Journal  2008;337(7662):160-163.
Objective To determine the incidence of and mortality from bullous pemphigoid and pemphigus vulgaris in the United Kingdom.
Design Retrospective historical cohort study.
Setting Computerised medical records from the health improvement network, a large population based UK general practice database.
Participants Patients with pemphigus vulgaris and bullous pemphigoid diagnostic codes and age, sex, and practice matched controls.
Main outcome measures Incidence and mortality compared with the control population by calendar period, age group, sex, geographical region, and degree of social deprivation.
Results 869 people with bullous pemphigoid and 138 people with pemphigus vulgaris were identified. The median age at presentation for bullous pemphigoid was 80 (range 23-102) years, and 534 (61%) patients were female. The median age at presentation for pemphigus vulgaris was 71 (21-102) years, and 91 (66%) patients were female. Incidences of bullous pemphigoid and pemphigus vulgaris were 4.3 (95% confidence interval 4.0 to 4.6) and 0.7 (0.6 to 0.8) per 100 000 person years. The incidence of bullous pemphigoid increased over time; the average yearly increase was 17% (incidence rate ratio=1.2, 95% confidence interval 1.1 to 1.2). An average yearly increase in incidence of pemphigus vulgaris of 11% (incidence rate ratio=1.1, 1.0 to 1.2) occurred. The risk of death for patients with bullous pemphigoid was twice as great as for controls (adjusted hazard ratio=2.3, 95% confidence interval 2.0 to 2.7). For pemphigus vulgaris, the risk of death was three times greater than for controls (adjusted hazard ratio=3.3, 2.2 to 5.2).
Conclusions Incidences of bullous pemphigoid and pemphigus vulgaris are increasing. The reasons for the changes in incidence are not clearly understood but have implications for identifying causative factors. Both disorders are associated with a high risk of death. Previous estimates may have underestimated the risk of death associated with these diseases.
doi:10.1136/bmj.a180
PMCID: PMC2483869  PMID: 18614511
5.  Neuromuscular training and the risk of leg injuries in female floorball players: cluster randomised controlled study 
BMJ : British Medical Journal  2008;337(7661):96-99.
Objective To investigate whether a neuromuscular training programme is effective in preventing non-contact leg injuries in female floorball players.
Design Cluster randomised controlled study.
Setting 28 top level female floorball teams in Finland.
Participants 457 players (mean age 24 years)—256 (14 teams) in the intervention group and 201 (14 teams) in the control group—followedup for one league season (six months).
Intervention A neuromuscular training programme to enhance players’ motor skills and body control, as well as to activate and prepare their neuromuscular system for sports specific manoeuvres.
Main outcome measure Acute non-contact injuries of the legs.
Results During the season, 72 acute non-contact leg injuries occurred, 20 in the intervention group and 52 in the control group. The injury incidence per 1000 hours playing and practise in the intervention group was 0.65 (95% confidence interval 0.37 to 1.13) and in the control group was 2.08 (1.58 to 2.72). The risk of non-contact leg injury was 66% lower (adjusted incidence rate ratio 0.34, 95% confidence interval 0.20 to 0.57) in the intervention group.
Conclusion A neuromuscular training programme was effective in preventing acute non-contact injuries of the legs in female floorball players. Neuromuscular training can be recommended in the weekly training of these athletes.
Trial registration Current Controlled Trials ISRCTN26550281.
doi:10.1136/bmj.a295
PMCID: PMC2453298  PMID: 18595903
6.  Imported malaria and high risk groups: observational study using UK surveillance data 1987-2006 
BMJ : British Medical Journal  2008;337(7661):103-106.
Objective To examine temporal, geographic, and sociodemographic trends in case reporting and case fatality of malaria in the United Kingdom.
Setting National malaria reference laboratory surveillance data in the UK.
Design Observational study using prospectively gathered surveillance data and data on destinations from the international passenger survey.
Participants 39 300 cases of proved malaria in the UK between 1987 and 2006.
Main outcome measures Plasmodium species; sociodemographic details (including age, sex, and country of birth and residence); mortality; destination, duration, and purpose of international travel; and use of chemoprophylaxis.
Results Reported cases of imported malaria increased significantly over the 20 years of the study; an increasing proportion was attributable to Plasmodium falciparum (P falciparum/P vivax reporting ratio 1.3:1 in 1987-91 and 5.4:1 in 2002-6). P vivax reports declined from 3954 in 1987-91 to 1244 in 2002-6. Case fatality of reported P falciparum malaria did not change over this period (7.4 deaths per 1000 reported cases). Travellers visiting friends and relatives, usually in a country in Africa or Asia from which members of their family migrated, accounted for 13 215/20 488 (64.5%) of all malaria reported, and reports were geographically concentrated in areas where migrants from Africa and South Asia to the UK have settled. People travelling for this purpose were at significantly higher risk of malaria than other travellers and were less likely to report the use of any chemoprophylaxis (odds ratio of reported chemoprophylaxis use 0.23, 95% confidence interval 0.21 to 0.25).
