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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.  Global, regional, and national consumption levels of dietary fats and oils in 1990 and 2010: a systematic analysis including 266 country-specific nutrition surveys 
Objectives To quantify global consumption of key dietary fats and oils by country, age, and sex in 1990 and 2010.
Design Data were identified, obtained, and assessed among adults in 16 age- and sex-specific groups from dietary surveys worldwide on saturated, omega 6, seafood omega 3, plant omega 3, and trans fats, and dietary cholesterol. We included 266 surveys in adults (83% nationally representative) comprising 1 630 069 unique individuals, representing 113 of 187 countries and 82% of the global population. A multilevel hierarchical Bayesian model accounted for differences in national and regional levels of missing data, measurement incomparability, study representativeness, and sampling and modelling uncertainty.
Setting and population Global adult population, by age, sex, country, and time.
Results In 2010, global saturated fat consumption was 9.4%E (95%UI=9.2 to 9.5); country-specific intakes varied dramatically from 2.3 to 27.5%E; in 75 of 187 countries representing 61.8% of the world’s adult population, the mean intake was <10%E. Country-specific omega 6 consumption ranged from 1.2 to 12.5%E (global mean=5.9%E); corresponding range was 0.2 to 6.5%E (1.4%E) for trans fat; 97 to 440 mg/day (228 mg/day) for dietary cholesterol; 5 to 3,886 mg/day (163 mg/day) for seafood omega 3; and <100 to 5,542 mg/day (1,371 mg/day) for plant omega 3. Countries representing 52.4% of the global population had national mean intakes for omega 6 fat ≥5%E; corresponding proportions meeting optimal intakes were 0.6% for trans fat (≤0.5%E); 87.6% for dietary cholesterol (<300 mg/day); 18.9% for seafood omega 3 fat (≥250 mg/day); and 43.9% for plant omega 3 fat (≥1,100 mg/day). Trans fat intakes were generally higher at younger ages; and dietary cholesterol and seafood omega 3 fats generally higher at older ages. Intakes were similar by sex. Between 1990 and 2010, global saturated fat, dietary cholesterol, and trans fat intakes remained stable, while omega 6, seafood omega 3, and plant omega 3 fat intakes each increased.
Conclusions These novel global data on dietary fats and oils identify dramatic diversity across nations and inform policies and priorities for improving global health.
doi:10.1136/bmj.g2272
PMCID: PMC3987052  PMID: 24736206
18.  Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments 
Objective To describe the potential benefits and harms of oseltamivir by reviewing all clinical study reports (or similar document when no clinical study report exists) of randomised placebo controlled trials and regulatory comments (“regulatory information”).
Design Systematic review of regulatory information.
Data sources Clinical study reports, trial registries, electronic databases, regulatory archives, and correspondence with manufacturers.
Eligibility criteria for selecting studies Randomised placebo controlled trials on adults and children who had confirmed or suspected exposure to natural influenza.
Main outcome measures Time to first alleviation of symptoms, influenza outcomes, complications, admissions to hospital, and adverse events in the intention to treat population.
Results From the European Medicines Agency and Roche, we obtained clinical study reports for 83 trials. We included 23 trials in stage 1 (reliability and completeness screen) and 20 in stage 2 (formal analysis). In treatment trials on adults, oseltamivir reduced the time to first alleviation of symptoms by 16.8 hours (95% confidence interval 8.4 to 25.1 hours, P<0.001). There was no effect in children with asthma, but there was an effect in otherwise healthy children (mean difference 29 hours, 95% confidence interval 12 to 47 hours, P=0.001). In treatment trials there was no difference in admissions to hospital in adults (risk difference 0.15%, 95% confidence interval −0.91% to 0.78%, P=0.84) and sparse data in children and for prophylaxis. In adult treatment trials, oseltamivir reduced investigator mediated unverified pneumonia (risk difference 1.00%, 0.22% to 1.49%; number needed to treat to benefit (NNTB) 100, 95% confidence interval 67 to 451). The effect was not statistically significant in the five trials that used a more detailed diagnostic form for “pneumonia,” and no clinical study reports reported laboratory or diagnostic confirmation of “pneumonia.” The effect on unverified pneumonia in children and for prophylaxis was not significant. There was no significant reduction in risk of unverified bronchitis, otitis media, sinusitis, or any complication classified as serious or that led to study withdrawal. 14 of 20 trials prompted participants to self report all secondary illnesses to an investigator. Oseltamivir in the treatment of adults increased the risk of nausea (risk difference 3.66%, 0.90% to 7.39%; number needed to treat to harm (NNTH) 28, 95% confidence interval 14 to 112) and vomiting (4.56%, 2.39% to 7.58%; 22, 14 to 42). In treatment of children, oseltamivir induced vomiting (5.34%, 1.75% to 10.29%; 19, 10 to 57). In prophylaxis trials, oseltamivir reduced symptomatic influenza in participants by 55% (3.05%, 1.83% to 3.88%; NNTB 33, 26 to 55) and households (13.6%, 9.52% to 15.47%; NNTB 7, 6 to 11) based on one study, but there was no significant effect on asymptomatic influenza and no evidence of a reduction in transmission. In prophylaxis studies, oseltamivir increased the risk of psychiatric adverse events during the combined “on-treatment” and “off-treatment” periods (risk difference 1.06%, 0.07% to 2.76%; NNTH 94, 36 to 1538) and there was a dose-response effect on psychiatric events in two “pivotal” treatment trials of oseltamivir, at 75 mg (standard dose) and 150 mg (high dose) twice daily (P=0.038). In prophylaxis studies, oseltamivir increased the risk of headaches on-treatment (risk difference 3.15%, 0.88% to 5.78%; NNTH 32, 18 to 115), renal events with treatment (0.67%, −0.01% to 2.93%), and nausea while receiving treatment (4.15%, 0.86% to 9.51%; NNTH 25, 11 to 116).
