Intervention Protocol

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Sexual counselling for sexual problems in patients with cardiovascular disease

  1. Molly Byrne1,*,
  2. Sally Doherty2,
  3. Bengt GA Fridlund3,
  4. Jan Mårtensson4,
  5. Elaine E Steinke5,
  6. Tiny Jaarsma6,
  7. Declan Devane7

Editorial Group: Cochrane Heart Group

Published Online: 25 FEB 2014

DOI: 10.1002/14651858.CD010988


How to Cite

Byrne M, Doherty S, Fridlund BGA, Mårtensson J, Steinke EE, Jaarsma T, Devane D. Sexual counselling for sexual problems in patients with cardiovascular disease (Protocol). Cochrane Database of Systematic Reviews 2014, Issue 2. Art. No.: CD010988. DOI: 10.1002/14651858.CD010988.

Author Information

  1. 1

    National University of Ireland, Galway, School of Psychology, Galway, County Galway, Ireland

  2. 2

    RCSI, Department of Population and Health Science, School of Psychology, Dublin, Ireland

  3. 3

    Jönköping University, School of Health Sciences, Jönköping, Sweden

  4. 4

    Jönköping University, Department of Nursing, School of Health Sciences, Jönköping, Sweden

  5. 5

    Wichita State University, School of Nursing, Wichita, Kansas, USA

  6. 6

    University of Linköping, Department of Health and Welfare Studies, Norrköping, Sweden

  7. 7

    National University of Ireland Galway, School of Nursing and Midwifery, Galway, Ireland

*Molly Byrne, School of Psychology, National University of Ireland, Galway, St. Anthony's, Galway, County Galway, Ireland. molly.byrne@nuigalway.ie.

Publication History

  1. Publication Status: New
  2. Published Online: 25 FEB 2014

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Background

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
 

Description of the condition

Sexual problems, such as erectile dysfunction among men and pain during intercourse among women, can frequently occur in relation to cardiac disease and its associated risk factors, medications, and psychological sequelae (Jaarsma 2010; Jaarsma 2010a). Such problems are more prevalent among both men (Schumann 2010) and women (Kutmeca 2011) with cardiovascular disease than those without disease; the prevalence rates for men range from 20% (Schumann 2010) to 70% (Mulat 2010) and for women from 43% (Kriston 2010) to 87% (Schwarz 2008).

Reasons for the association between sexual problems and cardiovascular disease include physical vascular causes (Dong 2011), fear of sexual activity provoking cardiac symptoms or a cardiac event (Katz 2007), patient-partner relationship changes following a cardiac event (Dalteg 2011) and associations with psychological problems such as depression (Kriston 2010). Although there is evidence to suggest that some cardiac medications, including beta blockers and lipid lowering medications, may have sexual side effects, more recent analyses have concluded that cardiovascular medications are uncommonly the true cause of sexual problems (Levine 2012).

Sexual dysfunction has been shown to negatively impact quality of life, psychological well-being and marital or partnership satisfaction (Traeen 2007; Gunzler 2009). Social support and strong intimate relationships are important predictors of outcomes for chronic illness patients and poor marital quality has been shown to predict patient mortality (Coyne 2001). Sexual problems also impact cardiac patients’ partners, who rate sexual concerns as one of the most prevalent stressors related to their partner's condition (O' Farrell 2000).

Return to sexual activity after an acute cardiac event, or maintaining a satisfactory sex life when living with chronic cardiovascular disease, can pose challenges for cardiovascular patients and their partners. It has been recommended that sexual problem assessment and counselling should form part of routine care for cardiovascular patients (Steinke 2013). While those with cardiac disease view information about return to sexual activity as an important component of their general rehabilitation (Steinke 1998; Mosack 2009), health professionals have been reluctant to address sexual counselling in practice (Byrne 2010; Djurovic 2010; Ivarsson 2010; Jaarsma 2010b; Goossens 2011; D'eath 2013), including staff in cardiac rehabilitation (Barnason 2011; Doherty 2011). Reasons for provider reluctance include a lack of confidence and education required to address these concerns adequately (Byrne 2010; Doherty 2011; Hoekstra 2012).