Conclusions Despite the availability of highly effective preventive measures, the preventable burden from falciparum malaria has steadily increased in the UK while vivax malaria has decreased. Provision of targeted and appropriately delivered preventive messages and services for travellers from migrant families visiting friends and relatives should be a priority.
doi:10.1136/bmj.a120
PMCID: PMC2453297  PMID: 18599471
7.  Cardiovascular evaluation, including resting and exercise electrocardiography, before participation in competitive sports: cross sectional study 
BMJ : British Medical Journal  2008;337(7661):88-92.
Objective To evaluate the clinical usefulness of complete preparticipation cardiovascular screening in a large cohort of sports participants.
Design Cross sectional study of data over a five year period.
Setting Institute of Sports Medicine in Florence, Italy.
Participants 30 065 (23 570 men) people seeking to obtain clinical eligibility for competitive sports.
Main outcome measures Results of resting and exercise 12 lead electrocardiography.
Results Resting 12 lead ECG patterns showed abnormalities in 1812 (6%) participants, with the most common abnormalities (>80%) concerning innocent ECG changes. Exercise ECG showed an abnormal pattern in 1459 (4.9%) participants. Exercise ECG showed cardiac anomalies in 1227 athletes with normal findings on resting ECG. At the end of screening, 196 (0.6%) participants were considered ineligible for competitive sports. Among the 159 participants who were disqualified at the end of the screening for cardiac reasons, a consistent proportion (n=126, 79.2%) had shown innocent or negative findings on resting 12 lead ECG but clear pathological alterations during the exercise test. After adjustment for possible confounders, logistic regression analysis showed that age >30 years was significantly associated with an increased risk of being disqualified for cardiac findings during exercise testing.
Conclusions Among people seeking to take part in competitive sports, exercise ECG can identify those with cardiac abnormalities. Follow-up studies would show if disqualification of such people would reduce the incidence of CV events among athletes.
doi:10.1136/bmj.a346
PMCID: PMC2453296  PMID: 18599474
8.  Association between muscular strength and mortality in men: prospective cohort study 
BMJ : British Medical Journal  2008;337(7661):92-95.
Objective To examine prospectively the association between muscular strength and mortality from all causes, cardiovascular disease, and cancer in men.
Design Prospective cohort study.
Setting Aerobics centre longitudinal study.
Participants 8762 men aged 20-80.
Main outcome measures All cause mortality up to 31 December 2003; muscular strength, quantified by combining one repetition maximal measures for leg and bench presses and further categorised as age specific thirds of the combined strength variable; and cardiorespiratory fitness assessed by a maximal exercise test on a treadmill.
Results During an average follow-up of 18.9 years, 503 deaths occurred (145 cardiovascular disease, 199 cancer). Age adjusted death rates per 10 000 person years across incremental thirds of muscular strength were 38.9, 25.9, and 26.6 for all causes; 12.1, 7.6, and 6.6 for cardiovascular disease; and 6.1, 4.9, and 4.2 for cancer (all P<0.01 for linear trend). After adjusting for age, physical activity, smoking, alcohol intake, body mass index, baseline medical conditions, and family history of cardiovascular disease, hazard ratios across incremental thirds of muscular strength for all cause mortality were 1.0 (referent), 0.72 (95% confidence interval 0.58 to 0.90), and 0.77 (0.62 to 0.96); for death from cardiovascular disease were 1.0 (referent), 0.74 (0.50 to 1.10), and 0.71 (0.47 to 1.07); and for death from cancer were 1.0 (referent), 0.72 (0.51 to 1.00), and 0.68 (0.48 to 0.97). The pattern of the association between muscular strength and death from all causes and cancer persisted after further adjustment for cardiorespiratory fitness; however, the association between muscular strength and death from cardiovascular disease was attenuated after further adjustment for cardiorespiratory fitness.
Conclusion Muscular strength is inversely and independently associated with death from all causes and cancer in men, even after adjusting for cardiorespiratory fitness and other potential confounders.
doi:10.1136/bmj.a439
PMCID: PMC2453303  PMID: 18595904
9.  Cardiovascular evaluation, including resting and exercise electrocardiography, before participation in competitive sports: cross sectional study 
Objective To evaluate the clinical usefulness of complete preparticipation cardiovascular screening in a large cohort of sports participants.
Design Cross sectional study of data over a five year period.
Setting Institute of Sports Medicine in Florence, Italy.
Participants 30 065 (23 570 men) people seeking to obtain clinical eligibility for competitive sports.
Main outcome measures Results of resting and exercise 12 lead electrocardiography.
