Prevalence of hypertension and its associated factors among professional drivers: a population-based study.

OBJECTIVE: Hypertension is one of the most important causes of cardiovascular disease. It has been found that professional drivers are at high risk of hypertension. This study has been performed to determine the prevalence of hypertension and its associated factors among professional drivers in Shahroud. METHODS AND RESULTS: In this study, the prevalence of hypertension was determined according to the definition by the American Heart Association among 1461 professional drivers participating in the first cross-sectional phase of Shahroud drivers' prospective cohort study. The prevalence of elevated blood pressure and hypertension was examined based on the initial age, and gender presented, along with the factors affecting this disease based on multinomial logistic regression. The prevalence of elevated blood pressure, stage 1 and 2 hypertension was 46.9%, 6%, and 1.3%, respectively. In the multivariate multinomial logistic regression model, having diabetes, Body Mass Index ≥25, and driving years was associated with an increased chance of developing elevated blood pressure and hypertension. CONCLUSIONS: Attention should be paid to high prevalence of elevated blood pressure and hypertension among professional drivers in Iran as a health priority for drivers. Plans should be made to reduce it as well as to prevent its complications.

Use of Pneumococcal Conjugate Vaccines to Prevent Acute Otitis Media in Children.

Editor's note: The mission of Cochrane Nursing is to provide an international evidence base for nurses involved in delivering, leading, or researching nursing care. Cochrane Corner provides summaries of recent systematic reviews from the Cochrane Library. For more information, see https://nursing.cochrane.org.

Organisation of health services for preventing and treating pressure ulcers.

BACKGROUND: Pressure ulcers, which are a localised injury to the skin, or underlying tissue, or both, occur when people are unable to reposition themselves to relieve pressure on bony prominences. Pressure ulcers are often difficult to heal, painful, expensive to manage and have a negative impact on quality of life. While individual patient safety and quality care stem largely from direct healthcare practitioner-patient interactions, each practitioner-patient wound-care contact may be constrained or enhanced by healthcare organisation of services. Research is needed to demonstrate clearly the effect of different provider-orientated approaches to pressure ulcer prevention and treatment. OBJECTIVES: To assess the effects of different provider-orientated interventions targeted at the organisation of health services, on the prevention and treatment of pressure ulcers. SEARCH METHODS: In April 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched three clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA: Randomised controlled trials (RCTs), cluster-RCTs, non-RCTs, controlled before-and-after studies and interrupted time series, which enrolled people at risk of, or people with existing pressure ulcers, were eligible for inclusion in the review. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment, data extraction and GRADE assessment of the certainty of evidence. MAIN RESULTS: The search yielded a total of 3172 citations and, following screening and application of the inclusion and exclusion criteria, we deemed four studies eligible for inclusion. These studies reported the primary outcome of pressure ulcer incidence or pressure ulcer healing, or both.One controlled before-and-after study explored the impact of transmural care (a care model that provided activities to support patients and their family/partners and activities to promote continuity of care), among 62 participants with spinal cord injury. It is unclear whether transmural care leads to a difference in pressure ulcer incidence compared with usual care (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.53 to 1.64; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision).One RCT explored the impact of hospital-in-the-home care, among 100 older adults. It is unclear whether hospital-in-the-home care leads to a difference in pressure ulcer incidence risk compared with hospital admission (RR 0.32, 95% CI 0.03 to 2.98; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision).A third study (cluster-randomised stepped-wedge trial), explored the impact of being cared for by enhanced multidisciplinary teams (EMDT), among 161 long-term-care residents. The analyses of the primary outcome used measurements of 201 pressure ulcers from 119 residents. It is unclear if EMDT reduces the pressure ulcer incidence rate compared with usual care (hazard ratio (HR) 1.12, 95% CI 0.74 to 1.68; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision). It is unclear whether there is a difference in the number of wounds healed (RR 1.69, 95% CI 1.00 to 2.87; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision). It is unclear whether there is a difference in the reduction in surface area, with and without EMDT, (healing rate 1.006; 95% CI 0.99 to 1.03; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision). It is unclear if EMDT leads to a difference in time to complete healing (HR 1.48, 95% CI 0.79 to 2.78, very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision).The final study (quasi-experimental cluster trial), explored the impact of multidisciplinary wound care among 176 nursing home residents. It is unclear whether there is a difference in the number of pressure ulcers healed between multidisciplinary care, or usual care (RR 1.18, 95% CI 0.98 to 1.42; very low-certainty evidence, downgraded twice for very serious study limitations and twice for very serious imprecision). It is unclear if this type of care leads to a difference in time to complete healing compared with usual care (HR 1.73, 95% CI 1.20 to 2.50; very low-certainty evidence; downgraded twice for very serious study limitations and twice for very serious imprecision).In all studies the certainty of the evidence is very low due to high risk of bias and imprecision. We downgraded the evidence due to study limitations, which included selection and attrition bias, and sample size. Secondary outcomes, such as adverse events were not reported in all studies. Where they were reported it was unclear if there was a difference as the certainty of evidence was very low. AUTHORS' CONCLUSIONS: Evidence for the impact of organisation of health services for preventing and treating pressure ulcers remains unclear. Overall, GRADE assessments of the evidence resulted in judgements of very low-certainty evidence. The studies were at high risk of bias, and outcome measures were imprecise due to wide confidence intervals and small sample sizes, meaning that additional research is required to confirm these results. The secondary outcomes reported varied across the studies and some were not reported. We judged the evidence from those that were reported (including adverse events), to be of very low certainty.