 

Description of the intervention

The aims of sexual counselling (hereafter referred to as counselling) interventions for cardiac patients are to assess existing sexual problems, provide information on concerns and support safe return to sexual activity after a cardiac event or procedure. Counselling interventions address specific psychological or interpersonal factors, sexual performance concerns, and issues related to medication and co-morbid conditions which may affect sexual functioning (Lue 2004). Non-sexual aspects of a relationship may also be addressed in a counselling intervention, such as the need for intimacy in the relationship (Steinke 2004). A range of different types of health professionals or appropriately trained individuals may administer counselling interventions. These interventions may be delivered as separate, stand-alone interventions or as a component of more comprehensive rehabilitation interventions, such as in hospital cardiac rehabilitation following a cardiac event or procedure. Counselling interventions may involve a one-to-one exchange between a health professional and patient (in person or over the telephone) or may be delivered by a health professional to a group of cardiac patients. They may use one or a number of didactic and counselling approaches, including oral information or dialogue, visual information, written materials, audiovisual materials and practical training. Counselling interventions may involve the cardiac patient alone or the cardiac patient with his or her partner or spouse. Interventions can be short-term, for example giving brief information on return to sexual activity (Kushnir 1976; Fridlund 1991), or longer-term, for example providing cognitive behavioural therapy directed towards both psychological and physical aspects of sex and intimate relations (Klein 2007; Song 2011). Interventions may involve a single encounter with a health professional or multiple encounters.

Many issues relating to both the health professional and the patient and their partner influence the delivery and effectiveness of counselling interventions. These can include gender and age differences of the health professional and the recipient, cultural and religious issues, and sexuality of the couple (Klein 2007; O'Donovan 2007; Hoga 2010; Goossens 2011). The nature and extent of the cardiac event itself may vary in complexity (Jaarsma 2010b), with more complex conditions requiring a more focused and specialised sexual counselling intervention (Ivarsson 2009; Ivarsson 2010). Health professionals’ own beliefs about sexuality may influence the delivery of counselling interventions, for example health professionals may adhere to myths and biases regarding the need for counselling based on the age of the patient experiencing the cardiac event and their gender (Kazemi-Saleh 2008; Taylor 2011; Hoekstra 2012; Hoekstra 2012a). Apart from the individual health professional, organisational structures relating to financial resources, availability of staff, time restrictions and availability of private spaces can dictate the delivery and organisation of counselling interventions (Song 2011; Steinke 2012).

 

How the intervention might work

Counselling interventions are likely to work by providing useful information, which may reduce anxiety related to sexual problems and fears about resuming sexual activity after a cardiac event. They may also increase confidence in sexual abilities and potential, improve patient-partner communication around changes to sexual activity required following a cardiac event, provide practical guidance and teach skills to support couples in returning to sex. In such interventions, health professionals may assess any risk associated with sexual activity and develop an individualised plan to guide safe resumption of sexual activity following a cardiac event or procedure (Gamel 1993; Levine 2012). Such information is likely to alleviate fears associated with return to sexual activity and provide patients and partners with greater confidence in their ability to assess if, and when, it is right for them to return to sexual activity. Counselling interventions aim to provide correct information and dispel myths about how cardiac disease impacts on sexual activity. By giving cardiac patients the opportunity to express their sexual concerns, interventions in this area are likely to ‘normalise’ these concerns and reassure patients and their partners that sexual problems are common after a cardiac event and can be addressed. In addition, counselling interventions may support patients in dealing with specific psychological or interpersonal factors and sexual performance concerns (Lue 2004). Non-sexual aspects of a relationship may be addressed in a counselling intervention, such as acknowledging the need for emotional intimacy and being close in a relationship (Steinke 2004). Counselling interventions may also provide practical guidance to patients about how to return to sexual activity (Mosack 2009). Such guidance may include aspects such as ideal timing (when the patient is not tired) and setting (comfortable and familiar), and warning against things that may increase risks associated with sexual activity, for example sex should generally be avoided following a heavy meal (Levine 2012).