Results Resting 12 lead ECG patterns showed abnormalities in 1812 (6%) participants, with the most common abnormalities (>80%) concerning innocent ECG changes. Exercise ECG showed an abnormal pattern in 1459 (4.9%) participants. Exercise ECG showed cardiac anomalies in 1227 athletes with normal findings on resting ECG. At the end of screening, 196 (0.6%) participants were considered ineligible for competitive sports. Among the 159 participants who were disqualified at the end of the screening for cardiac reasons, a consistent proportion (n=126, 79.2%) had shown innocent or negative findings on resting 12 lead ECG but clear pathological alterations during the exercise test. After adjustment for possible confounders, logistic regression analysis showed that age >30 years was significantly associated with an increased risk of being disqualified for cardiac findings during exercise testing.
Conclusions Among people seeking to take part in competitive sports, exercise ECG can identify those with cardiac abnormalities. Follow-up studies would show if disqualification of such people would reduce the incidence of CV events among athletes.
doi:10.1136/bmj.a346
PMCID: PMC2453296  PMID: 18599474
10.  Imported malaria and high risk groups: observational study using UK surveillance data 1987-2006 
Objective To examine temporal, geographic, and sociodemographic trends in case reporting and case fatality of malaria in the United Kingdom.
Setting National malaria reference laboratory surveillance data in the UK.
Design Observational study using prospectively gathered surveillance data and data on destinations from the international passenger survey.
Participants 39 300 cases of proved malaria in the UK between 1987 and 2006.
Main outcome measures Plasmodium species; sociodemographic details (including age, sex, and country of birth and residence); mortality; destination, duration, and purpose of international travel; and use of chemoprophylaxis.
Results Reported cases of imported malaria increased significantly over the 20 years of the study; an increasing proportion was attributable to Plasmodium falciparum (P falciparum/P vivax reporting ratio 1.3:1 in 1987-91 and 5.4:1 in 2002-6). P vivax reports declined from 3954 in 1987-91 to 1244 in 2002-6. Case fatality of reported P falciparum malaria did not change over this period (7.4 deaths per 1000 reported cases). Travellers visiting friends and relatives, usually in a country in Africa or Asia from which members of their family migrated, accounted for 13 215/20 488 (64.5%) of all malaria reported, and reports were geographically concentrated in areas where migrants from Africa and South Asia to the UK have settled. People travelling for this purpose were at significantly higher risk of malaria than other travellers and were less likely to report the use of any chemoprophylaxis (odds ratio of reported chemoprophylaxis use 0.23, 95% confidence interval 0.21 to 0.25).
Conclusions Despite the availability of highly effective preventive measures, the preventable burden from falciparum malaria has steadily increased in the UK while vivax malaria has decreased. Provision of targeted and appropriately delivered preventive messages and services for travellers from migrant families visiting friends and relatives should be a priority.
doi:10.1136/bmj.a120
PMCID: PMC2453297  PMID: 18599471
11.  Neuromuscular training and the risk of leg injuries in female floorball players: cluster randomised controlled study 
Objective To investigate whether a neuromuscular training programme is effective in preventing non-contact leg injuries in female floorball players.
Design Cluster randomised controlled study.
Setting 28 top level female floorball teams in Finland.
Participants 457 players (mean age 24 years)—256 (14 teams) in the intervention group and 201 (14 teams) in the control group—followedup for one league season (six months).
Intervention A neuromuscular training programme to enhance players’ motor skills and body control, as well as to activate and prepare their neuromuscular system for sports specific manoeuvres.
Main outcome measure Acute non-contact injuries of the legs.
Results During the season, 72 acute non-contact leg injuries occurred, 20 in the intervention group and 52 in the control group. The injury incidence per 1000 hours playing and practise in the intervention group was 0.65 (95% confidence interval 0.37 to 1.13) and in the control group was 2.08 (1.58 to 2.72). The risk of non-contact leg injury was 66% lower (adjusted incidence rate ratio 0.34, 95% confidence interval 0.20 to 0.57) in the intervention group.
Conclusion A neuromuscular training programme was effective in preventing acute non-contact injuries of the legs in female floorball players. Neuromuscular training can be recommended in the weekly training of these athletes.
Trial registration Current Controlled Trials ISRCTN26550281.
doi:10.1136/bmj.a295
PMCID: PMC2453298  PMID: 18595903
12.  Association between muscular strength and mortality in men: prospective cohort study 
Objective To examine prospectively the association between muscular strength and mortality from all causes, cardiovascular disease, and cancer in men.
Design Prospective cohort study.
Setting Aerobics centre longitudinal study.
Participants 8762 men aged 20-80.
Main outcome measures All cause mortality up to 31 December 2003; muscular strength, quantified by combining one repetition maximal measures for leg and bench presses and further categorised as age specific thirds of the combined strength variable; and cardiorespiratory fitness assessed by a maximal exercise test on a treadmill.