Do MOOCs encourage corporate social responsibility or are they simply a marketing opportunity?

This paper explores institutional drivers for developing MOOCs by juxtaposing them against the original drivers for generating MOOCs: to offer open access education. However, the original impetus for MOOC development may be shifting towards a business oriented model. Therefore, instead of contributing to corporate social responsibility and inclusivity agendas facilitating open access to education, MOOCs are akin to an institution's shop window allowing the pseudo 'purchaser' the opportunity to glimpse behind the scenes. Hence, we ask: are MOOCs merely a sophisticated form of window dressing, showing pseudo 'purchasers' what institutions want them to see enticing them to purchase more lucrative products? Notwithstanding the motivation for developing MOOCs participants must first access them. Therefore the paper examines what MOOCs actually offer participants who are likely to access them and concludes by examining how MOOCs can be developed to facilitate better completion rates and encourage wider participation from hard to access groups.

Do systematic reviews address community healthcare professionals' wound care uncertainties? Results from evidence mapping in wound care.

BACKGROUND: Complex wounds such as leg and foot ulcers are common, resource intensive and have negative impacts on patients' wellbeing. Evidence-based decision-making, substantiated by high quality evidence such as from systematic reviews, is widely advocated for improving patient care and healthcare efficiency. Consequently, we set out to classify and map the extent to which up-to-date systematic reviews containing robust evidence exist for wound care uncertainties prioritised by community-based healthcare professionals. METHODS: We asked healthcare professionals to prioritise uncertainties based on complex wound care decisions, and then classified 28 uncertainties according to the type and level of decision. For each uncertainty, we searched for relevant systematic reviews. Two independent reviewers screened abstracts and full texts of reviews against the following criteria: meeting an a priori definition of a systematic review, sufficiently addressing the uncertainty, published during or after 2012, and identifying high quality research evidence. RESULTS: The most common uncertainty type was 'interventions' 24/28 (85%); the majority concerned wound level decisions 15/28 (53%) however, service delivery level decisions (10/28) were given highest priority. Overall, we found 162 potentially relevant reviews of which 57 (35%) were not systematic reviews. Of 106 systematic reviews, only 28 were relevant to an uncertainty and 18 of these were published within the preceding five years; none identified high quality research evidence. CONCLUSIONS: Despite the growing volume of published primary research, healthcare professionals delivering wound care have important clinical uncertainties which are not addressed by up-to-date systematic reviews containing high certainty evidence. These are high priority topics requiring new research and systematic reviews which are regularly updated. To reduce clinical and research waste, we recommend systematic reviewers and researchers make greater efforts to ensure that research addresses important clinical uncertainties and is of sufficient rigour to inform practice.

Rapid research and implementation priority setting for wound care uncertainties.