The effectiveness of interventions can be evaluated by assessing outcomes that reflect the ways in which the intervention is likely to work. These include changes in sexual activity levels and resumption of sexual activity following a cardiac event or procedure, sexual knowledge, sexual function and satisfaction, and quality of life (Bertie 1992; Klein 2007; Song 2011; Steinke 2012).

 

Why it is important to do this review

Worldwide, cardiovascular disease is a leading cause of morbidity and mortality but with an improving survival rate, resulting in an increasing number of people living in the community with some form of cardiovascular disease (World Health Organisation 2012). Counselling for patients and their partners or spouses has been recommended as an important component of cardiac rehabilitation (Levine 2012; Steinke 2013). There is ample literature to indicate that counselling of cardiac patients is infrequently provided in practice (Steinke 1998; Goossens 2011; Steinke 2011) yet, when asked, cardiac patients (Byrne 2013) and their partners (O' Farrell 2000; Fisher 2005; Agren 2009) generally report that this is something they would appreciate. While health professionals report responsibility for, and some knowledge of, providing counselling (Steinke 2011a), there is a lack of follow through in implementing counselling interventions in daily practice (Pouraboli 2010; Yıldız 2012). There are published trials examining the effectiveness of counselling interventions, yet there is currently no systematic review of these studies. A well-conducted systematic review is needed to inform health professionals, patients and their partners, and policy makers about the effectiveness of such interventions. In addition, an evaluation of interventions may provide insight into which strategies might be most or least effective for cardiac patients, as well as which interventions may be most amenable to use in busy practice settings by health professionals.

 

Objectives

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest

To evaluate the effect of sexual counselling interventions (in comparison to usual care) on sexuality related outcomes in patients with cardiac disease and their partners.

 

Methods

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
 

Criteria for considering studies for this review

 

Types of studies

Randomised controlled trials (RCTs) and quasi-randomised controlled trials (including individual and cluster randomised trials) are eligible for inclusion.  

We will include studies which compare any form of sexual counselling with usual care.

 

Types of participants

Adults (age 18 years plus) with cardiac disease including those who have experienced a myocardial infarction, a revascularisation procedure (coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA)), those with angina or angiographically defined coronary heart disease, heart failure and congenital heart disease. Participants with heart transplants or implanted with either cardiac resynchronisation therapy (CRT) or implantable defibrillators (ICD) will also be included. We will include the partners of these patients.

While the patient or index participant will have cardiac disease, their partner will not necessarily have cardiac disease.

 

Types of interventions

All interventions designed to address and counsel cardiac patients in relation to sexual problems that may arise as a result of their cardiac condition will be considered.

For the purpose of this review we have used the following operational definitions.

A sexual counselling intervention is any intervention delivered by a health professional or appropriately trained individual (for example a sex therapist) with the aim of providing cardiac patients with information on sexual concerns and safe return to sexual activity after a cardiac event or procedure, as well as assessment, support, and specific advice related to psychosexual and sexual problems related directly to their cardiac condition. Sexual counselling interventions may be delivered as a component of hospital cardiac rehabilitation following a cardiac event or procedure. Sexual counselling interventions may involve a one-to-one exchange between a health professional and patient (in person or over the telephone) or may be delivered by a health professional to a group of cardiac patients. Sexual counselling interventions may use one or more didactic approaches, including oral information or dialogue, visual information, written materials, audiovisual materials and practical training. Sexual counselling interventions may involve the cardiac patient alone or the cardiac patient with his or her partner or spouse. Sexual counselling interventions can be short-term (for example brief provision of information and counselling in the acute care setting) or longer-term (for example ongoing counselling in the office setting on repeat patient visits) and may involve a single encounter with a health professional or multiple encounters.

Trials will only be considered where the comparison group is usual care or no sexual counselling intervention, and where follow-up is reported for at least three months post-intervention.

 

Types of outcome measures

Outcome measures will be included from both patients with cardiac disease and their partners, where available.