Results During an average follow-up of 18.9 years, 503 deaths occurred (145 cardiovascular disease, 199 cancer). Age adjusted death rates per 10 000 person years across incremental thirds of muscular strength were 38.9, 25.9, and 26.6 for all causes; 12.1, 7.6, and 6.6 for cardiovascular disease; and 6.1, 4.9, and 4.2 for cancer (all P<0.01 for linear trend). After adjusting for age, physical activity, smoking, alcohol intake, body mass index, baseline medical conditions, and family history of cardiovascular disease, hazard ratios across incremental thirds of muscular strength for all cause mortality were 1.0 (referent), 0.72 (95% confidence interval 0.58 to 0.90), and 0.77 (0.62 to 0.96); for death from cardiovascular disease were 1.0 (referent), 0.74 (0.50 to 1.10), and 0.71 (0.47 to 1.07); and for death from cancer were 1.0 (referent), 0.72 (0.51 to 1.00), and 0.68 (0.48 to 0.97). The pattern of the association between muscular strength and death from all causes and cancer persisted after further adjustment for cardiorespiratory fitness; however, the association between muscular strength and death from cardiovascular disease was attenuated after further adjustment for cardiorespiratory fitness.
Conclusion Muscular strength is inversely and independently associated with death from all causes and cancer in men, even after adjusting for cardiorespiratory fitness and other potential confounders.
doi:10.1136/bmj.a439
PMCID: PMC2453303  PMID: 18595904
13.  Bullous pemphigoid and pemphigus vulgaris—incidence and mortality in the UK: population based cohort study 
Objective To determine the incidence of and mortality from bullous pemphigoid and pemphigus vulgaris in the United Kingdom.
Design Retrospective historical cohort study.
Setting Computerised medical records from the health improvement network, a large population based UK general practice database.
Participants Patients with pemphigus vulgaris and bullous pemphigoid diagnostic codes and age, sex, and practice matched controls.
Main outcome measures Incidence and mortality compared with the control population by calendar period, age group, sex, geographical region, and degree of social deprivation.
Results 869 people with bullous pemphigoid and 138 people with pemphigus vulgaris were identified. The median age at presentation for bullous pemphigoid was 80 (range 23-102) years, and 534 (61%) patients were female. The median age at presentation for pemphigus vulgaris was 71 (21-102) years, and 91 (66%) patients were female. Incidences of bullous pemphigoid and pemphigus vulgaris were 4.3 (95% confidence interval 4.0 to 4.6) and 0.7 (0.6 to 0.8) per 100 000 person years. The incidence of bullous pemphigoid increased over time; the average yearly increase was 17% (incidence rate ratio=1.2, 95% confidence interval 1.1 to 1.2). An average yearly increase in incidence of pemphigus vulgaris of 11% (incidence rate ratio=1.1, 1.0 to 1.2) occurred. The risk of death for patients with bullous pemphigoid was twice as great as for controls (adjusted hazard ratio=2.3, 95% confidence interval 2.0 to 2.7). For pemphigus vulgaris, the risk of death was three times greater than for controls (adjusted hazard ratio=3.3, 2.2 to 5.2).
Conclusions Incidences of bullous pemphigoid and pemphigus vulgaris are increasing. The reasons for the changes in incidence are not clearly understood but have implications for identifying causative factors. Both disorders are associated with a high risk of death. Previous estimates may have underestimated the risk of death associated with these diseases.
doi:10.1136/bmj.a180
PMCID: PMC2483869  PMID: 18614511
14.  Routine care of peripheral intravenous catheters versus clinically indicated replacement: randomised controlled trial 
Objective To compare routine replacement of intravenous peripheral catheters with replacement only when clinically indicated.
Design Randomised controlled trial.
Setting Tertiary hospital in Australia.
Participants 755 medical and surgical patients: 379 allocated to catheter replacement only when clinically indicated and 376 allocated to routine care of catheter (control group).
Main outcome measure A composite measure of catheter failure resulting from phlebitis or infiltration.
Results Catheters were removed because of phlebitis or infiltration from 123 of 376 (33%) patients in the control group compared with 143 of 379 (38%) patients in the intervention group; the difference was not significant (relative risk 1.15, 95% confidence interval 0.95 to 1.40). When the analysis was based on failure per 1000 device days (number of failures divided by number of days catheterised, divided by 1000), no difference could be detected between the groups (relative risk 0.98, 0.78 to 1.24). Infusion related costs were higher in the control group (mean $A41.02; £19.71; €24.80; $38.55) than intervention group ($A36.40). The rate of phlebitis in both groups was low (4% in intervention group, 3% in control group).
Conclusion Replacing peripheral intravenous catheters when clinically indicated has no effect on the incidence of failure, based on a composite measure of phlebitis or infiltration. Larger trials are needed to test this finding using phlebitis alone as a more clinically meaningful outcome.