INTRODUCTION: People with complex wounds are more likely to be elderly, living with multimorbidity and wound related symptoms. A variety of products are available for managing complex wounds and a range of healthcare professionals are involved in wound care, yet there is a lack of good evidence to guide practice and services. These factors create uncertainty for those who deliver and those who manage wound care. Formal priority setting for research and implementation topics is needed to more accurately target the gaps in treatment and services. We solicited practitioner and manager uncertainties in wound care and held a priority setting workshop to facilitate a collaborative approach to prioritising wound care-related uncertainties. METHODS: We recruited healthcare professionals who regularly cared for patients with complex wounds, were wound care specialists or managed wound care services. Participants submitted up to five wound care uncertainties in consultation with their colleagues, via an on-line survey and attended a priority setting workshop. Submitted uncertainties were collated, sorted and categorised according professional group. On the day of the workshop, participants were divided into four groups depending on their profession. Uncertainties submitted by their professional group were viewed, discussed and amended, prior to the first of three individual voting rounds. Participants cast up to ten votes for the uncertainties they judged as being high priority. Continuing in the professional groups, the top 10 uncertainties from each group were displayed, and the process was repeated. Groups were then brought together for a plenary session in which the final priorities were individually scored on a scale of 0-10 by participants. Priorities were ranked and results presented. Nominal group technique was used for generating the final uncertainties, voting and discussions. RESULTS: Thirty-three participants attended the workshop comprising; 10 specialist nurses, 10 district nurses, seven podiatrists and six managers. Participants had been qualified for a mean of 20.7 years with a mean of 16.8 years of wound care experience. One hundred and thirty-nine uncertainties were submitted electronically and a further 20 were identified on the day of the workshop following lively, interactive group discussions. Twenty-five uncertainties from the total of 159 generated made it to the final prioritised list. These included six of the 20 new uncertainties. The uncertainties varied in focus, but could be broadly categorised into three themes: service delivery and organisation, patient centred care and treatment options. Specialist nurses were more likely to vote for service delivery and organisation topics, podiatrists for patient centred topics, district nurses for treatment options and operational leads for a broad range. CONCLUSIONS: This collaborative priority setting project is the first to engage front-line clinicians in prioritising research and implementation topics in wound care. We have shown that it is feasible to conduct topic prioritisation in a short time frame. This project has demonstrated that with careful planning and rigor, important questions that are raised in the course of clinicians' daily decision making can be translated into meaningful research and implementation initiatives that could make a difference to service delivery and patient care.

Antiseptics for burns.