 

Primary outcomes

 

Patient

1. Sexual function or sexual dysfunction, using validated instruments including:

  • Index of Erectile Function-5 (IIEF-5) (Rosen 1997);
  • Brief Male Sexual Function Inventory (BMSFI) (Mykletun 2006);
  • Female Sexual Function Index (FSFI) (Rosen 2000);
  • Brief Index of Sexual Functioning for Women (BISF-W) (Taylor 1994);
  • Derogatis Interview for Sexual Functioning (DISF) and Derogatis Interview for Sexual Functioning – Self-Report (DISF-SR) (Derogatis 1997);
  • Changes in Sexual Functioning Questionnaire (CSFQ) (Clayton 1997) and Changes in Sexual Functioning-Short Form (CSFQ-SF) (Keller 2006);
  • Arizona Sexual Experience Scale (ASEX) (McGahuey 2000);
  • Sexual Function Questionnaire (SFQ) (Syrjala 2000);
  • Sexual Function Questionnaire (Quirk 2002);
  • European Male Ageing Study Sexual Function Questionnaire (EMAS-SFQ) (O'Connor 2008).

2. Sexual satisfaction, using validated instruments including:

  • Sexual Self-Perception and Adjustment Questionnaire (SSPAQ) (Steinke 2013b);
  • Sexual Satisfaction Scale for Women (SSS-W) (Meston 2005).

 

Partner

1. Sexual satisfaction, using validated instruments including:

 

Secondary outcomes

 

Patient

1. Marital or relationship satisfaction, using validated instruments including:

2. Quality of life or psychological well-being, using validated instruments including:

  • Quality of Life Index (QLI) - Cardiac Version III (Ferrans 1985);
  • 36-item Short Form Health Survey (SF-36) (Ware 1992) or the 12-item Short Form Health Survey (SF-12) (Ware 1995).

3. Satisfaction in how sexual issues are addressed in cardiac rehabilitation services.

4. Resumption of sexual activity after a cardiac event: (a) presence or absence of sexual activity; (b) frequency of sexual activity; (c) time taken to resume sexual activity after cardiac event or procedure, using validated instruments including:

 

Partner

1. Satisfaction in how sexual issues are addressed in cardiac rehabilitation services.

2. Marital or relationship satisfaction, using validated instruments including:

Quality of life or psychological well-being, using validated instruments including:

 

Search methods for identification of studies

 

Electronic searches

We will search for studies from the following electronic databases without restrictions on language or date of publication. We will use the search strategies developed by the Cochrane Heart Group. All databases will be searched from the date of their inception. The following databases will be searched: the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCOhost), and PsycINFO (Ovid). Conference Proceedings will be searched on Web of Science: ISI Proceedings (Thomson Reuters). We will search the following clinical trial registers: Clinicaltrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (http://apps.who.int/trialsearch/).

The preliminary search strategy developed for MEDLINE will be adapted for use in the other databases (Appendix 1). The Cochrane sensitivity maximising RCT filter (Lefebvre 2011) will be applied to MEDLINE and adaptations of it to the other databases as applicable.

 

Searching other resources

We will also search reference lists of eligible papers and reviews. We will contact the principal investigators of identified studies to ascertain if they are aware of any other relevant published or unpublished studies in the area.

 

Data collection and analysis

 

Selection of studies

We will import citations from each database into the reference management software package Endnote, where we will remove duplicates. Two review authors (MB and SD) will independently screen titles and abstracts for potentially eligible studies. Full-text papers will be used to determine the final inclusion in the review. Disagreements between review authors will be resolved through discussion with a third review author (DD) when consensus cannot be reached.

All potentially relevant papers excluded from the review at the full-text stage will be listed as excluded studies, with reasons provided in the ‘Characteristics of excluded studies’ table. We will also provide citation details and any available information about ongoing studies. We will report the screening and selection process in an adapted PRISMA flow chart.

 

Data extraction and management

All eligible papers will be formally abstracted by at least two members of the group working independently (MB and SD) and using a purposefully designed data collection form.

We will extract the following data from each included trial.

  • Study details: author, year, research question or study aim; country where the research was carried out; recruitment source (e.g. patients attending hospital cardiac rehabilitation); inclusion and exclusion criteria; study design (RCT, individual or cluster randomised, and single or multi-centre); length of follow-up; description of usual care.
  • Intervention details: setting of intervention (hospital, general practice); delivered to individuals or groups; targeting patients only or patient and partner dyads; degree of training of the person who provided the intervention; topics covered in the intervention; number of sessions in intervention; overall duration of intervention; timing of delivery of intervention in relation to cardiac history; mode of intervention (e.g. written information, DVD, lecture or talk, individual counselling). Where this information is not provided, we will record this as 'unclear'.
  • Participant characteristics: primary cardiac diagnosis; age; sex; socio-economic status; ethnicity; reported co-morbidities.
  • Primary and secondary outcomes. Numbers of participants randomised and assessed at specified follow-up points. Adherence to intervention and rate of attrition.