Registration number Australian New Zealand Clinical Trials Registry ACTRN12605000147684.
doi:10.1136/bmj.a339
PMCID: PMC2483870  PMID: 18614482
15.  Secular trends in self reported sexual activity and satisfaction in Swedish 70 year olds: cross sectional survey of four populations, 1971-2001 
Objective To study secular trends in self reported sexual behaviour among 70 year olds.
Design Cross sectional survey.
Settings Four samples representative of the general population in Gothenburg, Sweden.
Participants 1506 adults (946 women, 560 men) examined in 1971-2, 1976-7, 1992-3, and 2000-1.
Main outcome measures Sexual intercourse, attitudes to sexuality in later life, sexual dysfunctions, and marital satisfaction.
Results From 1971 to 2000 the proportion of 70 year olds reporting sexual intercourse increased among all groups: married men from 52% to 68% (P=0.002), married women from 38% to 56% (P=0.001), unmarried men from 30% to 54% (P=0.016), and unmarried women from 0.8% to 12% (P<0.001). Men and women from later birth cohorts reported higher satisfaction with sexuality, fewer sexual dysfunctions, and more positive attitudes to sexuality in later life than those from earlier birth cohorts. A larger proportion of men (57% v 40%, P<0.001) and women (52% v 35%, P<0.001) reported very happy relationships in 2000-1 compared with those in 1971-2. Sexual debut before age 20 increased in both sexes: in men from 52% to 77% (P<0.001) and in women from 19% to 64% (P<0.001).
Conclusion Self reported quantity and quality of sexual experiences among Swedish 70 year olds has improved over a 30 year period.
doi:10.1136/bmj.a279
PMCID: PMC2483873  PMID: 18614505
16.  Prognosis in patients with recent onset low back pain in Australian primary care: inception cohort study 
Objective To estimate the one year prognosis and identify prognostic factors in cases of recent onset low back pain managed in primary care.
Design Cohort study with one year follow-up.
Setting Primary care clinics in Sydney, Australia.
Participants An inception cohort of 973 consecutive primary care patients (mean age 43.3, 54.8% men) with non-specific low back pain of less than two weeks’ duration recruited from the clinics of 170 general practitioners, physiotherapists, and chiropractors.
Main outcome measures Participants completed a baseline questionnaire and were contacted six weeks, three months, and 12 months after the initial consultation. Recovery was assessed in terms of return to work, return to function, and resolution of pain. The association between potential prognostic factors and time to recovery was modelled with Cox regression.
Results The follow-up rate over the 12 months was more than 97%. Half of those who reduced their work status at baseline had returned to previous work status within 14 days (95% confidence interval 11 to 17 days) and 83% had returned to previous work status by three months. Disability (median recovery time 31 days, 25 to 37 days) and pain (median 58 days, 52 to 63 days) took much longer to resolve. Only 72% of participants had completely recovered 12 months after the baseline consultation. Older age, compensation cases, higher pain intensity, longer duration of low back pain before consultation, more days of reduced activity because of lower back pain before consultation, feelings of depression, and a perceived risk of persistence were each associated with a longer time to recovery.
Conclusions In this cohort of patients with acute low back pain in primary care, prognosis was not as favourable as claimed in clinical practice guidelines. Recovery was slow for most patients. Nearly a third of patients did not recover from the presenting episode within a year.
doi:10.1136/bmj.a171
PMCID: PMC2483884  PMID: 18614473
17.  Role of quality measurement in inappropriate use of screening for colorectal cancer: retrospective cohort study 
Objective To examine whether the age based quality measure for screening for colorectal cancer is associated with overuse of screening in patients aged 70-75 in poor health and underuse in those aged over age 75 in good health.
Design Retrospective cohort study utilizing electronic data from the Veterans Affairs (VA) Health Care System, the largest integrated healthcare system in the United States.
Setting VA Health Care System.
Participants Veterans aged ≥50 due for repeat average risk colorectal cancer screening at a primary care visit in fiscal year 2010.
Main outcome measures Completion of colonoscopy, sigmoidoscopy, or fecal occult blood testing within 24 months of the 2010 visit.
Results 399 067 veterans met inclusion/exclusion criteria (mean age 67, 97% men). Of these, 38% had electronically documented screening within 24 months. In multivariable log binomial regression adjusted for Charlson comorbidity index, sex, and number of primary care visits, screening decreased markedly after the age of 75 (the age cut off used by the quality measure) (adjusted relative risk 0.35, 95% confidence interval 0.30 to 0.40). A veteran who was aged 75 and unhealthy (in whom life expectancy might be limited and screening more likely to result in net burden or harm) was significantly more likely to undergo screening than a veteran aged 76 and healthy (unadjusted relative risk 1.64, 1.36 to 1.97).