BACKGROUND: Burn wounds cause high levels of morbidity and mortality worldwide. People with burns are particularly vulnerable to infections; over 75% of all burn deaths (after initial resuscitation) result from infection. Antiseptics are topical agents that act to prevent growth of micro-organisms. A wide range are used with the intention of preventing infection and promoting healing of burn wounds. OBJECTIVES: To assess the effects and safety of antiseptics for the treatment of burns in any care setting. SEARCH METHODS: In September 2016 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL. We also searched three clinical trials registries and references of included studies and relevant systematic reviews. There were no restrictions based on language, date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that enrolled people with any burn wound and assessed the use of a topical treatment with antiseptic properties. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment and data extraction. MAIN RESULTS: We included 56 RCTs with 5807 randomised participants. Almost all trials had poorly reported methodology, meaning that it is unclear whether they were at high risk of bias. In many cases the primary review outcomes, wound healing and infection, were not reported, or were reported incompletely.Most trials enrolled people with recent burns, described as second-degree and less than 40% of total body surface area; most participants were adults. Antiseptic agents assessed were: silver-based, honey, Aloe Vera, iodine-based, chlorhexidine or polyhexanide (biguanides), sodium hypochlorite, merbromin, ethacridine lactate, cerium nitrate and Arnebia euchroma. Most studies compared antiseptic with a topical antibiotic, primarily silver sulfadiazine (SSD); others compared antiseptic with a non-antibacterial treatment or another antiseptic. Most evidence was assessed as low or very low certainty, often because of imprecision resulting from few participants, low event rates, or both, often in single studies. Antiseptics versus topical antibioticsCompared with the topical antibiotic, SSD, there is low certainty evidence that, on average, there is no clear difference in the hazard of healing (chance of healing over time), between silver-based antiseptics and SSD (HR 1.25, 95% CI 0.94 to 1.67; I2 = 0%; 3 studies; 259 participants); silver-based antiseptics may, on average, increase the number of healing events over 21 or 28 days' follow-up (RR 1.17 95% CI 1.00 to 1.37; I2 = 45%; 5 studies; 408 participants) and may, on average, reduce mean time to healing (difference in means -3.33 days; 95% CI -4.96 to -1.70; I2 = 87%; 10 studies; 979 participants).There is moderate certainty evidence that, on average, burns treated with honey are probably more likely to heal over time compared with topical antibiotics (HR 2.45, 95% CI 1.71 to 3.52; I2 = 66%; 5 studies; 140 participants).There is low certainty evidence from single trials that sodium hypochlorite may, on average, slightly reduce mean time to healing compared with SSD (difference in means -2.10 days, 95% CI -3.87 to -0.33, 10 participants (20 burns)) as may merbromin compared with zinc sulfadiazine (difference in means -3.48 days, 95% CI -6.85 to -0.11, 50 relevant participants). Other comparisons with low or very low certainty evidence did not find clear differences between groups.Most comparisons did not report data on infection. Based on the available data we cannot be certain if antiseptic treatments increase or reduce the risk of infection compared with topical antibiotics (very low certainty evidence). Antiseptics versus alternative antisepticsThere may be some reduction in mean time to healing for wounds treated with povidone iodine compared with chlorhexidine (MD -2.21 days, 95% CI 0.34 to 4.08). Other evidence showed no clear differences and is of low or very low certainty. Antiseptics versus non-antibacterial comparatorsWe found high certainty evidence that treating burns with honey, on average, reduced mean times to healing in comparison with non-antibacterial treatments (difference in means -5.3 days, 95% CI -6.30 to -4.34; I2 = 71%; 4 studies; 1156 participants) but this comparison included some unconventional treatments such as amniotic membrane and potato peel. There is moderate certainty evidence that honey probably also increases the likelihood of wounds healing over time compared to unconventional anti-bacterial treatments (HR 2.86, 95% C 1.60 to 5.11; I2 = 50%; 2 studies; 154 participants).There is moderate certainty evidence that, on average, burns treated with nanocrystalline silver dressings probably have a slightly shorter mean time to healing than those treated with Vaseline gauze (difference in means -3.49 days, 95% CI -4.46 to -2.52; I2 = 0%; 2 studies, 204 participants), but low certainty evidence that there may be little or no difference in numbers of healing events at 14 days between burns treated with silver xenograft or paraffin gauze (RR 1.13, 95% CI 0.59 to 2.16 1 study; 32 participants). Other comparisons represented low or very low certainty evidence.It is uncertain whether infection rates in burns treated with either silver-based antiseptics or honey differ compared with non-antimicrobial treatments (very low certainty evidence). There is probably no difference in infection rates between an iodine-based treatment compared with moist exposed burn ointment (moderate certainty evidence). It is also uncertain whether infection rates differ for SSD plus cerium nitrate, compared with SSD alone (low certainty evidence).Mortality was low where reported. Most comparisons provided low certainty evidence that there may be little or no difference between many treatments. There may be fewer deaths in groups treated with cerium nitrate plus SSD compared with SSD alone (RR 0.22, 95% CI 0.05 to 0.99; I2 = 0%, 2 studies, 214 participants) (low certainty evidence). AUTHORS' CONCLUSIONS: It was often uncertain whether antiseptics were associated with any difference in healing, infections, or other outcomes. Where there is moderate or high certainty evidence, decision makers need to consider the applicability of the evidence from the comparison to their patients. Reporting was poor, to the extent that we are not confident that most trials are free from risk of bias.

Antibiotics and antiseptics for pressure ulcers.