Any disagreements will be resolved between authors or, if unsuccessful, by bringing the full texts of the papers in dispute to a meeting of the full review group for a decision by the group. Data will be entered into the Cochrane Collaboration’s statistical software Review Manager 5.2 (RevMan 2012) by one review author (MB) and checked by a second review author (SD).

 

Assessment of risk of bias in included studies

Two review authors (MB and SD) will independently assess the risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) available from www.cochrane-handbook.org. If there are any discrepancies we will resolve them through discussion. We will summarise the results of the risk of bias assessment in both a risk of bias graph and a risk of bias summary.

Seven risk of bias domains have been identified and we outline below how we will assess the risk in relation to each of these domains.  

 

Random sequence generation (checking for possible selection bias)

For each included study, we will describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.

The method will be assessed as follows:

  •  low risk (any truly random process, e.g. random number table; computer random number generator);
  •  high risk (any non-random process, e.g. odd or even date of birth; hospital or clinic record number);
  •  unclear risk (insufficient information to permit judgment).

 

Allocation concealment (checking for possible selection bias)

For each included study, we will describe the method used to conceal the allocation sequence and determine whether intervention allocation could have been foreseen in advance of or during recruitment, or changed after assignment.

The method will be assessed as follows:

  • low risk (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);
  • high risk (open random allocation; unsealed or non-opaque envelopes; alternation; date of birth);
  • unclear risk (insufficient information to permit judgment).

 

Blinding of participants and personnel (checking for possible performance bias)

We will not include whether participants were blind to their allocation to the intervention or control groups in our risk of bias assessment as this is not likely to be possible with sexual counselling interventions.

 

Blinding of outcome assessment (checking for possible detection bias)

For each included study, we will describe the methods used, if any, to blind outcome assessors from knowledge of which intervention a participant received. We will consider studies to be at low risk of bias if they were blinded or if we judged that the lack of blinding could not have affected the results.

The method will be assessed as follows:

  • low risk (no blinding of outcome assessment but the authors judged that the outcome was not likely to be influenced by this); 
  • high risk (no blinding of outcome assessment and the outcome measurement was likely to have been influenced by this);
  • unclear risk (insufficient information to permit judgment; the study did not address this).

 

Incomplete outcome data (checking for possible attrition bias through withdrawals, dropouts, protocol deviations)

For each included study and for each outcome or class of outcomes, we will describe the completeness of data including attrition and exclusions from the analysis. We will state whether attrition and exclusions were reported, the numbers included in the analysis at each stage (compared with the total number of randomised participants), reasons for attrition or exclusion where reported, and whether missing data are balanced across groups or are related to outcomes. 

The method will be assessed as follows:

  • low risk (20% or less of missing data);
  • high risk (more than 20% of missing data);
  • unclear risk (insufficient reporting to permit judgment; the study did not address this).

 

Selective reporting (checking for reporting bias)

We will investigate the possibility of selective outcome reporting bias by identifying the outcomes in the study protocol (if available) and in the methods section of the publication, and by cross-checking to see if these outcomes are reported in the results section of the trial publication(s).

The method will be assessed as follows:

  • low risk (where it was clear that all of the study’s pre-specified outcomes as identified in the study protocol (where available) and in the methods section were reported on; that all expected outcomes of interest to the review were reported on);
  • high risk (where it was clear that not all of the study's pre-specified outcomes as identified in the study protocol (where available) and in the methods section were reported on; failure to include a key outcome that would have been expected to have been included);
  • unclear risk (insufficient information to permit judgment).