Conclusions Specification of a quality measure can have important implications for clinical care. Future quality measures should focus on individual risk/benefit to ensure that patients who are likely to benefit from a service receive it (regardless of age), and that those who are likely to incur harm are spared unnecessary and costly care.
doi:10.1136/bmj.g1247
PMCID: PMC3935739  PMID: 24574474
18.  Antenatal lifestyle advice for women who are overweight or obese: LIMIT randomised trial 
Objective To determine the effect of antenatal dietary and lifestyle interventions on health outcomes in overweight and obese pregnant women.
Design Multicentre randomised trial. We utilised a central telephone randomisation server, with computer generated schedule, balanced variable blocks, and stratification for parity, body mass index (BMI) category, and hospital.
Setting Three public maternity hospitals across South Australia.
Participants 2212 women with a singleton pregnancy, between 10+0 and 20+0 weeks’ gestation, and BMI ≥25.
Interventions 1108 women were randomised to a comprehensive dietary and lifestyle intervention delivered by research staff; 1104 were randomised to standard care and received pregnancy care according to local guidelines, which did not include such information.
Main outcome measures Incidence of infants born large for gestational age (birth weight ≥90th centile for gestation and sex). Prespecified secondary outcomes included birth weight >4000 g, hypertension, pre-eclampsia, and gestational diabetes. Analyses used intention to treat principles.
Results 2152 women and 2142 liveborn infants were included in the analyses. The risk of the infant being large for gestational age was not significantly different in the two groups (lifestyle advice 203/1075 (19%) v standard care 224/1067 (21%); adjusted relative risk 0.90, 95% confidence interval 0.77 to 1.07; P=0.24). Infants born to women after lifestyle advice were significantly less likely to have birth weight above 4000 g (lifestyle advice 164/1075 (15%) v standard care 201/1067 (19%); 0.82, 0.68 to 0.99; number needed to treat (NNT) 28, 15 to 263; P=0.04). There were no differences in maternal pregnancy and birth outcomes between the two treatment groups.
Conclusions For women who were overweight or obese, the antenatal lifestyle advice used in this study did not reduce the risk delivering a baby weighing above the 90th centile for gestational age and sex or improve maternal pregnancy and birth outcomes.
Trial registration Australian and New Zealand Clinical Trials Registry (ACTRN12607000161426).
doi:10.1136/bmj.g1285
PMCID: PMC3919179  PMID: 24513442
19.  Comparative effectiveness of renin-angiotensin system blockers and other antihypertensive drugs in patients with diabetes: systematic review and bayesian network meta-analysis 
Objective To assess the effects of different classes of antihypertensive treatments, including monotherapy and combination therapy, on survival and major renal outcomes in patients with diabetes.
Design Systematic review and bayesian network meta-analysis of randomised clinical trials.
Data sources Electronic literature search of PubMed, Medline, Scopus, and the Cochrane Library for studies published up to December 2011.
Study selection Randomised clinical trials of antihypertensive therapy (angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), α blockers, β blockers, calcium channel blockers, diuretics, and their combinations) in patients with diabetes with a follow-up of at least 12 months, reporting all cause mortality, requirement for dialysis, or doubling of serum creatinine levels.
Data extraction Bayesian network meta-analysis combined direct and indirect evidence to estimate the relative effects between treatments as well as the probabilities of ranking for treatments based on their protective effects.
Results 63 trials with 36 917 participants were identified, including 2400 deaths, 766 patients who required dialysis, and 1099 patients whose serum creatinine level had doubled. Compared with placebo, only ACE inhibitors significantly reduced the doubling of serum creatinine levels (odds ratio 0.58, 95% credible interval 0.32 to 0.90), and only β blockers showed a significant difference in mortality (odds ratio 7.13, 95% credible interval 1.37 to 41.39). Comparisons among all treatments showed no statistical significance in the outcome of dialysis. Although the beneficial effects of ACE inhibitors compared with ARBs did not reach statistical significance, ACE inhibitors consistently showed higher probabilities of being in the superior ranking positions among all three outcomes. Although the protective effect of an ACE inhibitor plus calcium channel blocker compared with placebo was not statistically significant, the treatment ranking identified this combination therapy to have the greatest probability (73.9%) for being the best treatment on reducing mortality, followed by ACE inhibitor plus diuretic (12.5%), ACE inhibitors (2.0%), calcium channel blockers (1.2%), and ARBs (0.4%).
Conclusions Our analyses show the renoprotective effects and superiority of using ACE inhibitors in patients with diabetes, and available evidence is not able to show a better effect for ARBs compared with ACE inhibitors. Considering the cost of drugs, our findings support the use of ACE inhibitors as the first line antihypertensive agent in patients with diabetes. Calcium channel blockers might be the preferred treatment in combination with ACE inhibitors if adequate blood pressure control cannot be achieved by ACE inhibitors alone.
doi:10.1136/bmj.f6008
PMCID: PMC3807847  PMID: 24157497
20.  Probable person to person transmission of novel avian influenza A (H7N9) virus in Eastern China, 2013: epidemiological investigation 
Objective To determine whether the novel avian influenza H7N9 virus can transmit from person to person and its efficiency.