BACKGROUND: Pressure ulcers, also known as bedsores, decubitus ulcers and pressure injuries, are localised areas of injury to the skin or the underlying tissue, or both. A range of treatments with antimicrobial properties, including impregnated dressings, are widely used in the treatment of pressure ulcers. A clear and current overview is required to facilitate decision making regarding use of antiseptic or antibiotic therapies in the treatment of pressure ulcers. This review is one of a suite of Cochrane reviews investigating the use of antiseptics and antibiotics in different types of wounds. It also forms part of a suite of reviews investigating the use of different types of dressings and topical treatments in the treatment of pressure ulcers. OBJECTIVES: To assess the effects of systemic and topical antibiotics, and topical antiseptics on the healing of infected and uninfected pressure ulcers being treated in any clinical setting. SEARCH METHODS: In October 2015 we searched: the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations), Ovid EMBASE, and EBSCO CINAHL Plus. We also searched three clinical trials registries and the references of included studies and relevant systematic reviews. There were no restrictions based on language or date of publication or study setting. SELECTION CRITERIA: Randomised controlled trials which enrolled adults with pressure ulcers of stage II or above were included in the review. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment and data extraction. MAIN RESULTS: We included 12 trials (576 participants); 11 had two arms and one had three arms. All assessed topical agents, none looked at systemic antibiotics. The included trials assessed the following antimicrobial agents: povidone iodine, cadexomer iodine, gentian violet, lysozyme, silver dressings, honey, pine resin, polyhexanide, silver sulfadiazine, and nitrofurazone with ethoxy-diaminoacridine. Comparators included a range of other dressings and ointments without antimicrobial properties and alternative antimicrobials. Each comparison had only one trial, participant numbers were low and follow-up times short. The evidence varied from moderate to very low quality.Six trials reported the primary outcome of wound healing. All except one compared an antiseptic with a non-antimicrobial comparator. There was some moderate and low quality evidence that fewer ulcers may heal in the short term when treated with povidone iodine compared with non-antimicrobial alternatives (protease-modulating dressings (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.62 to 0.98) and hydrogel (RR 0.64, 95% CI 0.43 to 0.97)); and no clear difference between povidone iodine and a third non-antimicrobial treatment (hydrocolloid) (low quality evidence). Pine resin salve may heal more pressure ulcers than hydrocolloid (RR 2.83, 95% CI 1.14 to 7.05) (low quality evidence). There is no clear difference between cadexomer iodine and standard care, and between honey a combined antiseptic and antibiotic treatment (very low quality evidence).Six trials reported adverse events (primary safety outcome). Four reported no adverse events; there was very low quality evidence from one showing no clear evidence of a difference between cadexomer iodine and standard care; in one trial it was not clear whether data were appropriately reported.There was limited reporting of secondary outcomes. The five trials that reported change in wound size as a continuous outcome did not report any clear evidence favouring any particular antiseptic/anti-microbial treatments. For bacterial resistance, one trial found some evidence of more MRSA eradication in participants with ulcer treated with a polyhexanide dressing compared with a polyhexanide swab (RR 1.48, 95% CI 1.02 to 2.13); patients in the dressing group also reported less pain (MD -2.03, 95% CI -2.66 to -1.40). There was no clear evidence of a difference between interventions in infection resolution in three other comparisons. Evidence for secondary outcomes varied from moderate to very low quality; where no GRADE assessment was possible we identified substantial limitations which an assessment would have taken into account. AUTHORS' CONCLUSIONS: The relative effects of systemic and topical antimicrobial treatments on pressure ulcers are not clear. Where differences in wound healing were found, these sometimes favoured the comparator treatment without antimicrobial properties. The trials are small, clinically heterogenous, generally of short duration, and at high or unclear risk of bias. The quality of the evidence ranges from moderate to very low; evidence on all comparisons was subject to some limitations.

Vibrating vaginal balls to improve pelvic floor muscle performance in women after childbirth: a protocol for a randomised controlled feasibility trial.

AIM: This paper presents a feasibility trial protocol the purpose of which is to prepare for a future randomised controlled trial to determine the effectiveness of vibrating vaginal pelvic floor training balls for postpartum pelvic floor muscle rehabilitation. BACKGROUND: Vibrating vaginal pelvic floor training balls are available in Austria to enhance women's pelvic floor muscles and thus prevent or treat urinary incontinence and other pelvic floor problems following childbirth. Nonetheless, there is currently little empirical knowledge to substantiate their use or assess their relative effectiveness in comparison to current standard care, which involves pelvic floor muscle exercises. DESIGN: Single blind, randomised controlled feasibility trial with two parallel groups. METHODS: It is planned to recruit 56 postpartum women in Vienna, who will be randomised into one of two intervention groups to use either vibrating vaginal balls or a comparator pelvic floor muscle exercises for 12 weeks. As this is a feasibility study, study design features (recruitment, selection, randomisation, intervention concordance, data collection methods and tools) will be assessed and participants' views and experiences will be surveyed. Tested outcome measures, collected before and after the intervention, will be pelvic floor muscle performance as reported by participants and measured by perineometry. Descriptive and inferential statistics and content analysis will serve the preparation of the future trial. DISCUSSION: The results of this feasibility trial will inform the design and conduct of a full randomised controlled trial and provide insight into the experiences of women regarding the interventions and study participation.