 

Other bias (checking for other biases)

For each included study, we will describe any important concerns we had about other possible sources of bias, for example sources of research funding. We will assess whether each study was free of other problems that could put it at risk of bias as follows:

  • low risk (study appeared to be free of bias);
  • high risk (had at least one important risk of bias, for example related to study design);
  • unclear risk (insufficient information to permit judgment).

Results of the systematic review and meta-analyses will be interpreted in light of the findings with respect to risk of bias.

 

Measures of treatment effect

 

Dichotomous data

For dichotomous data, we will present the results as summary risk ratio (RR) with 95% confidence interval (CI).

 

Continuous data

For continuous data, we will use the mean difference with 95% CI for outcomes measured in the same way between trials. We will use the standardised mean difference with 95% CI to combine data that measured the same outcome but used different scales.

We will use Review Manager 5 for all analyses.

 

Unit of analysis issues

 
Cluster randomised trials

If we identify any cluster randomised trials we will include them along with individually randomised trials. We will adjust their sample sizes using the methods described in the Handbook for Systematic Reviews of Interventions (Higgins 2011) using an estimate of the intracluster correlation co-efficient (ICC) derived from the trial (if possible), from a similar trial, or from a study of a similar population. If we use ICCs from other sources we will report this and conduct sensitivity analyses to investigate the effect of variation in the ICC. If we identify cluster randomised trials and individually randomised trials we will synthesise the relevant information. We will consider it reasonable to combine the results from both where there is little heterogeneity between the study designs and where we consider that there is unlikely to be an interaction between the effect of the intervention and the choice of randomisation unit. We will acknowledge heterogeneity in the unit of randomisation and perform a sensitivity analysis to investigate the effects of this heterogeneity on the review findings.

 

Dealing with missing data

We will note the levels of attrition for the included studies.

We will carry out analyses on an intention-to-treat basis for all outcomes, as far as possible, that is we will attempt to include all participants randomised to each group in the analyses, and all participants will be analysed in the group to which they were allocated originally regardless of whether or not they received the allocated intervention. The denominator for each outcome in each trial will be the number randomised minus any participants whose outcomes were known to be missing.

 

Assessment of heterogeneity

Where we pool data using meta analysis, we will assess the degree of heterogeneity by visual inspection of forest plots and by examining the Chi² test for heterogeneity. We will also assess statistical heterogeneity in each meta-analysis using the Tau² (tau-squared), I², and X² (Chi²) statistics. We will regard heterogeneity as substantial if:

(a) the I² value is high (exceeding 30%); and

either

(b) there is inconsistency between trials in direction or magnitude of effects (judged visually), or a low (< 0.10) P value in the Chi² test for heterogeneity;

or

(c) the estimate of between-study heterogeneity (Tau²) is above zero.

 

Assessment of reporting biases

If there are 10 or more studies included in the meta-analysis we will investigate publication bias using funnel plots, by assessing funnel plot asymmetry visually and by using formal tests for funnel plot asymmetry. For continuous outcomes we will use the test proposed by Egger 1997, and for dichotomous outcomes we will use the test proposed by Harbord 2006. If asymmetry is detected in any of these tests, or is suggested by a visual assessment, we will perform exploratory analyses to investigate it.

If there are fewer than 10 included studies, we will assess reporting bias qualitatively based on the characteristics of the included studies.

 

Data synthesis

We will conduct our statistical analysis using the Review Manager software (RevMan 2012). As diversity is likely in the types of and content of interventions included in the trials, we will use a random-effects model meta-analysis to produce an overall summary of the average treatment effect across all included trials. For each outcome reported, we will present the results of the random-effects model analyses as the average treatment effect with its 95% CI and the estimates of Tau² and I².

 

Subgroup analysis and investigation of heterogeneity

If a sufficient number of studies are identified (10 trials should be available for each characteristic modelled), we will perform subgroup analyses for the following.

  1. Delivery mode of intervention: intervention delivered to group versus delivered to individual.
  2. Delivery mode of intervention: 'face to face' versus 'distance delivery'.
  3. Target of intervention: intervention delivered to individuals (cardiovascular patients only) versus delivered to dyads or couples (cardiovascular patients plus their partners).
  4. Gender of intervention participant: male versus female.

We will restrict subgroup analysis to the primary outcomes.