Design Epidemiological investigations conducted after a family cluster of two patients with avian H7N9 in March 2013.
Setting Wuxi, Eastern China.
Participants Two patients, their close contacts, and relevant environments. Samples from the patients and environments were collected and tested by real time reverse transcriptase-polymerase chain reaction (rRT-PCR), viral culture, and haemagglutination inhibition assay. Any contacts who became ill had samples tested for avian H7N9 by rRT-PCR. Paired serum samples were obtained from contacts for serological testing by haemagglutination inhibition assays.
Main outcomes measures Clinical data, history of exposure before the onset of illnesses, and results of laboratory testing of pathogens and further analysis of sequences and phylogenetic tree to isolated strains.
Results The index patient became ill five to six days after his last exposure to poultry. The second patient, his daughter aged 32, who provided unprotected bedside care in the hospital, had no known exposure to poultry. She developed symptoms six days after her last contact with her father. Two strains were isolated successfully from the two patients. Genome sequence and analyses of phylogenetic trees showed that both viruses were almost genetically identical. Forty three close contacts of both patients were identified. One had mild illness but had negative results for avian H7N9 by rRT-PCR. All 43 close contacts tested negative for haemagglutination inhibition antibodies specific for avian H7N9.
Conclusions The infection of the daughter probably resulted from contact with her father (the index patient) during unprotected exposure, suggesting that in this cluster the virus was able to transmit from person to person. The transmissibility was limited and non-sustainable.
doi:10.1136/bmj.f4752
PMCID: PMC3805478  PMID: 23920350
21.  Safety and efficacy of intravenous iron therapy in reducing requirement for allogeneic blood transfusion: systematic review and meta-analysis of randomised clinical trials 
Objectives To evaluate the efficacy and safety of intravenous iron, focusing primarily on its effects on haemoglobin, requirement for transfusion, and risk of infection.
Design Systematic review and meta-analysis of randomised controlled trials investigating the safety and efficacy of intravenous iron therapy.
Data sources Randomised controlled trials from Medline, Embase, and the Cochrane Central Register of Controlled Trials from 1966 to June 2013, with no language restrictions.
Eligibility criteria for selecting studies Eligible trials were randomised controlled trials of intravenous iron compared with either no iron or oral iron. Crossover and observational studies were excluded.
Main outcome measures Change in haemoglobin concentration and risk of allogeneic red blood cell transfusion (efficacy) and risk of infection (safety).
Results Of the 75 trials meeting the inclusion criteria, 72 studies including 10 605 patients provided quantitative outcome data for meta-analysis. Intravenous iron was associated with an increase in haemoglobin concentration (standardised mean difference 6.5 g/L, 95% confidence interval 5.1 g/L to 7.9 g/L) and a reduced risk of requirement for red blood cell transfusion (risk ratio 0.74, 95% confidence interval 0.62 to 0.88), especially when intravenous iron was used with erythroid stimulating agents (ESAs) or in patients with a lower baseline plasma ferritin concentration. There were no significant interactions between the efficacy of intravenous iron and type or dose administered. Intravenous iron was, however, associated with a significant increase in risk of infection (relative risk 1.33, 95% confidence interval 1.10 to 1.64) compared with oral or no iron supplementation. The results remained similar when only high quality trials were analysed.
Conclusions Intravenous iron therapy is effective in increasing haemoglobin concentration and reducing the risk of allogeneic red blood cell transfusion and could have broad applicability to a range of acute care settings. This potential benefit is counterbalanced by a potential increased risk of infection.
doi:10.1136/bmj.f4822
PMCID: PMC3805480  PMID: 23950195
22.  Residential exposure to aircraft noise and hospital admissions for cardiovascular diseases: multi-airport retrospective study 
Objective To investigate whether exposure to aircraft noise increases the risk of hospitalization for cardiovascular diseases in older people (≥65 years) residing near airports.
Design Multi-airport retrospective study of approximately 6 million older people residing near airports in the United States. We superimposed contours of aircraft noise levels (in decibels, dB) for 89 airports for 2009 provided by the US Federal Aviation Administration on census block resolution population data to construct two exposure metrics applicable to zip code resolution health insurance data: population weighted noise within each zip code, and 90th centile of noise among populated census blocks within each zip code.
Setting 2218 zip codes surrounding 89 airports in the contiguous states.
Participants 6 027 363 people eligible to participate in the national medical insurance (Medicare) program (aged ≥65 years) residing near airports in 2009.
Main outcome measures Percentage increase in the hospitalization admission rate for cardiovascular disease associated with a 10 dB increase in aircraft noise, for each airport and on average across airports adjusted by individual level characteristics (age, sex, race), zip code level socioeconomic status and demographics, zip code level air pollution (fine particulate matter and ozone), and roadway density.
