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Ayer — Abril 19th 2024Tus fuentes RSS

Participant recruitment and attrition in surgical randomised trials with placebo controls versus non-operative controls: a meta-epidemiological study and meta-analysis

Por: Natarajan · P. · Menounos · S. · Harris · L. · Monuja · M. · Gorelik · A. · Karjalainen · T. · Buchbinder · R. · Harris · I. A. · Naylor · J. M. · Adie · S.
Objective

To compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls.

Design

Meta-epidemiological study.

Data sources

Randomised controlled trials were identified from an electronic search of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials from their inception date to 21 November 2018.

Study selection

Placebo control trials evaluating efficacy of any surgical intervention and non-operative control trials of the same surgical intervention were included in this study. 25 730 records were retrieved from our systemic search, identifying 61 placebo control and 38 non-operative control trials for inclusion in analysis.

Outcome measures

Primary outcome measures were recruitment and attrition. These were assessed in terms of recruitment rate (number of participants enrolled, as a proportion of those eligible) and overall attrition rate (composite of dropout, loss to follow-up and cross-overs, expressed as proportion of total sample size). Secondary outcome measures included participant cross-over rate, dropout and loss to follow-up.

Results

Unadjusted pooled recruitment and attrition rates were similar between placebo and non-operative control trials. Study characteristics were not significantly different apart from time to primary timepoint which was shorter in studies with placebo controls (365 vs 274 days, p=0.006). After adjusting for covariates (follow-up duration and number of timepoints), the attrition rate of placebo control trials was almost twice as high compared with non-operative controlled-trials (incident rate ratio (IRR) (95% CI) 1.8 (1.1 to 3.0), p=0.032). The incorporation of one additional follow-up timepoint (regardless of follow-up duration) was associated with reduced attrition in placebo control surgical trials (IRR (95% CI) 0.64 (0.52 to 0.79), p

Conclusions

Placebo control trials of surgery have similar recruitment issues but higher attrition compared with non-operative (non-placebo) control trials. Study design should incorporate strategies such as increased timepoints for given follow-up duration to mitigate losses to follow-up and dropout.

PROSPERO registration number

CRD42019117364.

AnteayerTus fuentes RSS

Association between sleep quality and blood pressure control among hypertensive patients at a rural tertiary hospital in Southern Nigeria: a cross-sectional study

Por: Oseni · T. I. A. · Udonwa · N. E. · Oku · A. O. · Makinde · M. T. · Archibong · F.
Objectives

Restorative sleep is critical in preventing hypertension and other chronic diseases. Limited research has explored the relationship between sleep quality and hypertension in Africa. This study investigated the association between sleep quality and blood pressure control among hypertensive patients in Southern Nigeria.

Design

Cross-sectional study.

Setting

A rural tertiary hospital in Southern Nigeria, April to June 2023.

Participants

250 systematically selected hypertensive adults. Participants completed a validated semistructured interviewer-administered questionnaire to assess their sleep patterns, including sleep duration, self-reported trouble sleeping and a history of clinical diagnosis of sleep disorders. Sleep patterns were categorised as restorative (healthy) or non-restorative (unhealthy). The blood pressure of respondents was checked and categorised as controlled (

Outcome measures

Quality of sleep and blood pressure control.

Results

Respondents had a mean age of 51.5±10.0 years, with the majority being female (156, 62.4%), married (135, 54.0%) and belonging to the Esan tribe (125, 50.0%). The prevalence of restorative sleep was 36%, while the blood pressure control rate was 23.6%. An association was found between restorative sleep and blood pressure control (adjusted OR =4.38; 95% CI=2.37–8.10; p

Conclusion

The study found an association between poor quality sleep and poor blood pressure control. Incorporating sleep assessments and interventions into comprehensive hypertension management strategies could be explored as a possible approach to improve sleep quality and enhance blood pressure control.

Trial registration number

PACTR202301917477205.

A qualitative longitudinal study of traumatic orthopaedic injury survivors experiences with pain and the long-term recovery trajectory

Por: Finstad · J. · Roise · O. · Clausen · T. · Rosseland · L. A. · Havnes · I. A.
Objectives

To explore trauma patients’ experiences of the long-term recovery pathway during 18 months following hospital discharge.

Design

Longitudinal qualitative study.

Setting and participants

Thirteen trauma patients with injuries associated with pain that had been interviewed 6 weeks after discharge from Oslo University Hospital in Norway, were followed up with an interview 18 months postdischarge.

Method

The illness trajectory framework informed the data collection, with semistructured, in-depth interviews that were analysed thematically.

Results

Compared with the subacute phase 6 weeks postdischarge, several participants reported exacerbated mental and physical health, including increased pain during 18 months following discharge. This, andalternating periods of deteriorated health status during recovery, made the pathway unpredictable. At 18 months post-discharge, participants were coping with experiences of reduced mental and physical health and socioeconomic losses. Three main themes were identified: (1) coping with persistent pain and reduced physical function, (2) experiencing mental distress without access to mental healthcare and (3) unmet needs for follow-up care. Moreover, at 18 months postdischarge, prescribed opioids were found to be easily accessible from GPs. In addition to relieving chronic pain, motivations to use opioids were to induce sleep, reduce withdrawal symptoms and relieve mental distress.

Conclusions and implications

The patients’ experiences from this study establish knowledge of several challenges in the trauma population’s recovery trajectories, which may imply that subacute health status is a poor predictor of long-term outcomes. Throughout recovery, the participants struggled with physical and mental health needs without being met by the healthcare system. Therefore, it is necessary to provide long-term follow-up of trauma patients’ health status in the specialist health service based on individual needs. Additionally, to prevent long-term opioid use beyond the subacute phase, there is a need to systematically follow-up and reassess motivations and indications for continued use throughout the recovery pathway.

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