We will assess subgroup differences by the interaction tests available within RevMan (RevMan 2012). We will report the results of subgroup analyses quoting the Chi² statistic and P value, and the I² value of the interaction test.

We will gather and present detailed information on types of intervention in the data extraction table (as outlined in the data extraction section above). This will allow us to generate hypotheses for future subgroup analyses that are possible according to types of interventions, which we will address in future updates.

 

Sensitivity analysis

A sensitivity analysis will be performed by limiting analyses to studies at low risk of bias. This will be done by excluding studies judged at high or unclear risk of bias for ‘sequence generation’, ‘allocation concealment’ and ‘incomplete outcome data’. Criteria for these judgments are given in the ‘Assessment of risk in included studies’ section above.

 

Acknowledgements

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest

None

 

Appendices

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
 

Appendix 1. Preliminary search strategy - MEDLINE (Ovid)

1 Sex Counseling/
2 Sexual Behavior/
3 Sexual Dysfunctions, Psychological/
4 exp Sexual Dysfunction, Physiological/
5 Libido/
6 (sex* adj10 (counsel* or psycholog* or therap*)).tw.
7 (sex* adj10 (help* or advi* or inform* or guid* or skill*)).tw.
8 (sex* adj4 (problem* or concern* or difficult*)).tw.
9 (sex* adj4 (interest* or wish* or activ* or behav* or libido)).tw.
10 ((sex* or erect*) adj2 (function* or dysfunction*)).tw.
11 ((sex* or intima*) adj4 (relation* or spouse* or partner*)).tw.
12 or/1-11
13 exp Cardiovascular Diseases/
14 cardio*.tw.
15 cardia*.tw.
16 heart*.tw.
17 coronary*.tw.
18 angina*.tw.
19 myocard*.tw.
20 isch?em*.tw.
21 arrhythmi*.tw.
22 tachycardi*.tw.
23 fibrillat*.tw.
24 or/13-23
25 12 and 24
26 randomized controlled trial.pt.
27 controlled clinical trial.pt.
28 randomized.ab.
29 placebo.ab.
30 drug therapy.fs.
31 randomly.ab.
32 trial.ab.
33 groups.ab.
34 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33
35 exp animals/ not humans.sh.
36 34 not 35
37 25 and 36

 

Contributions of authors

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest

MB is the primary contact author and guarantor for this protocol and review. MB coordinated the protocol.

MB and SD led the conception, design and drafting of this protocol.

DD contributed methodological expertise to the design and drafting of the protocol.

All authors contributed important intellectual content to the drafting of this protocol and approved the final protocol.

 

Declarations of interest

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest

No known commercial or financial conflicts of interest.

All review authors (except DD) are published researchers in the area of sexual counselling and cardiovascular disease. If during this review a potentially eligible study emerges authored by one of the review authors, this will be disclosed in the review and, where possible, there will be an independent assessment of eligibility and risk of bias by DD and by a second author with no conflict of interest.

References

Additional references

  1. Top of page
  2. Abstract
  3. Background
  4. Objectives
  5. Methods
  6. Acknowledgements
  7. Appendices
  8. Contributions of authors
  9. Declarations of interest
  10. Additional references
Agren 2009
  • Agren S, Frisman GH, Berg S, Svedjeholm R, Stromberg A. Addressing spouses' unique needs after cardiac surgery when recovery is complicated by heart failure. Heart and Lung 2009;38:284-91.
Barnason 2011
  • Barnason S, Steinke E, Mosack V, Wright DW. Comparison of cardiac rehabilitation and acute care nurses perceptions of providing sexual counseling for cardiac patients. Journal of Cardiopulmonary Rehabilitation and Prevention 2011;31:157-63.
Bertie 1992
  • Bertie J, King A, Reed N, Marshall A, Ricketts C. Benefits and weakness of a cardiac rehabilitation programme. Journal of the Royal College of Physicians of London 1992;26:147-51.
Byrne 2010
  • Byrne M, Doherty S, McGee HM, Murphy AW. General practitioner views about discussing sexual issues with patients with coronary heart disease: A national survey in Ireland. BMC Family Practice 2010;11:40.
Byrne 2013
Clayton 1997
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