Bangladeshi women's experiences of infant feeding in the London Borough of Tower Hamlets.

This study examined the main factors that influence Bangladeshi women living in London's decisions to partially breastfeed their children, including the influence of older women within the community. Fifty-seven women of Bangladeshi origin living in the London Borough of Tower Hamlets took part in seven discussion groups between April and June 2013. Five groups were held with women of child-bearing age and two groups with older women in the community. A further eight younger women and three older women took part in one-on-one interviews. Interviews were also carried out with eight local health care workers, including public health specialists, peer support workers, breastfeeding coordinators and a health visitor. The influences on women's infant feeding choices can be understood through a 'socio-ecological model', including public health policy; diverse cultural influences from Bangladesh, London and the Bangladeshi community in London; and the impacts of migration and religious and family beliefs. The women's commitment to breastfeeding was mediated through the complexity of their everyday lives. The tension between what was 'best' and what was 'possible' leads them not only to partially breastfeed but also to sustain partial breastfeeding in a way not seen in other socio-cultural groups in the United Kingdom.

Vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women post partum: A quantitative systematic review.

OBJECTIVES: the vaginal use of cones or balls aims to increase muscle performance and thereby prevent or treat urinary incontinence. To date, no systematic review has focused on the effectiveness of these devices specifically during the postpartum period. The objectives of this review were: to compare the effectiveness of vaginal cones or balls for improvement of pelvic floor muscle performance and urinary continence in the postpartum period to no treatment, placebo, sham treatment or active controls; to gather information on effect on perineal descent or pelvic organ prolapse, adverse effects and economical aspects. DESIGN: quantitative systematic review. DATA SOURCES: 14 scientific databases (including PubMed and CINAHL) and the world-wide web; experts were contacted for published and unpublished data. REVIEW METHODS: studies had to be randomised/quasi-randomised trials and have female participants up to one year after childbirth. The intervention is compared to no treatment, placebo, sham treatment or active controls. Outcome measures relate to pelvic floor muscle performance or urinary incontinence. Studies were selected, 'risk of bias' assessed, and data extracted by two reviewers independently with inter-reviewer agreement. MAIN FINDINGS: one study met the inclusion criteria; its original data were re-analysed. In an intention-to-treat analysis, compared with the control group, the cone group showed a statistically significant lower rate of urinary incontinence; compared with the exercise group, the prevalence was similar. However, the validity of the analysis is limited. CONCLUSIONS AND IMPLICATIONS: the evidence gained from this systematic review is very limited. The use of cones may be helpful for urinary incontinence after childbirth, but further research is needed.

Vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women postpartum: a quantitative systematic review and meta-analysis protocol.

AIM: To identify, critically appraise and synthesize the best current evidence on the use of vaginal cones or balls to improve pelvic floor muscle performance and urinary continence in women post partum. BACKGROUND: The vaginal use of cones or balls is a pelvic floor muscle training method that aims to enhance muscle performance and thereby prevent or treat urinary incontinence. Nonetheless to date, no systematic review has focused on the effectiveness of these devices specifically during the postpartum period. DESIGN: Quantitative systematic review with potential meta-analysis. METHODS: The review will be undertaken by searching 14 scientific databases (including PubMed and CINAHL, without date restriction) and the world-wide web; experts will also be contacted for published and unpublished data. Included studies must be randomized or quasi-randomized trials and have female participants until 1 year after childbirth. The intervention will be compared with no treatment, placebo, sham treatment or active controls. Outcome measures will relate to pelvic floor muscle performance or urinary incontinence. Studies will be selected, 'risk of bias' assessed and data extracted by two reviewers independently. Following inter-reviewer agreement of included studies, data will be checked after entry into systematic review processing software. If appropriate, data will be synthesized by meta-analysis; if this is not possible, a narrative review only will be undertaken. DISCUSSION: The information gained from this systematic review will help midwives, nurses, other health professionals and women after childbirth decide how to promote female pelvic floor health and in defining further areas of study.