Conclusions In prophylactic studies oseltamivir reduces the proportion of symptomatic influenza. In treatment studies it also modestly reduces the time to first alleviation of symptoms, but it causes nausea and vomiting and increases the risk of headaches and renal and psychiatric syndromes. The evidence of clinically significant effects on complications and viral transmission is limited because of rarity of such events and problems with study design. The trade-off between benefits and harms should be borne in mind when making decisions to use oseltamivir for treatment, prophylaxis, or stockpiling.
doi:10.1136/bmj.g2545
PMCID: PMC3981975  PMID: 24811411
19.  Zanamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments 
Objectives To describe the potential benefits and harms of zanamivir.
Design Systematic review of clinical study reports of randomised placebo controlled trials and regulatory information
Data sources Clinical study reports, trial registries, electronic databases, regulatory archives, and correspondence with manufacturers.
Eligibility criteria for selecting studies Randomised placebo controlled trials in adults and children who had confirmed or suspected exposure to natural influenza.
Main outcome measures Time to first alleviation of symptoms, influenza outcomes and complications, admissions to hospital, and adverse events in the intention to treat (ITT) population.
Results We included 28 trials in stage 1 (judgment of appropriate study design) and 26 in stage 2 (formal analysis). For treatment of adults, zanamivir reduced the time to first alleviation of symptoms of influenza-like illness by 0.60 days (95% confidence interval 0.39 to 0.81, P<0.001, I2=9%), which equates to an average 14.4 hours’ reduction, or a 10% reduction in mean duration of symptoms from 6.6 days to 6.0 days. Time to first alleviation of symptoms was shorter in all participants when any relief drugs were allowed compared with no use. Zanamivir did not reduce the risk of self reported investigator mediated pneumonia (risk difference 0.17%, −0.73% to 0.70%) or radiologically confirmed pneumonia (−0.06%, −6.56% to 2.11%) in adults. The effect on pneumonia in children was also not significant (0.56%, −1.64% to 1.04%). There was no significant effect on otitis media or sinusitis in both adults and children, with only a small effect noted for bronchitis in adults (1.80%, 0.65% to 2.80%), but not in children. There were no data to assess effects on admissions in adults and children. Zanamivir tended to be well tolerated. In zanamivir prophylaxis studies, symptomatic influenza in individuals was significantly reduced (1.98%, (0.98% to 2.54%); reducing event rates from 3.26% to 1.27%, which means 51 people need to be treated to prevent one influenza case (95% confidence interval, 40 to 103). In contrast, the prophylaxis effect on asymptomatic influenza cases was not significant in individuals (risk difference 0.14%, −1.10% to 1.10%) or in households (1.32%, −2.20% to 3.84%). In households treated prophylactically there was an effect on symptomatic influenza (14.84%, 12.18% to 16.55%), but this was based on only two small studies including 824 participants. Prophylaxis in adults reduced unverified pneumonia (0.32%, 0.09% to 0.41%; NNTB (number needed to treat to benefit) 311, 244 to 1086) but had no effect on pneumonia in children or on bronchitis or sinusitis in adults or children (risk difference 0.32%, 0.09% to 0.41%; NNTB 311, 244 to 1086).