Results Averaged across all airports and using the 90th centile noise exposure metric, a zip code with 10 dB higher noise exposure had a 3.5% higher (95% confidence interval 0.2% to 7.0%) cardiovascular hospital admission rate, after controlling for covariates.
Conclusions Despite limitations related to potential misclassification of exposure, we found a statistically significant association between exposure to aircraft noise and risk of hospitalization for cardiovascular diseases among older people living near airports.
doi:10.1136/bmj.f5561
PMCID: PMC3805481  PMID: 24103538
23.  Maternal obesity during pregnancy and premature mortality from cardiovascular event in adult offspring: follow-up of 1 323 275 person years 
Objectives To determine whether maternal obesity during pregnancy is associated with increased mortality from cardiovascular events in adult offspring.
Design Record linkage cohort analysis.
Setting Birth records from the Aberdeen Maternity and Neonatal databank linked to the General Register of Deaths, Scotland, and the Scottish Morbidity Record systems.
Population 37 709 people with birth records from 1950 to present day.
Main outcome measures Death and hospital admissions for cardiovascular events up to 1 January 2012 in offspring aged 34-61. Maternal body mass index (BMI) was calculated from height and weight measured at the first antenatal visit. The effect of maternal obesity on outcomes in offspring was tested with time to event analysis with Cox proportional hazard regression to compare outcomes in offspring of mothers in underweight, overweight, or obese categories of BMI compared with offspring of women with normal BMI.
Results All cause mortality was increased in offspring of obese mothers (BMI >30) compared with mothers with normal BMI after adjustment for maternal age at delivery, socioeconomic status, sex of offspring, current age, birth weight, gestation at delivery, and gestation at measurement of BMI (hazard ratio 1.35, 95% confidence interval 1.17 to 1.55). In adjusted models, offspring of obese mothers also had an increased risk of hospital admission for a cardiovascular event (1.29, 1.06 to 1.57) compared with offspring of mothers with normal BMI. The offspring of overweight mothers also had a higher risk of adverse outcomes.
Conclusions Maternal obesity is associated with an increased risk of premature death in adult offspring. As one in five women in the United Kingdom is obese at antenatal booking, strategies to optimise weight before pregnancy are urgently required.
doi:10.1136/bmj.f4539
PMCID: PMC3805484  PMID: 23943697
24.  Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial) 
Objective To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery.
Design Multicentre observer blinded randomised controlled trial.
Participants Patients undergoing laparotomy at 21 UK hospitals.
Interventions Standard care or the use of a wound edge protection device during surgery.
Main outcome measures Surgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient’s self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device.
Results 760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients, seven in each group, were lost to follow-up. A total of 184 patients experienced surgical site infection within 30 days of surgery, 91/369 (24.7%) in the device group and 93/366 (25.4%) in the control group (odds ratio 0.97, 95% confidence interval 0.69 to 1.36; P=0.85). This lack of benefit was consistent across wound assessments performed by clinicians and those reported by patients and across all secondary outcomes. In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device.
Conclusions Wound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy, and therefore their routine use for this role cannot be recommended.
Trial registration Current Controlled Trials ISRCTN 40402832
doi:10.1136/bmj.f4305
PMCID: PMC3805488  PMID: 23903454
25.  “Hardly worth the effort”? Medical journals’ policies and their editors’ and publishers’ views on trial registration and publication bias: quantitative and qualitative study 
Objectives To determine the proportion of medical journals requiring trial registration and to understand their reasons for adopting (or not adopting) such policies and other measures designed to reduce publication bias.
Design Quantitative study of journals’ instructions to authors (in June 2012) and qualitative study of editors’ and publishers’ views on trial registration and publication bias (carried out in Autumn 2012).
Setting Random selection of 200 medical journals publishing clinical trials identified from the Cochrane CENTRAL database.
Participants Editors (n=13) and publishers (n=3) of journals with different policies on trial registration (and with recently changed policies) identified from the survey of their instructions to authors.
Results Only 55/200 journals (28%) required trial registration according to their instructions and a further three (2%) encouraged it. The editors and publishers interviewed explained their journals’ reluctance to require registration in terms of not wanting to lose out to rival journals, not wanting to reject otherwise sound articles or submissions from developing countries, and perceptions that such policies were not relevant to all journals. Some interviewees considered that registration was unnecessary for small or exploratory studies.
Conclusions Although many major medical journals state that they will only publish clinical trials that have been prospectively registered, and such policies have been associated with a dramatic increase in the number of trials being registered, most smaller journals have not adopted such policies. Editors and publishers may be reluctant to require registration because they do not understand its benefits or because they fear that adopting such a policy would put their journal at a disadvantage to competitors.
doi:10.1136/bmj.f5248
PMCID: PMC3805489  PMID: 24014339

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