Conclusions Based on a full assessment of all trials conducted, zanamivir reduces the time to symptomatic improvement in adults (but not in children) with influenza-like illness by just over half a day, although this effect might be attenuated by symptom relief medication. Zanamivir also reduces the proportion of patients with laboratory confirmed symptomatic influenza. We found no evidence that zanamivir reduces the risk of complications of influenza, particularly pneumonia, or the risk of hospital admission or death. Its harmful effects were minor (except for bronchospasm), perhaps because of low bioavailability.
doi:10.1136/bmj.g2547
PMCID: PMC3981976  PMID: 24811412
20.  Effect of screening sigmoidoscopy and screening colonoscopy on colorectal cancer incidence and mortality: systematic review and meta-analysis of randomised controlled trials and observational studies 
Objectives To review, summarise, and compare the evidence for effectiveness of screening sigmoidoscopy and screening colonoscopy in the prevention of colorectal cancer occurrence and deaths.
Design Systematic review and meta-analysis of randomised controlled trials and observational studies.
Data sources PubMed, Embase, and Web of Science. Two investigators independently extracted characteristics and results of identified studies and performed standardised quality ratings.
Eligibility criteria Randomised controlled trials and observational studies in English on the impact of screening sigmoidoscopy and screening colonoscopy on colorectal cancer incidence and mortality in the general population at average risk.
Results For screening sigmoidoscopy, four randomised controlled trials and 10 observational studies were identified that consistently found a major reduction in distal but not proximal colorectal cancer incidence and mortality. Summary estimates of reduction in distal colorectal cancer incidence and mortality were 31% (95% confidence intervals 26% to 37%) and 46% (33% to 57%) in intention to screen analysis, 42% (29% to 53%) and 61% (27% to 79%) in per protocol analysis of randomised controlled trials, and 64% (50% to 74%) and 66% (38% to 81%) in observational studies. For screening colonoscopy, evidence was restricted to six observational studies, the results of which suggest tentatively an even stronger reduction in distal colorectal cancer incidence and mortality, along with a significant reduction in mortality from cancer of the proximal colon. Indirect comparisons of results of observational studies on screening sigmoidoscopy and colonoscopy suggest a 40% to 60% lower risk of incident colorectal cancer and death from colorectal cancer after screening colonoscopy even though this incremental risk reduction was statistically significant for deaths from cancer of the proximal colon only.
Conclusions Compelling and consistent evidence from randomised controlled trials and observational studies suggests that screening sigmoidoscopy and screening colonoscopy prevent most deaths from distal colorectal cancer. Observational studies suggest that colonoscopy compared with flexible sigmoidoscopy decreases mortality from cancer of the proximal colon. This added value should be examined in further research and weighed against the higher costs, discomfort, complication rates, capacities needed, and possible differences in compliance.
doi:10.1136/bmj.g2467
PMCID: PMC3980789  PMID: 24922745
21.  Influence of blood prostate specific antigen levels at age 60 on benefits and harms of prostate cancer screening: population based cohort study 
Objective To determine the relative risks of prostate cancer incidence, metastasis, and mortality associated with screening by serum prostate specific antigen (PSA) levels at age 60.
Design Population based cohort study.
Setting General male population of Sweden taking part in a screening trial in Gothenburg or participating in a cardiovascular study, the Malmö Preventive Project.
Participants The screened group consisted of 1756 men aged 57.5-62.5 participating in the screening arm of the Gothenburg randomized prostate cancer screening trial since 1995. The unscreened group consisted of 1162 men, born in 1921, participating in the Malmö Preventive Project, with PSA levels measured retrospectively in stored blood samples from 1981.
Intervention PSA screening versus no screening.
Main outcome measures Incidence rate ratios for the effect of screening on prostate cancer diagnosis, metastasis, and death by PSA levels at age 60.
Results The distribution of PSA levels was similar between the two cohorts. Differences in benefits by baseline PSA levels were large. Among men with baseline levels measured, 71.7% (1646/2295) had a PSA level <2 ng/mL. For men aged 60 with PSA level <2 ng/mL, there was an increase in incidence of 767 cases per 10 000 without a decrease in prostate cancer mortality. For men with PSA levels ≥2 ng/mL, the reduction in cancer mortality was large, with only 23 men needing to be screened and six diagnosed to avoid one prostate cancer death by 15 years.
Conclusions The ratio of benefits to harms of PSA screening varies noticeably with blood PSA levels at age 60. For men with a PSA level <1 ng/mL at age 60, no further screening is recommended. Continuing to screen men with PSA levels >2 ng/mL at age 60 is beneficial, with the number needed to screen and treat being extremely favourable. Screening men with a PSA level of 1-2 ng/mL is an individual decision to be based on a discussion between patient and doctor.
doi:10.1136/bmj.g2296
PMCID: PMC3968958  PMID: 24682399
22.  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
23.  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
24.  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
25.  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

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